Sofosbuvir/Velpatasvir/Voxilaprevir: A Review in Chronic Hepatitis C

Drugs. 2018 Apr;78(5):577-587. doi: 10.1007/s40265-018-0895-5.

Abstract

A fixed-dose combination of the hepatitis C virus (HCV) NS5B polymerase inhibitor sofosbuvir, the HCV NS5A inhibitor velpatasvir and the HCV NS3/4A protease inhibitor voxilaprevir (sofosbuvir/velpatasvir/voxilaprevir; Vosevi®) is approved in the EU for the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection in adults. In the phase III POLARIS trials, in patients who had HCV genotype 1-6 infection with or without compensated cirrhosis, overall rates of sustained virological response at 12 weeks post-treatment (SVR12) with sofosbuvir/velpatasvir/voxilaprevir were high after 8 weeks of treatment in direct-acting antiviral (DAA)-naïve patients and 12 weeks of treatment in DAA-experienced patients. However, 8 weeks of sofosbuvir/velpatasvir/voxilaprevir was inferior to 12 weeks of sofosbuvir/velpatasvir in cirrhotic or non-cirrhotic DAA-naïve patients with HCV genotype 1, 2, 4, 5 or 6 infection and non-cirrhotic DAA-naïve patients with HCV genotype 3 infection, mostly due to an insufficient treatment period. Sofosbuvir/velpatasvir/voxilaprevir was generally well tolerated, with most adverse events being of mild or moderate intensity. The most common adverse events included headache, fatigue, nausea and diarrhoea. In conclusion, sofosbuvir/velpatasvir/voxilaprevir is an important and effective option for the treatment of HCV genotype 1-6 infection in adults, especially those who have previously failed a DAA therapy with or without an HCV NS5A inhibitor.

Publication types

  • Review

MeSH terms

  • Aminoisobutyric Acids
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Carbamates / administration & dosage
  • Carbamates / adverse effects
  • Carbamates / therapeutic use*
  • Cyclopropanes
  • Drug Approval
  • Drug Combinations
  • Drug Resistance, Viral
  • Genotype
  • Hepatitis C, Chronic / drug therapy*
  • Heterocyclic Compounds, 4 or More Rings / administration & dosage
  • Heterocyclic Compounds, 4 or More Rings / adverse effects
  • Heterocyclic Compounds, 4 or More Rings / therapeutic use*
  • Humans
  • Lactams, Macrocyclic
  • Leucine / analogs & derivatives
  • Liver Cirrhosis / drug therapy
  • Macrocyclic Compounds / administration & dosage
  • Macrocyclic Compounds / adverse effects
  • Macrocyclic Compounds / therapeutic use*
  • Proline / analogs & derivatives
  • Quinoxalines
  • Sofosbuvir / administration & dosage
  • Sofosbuvir / adverse effects
  • Sofosbuvir / therapeutic use*
  • Sulfonamides / administration & dosage
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*
  • United States
  • United States Food and Drug Administration
  • Viral Nonstructural Proteins / antagonists & inhibitors*

Substances

  • Aminoisobutyric Acids
  • Antiviral Agents
  • Carbamates
  • Cyclopropanes
  • Drug Combinations
  • Heterocyclic Compounds, 4 or More Rings
  • Lactams, Macrocyclic
  • Macrocyclic Compounds
  • Quinoxalines
  • Sulfonamides
  • Viral Nonstructural Proteins
  • voxilaprevir
  • Proline
  • NS-5 protein, hepatitis C virus
  • Leucine
  • velpatasvir
  • Sofosbuvir