BibTex format
@article{Cooke:2025:10.1016/s0140-6736(25)00097-2,
author = {Cooke, GS and Hung, LM and Flower, B and McCabe, L and Hang, VTK and Thu, VT and Thuan, DT and Dung, NT and Phuong, LT and Khoa, DB and An, NTC and Thach, PN and Huong, VTT and Bich, DT and Tuyen, NK and Ansari, MA and Le, Ngoc C and Quang, VM and Phuong, NTN and Thao, LT and Tran, NB and Kestelyn, E and Kingsley, C and Van, Doorn R and Rahman, M and Pett, SL and Thwaites, GE and Barnes, E and Day, JN and Chau, NVV and Walker, AS},
doi = {10.1016/s0140-6736(25)00097-2},
journal = {The Lancet},
title = {Treatment options to support the elimination of hepatitis C: an open-label, factorial, randomised controlled non-inferiority trial},
url = {http://dx.doi.org/10.1016/s0140-6736(25)00097-2},
year = {2025}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - BackgroundWHO recommends treating hepatitis C infection with one of three antiviral combinations for 8–12 weeks. No randomised trials have compared these regimens, and high cure rates might be achievable with shorter durations of therapy. We aimed to compare sofosbuvir–daclatasvir with sofosbuvir–velpatasvir, and to evaluate potential novel treatment strategies.MethodsWe conducted a multi-arm, open-label, randomised controlled non-inferiority trial in two public hospitals in Viet Nam. Adults (aged ≥18 years) with chronic hepatitis C infection and mild-to-moderate liver fibrosis were eligible. Recruitment was stratified by centre and viral genotype (1–5 vs 6) with 1:1 random allocation to an oral fixed-dose combination of sofosbuvir 400 mg plus daclatasvir 60 mg (sofosbuvir–daclatasvir) or sofosbuvir 400 mg plus velpatasvir 100 mg (sofosbuvir–velpatasvir). Participants were simultaneously factorially randomly assigned to one of four treatment strategies: 12 weeks’ standard of care (SOC); 4 weeks’ therapy with four weekly PEGylated interferon alfa-2a subcutaneous injections; induction and maintenance therapy with 2 weeks’ standard therapy followed by 10 weeks’ therapy 5 days a week; and response-guided therapy (RGT) for 4, 8, or 12 weeks determined by viral load on day 7. The primary outcome was sustained virological response (SVR) 12 weeks after treatment completion, analysed in all evaluable participants regardless of actual treatment received. We chose a 5% non-inferiority margin for the drug comparison, and a 10% non-inferiority margin for the treatment strategy comparisons. Safety was assessed in all randomised participants. This trial is registered with ISRCTN, 61522291, and is completed.FindingsBetween June 19, 2020, and May 10, 2023, 624 participants were randomised (470 [75%] were male and 154 [25%] were female). 296 (47%) had genotype 6 and 328 (53%) had genotypes 1–5. The primary outcome w
AU - Cooke,GS
AU - Hung,LM
AU - Flower,B
AU - McCabe,L
AU - Hang,VTK
AU - Thu,VT
AU - Thuan,DT
AU - Dung,NT
AU - Phuong,LT
AU - Khoa,DB
AU - An,NTC
AU - Thach,PN
AU - Huong,VTT
AU - Bich,DT
AU - Tuyen,NK
AU - Ansari,MA
AU - Le,Ngoc C
AU - Quang,VM
AU - Phuong,NTN
AU - Thao,LT
AU - Tran,NB
AU - Kestelyn,E
AU - Kingsley,C
AU - Van,Doorn R
AU - Rahman,M
AU - Pett,SL
AU - Thwaites,GE
AU - Barnes,E
AU - Day,JN
AU - Chau,NVV
AU - Walker,AS
DO - 10.1016/s0140-6736(25)00097-2
PY - 2025///
SN - 0140-6736
TI - Treatment options to support the elimination of hepatitis C: an open-label, factorial, randomised controlled non-inferiority trial
T2 - The Lancet
UR - http://dx.doi.org/10.1016/s0140-6736(25)00097-2
UR - https://doi.org/10.1016/s0140-6736(25)00097-2
ER -