drugset / Trial / NCT01435044

Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection

NCT01435044

Phase 2 Completed 239 enrolled Gilead Sciences Quintiles, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).

Timeline

Start
2011-09
Primary completion
2013-04
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject PSI-352938 Small molecule 300 mg Oral
Subject Ribavirin Small molecule 1000 mg Oral
Subject Ribavirin Small molecule 1200 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral