Monday, September 17, 2012

Sofosbuvir (GS-7977) in HIV/HCV co-infected patients...


Posted 9/17/12 on Hep Mag.com. A small interferon-free Phase Ib 7-day trial of Sofosbuvir (GS-7977) plus ribavirin in 19 HIV/HCV co-infected patients yielded some impressive initial results in a population that is definitely in need of more anti-HCV options. Sofosbuvir showed no difference in viral kinetics vs non co-infected patients, no new safety signals, no HIV viral breakthrough and no added side-effects. Hopefully the larger Phase III trial in this population will be equally impressive in its results. 

Sofosbuvir (GS-7977) Shows Promise in HIV/Hep C-Coinfected People

Gilead Sciences' experimental NS5B polymerase inhibitor sofosbuvir (GS-7977) was just as likely to rapidly reduce hepatitis C virus (HCV) levels in people coinfected with HIV, compared with those living with HCV but not HIV, in a small seven-day study presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco. The clinical trial, which enrolled HCV/HIV-coinfected and HCV-monoinfected patients residing in Puerto Rico—75 percent of whom had difficult-to-treat genotype 1 HCV infection—also noted that side effects were no different or more severe among those with living with both viruses. After a week of sofosbuvir treatment, used without other hep C medications, HCV viral loads dropped by an average of 4 log (99.99 percent). Additionally, nearly 60 percent of patients achieved undetectable HCV viral loads during the study, with 15 percent maintaining undetectable levels seven days after treatment was discontinued. Sofosbuvir appeared to work equally well against the different HCV genotypes in the study and did not hinder the effectiveness of the antiretroviral regimens being used to suppress HIV. A Phase III clinical trial of sofosbuvir plus ribavirin enrolling people living with HCV and HIV began in July and is currently recruiting volunteers.

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