BMC Gastroenterology (Mar 2020)

Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study

  • Phunchai Charatcharoenwitthaya,
  • Virasak Wongpaitoon,
  • Piyawat Komolmit,
  • Wattana Sukeepaisarnjaroen,
  • Pisit Tangkijvanich,
  • Teerha Piratvisuth,
  • Theeranun Sanpajit,
  • Chinnavat Sutthivana,
  • Chalermrat Bunchorntavakul,
  • Abhasnee Sobhonslidsuk,
  • Soonthorn Chonprasertsuk,
  • Chotipong Siripipattanamongkol,
  • Supatsri Sethasine,
  • Tawesak Tanwandee,
  • The THASL Collaborating Group for the Study of the Use of Direct-acting Antivirals for Chronic Hepatitis C

DOI
https://doi.org/10.1186/s12876-020-01196-0
Journal volume & issue
Vol. 20, no. 1
pp. 1 – 15

Abstract

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Abstract Background We investigated real-world effectiveness and safety of sofosbuvir and the nonstructural protein 5A inhibitors in the treatment of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, or 6. Methods We analyzed data from 1021 patients with HCV infection (506 with genotype 1; 16 with genotype 2; 314 with genotype 3; 13 with genotype 4; 166 with genotype 6) who received 12 to 24 weeks of daclatasvir plus sofosbuvir (n = 767), ledipasvir/sofosbuvir (n = 197), or sofosbuvir/velpatasvir (n = 57), with or without ribavirin in 12 centers across Thailand to estimate sustained virologic response at post-treatment week 12 (SVR12). Results Overall, SVR12 rate was 98.0% (95% confidence interval [CI], 96.7–98.8%) with daclatasvir plus sofosbuvir, 97.9% (95% CI, 94.8–99.2%) with ledipasvir/sofosbuvir, and 96.5% (95% CI, 88.1–99.0%) with sofosbuvir/velpatasvir. SVR12 was achieved by 99.2% (95% CI, 97.9–99.7%) of subjects with genotype 1 infection, 100% (95% CI, 78.5–100%) of those with genotype 2 infection, 96.7% (95% CI, 94.0–98.2%) of those with genotype 3 infection, 90.9% (95% CI, 62.3–98.4%) of those with genotype 4 infection, and 96.7% (95% CI 92.5–98.6%) of those with genotype 6 infection. Patients with advanced liver disease were at risk of treatment failure. Only four patients discontinued treatment before week 4 due to non-hepatic adverse events. Conclusions In this large cohort of patients with various HCV genotypes managed in the real-world practice setting, daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir achieved high SVR rates with good safety profile, comparable to those observed in clinical trials.

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