Real-World Data from Turkey: Is Sofosbuvir/Ledipasvir With or Without Ribavirin Treatment for Chronic Hepatitis C Really Effective?

Turk J Gastroenterol. 2021 Feb;32(2):155-163. doi: 10.5152/tjg.2020.19569.

Abstract

Background: In this study, we aimed to investigate the efficacy and safety of sofosbuvir-based therapies in the treatment of chronic hepatitis C in real-world clinical practice.

Methods: Data from patients with chronic hepatitis C treated with SOF/LDV ± RBV or SOF/RBV in 31 centers across Turkey between April 1, 2017, and August 31, 2018, were recorded in a nationwide database among infectious disease specialists. Demographics, clinical, and virological outcomes were analyzed.

Results: A total of 552 patients were included in the study. The mean age of the patients was 51.28 ± 14.2, and 293 (55.8%) were female. The majority had HCV genotype 1b infection (65%), 75.04% of the patients underwent treatment, and non-cirrhosis was present at baseline in 381 patients (72.6%). SOF/LDV ± RBV treatment was given to 477 patients and 48 patients received SOF/RBV according to HCV genotype. The total SVR12 rate was 99% in all patients. Five patients experienced disease relapse during the study and all of them were genotype 2. In patients infected with HCV GT2, SVR12 was 77.3%. SVR was 100% in all patients infected with other HCV genotypes. All treatments were well tolerated by patients without causing severe adverse events. Side effects and side effects-associated treatment discontinuation rates were 28.2% and 0.4%, respectively. Weakness (13.7%) was the common side effect.

Conclusion: The present real-world data of 525 patients with HCV genotypes 1, 1a, 1b, 3, 4, and 5 who underwent SOF/LDV ± RBV treatment in Turkey demonstrated a high efficacy and safety profile. HCV GT2 patients should be treated with more efficacious treatment.

MeSH terms

  • Antiviral Agents / adverse effects
  • Benzimidazoles / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Fluorenes / therapeutic use*
  • Genotype
  • Hepacivirus / genetics
  • Hepatitis C* / drug therapy
  • Hepatitis C, Chronic* / drug therapy
  • Humans
  • Ribavirin / adverse effects
  • Sofosbuvir / therapeutic use*
  • Treatment Outcome
  • Turkey

Substances

  • Antiviral Agents
  • Benzimidazoles
  • Fluorenes
  • ledipasvir
  • Ribavirin
  • Sofosbuvir

Grants and funding

There isn’t financial support.