Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt

Aliment Pharmacol Ther. 2018 Feb;47(3):421-431. doi: 10.1111/apt.14428. Epub 2017 Nov 29.

Abstract

Background: Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment.

Aim: To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting.

Methods: Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented. Treatment-naïve patients without cirrhosis were treated without RBV, and those who had cirrhosis or were treatment-experienced (interferon experienced or SOF experienced) received RBV. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored.

Results: During the first 2 months of the programme, 18 378 patients with HCV-G4 started treatment with SOF-DCV with or without RBV. Overall, 95.1% achieved SVR12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV, P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal (n = 76) and pregnancy (n = 5). Five deaths occurred within this group.

Conclusions: Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • Drug Therapy, Combination / adverse effects
  • Drugs, Generic / administration & dosage*
  • Drugs, Generic / adverse effects
  • Egypt / epidemiology
  • Female
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / epidemiology
  • Humans
  • Imidazoles / administration & dosage*
  • Imidazoles / adverse effects
  • Liver Cirrhosis / drug therapy
  • Liver Cirrhosis / epidemiology
  • Liver Cirrhosis / virology
  • Male
  • Middle Aged
  • Retrospective Studies
  • Ribavirin / administration & dosage*
  • Ribavirin / adverse effects
  • Sofosbuvir / administration & dosage*
  • Sofosbuvir / adverse effects
  • Sustained Virologic Response
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Drugs, Generic
  • Imidazoles
  • Ribavirin
  • daclatasvir
  • Sofosbuvir