Industry News

Phase 3 trials for sofosbuvir/ribavirin produced SVR12 in HCV patients

Patients in Japan with genotype 2 hepatitis C virus infection assigned sofosbuvir and ribavirin achieved sustained virologic response in a phase 3 clinical trial, according to a press release from Gilead Sciences.

Ninety-seven percent of study participants (n=153) reached sustained virologic response (SVR) at 12 weeks after completing once-daily therapy with sofosbuvir (Sovaldi, Gilead Sciences) and ribavirin (RBV). Patients’ hepatitis C virus (HCV) became undetectable by the fourth week of treatment and remained undetectable through the remainder of the 12-week program in all participants, according to the release.

SVR12 rates among treatment-naive and treatment-experienced patients were 98% and 95%, respectively. There were five relapses, and the most common adverse events consistent with the population and safety profile of RBV included nasopharyngitis, anemia, headache, malaise and pruritis. Full trial results will be presented at a future meeting, Gilead said.

“This study confirms the high efficacy of all-oral therapy with sofosbuvir among genotype 2 hepatitis C patients in Japan, regardless of whether they are treatment experienced or new to treatment,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead, said in the release. “Based on these trial results, Gilead anticipates submitting a new drug application for sofosbuvir to the Japanese Pharmaceutical and Medical Devices Agency by mid-2014.”

According to the release, an estimated 2 million people in Japan have HCV infection, including 20% to 30% with genotype 2.

Sofosbuvir, a NS5B polymerase inhibitor, was approved by the FDA in December 2013.

Patients in Japan with genotype 2 hepatitis C virus infection assigned sofosbuvir and ribavirin achieved sustained virologic response in a phase 3 clinical trial, according to a press release from Gilead Sciences.

Ninety-seven percent of study participants (n=153) reached sustained virologic response (SVR) at 12 weeks after completing once-daily therapy with sofosbuvir (Sovaldi, Gilead Sciences) and ribavirin (RBV). Patients’ hepatitis C virus (HCV) became undetectable by the fourth week of treatment and remained undetectable through the remainder of the 12-week program in all participants, according to the release.

SVR12 rates among treatment-naive and treatment-experienced patients were 98% and 95%, respectively. There were five relapses, and the most common adverse events consistent with the population and safety profile of RBV included nasopharyngitis, anemia, headache, malaise and pruritis. Full trial results will be presented at a future meeting, Gilead said.

“This study confirms the high efficacy of all-oral therapy with sofosbuvir among genotype 2 hepatitis C patients in Japan, regardless of whether they are treatment experienced or new to treatment,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead, said in the release. “Based on these trial results, Gilead anticipates submitting a new drug application for sofosbuvir to the Japanese Pharmaceutical and Medical Devices Agency by mid-2014.”

According to the release, an estimated 2 million people in Japan have HCV infection, including 20% to 30% with genotype 2.

Sofosbuvir, a NS5B polymerase inhibitor, was approved by the FDA in December 2013.