Turnbull government to spend $1 billion on hepatitis C 'miracle cures' for all

Sydney, Australia - The Turnbull government will spend more than $1 billion to make breakthrough hepatitis C cures available to all as part of an ambitious new plan to eradicate the deadly disease within a generation. Health Minister Sussan Ley will announce the major new Pharmaceutical Benefits Scheme listing on Sunday, in a move that will give Australia's 230,000 hepatitis C sufferers affordable access to the drugs. Health Minister Sussan Ley has announced $1 billion in funding to make "miracle" hepatitis C drugs available to all. The drugs can currently cost patients up to $100,000. Under the subsidy, they will be available for the normal PBS co-payment of $37.70 for general patients and $6.10 for concessional patients. In what is being billed as the biggest PBS announcement since the government started funding the HPV vaccine Gardasil, the drugs – Sofosbuvir with ledipasvir (Harvoni), Sofosbuvir (Sovaldi), Daclatasvir (Daklinza), and Ribavirin (Ibavyr) – will be subsidised from March next year. The move will make Australia one of the first countries in the world to publicly subsidise the drugs for their entire population, no matter what a patient's condition is or how they contracted the disease. Crucially, the government will work with state and territory governments to make the treatments available to inmates in prison, where hepatitis C rates are typically very high. Ms Ley described the listing – which followed a positive recommendation from the Pharmaceutical Benefits Advisory Committee – as a "watershed moment" in Australian history. One in 100 Australians from all walks of life currently suffer from the disease and there are 10,000 new cases every year, she said. "However, with this announcement there is great hope we can not only halt the spread of this deadly infectious virus but eradicate it altogether in time," she said. The game changing new drugs have a success rate of more than 90 per cent across the entire hepatitis C population. The drugs are faster, less-invasive and inflict fewer side effects than anything currently available. In a majority of cases the medicines can be taken orally, with treatment duration as short as eight weeks. "Hepatitis C takes a heavy toll on patients and their families, but also the health system and the economy," Ms Ley said. "It's therefore important we tackle this disease head on, and that includes providing these medicines to all Australians, particularly vulnerable populations where rates of infection are high." Hepatitis Australia chief executive Helen Tyrrell said the government's decision was "simply fantastic". "Christmas will be a particularly joyous time for many people now," she said. "The uncertainty is over and they now have the prospect of a truly happy and healthy 2016." "This will be lifesaving for some people, and it will bring quality of life back to many more people." The funding was fully accounted for in last week's mid-year budget update but was not announced at the time because confidential pricing negotiations with medicine suppliers were still being finalised, Ms Ley said. The hepatitis C announcement comes on top of $620 million in new and amended medicine listings that were announced in the update. Hepatitis C is an infectious blood-borne virus that attacks the liver. It can lead to cirrhosis, end-stage liver disease and liver cancer. It has six different genotypes and kills an estimated 700 people a year, and debilitates thousands more. Deaths from primary liver cancer, for which untreated hepatitis C is a major driver, are rising faster than for any other type of cancer.

For more information: http://tinyurl.com/hts262h

Hep C World News - Week of December 20, 2015

Nations Awaiting Price Break in HCV Drug

San Francisco, CA - When it comes to hepatitis C, drug-makers may hold the health of the world in their hands. Physicians converging on San Francisco's Moscone Conference Center Saturday to attend the 2015 Liver Meeting (AASLD) had to make their way past demonstrators protesting the high prices of hepatitis C antivirals. But many attendees already had that issue in mind, panelists who spoke at conference session held Monday agreed. Entitled “Global Challenges and Advances in Hepatitis C Treatment” the session soon evolved into a shared gripe session over the unaffordable costs many nations face in getting direct-acting antivirals (DAAs) to people who need them. Among the points made were that the cost is often harder on middle-income nations that are less likely to benefit from price breaks negotiated with pharma companies or subsidies from outside organizations. Some nations have been successful in getting major discounts from drug companies. Generics are already emerging, but quality is unregulated, leading the World Health Organization to step in to come up with standards and tests. Puerto Rico has a particular problem, with a high prevalence of HCV infection, but with its Medicaid program unwilling or unable to cover the cost of DAAs. Some countries, notably Egypt, have ambitious programs underway to get the drugs to their residents. The US is far ahead of just about all the nations and global regions in getting DAAs to those who need them. The need for the drugs is most severe in the Asia-Pacific region, said Osamu Yokosuka, MD, of Chiba, Japan. There are between 49 million and 64 million people with hepatitis C living in that region, though good statistics are difficult to come by. HCV hotspots include Egypt, where about 14.7% of the populace is infected, or 13 million people, and Mongolia, where over 15% of the population or 500,000 people have the virus. Access to DAAs varies, with interferon remaining the standard of care in most places. DAAs are available in Australia, India, Taiwan and Turkey. “Unfortunately they are very expensive,” said Ayman Yosry, MD. Turkey launched a government program to get DAAs to those who need them and though 1.138 million people registered to take part, only 40% showed up for treatment. So far 134,000 patients have started treatment and 86% have shown a sustained viral response. “We get a lot of dropouts,” he said. Still the nation is aiming to get treatment to all by 2030. That would mean a 77% drop in liver cancer mortality. “The challenge is getting the drugs at an affordable price and convincing government to pay,” Yosry said. He also advocated for “punitive legislation for disease transmission to be made mandatory,” but did not elaborate. The picture in the Dominican Republic is bright, said Fernando Contreras, MD, addressing the issue of access to DAAs in Latin America. But “robust data” on infection rates is sorely lacking. Much work needs to be done in healthcare-acquired infections as well, he said, which are blamed for much of the spread of the virus. He said the Dominican Republic successfully negotiated for major discounts with pharma companies. That is not true for all of Latin America, he said. He urged others to “sit down with pharma” and work to get better prices. Political activism is also essential. “Make this a problem for politicians," he said.

For more information: http://hepatitis-c.curetoday.com/news/nations-awaiting-price-break-in-hcv-drugs

Hep C World News - Week of December 13, 2015

Ribavirin Not Necessary to Prevent HCV Recurrence
Nashville, TN - Patients with hepatitis C virus (HCV) infection aren’t out of danger from the virus even after a successful liver transplant. As a result of a compromised immune system due to taking anti-rejection drugs, treatment is tricky. Reporting at the Liver Meeting in San Francisco, CA, Molly Hassett, MD of Vanderbilt University Nashville, TN, and colleagues reported on drug regimens for these patients. They looked at whether patients with HCV could safely eliminate ribavirin (RBV) from their drug regimens. They found they could. Patients who had recurrent HCV infection after a transplant got 12 weeks of therapy with either simeprevir/sofosbuvir or ledipasvir/sofosbuvir without ribavirin. “Given the unique characteristics of this immuno-suppressed population the current clinical guidelines continue to recommend treating patient with recurrent HCV GT-1 infection with regimens that contain ribavirin when treating for 12 weeks or extending therapy to 24 weeks in those intolerant to RBV,” the researchers noted. But RBV can cause anemia and worsen renal function in the setting of nephrotoxic immuno-suppression. The team looked at 66 liver transplant patients who had recurrent HCV infection and were treated both with and without RBV. None of the patients treated without RBV had to interrupt or discontinue therapy due to adverse events, according to researchers. The researchers said they observed excellent responses when treating liver transplant patient with recurrent HCV GT1 using combinations of SIM/SOF of LDV/SOF without ribavirin for 12 weeks. Further corroboration of these data may result in the elimination of the need for RBV in post-transplant patients.
 

For more information: http://tinyurl.com/hhg36bv

Hep C World News - Week of December 6, 2015

Vancouver to tackle HepC
Vancouver, BC – Reported recently in the Vancouver Sun, AIDS expert Dr. Julio Montaner and B.C.’s Ministry of Health are said to be planning to take on another infectious disease with potentially deadly consequences: hepatitis C. Speaking at a news conference on Vancouver’s Downtown Eastside — where an estimated 80 per cent of area drug users have hep C — Health Minister Terry Lake said publicly funded treatment is now restricted to people who already have considerable liver damage, but that could change. “What Dr. Montaner is looking at is a targeted hep C program for core transmitters: people who are living a lifestyle that puts them at risk for re-transmitting,” said Lake. “That work will require help from the provincial government and we’re having discussions about that at the moment.” Hepatitis C is a blood-borne infection and almost all new cases among B.C.’s estimated 80,000 carriers are among drug users who spread it by sharing needles or pipes. But a large untreated pool of hep C is found among baby boomers who contracted it decades ago, often through unhygienic medical and dental practises. Many are undiagnosed. “As we expand treatment and as the cost of those drugs come down, we will reach further upstream and treat more people, and treat them earlier,” Lake explained. “We’re looking forward to getting rid of hepatitis C as we’re doing for HIV,” Montaner said. David Ramsay, a counsellor with the Vancouver Native Health Society, says many clients have been cured of hepatitis C in the past year through the latest medications. People who regularly drink alcohol aren’t candidates for treatment, however, because of the strain it adds to their already damaged livers. “It’s an expensive treatment so they really screen for those most at risk for cirrhosis of the liver,” said Ramsay. Untreated hepatitis C can not only lead to cirrhosis, but also liver cancer, although about one-quarter of carriers clear the infection without treatment or serious damage. B.C.’s Pharmacare program began covering a new range of medications earlier this year and has provided them to 1,774 patients up to November, according to the ministry. Taken as a daily pill, they are effective in more than 90 per cent of patients after a course of 12 or 24 weeks, a vast improvement on previous intravenous treatments. The government will not reveal how much it pays for the medications.

For more information: http://tinyurl.com/h6qjflt

Hep C World News - Week of November 29, 2015

Pricey Hepatitis C Drugs Denied to Almost Half of Medicaid Patients
Philadelphia, PA - Nearly half of Medicaid patients with chronic hepatitis C have been denied cutting-edge medications that would most likely cure their condition, due to tight controls that states have placed on coverage of the pricey drugs, a new study shows. About 46 percent of Medicaid patients in four northeastern states were denied treatment with new direct-acting antiviral (DAA) drugs, which have been shown to cure more than nine out of 10 hepatitis C patients, the researchers reported. These powerful medications include Sovaldi (sofosbuvir) and Harvoni (ledipasvir). By comparison, only 10 percent of privately insured patients and 5 percent of Medicare patients were denied treatment, said study author Dr. Vincent Lo Re III, an assistant professor of medicine and epidemiology in the division of infectious diseases at the Perelman School of Medicine at the University of Pennsylvania, in Philadelphia. State Medicaid programs have placed stringent pre-approval requirements on the drugs, due to their high cost, Lo Re explained. A 12-week round of treatment for just one patient can cost as much as $90,000. "These restrictions are set up to ration the medications, because of concerns that the high cost of these drugs is going to overwhelm the health care budget," he said. Lo Re presented the findings at the recent annual meeting of the American Association for the Study of Liver Diseases. Research presented at meetings is typically considered preliminary until published in a peer-reviewed journal. However, such tight coverage policies might prove pennywise but pound-foolish. Early treatment of hepatitis C with the new drugs can save billions in health care costs, according to another study, published online Nov. 23 in the journal JAMA Internal Medicine. Those researchers concluded that $3.3 billion in lifetime health care expenses could be saved if all hepatitis C patients received treatment with the cutting-edge drugs, regardless of how sick they are. "We found it is highly cost effective to treat everyone right away, rather than waiting for them to progress to more advanced liver disease," said senior study author Dr. James Kahn, a professor in the department of epidemiology and biostatistics at the University of California, San Francisco. Hepatitis C can do terrible damage to the liver if left untreated, including scarring of the liver and liver cancer, according to the U.S. National Institutes of Health. Serious cases often require a liver transplant.

For more information: https://www.nlm.nih.gov/medlineplus/news/fullstory_155882.html

Hep C World News - Week of November 22, 2015

Drug regimen eliminates hepatitis C virus in most patients in 3 months
Toronto, ON - A clinical trial has found that a simple drug regimen delivered over 12 weeks achieved sustained eradication of several strains of hepatitis C in 99 per cent of patients treated with the medications, researchers reported Monday. Their study, published in the New England Journal of Medicine, showed that receiving a once-daily combination of sofosbuvir-velpatasvir for a 12-week period was effective in both previously treated and never-treated patients with hepatitis C genotypes 1, 2, 4, 5 or 6. "This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment," said lead researcher Dr. Jordan Feld, a liver specialist at Toronto Western Hospital. Current approved treatments for chronic HCV are not equally effective in combating the virus' different forms. Testing to determine the particular genetic makeup — or genotype — of the virus has been required before treatment could be started. But Feld said the combination of sofosbuvir-velpatasvir has been shown to work on all strains of hepatitis C virus, effectively eliminating the need for this testing, which often delayed treatment. The drug combination was investigated in a randomized, placebo-controlled trial at 81 sites in eight different countries. After 12 weeks, 99 per cent of the 624 patients given sofosbuvir-velpatasvir were virus-free three months after completing treatment. None of the 116 patients receiving a placebo had the same result. "This is truly a one-size-fits-all treatment that is very easy to administer and extremely well-tolerated," said Feld. "Our challenge now is getting treatment to those who need it. Over half of people living with hepatitis C remain undiagnosed." Chronic HCV is known as a silent killer because symptoms often don't appear until the liver is severely damaged. Left undiagnosed, the infection can lead to cirrhosis, which can progress to liver failure or liver cancer. The virus is primarily spread through blood and is associated with IV drug use, contact with poorly sterilized medical equipment, and blood transfusions before 1992. "Knowing which treatment to use for which patient required expertise, which made it much more difficult for non-specialists to treat hepatitis C," Feld said by email. "There are simply not enough specialists to treat all of the 250,000 to 400,000 infected Canadians." With the single tablet that is effective for all strains of the virus, it's hoped that family doctors, internists and nurses will step in to treat hepatitis C, particularly in rural and under-served areas, he said. "We are now on a path where elimination of hepatitis C from Canada actually starts to become a realistic goal."

For more information: http://tinyurl.com/zfbdvdx

Hep C World News - Week of November 15, 2015

FDA expands approval of Gilead's hepatitis C therapy Harvoni
Washington, DC - The FDA expanded approval of Harvoni (ledipasvir/sofosbuvir) to include use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. Harvoni plus ribavirin for 12 weeks was cleared as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.  Harvoni first gained FDA approval in October 2014 to treat adults with chronic HCV genotype 1 infection. "Harvoni...continues to demonstrate high cure rates and a tolerable side-effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure," noted Norbert Bischofberger, chief scientific officer at Gilead. According to the company, the filing supporting approval for HCV genotypes 4 to 6 included data from a study evaluating Harvoni for 12 weeks in patients with genotype 4 or 5 who were treatment-naïve and treatment-experienced with or without cirrhosis. Results showed that 93 percent of those with genotype 4 and 93 percent of those with genotype 5 achieved a sustained viral response after 12 weeks (SVR12). Meanwhile, a second trial evaluated Harvoni for 12 weeks in treatment-naïve or previously-treated patients with genotype 6 HCV infection with or without cirrhosis, with data showing that 96 percent of patients achieved SVR12. Gilead added that clearance in patients co-infected with HIV-1 was supported by data from a Phase III study, evaluating Harvoni for 12 weeks for the treatment of genotypes 1 or 4 chronic HCV. Results demonstrated that 96 percent of patients achieved SVR12. The company indicated that approval of Harvoni plus ribavirin for 12 weeks for genotype 1 treatment-experienced HCV patients with cirrhosis was supported by data from a mid-stage trial. Results showed that 96 percent of patients treated with Harvoni plus ribavirin for 12 weeks, and 97 percent of patients treated with Harvoni for 24 weeks without ribavirin, achieved SVR12. Gilead noted that the European Medicines Agency recently approved updates to the Harvoni label to allow for the use of shorter durations of therapy in combination with ribavirin. The drugmaker said these include the use of Harvoni plus ribavirin for 12 weeks in genotypes 1 and 4 HCV-infected patients with compensated cirrhosis, decompensated cirrhosis and post-liver transplant patients. The new label also includes data further supporting use of Harvoni for 12 weeks in patients with genotypes 1 or 4 who are co-infected with HIV and in patients who had previously failed treatment with Gilead's Sovaldi (sofosbuvir) plus ribavirin with or without pegylated interferon.
Sales of Harvoni reached $3.3 billion in the third quarter.

