Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
- Author:
Soon Kyu LEE
1
;
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
Author Information
- Publication Type:2
- From:The Korean Journal of Internal Medicine 2022;37(6):1167-1175
- CountryRepublic of Korea
- Language:English
-
Abstract:
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-naïve 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.