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PUBLIC RELEASE DATE:
19-Jul-2014

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Contact: Lauren Nelson
lnelso35@jhmi.edu
410-955-8725
The JAMA Network Journals
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Combination treatment for Hep C associated with favorable response among patients with HIV

HIV-infected patients also infected with hepatitis C virus (HCV) who received a combination of the medications sofosbuvir plus ribavirin had high rates of sustained HCV virologic response 12 weeks after cessation of therapy, according to a study in the July 23/30 issue of JAMA, a theme issue on HIV/AIDS. The issue is being released early to coincide with the International AIDS Conference.

Up to 7 million persons worldwide are infected with both human immunodeficiency virus (HIV) and hepatitis C virus. Treatment of this coinfection has been limited due to the need to use interferon (an antiviral protein used to treat HCV) and drug interactions with antiretroviral therapies (ARTs), according to background information in the article.

Mark S. Sulkowski, M.D., of Johns Hopkins University, Baltimore, and colleagues evaluated the rates of sustained virologic response (SVR) (what is clinically considered "cure") and adverse events in 223 patients infected with HIV and HCV (genotypes 1, 2, or 3) who were treated with an interferon-free combination of the drugs sofosbuvir and ribavirin for 12 or 24 weeks. The trial was conducted at 34 treatment centers in the United States and Puerto Rico from August 2012 to November 2013.

Among participants with no prior treatment for HCV, 76 percent with genotype 1, 88 percent with genotype 2, and 67 percent with genotype 3 achieved SVR12 (serum HCV <25 copies/mL 12 weeks after cessation of HCV therapy). Among patients who had previously received treatment, 92 percent with genotype 2 and 94 percent with genotype 3 achieved SVR12.

Seven patients (3 percent) discontinued HCV treatment due to adverse events, of which the most common were fatigue, insomnia, headache, and nausea. No adverse effect on HIV disease or its treatment was observed.

"In this open-label, nonrandomized, uncontrolled study, HIV-infected patients with HCV genotypes 1, 2, or 3 coinfection who received an oral combination of sofosbuvir plus ribavirin for 12 or 24 weeks had high rates of sustained HCV virologic response 12 weeks after cessation of therapy," the authors write. "Further studies of this regimen in more diverse populations of coinfected patients are needed." (doi:10.1001/jama.2014.7734; Available pre-embargo to the media at http://media.jamanetwork.com)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

There will also be a digital news release available for this study, including the JAMA Report video, embedded and downloadable video, audio files, text, documents, and related links. This content will be available at 10 a.m. CT Saturday, July 19 at this link.

Editorial: Quantum Leaps, Microeconomics, and the Treatment of Patients With Hepatitis C and HIV Coinfection

Michael S. Saag, M.D., of the University of Alabama School of Medicine, Birmingham, writes in an accompanying editorial that although this study (PHOTON-l) represents a quantum leap forward in the treatment of patients coinfected with HIV and HCV, the current cost of the regimen makes wide-spread use unaffordable.

"When combined with ribavirin, the average wholesale price of a 12- week course of treatment is $94,500 and $189,000 for a 24-week course, as used in the PHOTON-l study. Industry analysts indicate that the pricing of the drug is not based on the cost of ingredients or the duration of therapy, but rather the 'cost per cure.' With more than 185 million HCV seropositive people worldwide with HCV infection and with 4.4 million HCV seropositive persons in the United States, the world simply cannot afford to pay on a 'cost per cure' basis, especially when the majority of persons with chronic infection, an estimated 75 percent, do not progress to cirrhosis or end-stage liver disease over 20 to 30 years."

"Hopefully, competition among the new products coming to market in the next 18 months will result in substantially lower pricing for the drugs. Indeed, the release of the new products will be, perhaps for the first time, a genuine test of whether there is a free market, microeconomic system in the pharmaceutical industry."

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(doi:10.1001/jama.2014.7734; Available pre-embargo to the media at http://media.jamanetwork.com)

Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.



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