Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study

• Published in: The Korean journal of internal medicine Vol. 37; no. 6; pp. 1167 - 1176
• Main Authors: Soon Kyu Lee, Sung Won Lee, Hae Lim Lee, Hee Yeon Kim, Chang Wook Kim, Do Seon Song, U Im Chang, Jin Mo Yang, Sun Hong Yoo, Jung Hyun Kwon, Soon Woo Nam, Seok-Hwan Kim, Myeong Jun Song, Jaejun Lee, Hyun Yang, Si Hyun Bae, Ji Won Han, Heechul Nam, Pil Soo Sung, Jeong Won Jang, Jong Young Choi, Seung Kew Yoon
• Format: Journal Article
• Language: Korean
• Published: 대한내과학회 30.11.2022
• Subjects: Genotype; Hepatitis C virus; Ledipasvir; Sofosbuvir; Sustained virologic response
• ISSN: 1226-3303; 2005-6648

Background/Aims: To evaluate the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) therapy in hepatitis C virus (HCV)-infected Korean patients in a real clinical setting. Methods: A total of 273 patients who received LDV/SOF therapy between May 2016 and February 2021 were consecutively enrolled and analyzed. A per-protocol analysis was performed to evaluate the virologic response. Results: Seventy-five percent were infected with genotype 1, and 25% were infected with genotype 2. A hundred eightyone (66.3%) patients had chronic hepatitis, 74 (27.1%) had compensated cirrhosis, eight (2.9%) had decompensated cirrhosis, and 10 (3.7%) had undergone liver transplantation. Undetectable HCV RNA at week 4 was achieved in 90.2% (231/256) of patients, 99.2% (250/252) achieved the end of treatment response, and 98.1% (202/206) achieved sustained virologic response at 12 weeks post-treatment (SVR12). According to liver function, the SVR12 rates were 99.3% (135/136) in chronic hepatitis, 96.4% (53/55) in compensated cirrhosis, and 100% (6/6) in decompensated cirrhosis. The SVR12 rates according to the genotype were 98.2% (167/170) for genotype 1 and 97.2% (35/36) for genotype 2. An 8-week LDV/SOF treatment in treatment-naive chronic hepatitis patients with HCV RNA < 6,000,000 IU/mL at baseline resulted in 100% (23/23) SVR12 rates. Overall, LDV/SOF was tolerated well, with a 0.7% (2/273) discontinuation rate due to adverse events that were unrelated to LDV/SOF. Conclusions: LDV/SOF is effective and safe for treating HCV-infected Korean patients with high SVR12 rates.