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Sofosbuvir effectively treated patients with HCV genotypes 2, 3 in phase 3 study
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Treatment with sofosbuvir led to sustained virological response in 78% of patients with chronic hepatitis C in a phase 3 study, according to a press release from Gilead Sciences.
The company released the results of the POSITRON study, in which patients with chronic HCV genotype 2 or genotype 3 randomly were assigned 400 mg sofosbuvir once daily and weight-based ribavirin twice daily (n=207) or placebo (n=71) for 12 weeks. All participants were intolerant of, ineligible for or unwilling to take interferon-based therapy.
All participants receiving the study drug had undetectable HCV RNA during treatment, and SVR12 occurred in 78% of treated patients, including 93% of those with genotype 2 and 61% with genotype 3, compared with no patients in the placebo group. Among patients with cirrhosis, 61% achieved SVR12.
Safety results were similar to those observed in previous studies, according to the release. Common adverse events, experienced by more than 10% of participants, included anemia, fatigue, headache, nausea, insomnia and pruritis.
“Achieving a sustained virologic response in three-quarters of patients is an impressive result for a sofosbuvir-based, all-oral treatment in a group of individuals for which no suitable alternative therapy exists,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer for the company, said in the release. “We look forward to sharing data from additional phase 3 studies in early 2013, and expect to submit our first regulatory filings for sofosbuvir by mid-2013.”
The trial is the first of three planned studies assessing the nucleotide analog polymerase inhibitor in this population, according to the release. Subsequent trials will assess 12 and 16 weeks of treatment, and an additional study will include a cohort of patients with HCV genotypes 1, 4, 5 and 6 receiving sofosbuvir, pegylated interferon and ribavirin. The company also is assessing the use of the drug as part of an interferon-free treatment in combination with GS-5885, an NS5A inhibitor, in patients with HCV genotype 1.