For more information: http://www.firstwordpharma.com/node/1331796#axzz3rNh9ey8j

Hep C World News - Week of November 8, 2015

Risk of Serious Liver Injury associated with Holkira Pak and Technivie
Ottawa, ON - In response to new international safety information, Health Canada is advising Canadians that it is working with the manufacturer of Holkira Pak and Technivie to update drug labels (product monographs) to include new information regarding serious liver injury. Holkira Pak and Technivie are both used to treat chronic Hepatitis C viral infection that can lead to serious liver and health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing the virus from multiplying, which may slow down the disease. International safety data has indicated that cases of serious liver injury (such as hepatic failure, including cases that resulted in liver transplantation or death) have been reported in patients treated with Holkira Pak or Technivie. Most patients with these serious outcomes had evidence of advanced liver disease (cirrhosis) prior to initiating therapy. While Health Canada is working to update the product monographs, healthcare providers are reminded that Holkira Pak and Technivie should not be used in patients with severe hepatic impairment (Child-Pugh Class C) or moderate hepatic impairment (Child-Pugh Class B). Patients should not stop taking these medications without first talking to their healthcare provider as stopping these medications early may result in drug resistance to other hepatitis C medicines. Health Canada recommends that you immediately consult your healthcare provider if you experience fatigue, weakness, lack of appetite, nausea and vomiting, as well as yellowing of your skin or eyes, darkening of your urine or discolored feces while on treatment with Holkira Pak or Technivie.

For more information: http://tinyurl.com/nrcwhqg

Hep C World News - Week of November 1, 2015

Study suggests 3-week hepatitis C cure possible
Hong Kong, China - A small study suggests it may be possible to cure some people of their infections in as few as 3 weeks. Fresh on the heels of recent approvals of four new combinations of HCV drugs that clear infections of many different types of the virus in about 3 months, a team led by hepatologist George Lau of the Humanity & Healthy GI and Liver Centre in Hong Kong, China, has mixed and matched various compounds to see whether they could further shorten the route to a cure. Following 3 weeks of treatment, 18 HCV infected people given three different combinations of drugs met the standard definition of being cured—at 12 weeks after treatment began, they had no signs of HCV’s genetic material, RNA, in their blood on standard tests. The researchers plan to present this data publicly for the first time at a scientific conference known as The Liver Meeting. Until the new HCV drugs emerged, infected people required treatment for 8 months, and the therapies often failed and had severe side effects. Now, standard treatment protocol calls for taking HCV drugs for just 12 weeks. Cutting that treatment time even more dramatically is “really, really intriguing” says Shyam Kottilil, an HCV researcher at the Institute of Human Virology in Baltimore, Maryland. And if the results hold, it could slash the overall treatment cost of $100,000 required by the most popular drugs used for the 12-week treatment. Kottilil’s own study of a 4-week treatment—which tested different drug combinations on a different patient population—had only a 40% cure rate in the 50 participants. (That study is in press at Annals of Internal Medicine.) Other researchers point out several caveats to the 3-week success, most notably that the 18 people treated had several characteristics of patients who respond well to HCV drugs. “It’s very interesting, but not unexpected,” says David Nelson, a hepatitis researcher at the University of Florida in Gainesville. Raymond Schinazi, a biochemist from Emory University in Atlanta who collaborated with Lau, acknowledges that this is only a pilot study and needs confirmation in a larger clinical trial. “But when you get 100%, it’s always statistically significant,” says Schinazi, who helped develop one of the new blockbuster HCV drugs, sofosbuvir, that was part of the combinations tried in the new study. The rapid clearance of HCV from the body seen in the study upends mechanistic models about how treatment cures people of HCV. “Our models did not predict this at all,” says another collaborator, Alan Perelson, a biophysicist at the Los Alamos National Laboratory in New Mexico, who has done key work on how treatment leads to clearance of both HCV and HIV.

For more information: http://news.sciencemag.org/health/2015/10/study-suggests-unprecedented-3-week-hepatitis-c-cure

Hep C World News - Week of October 25, 2015

Technivie Now Approved for Use
Ottawa, ON - Technivie with ribavirin is now an approved hepatitis C treatment in Canada. Health Canada has granted the treatment Technivie with ribavirin a Notice of Compliance (NOC) for treating adult patients with chronic hep C genotype 4 without cirrhosis and who have never tried treatment or who have previously been treated with pegylated interferon and ribavirin. Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance a doctor may prescribe it – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

For more information: http://www.pacifichepc.org/hepctip

Hep C World News - Week of October 18, 2015

Stem Cell Therapy Could Replace Liver Transplantation
Edinburgh, Scotland - STEM cell therapy could one day replace liver transplantation as the primary treatment for liver failure, according to a study which saw researchers successfully restore organ function to a severely damaged liver in a live animal for the first time. The researchers transplanted laboratory-grown hepatic progenitor cells (HPCs) into mice with severely damaged livers and, over time, observed that the cells were able to initiate the regeneration of major areas of the organ, improving its structure and function. Under normal circumstances, the liver is very good at healing itself due to the ability of hepatocytes to self-renew following injury. However, this process becomes less effective following severe injury, such as that caused by conditions such as cirrhosis and acute liver failure. In addition, hepatocytes are difficult to grow under laboratory conditions, which limits their potential for transplantation. This led the research team to their current line of investigation because HPCs are much easier to grow in vitro and they have the flexibility to transform into hepatocytes and other types of liver cell. If the success observed in the team’s murine model can be replicated using human HPCs, they believe that this could result in cell transplants as a treatment for liver failure instead of organ transplant. Senior author Prof Stuart Forbes, MRC Centre for Regenerative Medicine, University of Edinburgh, Edinburgh, UK, explained: “It will be some time before we can turn this into reality as we will first need to test our approach using human cells. This is much needed as liver disease is a very common cause of death and disability for patients in the UK and the rest of the world.” Moving away from dependency on transplantation should help patients with severe liver damage avoid the agonising wait for a donor, as well as many of the complications associated with the procedure, such as incompatibility and infection. In the longer term, the researchers hope to achieve the same results by using drugs that stimulate stem cells inside the patient to regenerate the damaged liver.

For more information: http://emjreviews.com/press/liver-failure-stem-cell-therapy-could-replace-liver-transplantation/

Hep C World News - Week of October 11, 2015

NICE Recommends Daklinza (daclatasvir) for Hep C Genotypes 1, 3 and 4
Princeton, NJ - Bristol-Myers Squibb announced that the National Institute for Health and Care Excellence (NICE) has recommended Daklinza (daclatasvir) in England and Wales for the treatment of adult patients with chronic hepatitis C virus (HCV) infection. Specifically, NICE recommended Daklinza, an oral, once-daily medication used in combination with other agents, to treat certain patients with HCV genotypes 1, 3 and 4. Approximately 214,000 people in the UK are thought to have chronic HCV, and roughly 100,000 of those patients are estimated to have genotype 3, a difficult-to-treat and often aggressive form of chronic HCV. “It is a challenge to treat patients with hepatitis C virus infection, including the significant number of patients with genotype 3, whose condition tends to progress rapidly,” said Anna Maria Geretti, Professor of Virology and Infectious Diseases, University of Liverpool. “In the past there have been limited treatment options available and therefore this decision is an important milestone. Daclatasvir in combination with other agents represents a much needed oral treatment regimen that has been shown to cure the infection in the majority of patients, and we have already seen positive results in the real-life setting in patients with advanced disease.” HCV genotype 3 is associated with accelerated progression of fibrosis compared to other genotypes, which can make treatment time critical. Recent research has also shown that the risk of cirrhosis for patients infected with HCV genotype 3 is 31% greater than for those with HCV genotype 1. “The burden of genotype 3 hepatitis C in the United Kingdom is one of the highest anywhere in Europe,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “England has now joined Italy, France, The Netherlands, Sweden, Belgium, Switzerland, Denmark, Scotland and Ireland in recognizing the value of Daklinza for the treatment of genotype 3 HCV, and we are excited to make it available to help address what is still a significant unmet need among the UK HCV population.” In the EU, Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. In genotype 3 HCV, Daklinza is currently approved in combination with sofosbuvir for 12 weeks in patients without cirrhosis and for 24 weeks in patients with cirrhosis with the optional use of ribavirin based on clinical assessment of the patient. Until recently, treatment options for genotype 3 patients in England were limited, and included interferon. Daklinza plus sofosbuvir, with or without ribavirin, is currently one of only two all-oral treatment regimens recommended by the European Association for the Study of the Liver’s (EASL) treatment guidelines for patients with HCV genotype 3.

For further information: https://www.nice.org.uk/.

Hep C World News - Week of October 4, 2015

Holkira Pak added to Corrections Service Canada formulary
Ottawa, ON - Corrections Service Canada (CSC) and Non-Insured Health Benefits for First Nations and Inuit (NIHB) have added Holkira Pak to their respective formularies for people with genotype 1 virus. The CSC runs the federal prison system. The NIHB is a program that provides health benefits for First Nations and Inuit. Holkira Pak is a combination of three direct-acting antivirals (DAAs). DAAs attack the ability of the Hep C virus to make copies of itself. Holkira Pak consists of: paritaprevir, a protease inhibitor, which is boosted with ritonavir; ombitasvir, an NS5A inhibitor; and dasabuvir, an NS5B inhibitor. Paritaprevir/ritonavir and ombitasvir are co-formulated into one tablet. Dasabuvir is its own tablet. Holkira Pak may also be taken with ribavirin. In clinical trials of Holkira Pak, the cure rates ranged from 90% to 100%.

For more information: http://www.catie.ca/en/news/hepcinfo-updates/2015-09-30#article1
 
Hep C World News - Week of September 27, 2015

AbbVie to present 34 hep C abstracts at AASLD meeting
North Chicago, Ill - AbbVie a global research-based biopharmaceutical company, today announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17, further demonstrating AbbVie's strong leadership and ongoing commitment to patients with chronic hepatitis C virus (HCV) infection. Presentations will highlight new data from Phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis. Additionally, new clinical studies will be presented on AbbVie's HCV pipeline medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks. "We are pleased to present new data from studies of the VIEKIRA PAK regimen in HCV patients, including those with chronic kidney disease and GT1b compensated cirrhosis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These data, as well as our findings from our investigational compounds, further demonstrate AbbVie's firm commitment to supporting the care of patients with chronic HCV infection." VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated). VIEKIRA is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA.

For more information: http://tinyurl.com/nzuwn47

Hep C World News - Week of September 20, 2015

Opioid misuse continues spread of disease & drug-related deaths
Lisbon, Portugal - The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) produces an annual report of the latest data available on drug demand and drug supply in all 28 EU Member States plus Norway and Turkey, available at http://www.emcdda.europa.eu/edr2015. The scientific journal Addiction has today published the EMCDDA's summary of the most important findings from that report. The most recent analysis of treatment data highlights the burden that opioid drugs continue to place on the drug treatment system, although both new entrants to heroin treatment and injecting have declined in importance. In 2013, opioids -- mainly heroin -- were reported as a 'primary drug' by only 20% of those entering treatment for the first time, and the number of new heroin treatment clients has more than halved since 2007. The illicit use of opioids remains responsible for a disproportionately large share of the morbidity and mortality resulting from drug use in Europe. Drug use, principally through injecting, continues to play an important role in the transmission of blood-borne infections in Europe, mainly HIV and hepatitis C virus. In 2013, the average rate of newly reported HIV diagnoses attributed to injecting drug use was 2.5 per million population, with the three Baltic States showing rates 8 to 22 times higher than the EU average. National estimates of drug-induced mortality rates vary considerably, from 2.2 per million population in Romania to 70 per million in Norway and Sweden, and 127 per million in Estonia. Drug overdose continues to be the main cause of death among problem drug users, and over three-quarters of overdose victims are male (78 %). Between 2006 and 2013, a pattern has emerged of decreasing numbers of overdose deaths among younger drug users and increasing numbers among older users. This reflects the ageing nature of Europe's opioid-using population, who are at greatest risk of drug overdose death. New psychoactive substances (NPS): More 100 new substances were reported to the European Early Warning System (EWS) in 2014, bringing the number of substances being monitored by the EWS to over 450.

For more information: http://tinyurl.com/ouwgjhv
 
Hep C World News - Week of September 13, 2015

World Hepatitis Summit harnesses global momentum to eliminate viral hepatitis
Glasgow, Scotland - Participants at the first-ever World Hepatitis Summit will urge countries to develop national programmes that can ultimately eliminate viral hepatitis as a problem of public health concern. “We know how to prevent viral hepatitis, we have a safe and effective vaccine for hepatitis B, and we now have medicines that can cure people with hepatitis C and control hepatitis B infection,” said Dr. Gottfried Hirnschall, Director of the WHO’s Global Hepatitis Programme. “Yet access to diagnosis and treatment is still lacking or inaccessible in many parts of the world. This summit is a wake-up call to build momentum to prevent, diagnose, treat - and eventually eliminate viral hepatitis as a public health problem.” Around 400 million people are currently living with viral hepatitis, and the disease claims an estimated 1.45 million lives each year, making it one of the world’s leading causes of death. Hepatitis B and C together cause approximately 80% of all liver cancer deaths, yet most people living with chronic viral hepatitis are unaware of their infection. The summit, co-sponsored by WHO and the World Hepatitis Alliance, and hosted in Glasgow by the Scottish Government this week, is the first high-level global meeting to focus specifically on hepatitis, attracting delegates from more than 60 countries. The aim is to help countries enhance action to prevent viral hepatitis infection and ensure that people who are infected are diagnosed and offered treatment. Policymakers, patient groups, physicians and other key stakeholders attending the summit aim to issue a declaration underlining their belief that the elimination of viral hepatitis is possible and urging governments to work with WHO to define and agree on global targets for prevention, diagnosis and treatment. WHO is launching a new manual for the development and assessment of national viral hepatitis plans at the summit. Policymakers and other key stakeholders at the 3-day meeting (2-4 September) are also discussing the draft WHO Global Health Sector Strategy on Viral Hepatitis, which sets targets for 2030. The targets include a 90% reduction in new cases of chronic hepatitis B and C, a 65% reduction in hepatitis B and C deaths, and treatment of 80% of eligible people with chronic hepatitis B and C infections. The World Summit, which is intended to become an annual event, aims to focus attention on a public health approach to viral hepatitis and to be a central forum for countries to share their experience and best practices to drive rapid advances in national responses. “This summit is about empowering countries to take the practical steps needed at a national level. It has brought here to Scotland patients’ groups and civil society from across the world to support countries in doing this. We can eliminate viral hepatitis as a major global killer but we must all work together to make that vision a reality,” said Charles Gore, President of the World Hepatitis Alliance. Putting in place a well-funded and comprehensive response is a challenge for many governments who have a high burden of hepatitis-related diseases. In sub-Saharan Africa and East Asia between 5-10% of the population is chronically infected with hepatitis B. High rates of chronic infections are also found in the Amazon and the southern parts of eastern and central Europe. Hepatitis C is found worldwide. Infection rates are high in Africa and Central and East Asia, and approximately two-thirds of people who inject drugs are infected with hepatitis C. An increasing number of countries are taking action to address viral hepatitis. They include Egypt, which has substantially increased the number of people receiving treatment for hepatitis C in recent years; Georgia, which has set a goal for the national elimination of hepatitis C; and Mongolia, which has endorsed a comprehensive strategy for the control of viral hepatitis.

