Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort

J Gastroenterol Hepatol. 2021 May;36(5):1300-1308. doi: 10.1111/jgh.15324. Epub 2020 Dec 5.

Abstract

Background and aim: Real-world data on sofosbuvir/velpatasvir with and without ribavirin (SOF/VEL ± RBV), particularly among patients with genotype 3 (GT3) decompensated cirrhosis, prior treatment, coinfection, and hepatocellular carcinoma (HCC), are scarce. We aimed to assess the efficacy and safety of SOF/VEL ± RBV in a real-world setting that included both community and incarcerated GT3 hepatitis C virus (HCV) patients.

Methods: We included all GT3 HCV patients treated with SOF/VEL ± RBV in our institution. The primary outcome measure was the overall sustained virological response 12 weeks after treatment (SVR12), reported in both intention-to-treat (ITT) and per-protocol analyses. The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, and HIV/hepatitis C virus coinfection and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization.

Results: A total of 779 HCV patients were treated with 12 weeks of SOF/VEL ± RBV, of which 85% were treated during incarceration. Among the 530 GT3 HCV patients, 31% had liver cirrhosis, and 6% were treatment-experienced. The overall SVR12 for GT3 was 98.7% (95% confidence interval: 97.3%, 99.5%) and 99.2% (95% confidence interval: 98.1%, 99.8%) in ITT and per-protocol analyses, respectively. High SVR12 was also seen in ITT analysis among GT3 HCV patients with decompensated cirrhosis (88%), prior treatment (100%), HCC (100%), and HIV/hepatitis B virus coinfection (100%). Apart from one patient who developed myositis, no other serious adverse events were observed.

Conclusion: The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real-world setting. SOF/VEL with RBV may be considered for decompensated GT3 HCV patients.

Keywords: Asia; Sofosbuvir-velpatasvir; cirrhosis; decompensated; failure; genotype; hepatitis C virus; incarceration; liver cancer; ribavirin.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Carbamates / administration & dosage*
  • Coinfection
  • Drug Therapy, Combination
  • Female
  • Genotype*
  • HIV Infections
  • Hepacivirus / genetics*
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology*
  • Heterocyclic Compounds, 4 or More Rings / administration & dosage*
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Ribavirin / administration & dosage
  • Sofosbuvir / administration & dosage*
  • Sustained Virologic Response
  • Treatment Outcome

Substances

  • Carbamates
  • Heterocyclic Compounds, 4 or More Rings
  • Ribavirin
  • velpatasvir
  • Sofosbuvir