Sofosbuvir-/Daclatasvir-based therapy for chronic HCV and HCV/hepatitis B virus coinfected patients in Egypt

Trans R Soc Trop Med Hyg. 2020 Feb 7;114(3):200-212. doi: 10.1093/trstmh/trz079.

Abstract

Background: Dramatic advances in hepatitis C virus (HCV) treatment were witnessed with the introduction of direct-acting antivirals (DAAs). Generic DAAs with remarkable efficacy and good safety profiles are currently manufactured by local pharmaceutical companies in Egypt.

Methods: In the real-world setting, of a total of 367 patients chronically infected with HCV, 289 (277 treatment-naïve and 12 treatment-experienced) patients were enrolled. Approximately 15% of the patients were coinfected with hepatitis B virus (HBV). Patients were treated with sofosbuvir+daclatasvir with or without ribavirin for 12 or 24 wk as the standard of care. HBV DNA levels were monitored throughout the study.

Results: A sustained virologic response at 12 wk (SVR12) was achieved in 98.3% of the patients. All non-responders were treatment-naïve and the response rate among treatment-experienced patients was 100.0%. Elevated α-fetoprotein and treatment with sofosbuvir+daclatasvir+ribavirin for 6 mo were predictors of non-response (OR [95% CI] = 1.06 [1.02 to 1.1] and 15.9 [1.8 to 136.2]; p<0.05, respectively). No HBV reactivation was noticed throughout the treatment and follow-up periods in HCV/HBV coinfected patients.

Conclusion: The present real-world findings add to the evidence for the efficacy of generic DAAs for the treatment of patients infected with HCV. HBV reactivation is unlikely to occur in those coinfected with HBV. Although liver cirrhosis affected the outcome, pretreatment liver chemistry did not seem to correlate with the results of treatment.

Keywords: BMS-790052; Egypt; HCV; Ribavirin; Sofosbuvir.

MeSH terms

  • Antiviral Agents / therapeutic use*
  • Carbamates / therapeutic use*
  • Drug Therapy, Combination
  • Egypt / epidemiology
  • Genotype
  • Hepacivirus
  • Hepatitis B virus
  • Hepatitis B* / complications
  • Hepatitis B* / drug therapy
  • Hepatitis C, Chronic* / complications
  • Hepatitis C, Chronic* / drug therapy
  • Humans
  • Imidazoles / therapeutic use*
  • Pyrrolidines / therapeutic use*
  • Ribavirin / therapeutic use
  • Sofosbuvir / therapeutic use*
  • Treatment Outcome
  • Valine / analogs & derivatives*
  • Valine / therapeutic use

Substances

  • Antiviral Agents
  • Carbamates
  • Imidazoles
  • Pyrrolidines
  • Ribavirin
  • Valine
  • daclatasvir
  • Sofosbuvir