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Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II-III)

Journal of Viral Hepatitis Aug 24, 2017

Shafran SD, et al. – Researchers here evaluated the efficacy and safety of an investigational combination of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) plus sofosbuvir (SOF) ± ribavirin (RBV) in patients with HCV genotype 2 or 3 infection with or without cirrhosis. As per findings, in patients with genotype 3 infection, the investigational combination of OBV/PTV/r with SOF ± RBV was well tolerated and achieved high SVR rates with no virologic failures. Combining DAAs with complementary mechanisms of action and different viral targets seemed an effective treatment strategy that could allow for shorter durations of therapy.

Methods

  • Researchers randomized patients with HCV genotype 3 infection without cirrhosis to receive OBV/PTV/r + SOF ± RBV for 12 weeks; to genotype 3–infected patients with cirrhosis, OBV/PTV/r + SOF + RBV was administered for 12 weeks and to genotype 2–infected patients without cirrhosis for either 6 or 8 weeks.
  • They assessed efficacy by sustained virologic response [HCV RNA <25 IU/mL] 12 weeks post–treatment (SVR12).
  • They assessed safety in all treated patients.

Results

  • Findings revealed an overall SVR12 rate of 98% (50/51) in patients with genotype 3 infection with or without cirrhosis treated with 12 weeks of OBV/PTV/r + SOF ± RBV with no virologic failures.
  • SVR12 rates of 90% (9/10) and 44% (4/9) were observed in patients with genotype 2 infection treated with OBV/PTV/r + SOF + RBV following 8– and 6–week treatment durations, respectively; failure to achieve SVR12 for these patients was due to relapse without baseline or treatment–emergent resistance–associated substitutions.

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