For more information: http://www.who.int/mediacentre/news/releases/2015/eliminate-viral-hepatitis/en/

Hep C World News - Week of September 6, 2015

Discovery allows study of naturally occurring forms of HCV in the lab
New York, NY - Worldwide, 185 million people have chronic hepatitis C. Since the late 1980s, when scientists discovered the virus that causes the infection, they have struggled to find ways to grow it in human cells in the lab -- an essential part of learning how the virus works and developing new effective treatments. In a study published in Nature on August 12, scientists led by The Rockefeller University's Charles M. Rice, Maurice R. and Corinne P. Greenberg Professor in Virology and head of the Laboratory of Virology and Infectious Disease, report that when they over-expressed a particular gene in human liver cancer cell lines, the virus could easily replicate. This discovery allows study of naturally occurring forms of hepatitis C virus (HCV) in the lab. "Being able to easily culture HCV in the lab has many important implications for basic science research," says Rice. "There is still much we don't understand about how the virus operates, and how it interacts with liver cells and the immune system. " Scientists have long attempted to understand what makes HCV tick, and in 1999 a group of German scientists succeeded in coaxing modified forms of the virus to replicate in cells in the laboratory. However, it was soon discovered that these forms of the virus were able to replicate because they had acquired certain "adaptive" mutations. This was true for the vast majority of all samples from patients, except one, and left scientists with a puzzling question for more than a decade: What prevents non-mutated HCV from replicating in laboratory-grown cell lines? Rice and colleagues hypothesized that one or more critical elements might be missing in these cell lines. To test this idea, they screened a library of about 7,000 human genes to look for one whose expression would allow replication of non-mutated HCV. When the scientists expressed the gene SEC14L2, the virus replicated in its wild-type, non-mutated form. Even adding serum samples from HCV-infected patients to these engineered cell lines resulted in virus replication. "Practically speaking, this means that if scientists want to study HCV from an infected patient, it's now possible to take a blood sample, inoculate the engineered cells, and grow that patient's form of the virus in the lab," says first author Mohsan Saeed, a postdoc in Rice's laboratory. It's not entirely clear how the protein expressed by SEC14L2 works, says Saeed, but it appears to inhibit lipids from interacting with dangerous reactive oxygen species, a process that prevents HCV replication. Recent advances in HCV treatment have made it possible for millions of people to be cured of the virus. "New therapies, however, are extremely expensive and not perfect," Saeed notes. "As more patients are treated, drug resistant forms of HCV are emerging. Having a cell culture system where patient isolates can be grown and tested for resistance or susceptibility to alternative antiviral drug combinations should be useful for optimizing re-treatment strategies for those that fail treatment." Even though effective therapies for HCV do exist, there is still much we need to understand about the virus, adds Saeed -- and understanding how HCV interacts with its host cell can help scientists learn more about similar viruses for which effective treatments have yet to be developed. "The lessons learned from one disease can be true for other diseases as well," he observes.

For more information: http://tinyurl.com/o7nt5k5

Hep C World News - Week of August 30, 2015

White House urged to stop states from rationing hep C drugs
Washington, DC - Hep C drugs like Gilead Sciences' (Sovaldi) and AbbVie's (Viekira Pak) can cure hepatitis C, preventing people from getting liver disease. But in some states like Illinois, a person on Medicaid can't get Sovaldi unless they already have advanced liver disease. Even then, other restrictions can block them from access to the pricey meds. This kind of rationing is to save money, not lives, and is discriminatory, White House medical advisors have told the administration. Experts have urged a reluctant administration to lay down some consistent guidelines for Medicaid on use of the new drugs. The Public Health Service and President Obama's Advisory Council on H.I.V./AIDS, have told the administration that restrictions, like barring patients who have been treated for alcohol or drug abuse within 12 months, are not sound medical practice, The New York Times reports. The Centers for Disease Control and Prevention has also expressed concern. They oppose state rules such as requiring patients to have been free of drug or alcohol abuse within 12 months or requiring an infectious disease expert to prescribe the drugs. Guidelines written by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases say any patient with chronic hepatitis C should be treated with the new drugs unless they have less than a year to live. Limits by some states are "unreasonable and discriminatory" and are "not supported by medical evidence," the advisory council said in a letter to Mr. Obama, The Times reports. It said the feds need require states to relax if not do away with the restrictions, which end up discriminating against low-income people on Medicaid, the panel said. "We can cure most patients with as few as 84 pills," Dr. David L. Thomas, of Johns Hopkins University School of Medicine told the newspaper. Thomas helped write the guidelines on use of the hep C drugs. "It's cheaper to treat patients than to wait for them to develop cirrhosis and complications and then get a liver transplant. "But the administration has so far been unwilling to set hard and fast rules, saying it House has also been sensitive to what impact the pricey drugs are having on the budget since the federal government covers half the cost of the drugs. The panel did not offer suggestions on how to cover the added costs. When Gilead Sciences first brought Sovaldi to market, it priced it at $1,000 a pill, $84,000 for a 12-week course. Its combo treatment Harvoni is even pricier. But since then, competition from AbbVie's Viekira Pak has led to price cuts. Some efforts have also been made to force the company to lower the price. Matt D. Salo, the executive director of the National Association of Medicaid Directors, told the newspaper he understood that with discounts, the new hep C drugs can now be bought for about $50,000 a person. Each state does its own price negotiating. But he said prices need to come down further to make the meds affordable for everyone that needs them. Toward that end, the advisory panel also suggested that states disclose what they are paying for the drugs and that the drug companies be required to disclose what it cost them to develop the treatments, something drugmakers are loathe to do. Some experts see discrimination in policies since hepatitis C is often associated with drug abuse. They say that even at full price, it is a little enough to be paid for a treatment that can cure a disease that kills more people in the U.S. each year than AIDS. "If there were a cure for Alzheimer's or breast cancer that cost $40,000 or $50,000, we would not be having this conversation," said D. Clary, the executive director of the National Viral Hepatitis Roundtable, an association of 250 groups which is working to end the hep C epidemic in the country.

For more information: http://tinyurl.com/owkwoyc

Hep C World News - Week of August 23, 2015

Hepatitis C Infection May Fuel Heart Risk
Baltimore, MD - People infected with the hepatitis C virus are at risk for liver damage, but the results of a new Johns Hopkins study now show the infection may also spell heart trouble. The findings, described online July 27 in The Journal of Infectious Diseases, emerged from a larger ongoing study of men who have sex with men, many but not all of whom were infected with HIV and followed over time to track risk of infection and disease progression. A subset of the participants had both HIV and hepatitis C, two infections that often occur together. Even though people infected with HIV are already known to have an elevated risk for heart disease, researchers emphasize their results offer strong evidence that hepatitis C can spark cardiovascular damage independent of HIV. Specifically, the research found that study participants chronically infected with hepatitis C were more likely to harbor abnormal fat-and-calcium plaques inside their arteries, a condition known as atherosclerosis and a common forerunner of heart attacks and strokes. “We have strong reason to believe that infection with hepatitis C fuels cardiovascular disease, independent of HIV and sets the stage for subsequent cardiovascular trouble,” says study principal investigator Eric Seaberg, Ph.D., assistant professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. “We believe our findings are relevant to anyone infected with hepatitis C regardless of HIV status.” Investigators emphasize they don’t know exactly how infection with the hepatitis C virus precipitates the growth of artery-clogging plaque but that their evidence is strong enough to warrant vigilant monitoring for cardiac symptoms among people infected with the virus. “People infected with hepatitis C are already followed regularly for signs of liver disease, but our findings suggest clinicians who care for them should also assess their overall cardiac risk profile regularly,” says study author Wendy Post, M.D., M.S., professor of medicine at the Johns Hopkins University School of Medicine and a cardiologist at the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease. Post says that at a minimum, patients with hepatitis C would benefit from an annual cardiac evaluation that includes cholesterol and glucose testing, a blood pressure check and assessment of lifestyle habits. The study involved 994 men 40 to 70 years old without overt heart disease who were followed across several institutions in Baltimore, Washington, D.C., Pittsburgh, Los Angeles and Chicago. Of the 994, 613 were infected with HIV, 70 were infected with both viruses and 17 were only infected with hepatitis C. Participants underwent cardiac CT scans to detect and measure the amount of fat and calcium deposits inside the vessels of their hearts. Those infected with hepatitis C, regardless of HIV status, had, on average, 30 percent more disease-fueling calcified plaque in their arteries, the main driver of heart attack and stroke risk. People infected with either HIV or hepatitis C, on average, had 42 percent more non-calcified fatty buildup, a type of plaque believed to confer the greatest cardiac risk. n addition, those who had higher levels of circulating hepatitis C virus in their blood were 50 percent more likely to have clogged arteries, compared with men without hepatitis C. Higher virus levels in the blood signal that the infection is not well controlled by drugs or the immune system. Poorly controlled infection, the investigators add, may lead to more inflammation throughout the body, which can fuel blood vessel damage and thus contribute to heart disease. Treating hepatitis C infection promptly can ward off long-term liver damage, but researchers say their findings now raise another critical question: whether a new class of medications that help 90 percent of patients clear the virus within a few short months could also halt the formation of plaque and reduce cardiac risk in the long run. More than 2.7 million people in the United States are infected with the hepatitis C virus, according to estimates from the Centers for Disease Control and Prevention.

For more information: http://tinyurl.com/nuosuse

Hep C World News - Week of August 16, 2015

Liver Damage in Hepatitis C Patients Significantly Under-estimated and Under-reported
Detroit, MI - The number of hepatitis C patients suffering from advanced liver damage may be grossly under-estimated and under-diagnosed, according to a study led by researchers at Henry Ford Health System and the U.S. Centers for Disease Control and Prevention. The findings, recently published in the American Journal of Gastroenterology, were the result of a study of nearly 10,000 patients suffering from hepatitis C. The results could have a significant effect on patient care and healthcare policy regarding the chronic disease. “Knowledge of the prevalence of liver damage will help decision making regarding screening for the effects of hepatitis C, when to start anti-viral therapy, and the need for follow-up counseling,” says Stuart Gordon, M.D., lead researcher and Director of Hepatology at Henry Ford Hospital. The Chronic Hepatitis Cohort Study is an analysis of records from a large, geographically and racially diverse group of 9,783 patients receiving care at four large U.S. health systems: Henry Ford Health System in Detroit; Kaiser Permanente Northwest in Portland, Oregon; Kaiser Permanente in Honolulu and Geisinger Health System in Danville, Pennsylvania. The records analyzed by the researchers indicated evidence of liver damage, or cirrhosis, in 29% or 2,788 of the hepatitis C patients included in the study. But surprisingly, 1727 of those 2,788 patients, or 62% of those suffering from liver damage, had no formal documentation in their medical records that they had cirrhosis. The results suggest cirrhosis may be underdiagnosed in a large segment of the population, he added. Clinicians typically rely on liver biopsies to diagnose cirrhosis. But in the hepatitis C patients studied, only 661 patients were diagnosed with cirrhosis through a liver biopsy. “Our results suggest a fourfold higher prevalence of cirrhosis than is indicated by biopsy alone,” says Gordon. The researchers discovered highly likely signs of liver damage by calculating the patients’ liver enzymes, platelet counts and age in a previously validated test called a FIB-4 score. “It’s an under-appreciated, easily obtained and, widely available test done through lab work that can point out there’s a problem,” says Dr. Gordon. “It’s a simple test not routinely used by clinicians. A lot of patients in our study had cirrhosis and probably didn’t know they had cirrhosis. In addition, electronic medical record reports may not be a reliable indicator of just how many hepatitis C patients may be suffering from cirrhosis.” Hepatitis C is a viral infection that causes inflammation and infection of the liver. The U.S. Centers for Disease Control and Prevention’s Division of Viral Hepatitis estimates 2.7 to 3.9 million people in the United States currently suffer from chronic hepatitis C. Without treatment, the virus over time can cause liver cancer or cirrhosis, which can lead to liver failure. “Sometimes the clues of liver damage or cirrhosis are very subtle – a dropping platelet count, a spleen size that is slightly increased on an ultrasound,” says Dr. Gordon. “It is not unusual for patients with hepatitis C to come in and they have liver cancer, and they didn’t even know that they had cirrhosis that led to their cancer.” The results could have wide impact on the treatment of those with hepatitis C, a disease now curable in many cases with oral antivirals. “People with hepatitis C need to find out the severity of their underlying liver disease, because they may not realize that they have cirrhosis,” says Dr. Gordon. “Obviously, treatment can slow down the progression.”

For more information: http://hepatitiscnewdrugs.blogspot.ca/2015/08/hepatitis-c-liver-damage-significantly.html

Hep C World News - Week of August 9, 2015

Trial looks at shorter treatment regimens for Hep C
Washington, DC - In a phase 2a study, investigators Anita Kohli, MD, and colleagues associated with the National Institutes of Health (NIH) investigated a short-course 6-week regimen of sofosbuvir/ledipasvir (Harvoni) with placebo, or an experimental third agent. Although existing direct-acting antivirals such as those in Harvoni target specific sites on the hepatitis C virus that hijack the virus's ability to persist in the body, NIH researchers posit that adding another targeted inhibitor might further shorten the virus's persistence. Current approved regimens with Harvoni range in length from 8 to 24 weeks, with the shortest 8-week course being recommended only for a certain small segment of patients—individuals with chronic hepatitis C virus infection (HCVI) with genotype 1 disease who have never received anti-HCV treatment before, do not have cirrhosis, and have HCV RNA serum levels lower than 6 million IU/mL before receipt of therapy. Current therapies offer HCV cures within 8 to 12 weeks in the majority of cases, and 24 weeks of therapy in hard-to-treat cases. By contrast, before direct-acting agents were available (that is, prior to 2013), standard treatment for HCV infection consisted of weekly interferon injections in combination with oral ribavirin for at least 6 months and up to 1 year of therapy. By adding a third drug to this treatment course, NIH investigators believe it may be possible to expand the group of patients eligible for short-course treatment while simultaneously decreasing the minimum length of therapy from 8 weeks to 6. Success with such a strategy would reduce the economic impact of anti-HCV treatment on the US government's health care spending, while simultaneously making treatment more convenient. The clinical trial, registered under the ClinicalTrials.gov designator NCT01805882, was imitated in January of 2013, and continued through December of the same year. A total of 60 patients were assigned equally to receive treatment with 1) sofosbuvir and ledipasvir for 12 weeks; 2) sofosbuvir, ledipasvir, and GS-9669 for 6 weeks; or 3) sofosbuvir, ledipasvir, and GS-9451 for 6 weeks. Patients in each 20-patient group were all adults over the age of 18, and had chronic genotype 1 HCV infection with serum RNA concentrations exceeding 2000 IU/mL. Liver biopsy and ultrasonic liver elasticity scans as well as serum liver enzyme tests ensured that all patients in the trial were free of cirrhosis. Patients in active treatment arms received the components of Harvoni (90 mg of ledipasvir and 400 mg of sofosbuvir daily) with either GS-9669 (as 2 tablets of 250 mg each, once daily), or GS-9451 (a single 80-mg tablet daily). Patients were assessed for treatment response through HCV RNA level reductions in the 4 weeks after completing therapy. A 100-fold reduction in HCV RNA levels signified a response, and undetectable HCV RNA levels 12 weeks after completion of treatment (SVR12) indicated sustained viral response—a functional cure. Four weeks after completion of therapy, all 20 of the 20 evaluable patients in the placebo group, 18 of the 19 evaluable patients in the GS-9669 group, and 20 of 20 evaluable patients in the GS-9451 group experienced sustained viral response. These responses remained durable at week 12 in all patients receiving placebo with Harvoni for 12 weeks, in 18 of 19 evaluable patients in the GS-9669 group, and in 18 of 19 evaluable patients in the GS-9451 group. The most common side effects were diarrhea, headache, and fatigue. Although most adverse events in the clinical trial were of mild severity, grade 3 adverse events included 1 case of liver biopsy–related pain, and 1 case of vertigo resulting in a hospital admission (in a patient with a history of vertigo). Regarding these favorable results, researchers concluded, “We can now speculate that a 6 week course of three direct-acting antiviral drugs can result in SVR12 in at least 75%, and perhaps nearly 100%, of people infected with HCV.” Noting the benefits of this strategy, the team wrote, “This quick and simple treatment for HCV might prove relevant for the global elimination of hepatitis C, in which simple and well tolerated therapy of short duration is needed to ensure adherence.”

