What is the efficacy of sofosbuvir/velpatasvir (Epclusa) for the treatment of hepatitis C (Hep C) infection?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Sofosbuvir/velpatasvir (Epclusa)

On June 28, 2016, the FDA approved the fixed-dose combination tablet containing sofosbuvir and velpatasvir as the first agent to treat all six major forms of HCV in adults with chronic hepatitis C with and without cirrhosis. [128, 129] The safety and efficacy of Epclusa for 12 weeks was evaluated in three phase III clinical trials of 1558 subjects without cirrhosis or with compensated cirrhosis. [128] Cure was noted in 95%-99% of patients. The safety and efficacy of sofosbuvir/velpatasvir was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis, of whom 87 subjects received this agent in combination with ribavirin for 12 weeks, with 94% cure rates. [128]

For patients with decompensated cirrhosis, sofosbuvir-velpatasvir is approved for use in combination with the drug ribavirin. For treatment-naïve patients, sofosbuvir-velpatasvir is given for 12 weeks, regardless of the presence of cirrhosis. This regimen results in SVR rates of approximately 98%-99%. The most common side effects of sofosbuvir-velpatasvir include headache and fatigue. Coadministration of amiodarone with combination sofosbuvir-velpatasvir is not recommended due to the possibility of symptomatic bradycardia.

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