Korean J Intern Med.
2022 Nov;37(6):1167-1175. 10.3904/kjim.2022.013.
Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
- Lee SK1,2
- Lee SW
2,3 - Lee HL2,3
- Kim HY2,3
- Kim CW2,4
- Song DS2,5
- Chang UI2,5
- Yang JM2,5
- Yoo SH1,2
- Kwon JH1,2
- Nam SW1,2
- Kim SH2,6
- Song MJ2,6
- Lee J2,7
- Yang H2,7
- Bae SH2,7
- Han JW2,8
- Nam H2,4
- Sung PS2,8
- Jang JW2,8
- Choi JY2,8
- Yoon SK2,8
- Affiliations
-
- 1Division of Hepatology, Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 2The Catholic University Liver Research Center, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 3Division of Hepatology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea
- 4Division of Hepatology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea
- 5Division of Hepatology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
- 6Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea
- 7Division of Hepatology, Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 8Division of Hepatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- KMID: 2535982
- DOI: http://doi.org/10.3904/kjim.2022.013
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.
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