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KMID : 0338420220370061167
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The Korean Journal of Internal Medicine
2022 Volume.37 No. 6 p.1167 ~ p.1175
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Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
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Lee Soon-Kyu
Lee Sung-Won
Lee Hae-Lim
Kim Hee-Yeon
Kim Chang-Wook
Song Do-Seon
Chang U-Im
Yang Jin-Mo
Yoo Sun-Hong
Kwon Jung-Hyun
Nam Soon-Woo
Kim Seok-Hwan
Song Myeong-Jun
Lee Jae-Jun
Yang Hyun
Bae Si-Hyun
Han Ji-Won
Nam Hee-Chul
Sung Pil-Soo
Jang Jeong-Won
Choi Jong-Young
Yoon Seung-Kew
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Abstract
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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 eighty-one (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.
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KEYWORD
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Hepatitis C virus, Sofosbuvir, Ledipasvir, Sustained virologic response, Genotype
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