Sofosbuvir, Pegylated Interferon and Ribavirin in the Treatment of an Egyptian Cohort with Hepatitis C Virus Infection in Real-Life Clinical Practice

Infect Disord Drug Targets. 2019;19(2):179-184. doi: 10.2174/1871526518666180912121835.

Abstract

Background & aims: Hepatitis C virus infection is a major public health problem in Egypt with a risk for morbidity and mortality due to chronic liver disease complications. Worldwide, Egypt has the highest prevalence of HCV infection with the overall prevalence of about 14.7%. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus Pegylated Interferon (Peg- IFNa) and Ribavirin (RBV) in Egyptian patients with chronic hepatitis C virus (HCV) infection.

Methods: This study was carried out in 1200 patients with chronic hepatitis C virus infection who were eligible for interferon therapy. They were treated with the triple therapy of sofosbuvir 400 mg once daily, Peg-INF subcutaneous injection weekly for 12 weeks in combination with oral weight-based ribavirin. The primary outcome measures were the number of patients with successful eradication of the virus evidenced by the sustained virologic response (SVR) at 12 Weeks. After discontinuation of Therapy (SVR12), the secondary outcome measures were the incidence of adverse effects associated with the tested HCV therapy.

Result: The mean age of the patients was 49.32 ± 6.97 years. 45.9% of them were males and 54.1% were females.70 patients (5.8%) had a history of previous HCV treatment. ''1077 (89.8%)'' of patients achieved successful eradication of virus while ''106 (8.8%)'' were resistant to treatment and ''17 (1.4%)'' stopped treatment. Good predictors of response to the triple therapy were female gender, treatment naive and non-cirrhotic patients.

Conclusion: The triple regimen of Pegylated interferon, sofosbuvir plus ribavirin is safe and effective in the treatment of Egyptian patients with hepatitis C virus and is associated with real-life SVR12 rates of 89.8%.

Keywords: Egypt; Hepatitis C virus; clinical practice; infection; interferon; treatment..

Publication types

  • Clinical Trial, Phase IV

MeSH terms

  • Adolescent
  • Adult
  • Antiviral Agents / therapeutic use*
  • Cohort Studies
  • Drug Therapy, Combination
  • Egypt
  • Female
  • Hepacivirus
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferon-alpha / therapeutic use*
  • Male
  • Middle Aged
  • Polyethylene Glycols / therapeutic use*
  • Recombinant Proteins / therapeutic use
  • Ribavirin / therapeutic use*
  • Sofosbuvir / therapeutic use*
  • Sustained Virologic Response
  • Treatment Outcome
  • Young Adult

Substances

  • Antiviral Agents
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • peginterferon alfa-2a
  • Sofosbuvir