1. The addition of sofosbuvir to peginterferon-ribavirin was effective at achieving sustained virologic response against HCV genotypes 1, 4, 5 and 6. For HCV genotypes 2 and 3, sofosbuvir and ribavirin was non-inferior to current treatment (peginterferon-ribavirin).
2. Patients treated with sofosbuvir experienced fewer adverse events overall.
Evidence Rating Level: 1 (Excellent)
Study Rundown: There are currently six hepatitis C virus (HCV) genotypes. Since the various genotypes respond differently to treatment, the genotype is one factor that influences the therapy chosen for a chronic HCV carrier. Sofosbuvir is a new HCV polymerase inhibitor that demonstrated high sustained virologic response (SVR) during phase 2 trials. In this study, sofosbuvir was successful at achieving SVR against HCV genotypes 1, 4, 5 and 6 when added to current therapies and was also non-inferior to peginterferon-ribavirin against HCV genotypes 2 and 3. Overall, groups treated with sofosbuvir experienced fewer adverse events. Rapid resistance to treatment has been an issue with past HCV treatments, and sofosbuvir continues to show promise since no viral resistance was detected with deep sequencing assays.
The major limitation to this study was the short follow up time of 12 weeks. Although there was early response to the addition of sofosbuvir, HCV is a chronic infection with various factors influencing relapse. Therefore, relapse rates beyond 12 weeks after sofosbuvir and adverse events from long-term treatment with sofosbuvir will need to be included for future studies.
In-Depth [randomized, open-label, active-control]: This two-part phase 3 trial added sofosbuvir to the current standard of care (peginterferon-ribavirin) for HCV genotypes 1, 4, 5 and 6 (NEUTRINO; n=327) and compared sofosbuvir-ribavirin to peginterferon-ribavirin for HCV genotypes 2 and 3 (FISSION; n=499). The primary endpoint was sustained virologic response at 12 weeks after the end of treatment. This was 90% for patients in the NEUTRINO study and 67% in both groups in FISSION. All common adverse events occurred at a lower rate for the sofosbuvir treated group in FISSION. With the exception of anemia, no hematologic adverse events (such as decreased lymphocyte count, neutrophil count, platelet count) were observed in the sofosbuvir-ribavirin group.
By Jonathan Liu and Mitalee Patil
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