Ledipasvir/sofosbuvir for HCV genotype 1, 2, 4–6 infection: Real-world evidence from a nationwide registry in Taiwan

Year: 2022

Type: article

Abstract: BACKGROUND/PURPOSE: 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. METHODS: 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). RESULTS: 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. CONCLUSION: LDV/SOF is effective and well tolerated in routine clinical practice in Taiwan. Cure rates were high across patient populations.

Source: Journal of the Formosan Medical Association

DOI: 10.1016/j.jfma.2022.01.012

Institutions: St. Martin de Porres Hospital, Kaohsiung Medical University, Kaohsiung Medical University Chung-Ho Memorial Hospital, National Cheng Kung University Hospital, National Cheng Kung University, Tzu Chi University, Tzu Chi Foundation, Buddhist Tzu Chi Medical Foundation, Dalin Tzu Chi Hospital, Tri-Service General Hospital, Chang Gung University, Kaohsiung Chang Gung Memorial Hospital, Chia-Yi Christian Hospital, National Defense Medical Center, Chi Mei Medical Center, National Yang Ming Chiao Tung University, Taipei Veterans General Hospital, E-Da Hospital, I-Shou University, China Medical University, China Medical University Hospital, Mackay Memorial Hospital, Mackay Medical University, Chang Gung Memorial Hospital, Keelung Chang Gung Memorial Hospital, Linkou Chang Gung Memorial Hospital, Taipei City Hospital, Fu Jen Catholic University, Shin Kong WHS Memorial Hospital, Chiayi Chang Gung Memorial Hospital, Kaohsiung Municipal Ta-Tung Hospital, Chang Bing Show Chwan Memorial Hospital, Cathay General Hospital, Taipei Tzu Chi Hospital, Changhua Christian Hospital, Kaohsiung Veterans General Hospital, Far Eastern Memorial Hospital, Ministry of Health and Welfare, Yuan's General Hospital, Taipei Medical University Hospital, Taipei Medical University, Tainan Municipal Hospital, Tainan Hospital, Taichung Veterans General Hospital, National Taiwan University Hospital

Language: English

Topic: Hepatitis C virus research

Subfield: Hepatology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,500

OpenAlex ID: W4210478726