Gilead announces topline results from phase III studies

Gilead has announced topline results from two phase III clinical trials for the compounds in combination with other medications for the treatment of chronic hepatitis C (HCV) infection.

The biopharmaceuticals company reported the Fission and Neutrino studies were carried out to evaluate a 12-week course of the once-daily nucleotide ofosbuvir  with ribavirin and in combination with ribavirin and pegylated interferon among treatment-naive patients.

Patients with genotype 2 or 3 infection were randomised to receive either a 12-week course of sofobuvir in the Fission study, or standard of care with 24 weeks of pegylated interferon.

Adverse effects recorded as part of the clinical trials were fatigue, headache, insomnia and dizziness.

Commenting on the findings, Norbert Bischofberger – executive vice president of research and development and chief scientific officer at Gilead Sciences – said: "These data support the favorable clinical profile of sofosbuvir as the backbone of a potent, safe and well-tolerated treatment regimen that is effective across a broad range of HCV patient genotypes."