Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.
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Drugs in Development / Clinical Trials—Updated August 19, 2014
Tuesday, August 19, 2014
Chicago—Patients coinfected with HIV and hepatitis C virus (HCV) who received combination therapy with sofosbuvir (Sovaldi, Gilead) and ribavirin had high rates of sustained HCV virologic response 12 weeks after discontinuation of therapy, according to a recent study in the Journal of the American Medical Association (JAMA 2014;312:353-361).
The results are an encouraging development for the 7 million people worldwide who are thought to be coinfected with HIV and HCV, according to Mark S. Sulkowski, MD, a professor of medicine and medical director of the Viral Hepatitis Center at Johns Hopkins University in Baltimore.
“Hepatitis C is an important cause of morbidity and mortality among people living with HIV,” said Dr. Sulkowski, the lead investigator of the PHOTON-1 study.
Libby Harrison, program manager at Cincinnati Exchange Project, said the advocacy agency opened its door in January in an effort to combat the spread of HIV and hepatitis C. The agency offers drug addicts a safe place for a one-to-one exchange of used syringes for clean syringes.
“People who come to us are already drug addicts,” Harrison said. “Our goal is disease prevention and to be happy to see them to build a sense of trust for when they’re ready for treatment.”
"We believe that this key patent grant will provide another important anchor for Achillion's intellectual property portfolio. With the issuance of this patent for our differentiated NS5A inhibitor, ACH-3102, along with the previously granted patent for sovaprevir, our NS3/4A protease inhibitor, we are pleased to recognize the talented Achillion team that discovered and has advanced these compounds into Phase 2 trials evaluating their use in all-oral combination regimens for the treatment of chronic HCV," commented Milind Deshpande, President and Chief Executive Officer of Achillion.
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's discovery, clinical development, and commercial teams have advanced multiple novel product candidates with proven mechanisms of action into studies and toward the market. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Read complete press release here...
Monday, August 18, 2014
—Alan Franciscus, Editor-in-Chief
“Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure; virologic cure is expected to benefit chronically infected persons. Limitations of workforce and societal resources may limit the feasibility of treating all patients within a short period of time. Therefore, when such limitations exist, initiation of therapy should be prioritized first to those specific populations that will derive the most benefit or have the greatest impact on further HCV transmission. Others should be treated as resources allow.”
“Treatment is assigned the highest priority for those patients with advanced fibrosis (Metavir F3), those with compensated cirrhosis (Metavir F4), liver transplant recipients, and patients with severe extrahepatic hepatitis C.”
This is an appropriate and important recommendation. People with advanced disease and severe extrahepatic disease need to be treated as soon as possible and should be treated regardless of resources or the price of the medications.
Treating HCV in people who are HBV or HIV coinfected
People with another liver disease such as fatty liver disease, debilitating fatigue, diabetes, porphyria cutanea tarda (a severe skin condition)
This is where it gets confusing to me. The recommendations list these categories as high priority, but only where resources are available. I think this is contradictory. In other words, treat if you can, but wait if the resources are not available. Most likely this will be interpreted as ‘let’s wait.’ People who are coinfected with HIV or HBV, or coinfected with fatty liver disease, diabetes and porphyria and who are suffering from debilitating fatigue should really be given priority access to treatment regardless of resources available – resources should be made available. I just can’t imagine a medical society making recommendations to defer treatment in people with these medical conditions. But maybe I am taking the long view and the authors are looking at the short term – until other HCV medications are approved since we know that the approval is only months away?
MSM (men who have sex with men) with high-risk sexual practices
Active injection drug users
Persons on long-term hemodialysis
These are all populations that typically have very high rates of hepatitis C. It stands to reason that by treating high risk people we can prevent the transmission of hepatitis C and decrease the prevalence. But I’m still stuck on the ‘as resources are available’ portion of these recommendations.
“Populations Unlikely to Benefit from HCV Treatment”
“Patients with limited life expectancy for whom HCV therapy would not improve symptoms or prognosis do not require treatment. Chronic hepatitis C is associated with a wide range of comorbid conditions. (Butt. 2011): (Louie, 2012). Little evidence exists to support initiation of HCV treatment in patients with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. For these patients, the benefits of HCV treatment are unlikely to be realized, and palliative care strategies should take precedence. (Holmes, 2006); (Maddison, 2011)”
I included this in the article because we know that hepatitis C causes non-liver related deaths – one study estimated that hepatitis C reduced survival by more than 20 years. Unfortunately, these recommendations will only create more apathy among medical professionals, government officials, and society in general and lead to even more people dying from hepatitis C and from hepatitis C non-liver related deaths.
At first I was baffled and very angry with these recommendations. We have medications that are approved by the Food and Drug Administration that have cure rates up to 90%, with tolerable side effects and shorter treatment durations. Medical societies generally put the health of patients and society before political, monetary or any other concerns. But after reading the recommendations over and over and especially reading the following section I think I get what was driving the recommendation:
The two medications that are the current standard of care are sofosbuvir (Sovaldi) and simeprevir (Olysio), which cost $80,000 and $66,000 respectively and that is not counting any other medications that might be included. The pricing of the drugs, especially sofosbuvir, has caused uproar within the press and the government, among advocates and insurance companies and just about anyone else who has heard about the pricing. Some insurance companies are refusing to cover it. State Medicaids are refusing to provide coverage except to the sickest patients. Medicare is worried it will be bankrupted by sofosbuvir. Insurance companies are telling us it is going to cost every insured American $100 to $200 more every year on premiums. Politicians are holding meetings demanding to know why it is priced so high. Advocates are demonstrating. Scare tactics – definitely, but some of these are valid concerns.
Details are available in the NICE Appraisal Consultation Document. The agency says that Sovaldi, plus interferon and ribavirin, is for adults with genotype 1, which accounts for 46 percent of the Hepatitis C patients in the U.K. The treatment also extends to patients with genotype 3, accounting for 43 percent of patients.
However, NICE’s recommendation does not allow coverage for patients with genotype 1. This decision was made upon NICE’s measurement of the quality of patients’ remaining years while taking a medication and the cost to attain that quality. For this subgroup, Sovaldi’s cost-effectiveness was $80,000.