For more information: http://tinyurl.com/qgthnx2

Hep C World News - Week of August 2, 2015

CLF congratulates government for funding hep C network
Toronto, ON - Hepatitis C is a serious liver disease that has been lurking undiagnosed in many individuals for decades and is now exacting a deadly toll in the form of rising rates of cirrhosis, liver cancer and liver failure. To address this health care crisis, the Public Health Agency of Canada and Canadian Institutes for Health Research have a new $4.5 million partnership to fund a National Collaborative Hepatitis C Network which will help ensure breakthroughs in treatment and prevention make it from the lab to the people living with or at risk of contracting hepatitis C. “We can prevent Canadians from suffering and dying from hepatitis C by identifying and treating individuals before they develop life-threatening consequences and by putting measures in place for prevention,” says Dr. Morris Sherman, Chairperson of the Canadian Liver Foundation. “Age- and risk-based testing, access to care and finding ways to prevent transmission are all important if we want to eliminate hepatitis C in Canada. We applaud the Government of Canada for providing funding to allow the experts in this field to continue their collaborations that are leading to solutions that can help save lives.” The Canadian Liver Foundation strongly believes in this national collaborative research model and has been a proud partner of the National CIHR Research Training Program in Hepatitis C (NCRTP-HepC) for 12 years. This initiative first began as an innovative program to connect mentors and students from academic and clinical institutions from coast to coast in a multi-disciplinary approach to combating hepatitis C. With the Government’s support of this next generation research network, the CLF will continue its commitment to provide funding, secure additional non-governmental research funds and offer support and input in the areas of knowledge translation, communications and advocacy. “Hepatitis C treatment has evolved dramatically in a relatively short time,” says Dr. Sherman, “but there are still significant hurdles in determining how to manage hepatitis C prevention, testing, treatment and care efficiently while ensuring the widest possible access. We look forward to working with Dr. Naglaa Shoukry and the National Collaborative Hepatitis C Network team in their research into these challenges and in sharing their findings with patients, the medical community, the public and key decision-makers.”

For more information: http://tinyurl.com/o2mk67w

Hep C World News - Week of July 26, 2015

Harvoni and Holkira Pak are now covered by the public drug plan in Quebec
Montreal, PQ - The Centre and Association for People Living with Hepatitis C (CAPAHC) welcomes the Québec Ministry of Health and Social Services' decision to add Harvoni (sofosbuvir/ledipasvir) and Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) to the list of medications that are covered by its public drug plan to treat chronic hepatitis C. "This is very good news for people struggling with genotype 1 hepatitis C, which is the most frequent type in Québec. Most patients can now be cured in as little as 8 to 12 weeks when treated with Harvoni or Holkira Pak. Both drugs show very high cure rates for hepatitis C, including for those with liver cirrhosis, while significantly reducing side effects compared with the previous generation of treatments," says Dr. Marie-Louise Vachon, microbiologist/infectious disease specialist at the CHU de Québec-Université Laval. "A few years ago, hepatitis C medications were poorly tolerated and required about a year of treatment. We are definitely experiencing a turning point in the treatment of this disease." Harvoni is the first and only once-daily, single-tablet regimen for the treatment of chronic hepatitis C virus genotype 1 in adults. Harvoni eliminates interferon and ribavirin, which can be difficult to tolerate, and offers the majority of people a cure in as little as eight weeks of treatment. Holkira Pak is the only hepatitis C treatment to combine three direct-acting antivirals to attack the virus at three separate stages of its replication process. "For some patients, these new treatments represent the possibility to go back to work or school, break down the social isolation that they are experiencing, or simply get their energy back to achieve their ambitions," says CAPAHC general manager Laurence Mersilian. "We want to congratulate the Government of Québec for seizing the opportunity to make a difference for these people." The Ministry of Health and Social Services opted for a comprehensive disease management approach that is staged over 6 years. The eligibility criteria for treatment will evolve over time, along with the implementation of various healthcare initiatives to prevent the disease and support patients. The CAPAHC is very pleased with this progressive approach, which takes into consideration the community's involvement as a key element for success to cure hepatitis C. In addition to improving the quality of life for people who are treated and cured, more effective hepatitis C treatment options can produce positive impacts for the Québec health system. A better management of the disease has the potential to reduce the number of hospitalizations, the number of liver transplants, and the multiple complications related to the disease, including death. In Québec, it is estimated that there are 50,000 patients living with chronic hepatitis C.

For more information: http://tinyurl.com/oxvmn3q

Hep C World News - Week of July 19, 2015

Hep C treatment program improves access to housing, income and healthcare
Toronto, ON - Despite high rates of hepatitis C virus (HCV) infection among people who use street drugs, access to treatment for HCV is very low for this population. Studies in Canada and the U.S. have shown that less than 1% of people with HCV who inject drugs access treatment. A number of barriers to HCV treatment have been documented for people who use drugs, including a lack of knowledge about HCV infection and its impact on health, past negative experiences with healthcare providers, competing issues such as unstable housing or other health problems, and specialists who are not willing to treat people who use drugs. In order to address barriers to HCV treatment for people who use drugs, the Toronto Community Hepatitis C Program (TCHCP) has developed a low-barrier community-based multidisciplinary team model for providing HCV care. Previous research on this program demonstrated cure rates for HCV treatment among the program’s clients that were similar to those seen in people in clinical trials. The current study goes beyond HCV cure rates to examine the impact of TCHCP on clients’ physical and mental health, substance use, housing, income supports and access to healthcare. It found that access to housing, income supports and healthcare improved over the course of the study. There was no change in participants’ perception of their overall health. TCHCP consists of multidisciplinary teams based in three primary healthcare settings that receive support from hospital-based medical specialists who offer appointments onsite. The program provides low-barrier HCV treatment and support to people who use drugs or have mental health issues, or both. The anchor of the program is a two-hour weekly support group meeting. Each support group cycle lasts 16 to 18 weeks and people can participate in multiple cycles. This support group is designed to be a low-barrier way for people who may avoid healthcare due to stigma and discrimination to be linked to HCV care and treatment. This group is the base through which they are connected to HCV nurses, doctors and specialists. To encourage access to the group, participants receive a meal during the meeting as well as transit fare and an honorarium. During the support group, people receive and share information about HCV and how to take care of their health. Appointments with HCV nurses, doctors and specialists take place while the group meets, allowing for easier access to these healthcare providers. Outside of the group, participants can also receive case management, counselling and further peer support. Abstinence from drugs and alcohol or participation in an opiate substitution program or addiction treatment program is not a requirement for joining the program. The goal of the study was to evaluate the health and psychosocial outcomes of TCHCP participants over time. Starting in 2011, all new participants in the program were invited to join the study. Participants were interviewed at three time points: upon joining the program, at the end of the first support group cycle they attended, and one year after they finished their first support group cycle. This study is ongoing and will end in 2016, when the last group finishes its one-year anniversary interviews.

For more information: http://tinyurl.com/oqd5so9

Hep C World News - Week of July 12, 2015

Heroin Use on the Rise Among Women, Wealthier People, CDC Finds
Atlanta, GA - The face of heroin addiction in the United States is changing, as well-off abusers of prescription painkillers switch to illicit narcotics to feed their habit, federal officials reported Tuesday. Heroin use increased 63 percent over the past decade. From 2002 to 2004, the annual rate of heroin use was 1.6 per 1,000 persons aged 12 or older. By 2011 to 2013, that rate was 2.6 per 1,000 people, officials from the U.S. Centers for Disease Control and Prevention said. Correspondingly, there has been a rapid increase in heroin overdose deaths. The number of heroin overdose deaths nearly doubled between 2011 and 2013, and in 2013 more than 8,200 people died from the narcotic. Overdoses have nearly quadrupled since 2002, the officials said. The findings were published in the July 7 issue of the CDC's Morbidity and Mortality Weekly Report. CDC Director Dr. Tom Frieden said heroin use is increasing at an alarming rate in many parts of society. And the problem is being driven by both the prescription opioid epidemic and cheaper, more available heroin, he said. "It's really a one-two punch," Frieden said during a media briefing. "Those two factors are driving the increase, and will drive the strategies we need to pursue to turn this around." The people most at risk for heroin addiction include whites, males, 18- to 25-year-olds, people making less than $20,000 a year, Medicaid recipients and the uninsured, the CDC report found. But the biggest increases in heroin use in recent years were found in groups that typically aren't expected to go near the drug, including women, people with private insurance and higher-income individuals, the report said. The gaps in heroin use between men and women, people on Medicaid or with private insurance, and those with low or high incomes have all narrowed during the past decade, the CDC said. Frieden said the narrowing gaps in heroin abuse are occurring due to across-the-board increases, causing a "leveling" of heroin use. "We're seeing an increase throughout many segments of society," he added. This expansion of heroin abuse can be largely chalked up to an earlier wave of prescription opioid drug abuse -- including such drugs as Vicodin, OxyContin and Percocet -- and government efforts to counter that trend, said Brad Lander, an addiction medicine specialist at the Ohio State University Wexner Medical Center. "We've seen an explosion of heroin use here in Ohio," Lander said. "They thought by shutting down the pill mills, they thought they were shutting down the addiction problem. Instead, people just shifted over to heroin, which is easier to get and cheaper." The CDC's new report bears this out.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_153448.html

Hep C World News - Week of July 5, 2015

AbbVie's HOLKIRA™ PAK Now Reimbursed in Ontario
Montreal, PQ - AbbVie, a global biopharmaceutical company, today announced that the Common Drug Review (CDR) has posted the Canadian Drug Expert Committee (CDEC)'s positive recommendation1of HOLKIRA PAK for listing with provincial drug formularies. HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets) is an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. During their review, the CDEC clearly recognized the clinical value that HOLKIRA PAK brings to people living with hepatitis C and recommended that the treatment be covered under minimal conditions: liver fibrosis stage of ≥2, and treatment should be initiated by physicians with experience in the management of hepatitis C. Following the positive CDR recommendation announcement, Ontario is the second province to reimburse HOLKIRA PAK on its public formulary through its Exceptional Access Program (EAP) as of June 29, 20152. In Ontario, HOLKIRA PAK will be covered under the following EAP criteria: for treatment-naïve and treatment-experienced adult patients with GT1 chronic HCV infection, with compensated cirrhosis. "We finally have the tools to address hepatitis C. Although this disease is sometimes overlooked, it is the infectious disease that causes the most years of life lost in Canada. With new, extremely well-tolerated treatments, cure rates are now above 95 per cent," said Dr. Jordan Feld, a hepatologist at the Francis Family Liver Clinic at Toronto Western Hospital, part of the University Health Network. "Now that we can access these life-saving therapies for those who need them most, we have the possibility to actually eliminate hepatitis C from Canada." HOLKIRA PAK combines three direct-acting antivirals to attack the virus at three separate stages of its replication process. In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of GT1 HCV patients, and 98 percent of patients completed treatment. "Most patients with hepatitis C have been living with the disease for years or even decades," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation. "And after such a long duration of infection they are rapidly running into problems with liver failure and liver cancer. Having therapies that are both highly effective and accessible is critical to curing these individuals and preventing these complications." According to the Public Health Agency of Canada, an estimated 242,500 Canadians are living with hepatitis C.3 A significant number of the estimated cases in Canada remain undiagnosed, although the exact proportion is unclear.4There are six different genotypes of hepatitis C; two-thirds of Canadians living with hepatitis C have genotype 1 – either subtype 1a or 1b – which are the most difficult to cure.5 "AbbVie is committed to providing the best solution to Canadians living with hepatitis C. With this milestone, we are getting closer to fulfilling this ambition," said Stéphane Lassignardie, general manager, AbbVie Canada. "Furthermore, Canadians prescribed HOLKIRA PAK will have the opportunity to be enrolled in AbbVie Care, our signature care program designed to provide a wide range of services including reimbursement assistance, education and ongoing disease management support for health care professionals and people living with genotype 1 hepatitis C."

For more information: http://www.newswire.ca/en/story/1563367/abbvie-s-holkiratm-pak-now-reimbursed-in-ontario

Hep C World News - Week of June 28, 2015

Cost of Hep C Drug Prompts Activists
New York, NY - Activists in several countries are seeking to void patents on the blockbuster hepatitis C drug Sovaldi, saying that the price being sought by the manufacturer, Gilead Sciences, was prohibitive. The Initiative for Medicines, Access and Knowledge, a legal group in New York, is expected to file challenges in Argentina, Brazil, China, Russia and Ukraine. In all those countries except China, the organization is being joined by local patient advocacy groups. The actions are a sign that the controversy over Sovaldi is spreading beyond the United States, where the $84,000 charge for a course of treatment has strained Medicaid budgets, to middle-income countries. Sovaldi, when used with another drug, can cure most cases of hepatitis C in 12 weeks with few side effects. That has stoked huge demand for the medicine around the world. Globally about 150 million people have hepatitis C, which gradually destroys the liver. Gilead is allowing 11 generic drug manufacturers in India to make sofosbuvir, as Sovaldi is known generically, and sell it in 91 developing countries. But those do not include some middle-income countries like Argentina, Brazil, China and Ukraine, or Russia, which is considered a high-income country by World Bank standards. I-MAK, as the New York organization is known for short, estimates it would cost $270 billion to treat the 40 million people with hepatitis C in those five countries, assuming Gilead charges most of the other countries the $7,500 a treatment it is proposing in Brazil. “What that means in simple terms is that people who need the drug aren’t getting it or are not going to get it in the near term,” said Priti Radhakrishnan, a founder and director of I-MAK. If there were no patents, the generic versions selling for about $1,000 in India could be sold in those countries as well, she said. Patent challenges are already underway elsewhere. In January, the patent office in India denied a patent on sofosbuvir, the active ingredient in Sovaldi, after challenges were filed by I-MAK and others. A patent challenge was filed in Europe in February by Doctors of the World, a humanitarian aid group. I-MAK officials said it would be too expensive for them to try to nullify Gilead’s patents in the United States. But they say they have received inquiries from others, whom they would not identify, who might be interested. Gregg H. Alton, executive vice president for corporate and medical affairs at Gilead, said the company was “working to facilitate broad patient access to its hepatitis C treatments as quickly as possible in as many places as possible.” He said at least 50,000 people in lower-income countries had already been treated with sofosbuvir. “We recognize that challenges to our intellectual property are an inevitable consequence of implementing such a worldwide access effort with such breakthrough products,” he said.

For more information: http://tinyurl.com/kzbbsd9

Hep C World News - Week of June 21, 2015

China rejects patent linked to Gilead hepatitis C drug
Shanghai, China - China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment. Gilead has drawn fire for the cost of its top-selling drug Sovaldi, priced at US$1,000 per pill in the United States or US$84,000 for a typical 12-week course and its patents have been challenged in the U.S., India and Europe. The application China has rejected was for a so-called prodrug, the inactive form of the drug which then converts into the chemically active compound once in the body, the New York-based Initiative for Medicines, Access & Knowledge (I-MAK) said. Gilead, however, holds the China patent to the base compound in the drug, also known by its generic name sofosbuvir and China's rejection of the prodrug patent does not open the way for copycat drugs to be made in the world's No. 2 drug market. China-based officials for Gilead were not immediately available for comment. Emails and calls to Gilead's U.S. offices outside office hours went unanswered. Officials at China's State Intellectual Property Office did not confirm the decision when contacted by Reuters, but a notice posted on the body's website said Gilead's application for "nucleoside phosphramidates", a kind of prodrug, had recently been rejected. China's move follows a decision by India's patent office in January to reject Gilead's patent application for Sovaldi, finding it was not inventive enough. Gilead is appealing the ruling. Under pressure to cut prices, the California-based firm agreed last year to make the drug available for lower prices in 91 developing countries I-MAK has brought legal challenges against Gilead's patents or patent applications in five countries not covered by the agreement: China, Argentina, Brazil, Russia and Ukraine. Charities in Europe have also challenged Gilead's patent over its prices. The World Health Organization says as many as 150 million people worldwide live with chronic hepatitis C infection, most of them in low and middle-income countries. It recently added Sovaldi to its essential medicines list and urged lower prices, especially in middle income countries.

