en Infectious Diseases Infectious Diseases Original Article Original Article <span style="font-size:14px;"><span style="font-family:times new roman;"><span style="color:#0000FF;"><strong><em>Background</em></strong><em>:</em> </span>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.<br> <span style="color:#0000FF;"><strong><em>Methods</em></strong><em>:</em></span> 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&rsquo; condition, they were treated with SOF/LDV fixed-dose combination with or without ribavirin (RBV) for 12 or 24 weeks.<br> <span style="color:#0000FF;"><strong><em>Results</em></strong><em>:</em></span> 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.<span dir="RTL"></span><br> <span style="color:#0000FF;"><strong><em>Conclusion</em></strong><em>:</em></span> 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.</span></span> Direct-acting antiviral agent, Hepatitis C, Ledipasvir, Sofosbuvir, Treatment 41 46 http://caspjim.com/browse.php?a_code=A-10-1179-1&slc_lang=en&sid=1 Heidar Sharafi heidarsharafi@gmail.com 100319475328460019910 100319475328460019910 No Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran Seyed Hoda Alavian alavian1400@yahoo.com 100319475328460019911 100319475328460019911 No Middle East Liver Diseases (MELD) Center, Tehran, Iran Bita Behnava bita_behnava@yahoo.com 100319475328460019912 100319475328460019912 No Middle East Liver Diseases (MELD) Center, Tehran, Iran Mohammad Saeid Rezaee-Zavareh dr_rezaee@live.com 100319475328460019913 100319475328460019913 No Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran Mehri Nikbin nikbin_mehri@yahoo.com 100319475328460019914 100319475328460019914 No Middle East Liver Diseases (MELD) Center, Tehran, Iran Seyed Moayed Alavian alavian@thc.ir 100319475328460019915 100319475328460019915 Yes Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran