The study, which is the first of three phase 3 studies, had found that 78% of patients remained HCV RNA undetectable after completing the course and the safety profile of sofosbuvir was also the same as in the previous studies.
Gilead Sciences chief scientific officer and research and development executive vice president Norbert Bischofberger said achieving a sustained virologic response in three quarters of patients is good result for a sofosbuvir-based, all-oral treatment in a group of individuals for which no suitable alternative therapy exists.
"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," Bischofberger added.
Sofosbuvir is a once-daily nucleotide analog polymerase inhibitor to treat HCV infection.