For more information: http://hepatitiscnewdrugs.blogspot.ca/2015/06/china-rejects-patent-linked-to-gilead.html

Hep C World News - Week of June 14, 2015

NHS accused of delaying access hep C drugs over cost concerns
London, UK - The NHS has been accused by leading health charities of attempting to “severely limit” the introduction of new drugs to treat hepatitis C because they are too expensive – despite the cost of them being cleared by officials. The organisations have called on the Health Secretary to intervene, saying that NHS England has made a series of “unprecedented requests” for patients’ access to new drugs to be delayed because of the price. Hepatitis C is a blood-borne virus that can damage the liver. New drugs such as Sofosbuvir, which was approved by the National Institute for health and Care Excellence (Nice) in January, have significantly higher cure rates, minimal side effects and much shorter treatment durations, according to experts. A 12-week course of Sofosbuvir costs £35,000, a figure that NHS England has claimed is prohibitive and not “affordable”. It also believes NHS infrastructure is incapable of dealing with the change in policy. Yet Nice has approved the drugs as “cost-effective”, leading to a plea from 14 organisations and senior doctors including the Hepatitis C Trust, the National Aids Trust and The Haemophilia Society to Jeremy Hunt. “Patients have been waiting years for these new highly tolerable drugs that can cure almost everyone, all but eliminate hepatitis C in England and address a major health inequality,” they said. “Many of them are desperate to access the new treatments, yet they are now faced with being denied access because NHS England wishes to ignore Nice and spend only an arbitrarily decided amount on hepatitis C treatment. How can this be right?” The chief executive of the Hepatitis C Trust, Charles Gore, who organised the letter, said NHS England’s arguments for delaying treatment were “absolutely ridiculous” given the money that would be saved in preventing rather than treating the disease. Wendy Kirby, 63, contracted hepatitis C 30 years ago and is in “very poor” health with cirrhosis, severe pain and exhaustion. Ms Kirby, from Putney, west London, spoke of her anger after being told her particular type of condition does not qualify. “My doctor would have loved to have given the new drugs to me last year when Sofosbuvir was licensed but his hands were tied,” she said. “The delays are very frustrating. It’s like someone turning up to the hospital with cancer expecting treatment but the doctor says ‘I’d love to treat you but your tumour isn’t big enough. When it’s enormous then we’ll treat it’, which is crazy.” She added: “If I get more sick, I would become eligible for a liver transplant, which is going to cost an awful lot more money – and then there’s the follow-up treatment.” An NHS England spokesperson said: “NHS England is supportive of expanded new treatment options for people with hepatitis C, and has already begun funding their care. “We also want to ensure that unresolved questions about the best treatment strategies are answered, and phased investment in hepatitis C services does not mean service reductions elsewhere.”

For more information: http://tinyurl.com/nmakpvr 

Hep C World News - Week of June 7, 2015

Patients Get Extreme to Obtain Hepatitis Drug
New York, NY - Some people living with the hepatitis C virus (HCV) are going to extreme lengths to obtain cheaper versions of Gilead Science’s HCV drug Sovaldi (sofosbuvir). It boasts over 90 percent cure rates, costs $84,000 for 12 weeks of treatment in the United States, and is being distributed at 1 percent of the cost in many low-income countries, Bloomberg Business reports. In one recent plan for cheaper treatment, Steve Miller, chief medical officer at Express Scripts Holding Co.—the largest U.S. pharmacy benefits manager—considered docking an Indian cruise ship off the coast of Miami stocked with generic versions of Sovaldi. His idea was to ferry U.S. customers to the boat, supplying them with hep C drugs for $83,000 less than their U.S. listing price. Miller then discovered the scheme would almost certainly violate U.S. drug importation laws. However, the executive, and many other hep C treatment advocates, are still looking for creative ways to get cheaper drugs to those in need. One alternative option gaining momentum among HCV-positive people is to travel to one of the 91 developing countries that are licensed to sell copies of Sovaldi at well below U.S. market rates. Hep blogger Greg Jefferys is one of them. Check out his story here. According to Jonathan Edelheidt, the chief executive officer of the Medical Tourism Association, his group’s members are already preparing to help more people toward a solution like Jefferys. The U.S. organization Health Flight Solutions is also putting together a network of foreign doctors and hospitals that are willing to prescribe generic hep C drugs to U.S. patients. However, there are some alternative paths that health experts warn are a no-go. The U.S. Food and Drug Administration has specifically warned that many hep C drugs sold by Internet pharmacies are counterfeit or possibly tainted with harmful chemicals. The FDA also warns against potential online fraud schemes.

For more information: http://tinyurl.com/op6swnk

Hep C World News - Week of May 31, 2015

Statins Show Benefit in Hepatitis C Compensated Cirrhosis
Vienna, Austria — Statin use is associated with a 40% reduction in the rate of hepatic decompensation and death in patients with hepatitis C compensated cirrhosis, according to a retrospective analysis. Statin use is generally avoided in people with liver disease because of the possibility of hepatotoxicity, said Arpan Mohanty, MBBS, from the VA Connecticut Healthcare System in West Haven. However, this study suggests that statins are less dangerous for patients with liver disease than has been thought, she said here at the International Liver Congress 2015. "In patients with compensated hepatitis C–related cirrhosis, statin users have a significantly lower incidence of decompensation and better overall survival than nonusers," Dr Mohanty reported. "Until randomized controlled trials confirm these results, statins cannot be widely recommended in this setting; however, in patients who otherwise require statins, their use should not be avoided," she added. This study builds on previous animal data and a randomized clinical trial reported at last year's Liver Congress showing that statins are associated with prolonged survival in patients with cirrhosis and previous variceal bleeding, said session moderator Aleksander Krag, MD, from the University of Southern Denmark in Odense. We may have something right in front of us that's very effective. "The key thing we can say is that it's safe to use statins in these patients. And it seems to be related to a decreased risk for decompensation. We should be cautious in interpreting a retrospective study, but this really reinforces the need to do a randomized trial to prove this. We may have something right in front of us that's very effective," Dr Krag noted.For now, he said, the clinical implications are that "you should not withdraw statins and they should be used in people who have the right indications for them." Using 1996 to 2009 data from the Department of Veterans clinical case registry, Dr Mohanty and colleagues identified patients infected with hepatitis C who had compensated cirrhosis. From this cohort, 685 statin users were propensity-matched with 2062 nonusers. Characteristics known to influence the receipt of statins were used for propensity matching, including cardiovascular risk factors, age, sex, race, year of index visit, clinic attended, and comorbid conditions. In a median follow-up of approximately 2 years, rates of death from all causes and of decompensation — defined as the presence of one inpatient or two outpatient ICD-9 codes for esophageal varices with bleeding, ascites, and spontaneous bacterial peritonitis — were significantly lower in the statin users. After adjustment for age, cirrhosis prognosis assessed with a Child score, and Model for End-Stage Liver Disease (MELD) score, hazard ratios remained a significant 0.55 for both death and decompensation in the statin users, compared with the nonusers. The results did not change significantly in three sensitivity analyses — one using an alternate definition for decompensation, one excluding the 1096 patients with no confirmatory hepatitis C RNA test, and one excluding the 1054 who received antiviral therapy, Dr Mohanty reported. This study provides "strong encouragement for a proper randomized controlled trial," Dr Krag. However, "statins are really cheap now," he pointed out. Therefore, "it's unlikely that drug companies will fund such a trial. The government should fund it," he said.

For more information: http://tinyurl.com/q8j3k6c

Hep C World News - Week of May 24, 2015

Hep C Cure Costs Pose Challenge for Medicare
Boston, MA - Researchers estimate that 3 to 5 million Americans carry the insidious hep C virus. The biggest concentration is among those born between 1945 and 1965. Many, got hep C from injecting street drugs in their youth. Other baby boomers got the virus from transfusions before 1992, a period when blood wasn't screened. Some got it from sharing razors or from contaminated tattoo needles or hospital equipment. For some, transmission was sexual, although fortunately this isn't the highest-risk route. The timing of these infections spells trouble for Medicare, which insures Americans over 65. Hepatitis C is a slow-acting virus. Over a period of 20 to 40 years, it causes liver damage in about 70% of people it infects. A growing number of people who got infected in the 1960s through the 1990s have now "used up" the infection's latency period, notes Dr. Camilla Graham of Beth Israel Deaconess Hospital in Boston, "which is why we're now seeing this dramatic increase in the number of people developing complications and dying of hepatitis. And we expect this to continue to increase for the next 10 years."Another part of Medicare's problem is that new hep C medications are among the priciest of any drugs. One called Sovaldi, federally approved last December, costs $1,000 a pill -- or $84,000 for a typical 12-week treatment course. The other recently approved drug, Olysio, costs around $66,000. Others in the pipeline are expected to be similarly expensive. "People were very shocked about the price because it hit a psychological barrier in terms of 'this is too expensive,'" Graham says. She has  a 65-year-old patient whose severe liver damage puts her on the edge of liver failure. Graham believes her patient's best chance at cure lies in the use of both Sovaldi and Olysio. "We have about 160 people who were studied in a clinical trial called COSMOS that showed a very high cure rate -- 90% to 100% -- for even the most difficult-to-treat patients with this combination," she says. But, the Medicare drug-benefit contractor that covers this patient has refused to approve payment. The apparent reason is that the FDA has not yet approved use of the two drugs in combination. (On May 7, Olysio's maker, Janssen Therapeutics, asked the agency for such approval.) But Graham notes that in the early days of successful antiviral drug treatment for HIV, payers allowed doctors to "mix and match" medications in "off-label" or unapproved combinations as they thought best. "Medicare has been slower to adopt off-label combinations than most of the other insurance plans," Graham says. Medicare officials wouldn't comment on coverage of new hep C drugs. A spokesman wrote in an email that the federal program turns such decisions over to private insurers that administer its drug plan, called Medicare Part D. However, advocates say Medicare officials are well aware of the program's looming exposure to the enormous costs of treating hep C. Some say it could run in the tens or hundreds of billions of dollars, though it's not clear over what period of time. One thing likely to accelerate demand for treatment: Medicare is expected to approve payment for routine blood tests for hep C infection soon. That will reveal many people who don't yet know they're infected -- and spark difficult conversations between patients and doctors on when to use the expensive new medications to clear the virus from their blood. Many hepatitis specialists and patient advocates are worried that the cost of the drugs will lead payers to limit access to patients who already have advanced liver disease, or even more narrowly, those who are on transplant waiting lists. "We're very scared that these programs to limit access to treatment could interfere with our goals of trying to find people with hepatitis C," Graham says. Ryan Clary of the National Viral Hepatitis Roundtable, a patient advocacy group, says public health may be on a collision course with treatment and reimbursement policy. "On the one hand, we're saying 'Now is the time to be tested for hep C. There are these promising treatments,'" Clary says. "But on the other hand, we're saying 'You can't have access to these cures. It'll bankrupt the country.' So where's the incentive to test?" Apart from expensive drug treatment aimed at cure, doctors say there are other good reasons for identifying infected patients. They can be counseled to stay away from alcohol, which accelerates hep C-related liver damage. They can also be told about steps to take to avoid infecting others. There are other implications of delaying treatment until liver damage is advanced. Once a patient has developed cirrhosis, he'll need to be monitored every 6 months for the rest of his life for signs of liver cancer. And if a patient tips into liver failure or cancer before getting cured, treatment will cost an estimated $50,000 a year -- possibly over several years. "Hepatitis C is a ticking time bomb," Graham says. "We have a very limited amount of time to get in here and alter the course of the disease for a good number of people. And we either do that, and we do it well now, or we face a whole lot more people suffering severe complications of this disease." While the cost and treatment implications get sorted out many patients are in limbo.

For more information: http://tinyurl.com/lxk4god

Hep C World News - Week of May 17, 2015

Challenge in identifying those with Hep C
London, UK - HCV is dubbed the slow, silent killer because it can cause chronic liver disease that progresses insidiously, unnoticed for decades. However, just 25 years after its discovery, we now have effective cures. HCV affects over 216,000 people in the UK and up to 150 million worldwide, but it could now be eradicated by new, game-changing drugs offering cure rates in excess of 90 per cent along with improved tolerability. These treatments have the potential to cure the disease in a single, short course. However, the sheer numbers of people who require these expensive medicines are putting financial pressure on healthcare providers and leaving patients with an anxious wait to find out if they qualify for treatment. With minimal side effects and vastly reduced treatment duration, the new drugs offer a dramatic contrast to previous medications and mark out HCV as the only chronic viral illness that can be halted and the fastest to have been identified and cured. This is not a story that ends with scientists; it is also one of doctors. They have faced frustration and desperation to find the people infected, to implement treatment and wipe out this virus, all while fighting the politics and economics, ignorance and apathy that hold them back. Only in recent years have doctors realised that HCV can be sexually transmitted. As it is carried in the blood in low amounts, in semen and other bodily fluids emitted during sex, the risk of transmission during sex was presumed to be negligible. That was until patients who had never injected drugs started testing positive. Rougher sex, anal sex and the sharing of sex toys, especially among the MSM (Men who have sex with men) community, who may also be infected with HIV, make sexual transmission possible. The virus can exist on surfaces outside the body for a few days, and even for weeks within syringes. It is most common in those who have shared needles, or who received blood transfusions or tattoos before the virus was discovered. In low-income countries many transmissions result from unsterile medical treatments. Prevalence of HCV around the globe varies from about 1 per cent in the US, and lower still in the UK, to 10 per cent of 15-to-59-year-olds in Egypt, which has the highest incidence in the world.

For more information: http://www.design-redefined.co.uk/hepatitis-c-treatment/458917245

Hep C World News - Week of May 10, 2015

Injecting Opana Tied to Blood Clotting Disorder
Washington, DC - Injection drug users who have been Shooting up Opana have developed permanent heart, lung, and kidney damage after the oxymorphone drug caused a clotting disorder that cut off vital blood supply to those organs. The result is the need for valve replacement surgery, and dialysis for life-unless a kidney transplant becomes an option. Users becoms weak, dehydrated, and jaundiced with a chalky yellow color of the skin. There is a concern that not all healthcare providers are aware of the potential side effect of abuse of this drug. The blood-clotting disorder has been limited to the abuse-deterrent formulation of Opana, which drugmaker Endo Pharmaceuticals put on the market in early 2012. The new version of the drug was intended to be harder to abuse. An outer coating was supposed to make it too hard to crush so that it couldn't be snorted, and it was supposed to turn into a thick gooey gel if it was dissolved or melted. That way it couldn't be drawn up into a syringe and injected. Those determined to abuse the drug couldn't foil the anti-snorting mechanism, but they found a way to melt it down and inject it, with the help of larger gauge needles that could still channel the thicker substance into veins. Other opioids have adopted similar abuse-deterrent technologies, particularly OxyContin, which has been implicated as a major contributor to the opioid-abuse epidemic in the U.S. When drugmaker Purdue Pharma put the new version on the market in 2010, the FDA banished OxyContin generics, citing concerns that the old version was easily abused. But Endo Pharmaceuticals did not win abuse-deterrent labeling from the FDA. Although the agency's decision wasn't clear at the time, some experts said they may have made the right call about problems with reformulated Opana's abuse-deterrent technology. Andrew Kolodny, MD, chief medical officer of the addiction recovery program Phoenix House, said abuse of reformulated OxyContin is rare, potentially because both its anti-snorting and anti-injection technology work. "I've heard that making Opana harder to crush led some folks to shift from snorting to injecting it because the [abuse-deterrent formulation] was effective for stopping snorting but easy to defeat for injecting," Kolodny said. An analysis of FDA adverse events reporting system (FAERS) data found that blood-clotting disorders are a bigger problem for Opana than OxyContin. In the 4 years prior to reformulation, there were only two cases of blood clotting disorders with Opana as the primary suspect. But in 2012, there were 53 cases -- accounting for some 5% of all adverse event reports where Opana was the primary suspect. There were 24 cases in 2013 and six cases in 2014 (although data were not yet complete for this year), accounting for 18% and 10% of all Opana adverse event reports, respectively. Cases can take years to be reported to the FDA's system, meaning the number of Opana reports overall would likely increase. Although the data are known to be incomplete for a multitude of reasons, it is still the only public indicator of problems with drugs that are currently on the market. By comparison, there were seven cases of blood clotting disorder in the 3 years prior to OxyContin formulation, and the numbers didn't change much thereafter. The analysis showed 10 cases in 2010, followed by eight cases in 2011, and four in 2012, dropping off to two each year thereafter. Those reports made up 1% or less of all adverse event reports with OxyContin for each year. Endo added a warning about thrombotic microangiopathy to the drug's label in April 2014.

