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Real-life efficacy of generic sofosbuvir/ledipasvir for treatment of Iranian patients with chronic hepatitis C: A cohort study

Authors
  • Sharafi, Heidar1, 2
  • Alavian, Seyed Hoda2
  • Behnava, Bita2
  • Saeid Rezaee-Zavareh, Mohammad1, 2
  • Nikbin, Mehri2
  • Alavian, Seyed Moayed1, 2
  • 1 Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran
  • 2 Middle East Liver Diseases (MELD) Center, Tehran, Iran
Type
Published Article
Journal
Caspian Journal of Internal Medicine
Publisher
Babol University of Medical Sciences
Publication Date
Jan 01, 2020
Volume
11
Issue
1
Pages
41–46
Identifiers
DOI: 10.22088/cjim.11.1.41
PMID: 32042385
PMCID: PMC6992720
Source
PubMed Central
Keywords
License
Green

Abstract

Background: Treatment of hepatitis C virus (HCV) infection with recently introduced direct-acting antiviral agents (DAA) is effective and safe, however there is little known regarding safety and efficacy of generic DAAs in the real-life clinical setting. This study aimed to evaluate the efficacy and safety of generic sofosbuvir/ledipasvir (SOF/LDV) in a real-life clinical experience. Methods: In this prospective cohort study, patients with chronic HCV infection who referred to Middle East Liver Diseases (MELD) Center were included. Based on the patients’ condition, they were treated with SOF/LDV fixed-dose combination with or without ribavirin (RBV) for 12 or 24 weeks. Results: A total of 30 (M/F: 19/11) patients with chronic HCV genotype 1 infection with a mean age of 49.8 years were treated with generic SOF/LDV with (9 patients) or without (11 patients) RBV for 12 (27 patients) or 24 (3 patients) weeks. Ten (33.3%) had cirrhosis and 13 (43.3%) with a previous history of treatment with interferon (IFN)-based regimens. Among the 30 patients, 26 (86.7%, 95% CI=70.3%-94.7%) achieved a rapid virologic response, 30 (100%, 95% CI=88.7%-100%) achieved the end of treatment response and 30 (100%, 95% CI=88.7%-100%) achieved a sustained virologic response. No severe treatment adverse event was observed however, 6 (20%) patients experienced mild to moderate adverse events. Conclusion: The treatment of HCV genotype 1 infection with generic SOF/LDV found to be safe and effective even in patients with cirrhosis and previous history of treatment with IFN-based treatments.

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