Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection

Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection

April 23, 2013 | Eric Lawitz, M.D., Alessandra Mangia, M.D., David Wyles, M.D., Maribel Rodriguez-Torres, M.D., Tarek Hassanein, M.D., Stuart C. Gordon, M.D., Michael Schultz, M.D., Ph.D., Mitchell N. Davis, D.O., Zeid Kayali, M.D., K. Rajender Reddy, M.D., Ira M. Jacobson, M.D., Kris V. Kowdley, M.D., Lisa Nyberg, M.D., G. Mani Subramanian, M.D., Ph.D., Robert H. Hyland, D.Phil., Sarah Arterburn, M.S., Deyuan Jiang, Ph.D., John McNally, Ph.D., Diana Brainard, M.D., William T. Symonds, Pharm.D., John G. McHutchison, M.D., Aasim M. Sheikh, M.D., Zobair Younossi, M.D., M.P.H., and Edward J. Gane, M.D.*
This article presents the results of two phase 3 studies evaluating the efficacy and safety of sofosbuvir, a nucleotide polymerase inhibitor, in previously untreated patients with chronic hepatitis C virus (HCV) infection. The first study was a single-group, open-label trial involving 327 patients with HCV genotypes 1, 4, 5, or 6, while the second study was a randomized, open-label, active-control trial involving 499 patients with HCV genotypes 2 or 3. The primary endpoint was a sustained virologic response at 12 weeks after the end of therapy. In the single-group study, a sustained virologic response was achieved in 90% of patients. In the noninferiority trial, a sustained response was reported in 67% of patients in both the sofosbuvir-ribavirin group and the peginterferon-ribavirin group. Adverse events were less common with sofosbuvir compared to peginterferon. The study concluded that sofosbuvir combined with peginterferon-ribavirin achieved high efficacy and safety in previously untreated patients with HCV infection, particularly those with genotypes 1 or 4.This article presents the results of two phase 3 studies evaluating the efficacy and safety of sofosbuvir, a nucleotide polymerase inhibitor, in previously untreated patients with chronic hepatitis C virus (HCV) infection. The first study was a single-group, open-label trial involving 327 patients with HCV genotypes 1, 4, 5, or 6, while the second study was a randomized, open-label, active-control trial involving 499 patients with HCV genotypes 2 or 3. The primary endpoint was a sustained virologic response at 12 weeks after the end of therapy. In the single-group study, a sustained virologic response was achieved in 90% of patients. In the noninferiority trial, a sustained response was reported in 67% of patients in both the sofosbuvir-ribavirin group and the peginterferon-ribavirin group. Adverse events were less common with sofosbuvir compared to peginterferon. The study concluded that sofosbuvir combined with peginterferon-ribavirin achieved high efficacy and safety in previously untreated patients with HCV infection, particularly those with genotypes 1 or 4.
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[slides] Sofosbuvir for previously untreated chronic hepatitis C infection. | StudySpace