For more information: http://www.medpagetoday.com/Psychiatry/Addictions/5144

Hep C World News - Week of May 3, 2015

Challenge in paying for new HepC drugs
London, UK - The advent of effective, interferon-free treatment for hepatitis C (HCV) represents a significant medical advance, but challenges remain in identifying those infected, effective implementation and paying for the new drugs. HCV is dubbed the slow, silent killer because it can cause chronic liver disease that progresses insidiously, unnoticed for decades. However, just 25 years after its discovery, we now have effective cures. HCV affects over 216,000 people in the UK and up to 150 million worldwide, but it could now be eradicated by new, game-changing drugs offering cure rates in excess of 90 per cent along with improved tolerability. These treatments have the potential to cure the disease in a single, short course. However, the sheer numbers of people who require these expensive medicines are putting financial pressure on healthcare providers and leaving patients with an anxious wait to find out if they qualify for treatment. With minimal side effects and vastly reduced treatment duration, the new drugs offer a dramatic contrast to previous medications and mark out HCV as the only chronic viral illness that can be halted and the fastest to have been identified and cured. This is not a story that ends with scientists; it is also one of doctors. They have faced frustration and desperation to find the people infected, to implement treatment and wipe out this virus, all while fighting the politics and economics, ignorance and apathy that hold them back. Only in recent years have doctors realised that HCV can be sexually transmitted. As it is carried in the blood in low amounts, in semen and other bodily fluids emitted during sex, the risk of transmission during sex was presumed to be negligible. That was until patients who had never injected drugs started testing positive. Rougher sex, anal sex and the sharing of sex toys, especially among the MSM (Men who have sex with men) community, who may also be infected with HIV, make sexual transmission possible. The virus can exist on surfaces outside the body for a few days, and even for weeks within syringes. It is most common in those who have shared needles, or who received blood transfusions or tattoos before the virus was discovered. In low-income countries many transmissions result from unsterile medical treatments. Prevalence of HCV around the globe varies from about 1 per cent in the US, and lower still in the UK, to 10 per cent of 15-to-59-year-olds in Egypt, which has the highest incidence in the world. In England, the National Institute for Health and Care Excellence (NICE) has approved the use of Sovaldi for HCV. Even though England is getting the drug at a discounted price of £35,000 (about $53,000) for a 12-week course, rather than the $84,000 wholesale price, NICE is allowing NHS England to postpone implementation for 180 days rather than the standard 90, which means that the drug is unlikely to be available widely until the end of July 2015. Many governments can not afford to treat all the people with HCV. It would cost trillions, globally, to wipe it out using the new medications. In the UK alone it is estimated the cost for treating all patients with HCV would amount to £6 billion, which is more than 20 times greater than the annual budget for England’s Cancer Drugs Fund. There are no easy answers to the funding problem. Keeping the drugs for the most ill patients would not be the most effective way to eradicate the disease. The longer you wait, the greater the risk of patients developing liver cancer or end-stage liver disease. They also remain infectious to others.

For more information: http://www.design-redefined.co.uk/hepatitis-c-treatment/4589172459

Hep C World News - Week of April 26, 2015

WHO adds new hepatitis C, cancer drugs to essential medicines list
The World Health Organization on Friday said that it added a number of new treatments for hepatitis C to its essential medicines list, although the agency noted that "high prices currently make them unaffordable and thus inaccessible to most people who need them." The WHO also included new drugs for a variety of cancers, including breast cancer and leukaemia, and multi-drug resistant tuberculosis on its list. The WHO noted that five direct-acting oral antivirals have recently been launched, adding that the products have transformed chronic hepatitis C from "a barely manageable to a curable condition." The drugs include Gilead Sciences' Sovaldi (sofosbuvir) and Bristol-Myers Squibb's Daklinza (daclatasvir). "Treatments for hepatitis C are evolving rapidly, with several new, highly effective and safe medicines on the market and many in the development pipeline," commented Marie-Paule Kieny, WHO assistant director-general for Health Systems and Innovation. "While some efforts have been made to reduce their price for low-income countries, without uniform strategies to make these medicines more affordable globally the potential for public health gains will be reduced considerably," Kieny added.

For more information: http://www.firstwordpharma.com/node/1282148#axzz3ZYQzwzTy

Hep C World News - Week of April 19, 2015

WHO issues its first hepatitis C treatment guidelines
London, UK - WHO has issued its first guidance for the treatment of hepatitis C, a chronic infection that affects an estimated 130 million to 150 million people and results in 350 000 to 500 000 deaths a year. The publication of the "WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection" coincides with the availability of more effective and safer oral hepatitis medicines, along with the promise of even more new medicines in the next few years. “The WHO recommendations are based on a thorough review of the best and latest scientific evidence,” says Dr Stefan Wiktor, who leads WHO’s Global Hepatitis Programme. “The new guidance aims to help countries to improve treatment and care for hepatitis and thereby reduce deaths from liver cancer and cirrhosis.” WHO will be working with countries to introduce the guidelines as part of their national treatment programmes. WHO support will include assistance to make the new treatments available and consideration of all possible avenues to make them affordable for all. WHO will also assess the quality of hepatitis laboratory tests and generic forms of hepatitis medicines. “Hepatitis C treatment is currently unaffordable to most patients in need. The challenge now is to ensure that everyone who needs these drugs can access them,” says Dr Peter Beyer, Senior Advisor for the Essential Medicines and Health Products Department at WHO. “Experience has shown that a multi-pronged strategy is required to improve access to treatment, including creating demand for treatment. The development of WHO guidelines is a key step in this process.” The new guidelines make nine key recommendations. These include approaches to increase the number of people screened for hepatitis C infection, advice as to how to mitigate liver damage for those who are infected and how to select and provide appropriate treatments for chronic hepatitis C infection. WHO recommends a screening test for those considered at high risk of infection, followed by another test for those who screen positive, to establish whether they have chronic hepatitis C infection. Since alcohol use can accelerate liver damage caused by hepatitis C, WHO now advises that people with chronic hepatitis C infection receive an alcohol assessment. The Organization also recommends providing counseling to reduce alcohol intake for people with moderate or high alcohol use. In addition, the guidelines provide advice on the selection of the most appropriate test to assess the degree of liver damage in those with chronic hepatitis C infection. The guidelines provide recommendations on existing treatments based on interferon injections as well as the new regimens that use only oral medicines. WHO will update recommendations on drug treatments periodically as additional antiviral medicines are registered on the market and new evidence emerges. The 2014 recommendations also summarize for policy makers and health care workers interventions that should be put in place to prevent transmission of hepatitis C, including measures to assure the safety of medical procedures and injections in health care settings and among persons who inject drugs. Rates of new hepatitis C infections remain unacceptably high in many countries because of the reuse of injection equipment and lack of screening of blood transfusions. “Many people remain unaware - sometimes for decades - that they are infected with hepatitis C,” says Dr Andrew Ball, Senior Advisor for Policy, Strategy and Equity for WHO’s HIV/AIDS Department where the Global Hepatitis Programme is housed. “Today’s launch highlights the need for more awareness and education on hepatitis for the general public. Greater awareness on the risks associated with hepatitis C should lead to a demand for services and expansion of laboratory capacity and clinical services so that more people can be tested, treated and cured.” There are five main hepatitis viruses, referred to as types A, B, C, D and E. Hepatitis B and C have the greatest public health impact because they cause chronic infection which can progress to cirrhosis and liver cancer. Hepatitis A and E, spread though unsafe water and contaminated food, have the potential to cause outbreaks in certain populations. Hepatitis C virus is most commonly transmitted through exposure to contaminated blood. Those at risk include people undergoing invasive medical procedures and therapeutic injections where there is poor infection control. Also at risk are those exposed to contaminated injecting and skin piercing equipment, including through injecting drug use, tattooing and body piercing. The WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection were launched on the eve of the opening of the 2014 International Liver Congress, attended by around 10 000 delegates in London.

For more information: http://www.who.int

Hep C World News - Week of April 12, 2015

Statin use found beneficial in hepatitis C treatment
Pittsburgh, PA - For patients with hepatitis C virus (HCV), statin therapy is associated with improved virologic response rates, as well as decreased liver fibrosis progression and hepatocellular carcinoma (HCC) incidence, according to a study published online April 6 in Hepatology. Adeel A. Butt, M.D., from the VA Pittsburgh Healthcare System, and colleagues examined the impact of adding statins to antiviral therapy upon sustained virologic response (SVR) rates, fibrosis progression, and HCC development among HCV infected persons. Data were collected from 7,248 eligible subjects from the Electronically Retrieved Cohort of HCV Infected Veterans, of whom 46 percent received statins. The researchers observed significant correlations for statin use with attaining SVR (39.2 versus 33.3 percent); decreased development of cirrhosis (17.3 versus 25.2 percent); and decreased incident HCC (1.2 versus 2.6 percent). After adjustment for other relevant clinical factors, statins remained significantly associated with increased odds of SVR (odds ratio, 1.44) and with lower risk of progression to cirrhosis and incident HCC. "Statin use was associated with improved virologic response rates to antiviral therapy and decreased progression of liver fibrosis and incidence of HCC among a large cohort of HCV positive veterans," the authors write.

For more information: http://medicalxpress.com/news/2015-04-statin-beneficial-hepatitis-treatment.html

Hep C World News - Week of April 5, 2015

Allergy drug inhibits hepatitis C in mice
Washington, DC - An over-the-counter drug indicated to treat allergy symptoms limited hepatitis C virus activity in infected mice, according to a National Institutes of Health study. The results suggest that the drug, chlorcyclizine HCl (CCZ), potentially could be used to treat the virus in people. The hepatitis C virus (HCV) causes liver inflammation and often leads to serious complications such as cirrhosis. Early diagnosis and treatment of HCV can prevent liver damage. Drugs are available to treat HCV, but costs can reach tens of thousands of dollars. “Although hepatitis C is curable, there is an unmet need for effective and affordable medication,” said T. Jake Liang, M.D., senior investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “CCZ is a promising candidate for part of a treatment regimen for this potentially life-threatening disease.” Conducted at the NIH campus in Bethesda, Maryland, the study found that CCZ blocked the early stage of HCV infection likely by impairing the ability of the virus to enter human liver cells grafted in the mice. The outcome was similar to that of commonly used antiviral drugs but without those drugs’ toxic side effects. “Using an innovative high-throughput screening process, we identified CCZ as a potent inhibitor of hepatitis C,” said Anton Simeonov, Ph.D., acting scientific director of NIH’s National Center for Advancing Translational Sciences (NCATS), which collaborated in the study. “Identifying already approved drugs from the NCATS Pharmaceutical Collection may offer a faster route to potential discovery of treatments for all diseases.” The researchers will next study how the drug affects people. CCZ is currently used for the treatment of allergies, not for HCV. “People should not take CCZ to treat their hepatitis C until it has been demonstrated that CCZ can be used safely and effectively for that purpose,” cautions Liang. “NIH research is vital to finding creative solutions for some of today’s most serious public health issues,” said NIDDK Director Griffin P. Rodgers, M.D. “The CCZ medication may eventually provide an affordable alternative to costly options, especially in low-resource communities where hepatitis C infection is widespread.” HCV infection affects an estimated 185 million people worldwide.

For more information: http://www.nih.gov/news/health/apr2015/niddk-08.htm

Hep C World News - Week of March 29, 2015

Saskatchewan, Alberta and Nova Scotia initiate HEP C drug coverage
Regina, Saskatchewan - The governments of Saskatchewan, Alberta and Nova Scotia have initiated coverage for two new lifesaving drugs for treating hepatitis C; Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults (with criteria), and Sovaldi (sofosbuvir) for chronic HCV genotypes 1, 2 and 3 infection (with criteria). These new drugs are better tolerated by patients compared to other available therapies and have the advantage of being a once daily tablet. They have much better cure rates in shorter periods of time; 90-98 per cent of patients in as little as eight to 12 weeks compared to traditional therapies that cure 60-75 per cent of patients in 24-48 weeks. “We are committed to providing Saskatchewan patients with better access to new and effective medications,” Health Minister Dustin Duncan said. “These two drugs offer effective, simple and fast treatment. They provide a cure for chronic hepatitis C patients and greatly improve the quality of life for those affected.” Over the next three years, the ministry expects to provide coverage for about 1,100 patients who will meet the Exception Drug Status criteria for these therapies. Through the pan-Canadian Pharmaceutical Alliance, provinces and territories negotiated with the drugs’ manufacturer to leverage their collective buying power and receive better prices for new drugs. “We are very pleased that the Saskatchewan Ministry of Health has approved funding for these new treatments for chronic hepatitis C virus infection,” Royal University Hospital Head of the Division of Infectious Diseases Dr. Stephen Sanche said. “These medications will offer our patients a substantially greater chance of cure with fewer side effects and shorter treatment courses."

For more information: http://tinyurl.com/qd6hhzl

FDA Approves Software to Determine Liver Disease Severity
Irvine, CA - The U.S. Food and Drug Administration (FDA) has approved a new liver-scanning software to help doctors better determine the severity of damage caused by the hepatitis C virus (HCV) and other chronic liver diseases. The software automates the quantitative liver spleen scan shown to be an accurate predictor of clinical outcomes in the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis trial, the company explains in a news release. John Hoefs, MD, cofounder and chief operating officer of the company, developed the quantitative liver spleen scan methods to measure hepatic function, fibrosis, hepatic and spleen volume, and cirrhosis, whereas Dipu Ghosh, the company's chief executive officer, created the algorithms for automating the quantitative liver spleen scan techniques. "As hepatologists," Dr Hoefs commented in the release, "we have needed and searched for a reliable, precise method of measuring liver function that can be used in the clinical setting. Hepatic function is more important than hepatic fibrosis as hepatic function determines both the likelihood of clinical problems and patient survival. We are very excited that this method will now be available to physicians and patients." Researchers say the new software works better than older methods because it focuses more on the idea of overall liver function data, rather than simply looking at the visual extent of a patient’s hepatic fibrosis. In the recently concluded HALT-C (Hepatitis C Antiviral Long-term Treatment Against Cirrhosis) trial, Hepatiq’s medical algorithms were proven to be a highly accurate predictor of clinical outcomes for end-stage liver disease. It is estimated that 15 percent of adults worldwide currently have chronic liver disease. In the United States, about 32,000 people die every year from hepatic conditions.

For more information: http://www.medscape.com/viewarticle/838013

Hep C World News - Week of March 22, 2015

Provinces to Provide Public Funding for Harvoni
Mississauga, ON - Gilead Sciences Canada, Inc. today announced that multiple provinces will provide public access to Harvoni™ (ledipasvir/sofosbuvir), the first once-daily, single tablet regimen for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults. In Canada, it is estimated that more than 250,000 Canadians are living with chronic HCV infection, with thousands of new cases diagnosed each year.1 Genotype 1 infection represents an estimated 65 per cent of patient cases.2 Public reimbursement comes after a positive recommendation from the Common Drug Review, and as a result of a productive collaboration between Gilead Canada and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure participating provinces are able to provide timely access to patients in need of curative treatment. This review, co-led by the BC Ministry of Health and the Ontario Ministry of Health and Long-Term Care, resulted in an agreement with member provinces to fund the innovative therapy for patients. "We have been waiting for an innovative therapy like Harvoni since interferon was first used to treat the disease," said Dr. Alnoor Ramji, Clinical Associate Professor of Medicine (Gastroenterology and Hepatology), UBC. "This is a transformative, interferon-free therapy, with a combination of high cure rates, good tolerability and simplicity of treatment. Harvoni provides patients with the confidence to commit to therapy and a very high probability to achieve a cure." Current treatments include interferon and ribavirin that often exclude patients from treatment or lead to early discontinuation of treatment due to associated side effects. Harvoni represents a significant advance in the treatment of genotype 1 HCV infection, the most prevalent genotype in Canada. Harvoni is the only once-daily, single tablet regimen that offers cure rates between 94 and 99 per cent, eliminates the need for interferon and ribavirin, and shortens the duration of treatment to as little as eight weeks for many patients. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL. Recently, the Canadian Association for the Study of the Liver updated the Canadian consensus guidelines on the management of hepatitis C and recommended Harvoni as first-line therapy for all genotype 1 patients. "Today's announcement recognizes the significant health-system and societal benefits associated with curing this disease and preventing its complications," said Dr. Paul Marotta, Associate Professor, University of Western Ontario and with London Health Sciences Centre. "Access to Harvoni will help us confront this serious public health issue and start formulating longer-term solutions that may prove relevant to the hepatitis C disease elimination efforts across Canada." In a recent article, "Burden of disease and cost of chronic hepatitis C virus infection in Canada," (Canadian Journal of Gastroenterology and Hepatology), leading Canadian hepatitis C specialists highlighted an expected 205 per cent increase in cases of liver cancer, a 160 per cent increase in liver-related deaths, and a 60 per cent increase in total healthcare costs over the next 20 years.2 Recently, the article was recognized with a scientific award for its ground-breaking research in Canada. In addition to Harvoni, Gilead Canada's Sovaldi® (sofosbuvir) has also been listed for public reimbursement for chronic HCV genotypes 1, 2 and 3 infection in multiple provinces. "We live in an era of rapid evolution in the treatment of chronic hepatitis C infection, and Gilead Canada is pleased that our collaboration with the pCPA has allowed multiple provinces to recognize the clinical value of Harvoni as a simple, well tolerated and curative therapy for patients living with genotype 1 HCV," said Edward Gudaitis, General Manager, Gilead Sciences Canada, Inc. "Gilead Canada will continue to work closely with all provinces and territories to bring this cost-effective, once-daily treatment to patients across Canada."

