Caspian Journal of Internal Medicine
Babol University of Medical Sciences
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Volume 11, Issue 1 (1-2020)
Caspian J Intern Med 2020, 11(1): 41-46 |
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Sharafi H, Alavian S H, Behnava B, Rezaee-Zavareh M S, Nikbin M, Alavian S M. Real-life efficacy of generic sofosbuvir/ledipasvir for treatment of Iranian patients with chronic hepatitis C: A cohort study. Caspian J Intern Med 2020; 11 (1) :41-46
URL: http://caspjim.com/article-1-1576-en.html
URL: http://caspjim.com/article-1-1576-en.html
Heidar Sharafi 
, Seyed Hoda Alavian , Bita Behnava , Mohammad Saeid Rezaee-Zavareh , Mehri Nikbin , Seyed Moayed Alavian *
, Seyed Hoda Alavian , Bita Behnava , Mohammad Saeid Rezaee-Zavareh , Mehri Nikbin , Seyed Moayed Alavian *
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran , alavian@thc.ir
Abstract: (3979 Views)
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.
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.
Type of Study: Original Article |
Subject:
Infectious Diseases
Received: 2018/07/31 | Accepted: 2019/08/28 | Published: 2019/12/15
Received: 2018/07/31 | Accepted: 2019/08/28 | Published: 2019/12/15
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