Ledipasvir/sofosbuvir for HCV genotype 1, 2, 4–6 infection: Real-world evidence from a nationwide registry in Taiwan
Journal
Journal of the Formosan Medical Association
Journal Volume
121
Journal Issue
8
Pages
1567-1578
Date Issued
2022
Author(s)
Lo C.-C.
Huang C.-F.
Cheng P.-N.
Tseng K.-C.
Chen C.-Y.
Kuo H.-T.
Huang Y.-H.
Tai C.-M.
Peng C.-Y.
Bair M.-J.
Chen C.-H.
Yeh M.-L.
Lin C.-L.
Lin C.-Y.
Lee P.-L.
Chong L.-W.
Hung C.-H.
Chang T.S.
Huang J.-F.
Yang C.-C.
Hu J.-T.
Lin C.-W.
Chen C.-T.
Wang C.-C.
Su W.-W.
Hsieh T.-Y.
Lin C.-L.
Tsai W.-L.
Lee T.-H.
Chen G.-Y.
Wang S.-J.
Chang C.-C.
Mo L.-R.
Yang S.-S.
Wu W.-C.
Huang C.-S.
Hsiung C.-K.
Kao C.-N.
Tsai P.-C.
Lee M.-H.
Dai C.-Y.
Chuang W.-L.
Lin H.-C.
Yu M.-L.
TACR investigators
Abstract
The Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) is a nationwide registry of chronic hepatitis C patients in Taiwan. This study evaluated antiviral effectiveness of ledipasvir (LDV)/sofosbuvir (SOF) in patients in the TACR. Patients enrolled in TACR from 2017-2020 treated with LDV/SOF were eligible. The primary outcome was the proportion of patients with sustained virologic response 12 weeks after end of treatment (SVR12). 5644 LDV/SOF ± ribavirin-treated patients were included (mean age: 61.4 years; 54.4% female). Dominant viral genotypes were GT1 (50.8%) and GT2 (39.3%). 1529 (27.1%) patients had liver cirrhosis, including 201 (3.6%) with liver decompensation; 686 (12.2%) had chronic kidney disease. SVR12 was achieved in 98.6% of the overall population and in 98.2% and 98.7% of patients with and without cirrhosis, respectively. SVR12 rates in patients with compensated cirrhosis treated with LDV/SOF without RBV were >98%, regardless of prior treatment experience. SVR12 was 98.6%, 98.4%, 100%, 100%, and 98.7% among those with GT1, GT2, GT4, GT5, and GT6 infections, respectively. Although patient numbers were relatively small, SVR12 rates of 100% were reported in patients infected with HCV GT2, GT5, and GT6 with decompensated cirrhosis and 98% in patients with severely compromised renal function. LDV/SOF adherence ≤60% (P < 0.001) was the most important factor associated with treatment failure. Incidence of adverse events was 15.8%, with fatigue being the most common. LDV/SOF is effective and well tolerated in routine clinical practice in Taiwan. Cure rates were high across patient populations.
SDGs
Publisher
Elsevier B.V.
Type
journal article