SOF/VEL/VOX results in high SVR12 rates when administered for 12 weeks in DAA-experienced patients or for 8 weeks in DAA-naive patients: An integrated analysis of the POLARIS-1 POLARIS-2, POLARIS-3 and POLARIS-4 studies.
Roberts SK, Cooper CL, Lawitz E, Rajender Reddy K, Thompson AJ, Zeuzem S, Jacobson IM, Ruane P, Hyland RH, Stamm LM, Han L, Brainard DM, Yip CSM, Huang HC, Brau N, Asselah T, Willems BE, Flamm S, Bourliere M, Foster GR, Gane EJ, Manns M, Gordon SC, and Kowdley K. SOF/VEL/VOX results in high SVR12 rates when administered for 12 weeks in DAA-experienced patients or for 8 weeks in DAA-naive patients: An integrated analysis of the POLARIS-1 POLARIS-2, POLARIS-3 and POLARIS-4 studies. Gut 2018; 67:A100-A101.
Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX) was evaluated for the treatment of genotype 1-6 HCV infection in four Phase 3 studies in direct-acting antiviral (DAA)-experienced (POLARIS-1 and POLARIS-4) and DAA-naïve (POLARIS-2 and POLARIS-3) patients with and without compensated cirrhosis. DAA-experienced patients received treatment for 12 weeks, and DAA-naive patients received treatment for 8 weeks. Overall SVR12 rates were >95% across all the studies. This post-hoc analysis assesses efficacy in patients with and without traditional negative predictors of response. Methods This was a retrospective analysis of data from 1056 patients treated with SOF/VEL/VOX in the Phase 3 studies. Presence of cirrhosis was determined by histology, Fibrotest/APRI, or Fibroscan. Viral load and other clinical and laboratory assessments were determined prior to treatment with SOF/VEL/VOX. Prior treatment records were source verified and race was self-reported by the patient to the investigator. Results Overall, 38% of patients had cirrhosis, 70% had HCV RNA 800,000 IU/mL, 59% of the DAA-experienced patients had received an NS5A inhibitor-containing regimen, 20% of the DAA-naive patients had prior treatment failure with pegylated interferon +ribavirin, 12% were 65 years old and 10% were black. Conclusions The POLARIS-1, POLARIS-2, POLARIS-3, and POLARIS-4 studies enrolled a diverse patient population that included a significant number of patients with historically negative predictors of response including cirrhosis and prior exposure to DAA-containing regimens. High SVR12 rates for the ribavirin-free regimen of SOF/VEL/VOX were achieved across subgroups.