Sofosbuvir plus simeprevir for the treatment of genotype 1 chronic hepatitis C: a review of evidence

Expert Rev Gastroenterol Hepatol. 2016 Nov;10(11):1289-1303. doi: 10.1080/17474124.2016.1236682. Epub 2016 Sep 21.

Abstract

Sofosbuvir (SOF) with simeprevir (SIM) combination was the first interferon-free regimen that reached optimal results in terms of sustained viral response (SVR). Areas covered: A systematic review of the scientific literature concerning the effects that the SOF/SIM combination had on hepatitis C genotype 1 patients yielded 771 references. After the revision process, four clinical trials and 15 observational studies met the inclusion criteria; in total, these studies involved 5,766 patients. The SVR ranged from 67% to 100% depending on the patients' viral subtype and cirrhosis status. Adverse effects were common, but treatment discontinuation related to drug toxicity occurred in less than 5% of cases. Expert commentary: The SOF/SIM combination exhibits efficacy and tolerability profiles that are similar to those of the other available interferon-free combinations used for non-cirrhotic genotype 1b patients. Meanwhile, for patients with advanced cirrhosis or genotype 1a, this approach cannot be considered a routine treatment option due to the unsatisfactory results.

Keywords: Chronic hepatitis C; direct acting antivirals; genotype 1; pegylated interferon; protease inhibitors; ribavirin; simeprevir; sofosbuvir; systematic review.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Antiviral Agents / adverse effects
  • Antiviral Agents / pharmacokinetics
  • Antiviral Agents / therapeutic use*
  • Drug Resistance, Viral
  • Drug Therapy, Combination
  • Genotype
  • Hepacivirus / drug effects*
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / diagnosis
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology
  • Humans
  • Patient Selection
  • Risk Factors
  • Simeprevir / adverse effects
  • Simeprevir / pharmacokinetics
  • Simeprevir / therapeutic use*
  • Sofosbuvir / adverse effects
  • Sofosbuvir / pharmacokinetics
  • Sofosbuvir / therapeutic use*
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Simeprevir
  • Sofosbuvir