For more information: http://tinyurl.com/mgsts6l

Hep C World News - Week of March 15, 2015

New Canadian guidelines for managing chronic hepatitis C
Markham, ON - The Canadian Association for the Study of the Liver has issued revised guidelines for the management of chronic hepatitis C infection. Since the last update of the guidelines (published in 2012), several major advances have been made in hepatitis C management, including the approval of novel direct-acting antiviral agents and the approval of all-oral (interferon-free) direct-acting antiviral agent combination therapies that have markedly improved efficacy and tolerability compared with first-generation agents and/or standard peginterferon-based therapy. An estimated 252,000 Canadians were chronically infected with hepatitis C in 2013; about 60% were people who use or used injection drugs, 20% were infected immigrants and 11% received contaminated blood products. Genotype 1 accounts for 65% of infected individuals (of these 56% are genotype 1a, 33% genotype 1b, 10% mixed). Genotypes 2 and 3 account for approximately 14% and 20% of infections in Canada, respectively; genotypes 4, 5 and 6 are responsible for < 1%. The overall prevalence of hepatitis C is declining in Canada, but the complications are increasing because of the aging of the infected population and the progression of liver fibrosis. The updated guidelines outline the steps for pre-treatment patient assessment, including routine assessment, virologic testing, assessment of the severity of hepatic fibrosis, and the utility of interleukin 28B testing (which may provide useful information on the likelihood of achieving a sustained virologic response). The main objective of therapy is complete eradication of the hepatitis C virus (i.e., sustained virologic response). The guidelines provide detailed recommendations for therapy according to hepatitis C genotype, the presence or absence of cirrhosis, and whether patients have received previous treatment or are treatment-naïve. Summary tables outline recommended regimens for each hepatitis C genotype, alternative interferon-free regimens, alternative interferon-containing regimens and therapies that are not recommended. The guidelines note that all patients would benefit from interferon-free drug regimens. Therefore, the newly approved all-oral regimens are recommended as first-line therapies. However, since access to interferon-free regimens is not universal across Canada, the decision to initiate therapy with an interferon-based regimen or to wait for an all-oral regimen must be individualized according to the patient’s wishes, urgency of therapy, severity of liver disease, expected tolerability of interferon-based therapy, likelihood of sustained virologic response and the expected timeline for access to an interferon-free regimen. In treating hepatitis C, the emergence of resistance to direct-acting antiviral agents must be considered. Strategies to minimize the development of resistance include not using direct-acting antiviral agents as monotherapy, not reducing the dosage of direct-acting antiviral agents to manage side effects, maximizing adherence, and not using a protease-inhibitor-containing regimen in patients who have failed on previous therapy with a protease inhibitor.
Potential drug interactions must also be considered before starting any direct-acting antiviral agent, including interactions with OTC and herbal medications.

For more information: http://tinyurl.com/qd3tncc

Hepatitis Pills Spark Biggest Jump In Drug Costs In A Decade
St. Louis, MO - New pills to treat hepatitis C that are hailed for their effectiveness and bemoaned because of their costs were a big contributor to a 13 percent increase in drug spending last year, according to a new report from drug benefit firm Express Scripts. It was the biggest percentage increase in total spending on prescription drugs in more than a decade, said Express Scripts, which administers drug benefits for some of the nation’s largest employers. Excluding hepatitis C pills and compounded medications, Express Scripts said the year over year increase in per capita drug spending was just 6.4 percent. “For the past several years, annual drug spending increases have been below the annual rate of overall healthcare inflation in the U.S., but that paradigm is shifting dramatically as prices for medications increase at an unprecedented and unsustainable rate,” Dr. Glen Stettin, Express Scripts senior vice president of clinical, research and new solutions said in a statement accompanying the report. The pharmacy benefit manager’s 2014 drug trend report, released today, showed hepatitis C pills accounted for almost half of the percentage increase in so-called “specialty drug spend.” Specialty prescriptions, which are generally high cost biologic drugs to treat everything from multiple sclerosis to cancer accounted for almost one-third of total drug spending, the Express Scripts report said. Hepatitis C pills Harvoni and Sovaldi, which are sold by Gilead Sciences, and Viekira Pak, sold by Abbvie (ABBV), are triggering pharmacy benefit firms like Express Scripts, CVS/Caremark (CVS), health insurers and Medicaid programs to negotiate exclusive deals with one drug maker or the other to blunt the costs of pills that are $1,000 each. In some states, Medicaid programs are severely restricting access to such Hepatitis C pills or not covering them at all. Express Scripts struck a deal with Abbvie that is reportedly much below Viekira’s $83,000 list price for a 12-week course of treatment though neither Abbvie nor Express Scripts would disclose the size of the discount. Express Script said the deal, which excludes Gilead drugs on the preferred list of medicines known as a formulary, would save its customers $1 billion in 2015. Express Scripts’ deal with Abbvie wasn’t signed until the end of 2014. Express Scripts, which manages pharmacy benefits for 85 million Americans, said its annual drug trend report looked at more than 750 million pharmacy claims, or more than half of its “entire book of business,’’ a company spokesman said.

For more information: http://tinyurl.com/lht7r4d

Hep C World News - Week of March 8, 2015

P.E.I. to offer newly-approved HepC treatments with cure rates of 95% to 100%
Charlottetown, PEI - A new $5-million hepatitis C management strategy unique to P.E.I. was announced by the province's Health and Wellness Minister. Health Canada recently approved new treatments that can cure the HCV Hepatitis C genotype 1, which is carried by 70 to 75 per cent of Islanders with the contagious liver disease. The new treatments have a cure rate of 95 to 100 per cent, few or no side effects, and a much shorter treatment cycle. Currently available medications in PEI have a cure rates of up to 70 per cent but they have serious side effects. "These are lifesaving and life-changing therapies… and I am very pleased that Prince Edward Island will be among the first provinces in Canada to make them available," Health and Wellness Minister Doug Currie said in a news release. Currie said the province's small size offers advantages in implementing this type of strategy. "As a small province, we can closely monitor and assess HCV cases and mobilize and coordinate our provincial health care resources." The province will work with the Quebec-based pharmaceutical company AbbVie to offer services including referral of patients, assessments, treatment support, education and follow-up. Patients will be screened from emergency rooms, addiction services, primary care centres, methadone clinics and corrections facilities. "This strategy will provide the best treatment available to many Islanders with hepatitis C and prevent further spread and serious complications among those with the disease," said P.E.I. physician and former chief public health officer Dr. Lamont Sweet. The province will invest $1.6 million in the program in each of the next three years. The P.E.I. government says about 400 Islanders are known to have been infected with the hepatitis C virus and at least 60 are in the advanced stages of the disease. Dr. Morris Sherman, chairman of the Canadian Liver Foundation, said the province has "stepped up as a role model" and he hopes that "other provinces will soon follow their lead."

For more information: http://hepatitiscnewdrugs.blogspot.ca/2015/02/5m-hepatitis-c-strategy-announced-by.html

Charity challenges Gilead's European patent on hepatitis C therapy Sovaldi
Paris, France - Médecins du Monde (MdM) said it filed a patent challenge in Europe against Gilead Sciences' hepatitis C therapy Sovaldi (sofosbuvir), arguing that "the molecule itself is not sufficiently innovative." MdM accused Gilead of hindering access by marketing Sovaldi at "extremely high prices, adding that the price is not justified because public funds were used to research and develop the drug. "Patent challenges have already been used by civil society in India, Brazil, the United States and around the world to remove weak or unmerited patents for drugs and to make low-cost generic versions available," commented Olivier Maguet, MdM board member delegate for hepatitis C. "This has led to a substantial reduction in the cost of treatments, enabling access to drugs of patients who would otherwise be deprived of life-saving medicines," Maguet added.
 For more information: http://www.firstwordpharma.com/node/1263122#axzz3RLrUYIqg


Hep C World News - Week of March 1, 2015

New Lower Prices for Gilead Hepatitis C Drugs
San Francisco, CA - Gilead Sciences, the maker of Sovaldi® and Harvoni®, two of the highly-effective but expensive new drugs for hepatitis C infection, recently announced that in 2015 it expects to give an average discount of 46% off the original list prices of these drugs. This discount would produce an average price of approximately $40,000 for a course of treatment with Harvoni, assuming two-thirds of patients can benefit from a shorter 8-week regimen. At this price, not only does Harvoni (or comparable treatment options) represent a high value in the care of individual patients, but its likely budget impact across broader patient populations will meet the threshold at which the California Technology Assessment Forum (CTAF) would identify it as a "high value" for most health care systems. The announcement of steep price discounts follows a brief period of intense negotiations between Gilead and insurance companies following the FDA approval of a rival drug treatment, Viekira Pak®, made by AbbVie. At its meeting on December 18, 2014, the independent review panel of CTAF [a core program of the Institute for Clinical and Economic Review (ICER)] voted that the evidence was insufficient to distinguish between the clinical effectiveness of the Gilead and AbbVie drug regimens, both of which have demonstrated hepatitis C viral clearance in over 90% of patients treated. At the time of the CTAF meeting, the AbbVie drug was not yet FDA approved and did not have a list price, but the CTAF panel voted that Harvoni, with a list price of about $95,000 for a 12-week course of treatment, represented a "low" health system value on the basis of its potential to push up state Medicaid costs by over 5% in a single year if all patients with known infections were treated. The CTAF panel vote was informed by a drug pricing analysis performed by researchers at the University of California at San Francisco and ICER that suggested that a price range for Harvoni - or any other comparably effective drug regimen - of $34,000-$42,000 for an average course of therapy would serve as a benchmark for keeping health system cost increases below a threshold of 0.5%-1.0%. The ICER report notes that this threshold budget impact for a single new treatment is viewed by many payers as manageable without resorting to severe treatment delays or cuts in other services. "The mission of CTAF and ICER is to help all participants in health care -- and the public at large -- tackle controversial questions about the appropriate use of new tests and treatments," stated Steven D. Pearson, MD, the President of ICER. "We are gratified that our work has contributed to the national conversation about the benefits and the costs of new treatments for hepatitis C. Our analyses and the public discussion at our CTAF meetings have made it clear that the high list prices of these new hepatitis C treatments would make treating all patients unaffordable in the short term. Lower prices may therefore open up opportunities for expanding coverage to more patients. Looking forward, we remain committed to the vision that public discussion of medical evidence, including costs, can help ensure that new medical innovations bring high value for patients and the health care system."

For more information: http://tinyurl.com/nbn8jke

Hep C World News - Week of February 22, 2015

Sovaldi® (sofosbuvir) now covered by Ontario and the Yukon
Toronto, ON - Sovaldi is now available in Ontario through the Exceptional Access Program (EAP) of the Ontario Drug Benefit Program (ODBP). According to the EAP web site the price to be reimbursed is $654.7619 per 400 mg tab. The Exceptional Access Program (EAP) facilitates patient access to drugs not funded on the Ontario Drug Benefit (ODB) Formulary, or where no listed alternative is available. In order to receive coverage, the patient must be eligible to receive benefits under the Ontario Drug Benefit (ODB) program. To apply through EAP, the patient's physician must submit a request documenting complete and relevant medical information to the ministry, providing the clinical rationale for requesting the unlisted drug and reasons why covered benefits are not suitable. All requests are reviewed according to recommendations and guidelines from the ministry's expert advisory committee, the Committee to Evaluate Drugs (CED). This review includes a thorough assessment of the patient's specific case and clinical circumstances, as provided by the physician, as well as the scientific evidence available. If EAP approval is granted, the coverage period begins as of the effective date and extends only to the specified date. To assist physicians applying for exceptional access, the ministry has developed a standard form. In addition, for a limited group of drugs, physicians can call to submit requests through the Telephone Request Service (TRS) and obtain faster approvals for patients who qualify. Sovaldi will be reimbursed with specific criteria for Genotype 1 patients who are treatment naïve and Genotype 2 or 3 treatment naïve patients in whom interferon is medically contraindicated or patients who are interferon/ribavirin treatment-experienced. In addition, the Yukon Territory has also listed Sovaldi on their drug benefit formulary under their exceptional access program. This is very good news for HCV patients in those jurisdictions.

For more information: http://www.health.gov.on.ca/en/pro/programs/drugs/odbf/odbf_except_access.aspx

Report Examines Controversial Pricing of Hepatitis C Treatment
New York, NY – Despite important price reductions for some low- and middle-income countries, the exorbitant drug pricing of breakthrough treatments for hepatitis C (HCV) infection will inevitably limit access to the drugs, leading to unnecessary loss of life, according to a new report from amfAR, The Foundation for AIDS Research. While the new drugs have made curing HCV easier and more effective, the report finds that the aggressive pricing of the treatments will place an unjustifiable and unsustainable burden on healthcare systems in the U.S. and around the world, with potentially devastating consequences for people living with HCV. Globally, as many as 185 million people are living with hepatitis C, including more than three million Americans. HCV is a blood-borne disease that can be transmitted sexually and perinatally as well as through needle sharing, unsterilized medical equipment, and contaminated blood products. Chronic HCV infection can lead to serious liver problems, including cirrhosis (scarring of the liver) or liver cancer. It is estimated that up to 350,000 people die every year due to HCV-related liver disease. The new amfAR report, titled “Hepatitis C and Drug Pricing: The Need for a Better Balance,” urges structural changes that alter the pricing incentives for pharmaceutical companies in such a way that they cannot charge exorbitant prices for their products, however effective they may be. Among the HCV drugs highlighted in the report is sofosbuvir, which is priced at $1,000 a pill, or $84,000 for a 12-week course of treatment in the U.S. Marketed as Sovaldi by the pharmaceutical company Gilead Sciences, sofosbuvir has a much higher cure rate, is easier to administer, and has fewer side effects than older hepatitis C treatments. “Due to their astronomical cost, it is unfortunate that effective treatments for hepatitis C will remain largely out of reach and unaffordable for most people with hepatitis C, especially among populations in resource-limited settings,” said Kevin Robert Frost, amfAR Chief Executive Officer. “We cannot let the pursuit of huge profits undermine access to these life-saving treatments for those who need them. The healthcare system in the U.S. is broken, and the unregulated pricing of drugs is a significant factor contributing to its demise. If we are serious about making health care more affordable for everyone in the U.S. and around the world, a change must be made now, or else the magnitude of this problem will only worsen.” The controversial pricing of the HCV medications has prompted much criticism among patient advocacy groups, healthcare providers and government officials, including a bipartisan group of U.S. Senators, who have requested evidence to support the company’s pricing as part of an investigation into Gilead. The company earned $12.4 billion in 2014 alone from sales of sofosbuvir and Harvoni (ledipasvir/sofosbuvir). The report also points to the unsustainable burden of HCV drug pricing on U.S. and global healthcare systems. In the U.S., hepatitis C patients are mostly uninsured, underinsured and/or incarcerated. Even with some form of health insurance coverage, the new HCV drugs will still be out of reach to many because Medicaid, Medicare, the Department of Veterans Affairs and the prison system are limiting access to them because of their high cost. It is estimated that treating all HCV-infected individuals in the U.S., even with all available discounts, would cost approximately $110 billion. The report finds that even wealthy countries, including Canada, the United Kingdom and Germany, are finding the price of sofosbuvir difficult to bear. Gilead recently licensed seven pharmaceutical companies in India to manufacture generic formulations of sofosbuvir in 91 developing countries. But for the millions of people in the 51 middle-income countries not covered by the licenses, the treatment will likely remain all but inaccessible. “The advent of these drugs that can cure hepatitis C is a ground-breaking achievement, but the irrational pricing makes it virtually impossible to treat millions of people around the world who are disproportionately affected, in particular, the five million living with HIV who are co-infected with hepatitis C,” said Greg Millett, amfAR Vice President and director of public policy. “Innovative strategies and open dialogue between pharmaceutical companies, national governments, patient advocates and other stakeholders will be needed to solve the problem of how to deliver effective and affordable hepatitis C treatment to the people who need it most.”

