The protease inhibitor Victrelis (boceprevir), when added to a regimen of interferon and ribavirin, vastly improves cure rates of hepatitis C virus (HCV) and does not raise significant treatment risks among people coinfected with HIV, according to findings published in The Lancet and reported by the Skin & Allergy News Digital Network. The investigators conducted a double-blind, randomized, controlled Phase II trial of 99 coinfected adults who had untreated genotype 1 of hep C and an undetectable HIV viral load. The study was conducted at 30 sites throughout 2010.
The participants were randomized into two treatment groups at a ratio of one to two. All of them began with just pegylated interferon and ribavirin for four weeks. Then the smaller control group added a placebo, and the rest of the participants received Victrelis three times daily. The trial continued for 44 weeks.
Ninety-eight participants received at least one dose of treatment, including 64 in the group taking Victrelis and 34 in the control arm. Twenty-four weeks after completing treatment, 63 percent of those in the Victrelis arm achieved a sustained virologic response (SVR, considered a cure), compared with just 29 percent of the control group.
Adverse events were higher in the Victrelis group when compared with the control, including anemia (a respective 41 vs. 26 percent), fever (36 vs. 21 percent), diminished appetite (34 vs. 18 percent), a distortion in the sense of taste (28 vs. 15 percent), vomiting (28 vs. 15 percent) and neutropenia (19 vs. 6 percent), which is an abnormally low count of certain white blood cells key for fighting infections.
To read the Lancet abstract, click here.
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