SAN FRANCISCO, CA—Oral combination sofosbuvir (SOF) and ribavirin (RBV) therapy was “efficacious and well-tolerated” among patients with hepatitis C virus (HCV) genotype 2 or genotype 3 infection, confirmed authors of a study presented at the The Liver Meeting® 2015.
Sustained virologic responses at Week 12 (SVR12) rates in genotype 2 (GT2) patients “were higher and similar to those in pivotal studies,” reported lead study author Tania M. Welzel, MD, of the Department of Medicine, JW Goethe University Hospital in Frankfurt am Main, Germany, and coauthors. “For GT3, the lower response rates in this study, compared to clinical trials, may be attributable to a higher proportion of treatment-experienced (TE) patients with cirrhosis. The low response rates in GT3 patients indicate a need for better-optimized treatment strategies.”
In prior Phase 3 trials, treatment with SOF/RBV resulted in higher SVR for GT2 than GT3. “For GT2, SOF/RBV for 12 weeks is standard, but 16 weeks of therapy may be considered in patients with cirrhosis. For GT3, 24 weeks of treatment resulted in higher SVR,” explained Dr. Welzel.
HCV-TARGET was an international, prospective observational study collecting clinical practice data on novel direct-acting antiviral (DAA) therapies from 61 centers in the US, Canada, Germany and Israel. “This analysis includes patients who started SOF/RBV before 10/10/14 (GT2) or 7/15/14 (GT3) and for whom a known outcome is available,” Dr. Welzel noted.
A total of 316 patients had GT2 infection and 163 had GT3 infection. Twenty-six percent of the GT2 patients and 50% of the GT3 patients had cirrhosis.
“Outcomes are currently available for 297 GT2 and 144 GT3. Overall SVR12 rates were 84.0% (GT2) and 69.7% (GT3),” Dr. Welzel reported. Patients lost to follow-up included 26 (8.0%) in the GT2 group and 11 (7.0%) in the GT3 group. SVR was lowest in treatment-experienced GT3 patients with cirrhosis (44.0%) who received SOF/RBV, the researchers found.
Common adverse events affecting 10% or more of patients included fatigue, influenza-like illness, nausea, headache, insomnia, rash, anemia, and dyspnea. “Serious adverse events were reported in about 6% of patients,” noted Dr. Welzel.