For more information: http://www.amfar.org

Hep C World News - Week of February 15, 2015

Combo regimen achieves 100% SVR12 in 6 weeks
New Haven, CT - Achillion Pharmaceuticals, Inc. announced updated interim results from the ongoing interferon-free, ribavirin-free, Phase 2 study to evaluate the efficacy, safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after completion of therapy. One hundred percent of patients (12/12) in the six-week treatment duration arm achieved SVR12, which included patients with high baseline viral load. "The ability to further shorten treatment duration to only six weeks and maintain excellent SVR12 rates remains the goal for clinicians and patients, and I am pleased that these Phase 2 results support that goal. The profile of ACH-3102, represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV," commented Professor Edward Gane, M.D., Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and Lead Investigator in the Phase 2 study of ACH-3102 and sofosbuvir and the ACH-3422 nucleotide inhibitor program. Dr. Milind Deshpande, President and Chief Executive Officer of Achillion, commented, "Our goal is to deliver short duration, widely accessible treatments to all HCV patients. We believe that these results with ACH-3102 represent the shortest duration and highest response achieved to date with any two-drug, direct-acting antiviral regimen for HCV. Given the exceptional profile of ACH-3102, we will now be evaluating four- and six-week treatment durations that leverage all of our HCV assets including ACH-3102, ACH-3422, and sovaprevir." This ongoing study is a Phase 2 open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight- and six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, once daily, in treatment-naïve genotype 1 HCV-infected patients. Initially, eighteen patients were enrolled, including six observational patients, into an eight-week treatment cohort. Following the achievement of 100 percent SVR12 (12/12) in the eight-week cohort, the six-week treatment cohort was initiated. In all, eighteen patients were enrolled, including twelve active and six observational patients. Mean baseline HCV RNA viral load was 10 million (7 log10) IU/ml, range 2 million (6.23 log10) - 97 million (7.99 log10) IU/ml, including seven patients with baseline HCV RNA viral load exceeding 6 million (6.78 log10) IU/ml. Of the 12 active patients enrolled, seven patients were genotype 1a and five were genotype 1b. Twelve weeks after the completion of therapy, 100 percent (12/12) achieved SVR12, independent of baseline viral load, gender, and IL28B status, in the six-week treatment arm. Additionally, one hundred percent of patients (12/12) in the eight-week treatment duration arm have achieved SVR24. The combination of ACH-3102 and sofosbuvir was well-tolerated with no serious adverse events, no discontinuations due to adverse events, and no clinically significant laboratory or ECG abnormalities. "The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports our belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration," commented Dr. David Apelian, Executive Vice President of Clinical Development and Chief Medical Officer at Achillion. "We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program."

For more information: http://ir.achillion.com/releases.cfm?relnav=media

Hep C World News - Week of February 8, 2015

Hepatitis C on Track to Become a Rare Disease by 2036
Pittsburgh, PA - Screening of newborn children for hepatitis C and new, more effective hepatitis C treatments may virtually eliminate the disease in the United States by 2036, according to some liver disease experts. In the US, hepatitis C virus (HCV) is the source of considerable health care costs in the form of chronic liver disease and hepatocellular carcinoma, accounting for an estimated $6.5 billion in expenditures in 2011 alone. Fortunately, according to researchers at the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh, Pennsylvania, the combination of screening initiatives and the availability of direct-acting antivirals such as sofosbuvir (Sovaldi) and simeprevir (Olysio) may change the future of HCV. Although HCV remains a common disease, affecting an estimated 2.3 million individuals in the US alone as of 2013, that number of patients is down from 3.2 million cases in 2001. The authors based their model on the recommendation from the Centers for Disease Control and Prevention and the US Preventive Services Task Force to expand HCV screening for all people born between 1945 and 1965, the so-called baby boomers. To project the future of HCV, investigators estimated the effect of one-time screening of both baby boomers and of children at birth. The authors also accounted for the increased efficacy of antiviral treatments, and based the model on data collected by the National Health and Nutrition Examination Survey between 1999 and 2002. Over the next 10 years, with implementation of one-time screening of newborns, investigators estimate that 487,000 cases of HCV infection could be identified and treated. According to investigators, universal screening of all adults would identify 933,700 cases of HCV over the same 10-year period, although universal screening was not a prerequisite of the investigators’ model. The investigators suggest that by 2036 the combination of one-time screening at birth and the use of direct-acting antivirals could be expected to transform HCV from the relatively common disease it is today to a rare disease, affecting 1 person in every 1500. Several sensitivity analyses were conducted, all of which predict virtual elimination of HCV by the year 2050. It is important to remember that these optimistic predictions hinge on implementation of coverage and screening recommendations. With the availability of new, effective medications that act directly against HCV, dramatic reductions in the prevalence of the disease and its eventual eradication are strong possibilities in the future, these investigators argue.

For more information: http://tinyurl.com/pr3bmr3

Hep C World News - Week of February 1, 2015

Gilead, AbbVie rack up new payer deals
London, UK - The hepatitis C market is breaking new ground all over the place. As payers put the squeeze on Gilead Sciences and AbbVie for discounts in the U.S., England's National Health Service is delaying a broad rollout of Gilead's blockbuster Sovaldi till July, citing the drug's high cost--an unprecedented move on a treatment already blessed by the country's cost-effectiveness watchdogs. And with AbbVie's cocktail now approved in Europe and the U.K.--under the brand names Viekirax and Exviera, rather than Viekira Pak like in the U.S.--the two drug makers will be squaring off there in country-by-country negotiations for coverage. With two U.S. discounts announced late Friday, the latest tally in the Gilead vs. AbbVie hepatitis deal-making contest is now 7-to-3 in Gilead's favor. After Humana and Harvard Pilgrim signed on with Gilead late last week, the company rolled out news of an exclusive Aetna arrangement on its combo pill Harvoni. The deal is "competitive with other recently announced agreements for this class of therapy," the insurer said (as quoted by Reuters). As the life sciences industry evolves, commercial leaders are demanding more innovative and effective customer engagement, but traditional processes limited by legacy technology are holding them back. There is a better way that puts control back in the hands of commercial leaders and eliminates the barriers to coordinated customer engagement. Meanwhile, AbbVie linked up with state-based drug programs for HIV patients, giving the purchasing group a "substantial discount" on its Viekira Pak cocktail. It's not an exclusive, but Gilead has so far been uninterested in negotiating, said Britten Pund, associate director of healthcare access for the National Alliance of State & Territorial AIDS Directors (as reported by Bloomberg). That adds to Gilead's exclusive with CVS Health and Anthem, and AbbVie's Express Scripts agreement, which kicked off the whole show.

For more information: http://tinyurl.com/lehmlsr

Hep C World News - Week of January 25, 2015

'Pay If You Clear' scheme introduced in England
London, UK - A new hepatitis C medicine, called simeprevir, is now available that the NHS in England will only pay for if patients successfully clear the virus. The 'pay if you clear' reimbursement scheme, agreed with NHS England, refunds the cost of simeprevir for patients who do not successfully clear the virus after 12 weeks. The introduction of this scheme allows patients in England, who are infected with hepatitis C virus (HCV) genotype 1, access to a new treatment option. Simeprevir is a next generation protease inhibitor (PI) that is used in combination with other medicines to treat HCV infection.1 Janssen is keen to state that the 'pay if you clear' scheme that has been agreed with NHS England is separate from the current and ongoing review by the National Institute for Health and Care Excellence (NICE). In addition, Janssen is funding pre-treatment blood tests for patients that can predict whether simeprevir is likely to be effective before treatment is initiated, and recommends that any patient not achieving a good response to triple-therapy treatment at 4 weeks should discontinue treatment. Those patients who are not likely to benefit can then be offered alternative treatments. Together, the reimbursement scheme and pre-treatment blood tests for patients will provide a framework to ensure the optimal use of simeprevir, saving NHS resources and also sparing patients from a treatment that is unlikely to clear the virus. Charles Gore, Chief Executive of The Hepatitis C Trust said: "The availability of an additional treatment option in hepatitis C is very welcome news for patients. We know that only 3 per cent of those with hepatitis C are currently receiving treatment for their infection. This leaves the majority of patients at risk of long term complications of hepatitis C infection such as cirrhosis and liver cancer." Peter Barnes, Medical Director of Janssen UK, commented: "We now have excellent clearance rates in hepatitis C. Ensuring clinicians are equipped with pre-treatment blood tests that determine which patients are most likely to benefit, and treating only those in whom the medicine is working, optimises the use of this hepatitis C medicine and hopefully improves the patient experience. It means the right patients get the right choice of medicine, at the right time and reduces the likelihood of NHS wastage. Most importantly, we believe it spares patients a course of treatment that may not clear the virus." Mark Hicken, Managing Director of Janssen UK, commented: "This unique scheme to make simeprevir and a predictive blood test available in England, with the NHS paying only for successful outcomes, is a great example of an innovative, collaborative partnership that can deliver benefits to both patients and healthcare providers.

For more information: http://www.medicalnewstoday.com/releases/288178.php

Hep C World News - Week of January 18, 2015

Gilead and AbbVie take hepatitis C battle to Europe
London, UK - Europe is to become the next battleground between Gilead Sciences and AbbVie in their scramble to win share of the fast-growing market for hepatitis C drugs. The companies have been fighting a high-profile price war in the US over a new generation of blockbuster medicines that can cure most people with the virus within weeks. The pair are preparing to open a new front across the Atlantic after European regulators gave AbbVie’s hepatitis C treatment the green light on Friday. Competition will be welcomed by public-funded European health systems that have been rattled by the high cost of Gilead’s Sovaldi medicine, which is priced at £34,983 for a 12-week course in the UK. Rick Gonzalez, AbbVie chief executive, said the company was “committed to working with local governments and healthcare systems to support broad access” to its treatment. According to the World Health Organisation there are about 15m people infected with hepatitis C in Europe — about one in 50 of the population. The disease leads to potentially life-threatening liver cirrhosis in about a third of cases.  It was announced last week that NHS England would delay full-scale introduction of Sovaldi by four months until the end of July to give it more time to prepare. Patient groups saw this as a cost-saving measure. Charles Gore, chief executive of the UK-based Hepatitis C Trust, urged European governments and health providers to use the arrival of AbbVie’s product as an opportunity to push for lower prices and wider access. He said: “Governments should say: ‘give us a better price and we will guarantee higher volumes’. Here we have a life-threatening infectious disease which is suddenly curable in most cases. So let’s find a way to give it to everyone.” The negotiating power of Europe’s single-payer health systems has already secured discounts from Gilead of more than 36 per cent over the US price of Sovaldi and the entry of AbbVie could drive deeper cuts.  AbbVie launched its product in the US at a price of $83,319 for a 12-week course — just below the price of Sovaldi and sharply less than the $94,500 charged by Gilead for a new Sovaldi-based combination treatment called Harvoni. This has triggered a discounting battle as the pair compete to sell their medicines to rival US health insurance plans.  Both companies declined to comment on their European pricing strategy.  AbbVie’s treatment was approved by the European Medicines Agency for use in patients with the genotype 1 form of hepatitis C, which represent 60 per cent of cases. The market for hepatitis C drugs is forecast by Datamonitor Healthcare to increase from $2.9bn in 2013 to $19.2bn in 2016. Of this, the top five European markets — France, Germany, Italy, Spain and the UK — accounted for $872m in 2013, rising to a forecast $4bn next year. The medicines are replacing old interferon-based treatments that have much lower success rates and more unpleasant side effects. Gilead and AbbVie have sought to justify their high prices by arguing that curing the disease saves money in the long-run by avoiding the higher cost of liver transplants and other care.

For more information: http://tinyurl.com/p4fk4q8
 

Hep C World News - Week of January 11, 2015

HCV screening in Canada could be cost effective, save lives
Ottawa, ON - New data published in the Canadian Medical Association Journal suggest that screening all Canadians aged 25 to 64 years would be cost effective and save lives.  “The screening programs that we evaluated would identify people with chronic [hepatitis C virus] infection who are asymptomatic, which would in turn allow medical treatment to be offered, if needed, according to published guidelines, ideally before development of advanced liver disease,” William W.L. Wong, PhD, of the Toronto Health Economics and Technology Assessment Collaborative and the Leslie Dan Faculty of Pharmacy at the University of Toronto, and colleagues, wrote. Wong and colleagues created a model to evaluate cost effectiveness of four screening methods: no screening; screening and treating with interferon and ribavirin; screening and treating with interferon and ribavirin, with direct-acting antiviral (DAAs); or screening with the same treatment options except for patients with genotype 1 infection, who receive an interferon-free regimen with DAAs. They found that the screen-and-treat strategies for adults aged 25 to 64 years were more costly than no screening, but they also were effective. For every 10,000 people screened, there would be approximately 63 cases of HCV identified, of which 37 (59%) would be eligible for treatment. Treating these cases would avert nine HCV-related deaths if interferon and ribavirin were used, and 18 HCV-related deaths if DAAs were used. If interferon and ribavirin were used, the health benefit was 0.0032 quality-adjusted life-years (QALYs) gained per person screened. Screening increased HCV-related costs by $124 per person, for an incremental cost-effectiveness ratio of $38,117 per QALY gained. For treatment with interferon, ribavirin and DAAs, the health benefit was 0.0063 QALYs gained per person screened and increased HCV-related costs by $267, for an incremental cost-effective ratio of $42,398 per QALY gained. Lastly, with DAA treatment alone, the health benefit was 0.0077 QALYs gained per person, a cost increase of $266 per person, and an incremental cost-effectiveness ratio of $34,783 per QALY gained.  When considering only the population aged 45 to 64 years, the cost-effectiveness ratios increased from $34,359 per QALY for treatment with interferon and ribavirin to $35,562 per QALY for treatment with interferon-free treatment with DAAs to $44,034 for interferon, ribavirin and DAA therapy.  “Early recognition of infected individuals and linkage of these people with care, treatment, alcohol and other lifestyle counseling, and other forms of support could reduce the large pool of undiagnosed HCV infections, save and prolong the lives of people with such infections, and avert the lengthy hospital stays and costs associated with HCV-related end-stage liver disease, liver transplant and hepatocellular carcinoma,” the researchers wrote. Disclosure: One researcher has received grants and/or consulting fees from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, Roche and Theravance.

For more information: http://tinyurl.com/olju3qb

Hep C World News - Week of January 4, 2015

Hepatitis C infection isn't related to HIV brain woes
St Louis, MO - Hepatitis C infection does not contribute to mental decline in people with HIV, according to a new study. Treatment advances have made it possible for people with HIV to survive much longer, but many develop memory and thinking problems, mood swings and other types of mental impairment as they age, the study authors said. It's believed that long-term infections with other viruses -- a common problem in people with HIV -- may affect the brain. One of the prime suspects has been the hepatitis C virus, which infects about one in three HIV patients in the United States, according to background information on the study. Researchers examined nearly 1,600 HIV patients -- about one-quarter of whom were also infected with hepatitis C -- and found no link between hepatitis C infection and mental decline. The study was published recently in the journal Neurology. "Hepatitis C infection has serious long-term side effects, such as damage to the liver, but our research indicates that it does not affect the brain," lead author Dr. David Clifford, a professor of neurology and medicine from Washington University School of Medicine in St. Louis, said in a university news release. He and his team will now focus on immune responses triggered by HIV in the brain and the bowel during the initial stages of infection. These early immune responses may trigger chronic inflammation that harms the brain. "If a hepatitis C infection gets to the point where it damages liver function, the resulting inflammation might well contribute to mental impairment," Clifford said. "Beyond that, though, it doesn't seem to be an active collaborator in the harm HIV does to the brain."

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_150142.html