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BibTex format

@article{Cooke:2021:10.12688/wellcomeopenres.16594.2,
author = {Cooke, GS and Pett, S and McCabe, L and Jones, C and Gilson, R and Verma, S and Ryder, SD and Collier, JD and Barclay, ST and Ala, A and Bhagani, S and Nelson, M and Ch'Ng, C and Stone, B and Wiselka, M and Forton, D and McPherson, S and Halford, R and Nguyen, D and Smith, D and Ansari, A and Dennis, E and Hudson, F and Barnes, EJ and Walker, AS},
doi = {10.12688/wellcomeopenres.16594.2},
journal = {Wellcome Open Res},
title = {Strategic treatment optimization for HCV (STOPHCV1): a randomised controlled trial of ultrashort duration therapy for chronic hepatitis C.},
url = {http://dx.doi.org/10.12688/wellcomeopenres.16594.2},
volume = {6},
year = {2021}
}
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TY  - JOUR
AB  - Background: The World Health Organization (WHO) has identified the need for a better understanding of which patients with hepatitis C virus (HCV) can be cured with ultrashort course HCV therapy. Methods: A total of 202 individuals with chronic HCV were randomised to fixed-duration shortened therapy (8 weeks) vs variable-duration ultrashort strategies (VUS1/2). Participants not cured following first-line treatment were retreated with 12 weeks' sofosbuvir/ledipasvir/ribavirin. The primary outcome was sustained virological response 12 weeks (SVR12) after first-line treatment and retreatment. Participants were factorially randomised to receive ribavirin with first-line treatment. Results: All evaluable participants achieved SVR12 overall (197/197, 100% [95% CI 98-100]) demonstrating non-inferiority between fixed-duration and variable-duration strategies (difference 0% [95% CI -3.8%, +3.7%], 4% pre-specified non-inferiority margin). First-line SVR12 was 91% [86%-97%] (92/101) for fixed-duration vs 48% [39%-57%] (47/98) for variable-duration, but was significantly higher for VUS2 (72% [56%-87%] (23/32)) than VUS1 (36% [25%-48%] (24/66)). Overall, first-line SVR12 was 72% [65%-78%] (70/101) without ribavirin and 68% [61%-76%] (69/98) with ribavirin (p=0.48). At treatment failure, the emergence of viral resistance was lower with ribavirin (12% [2%-30%] (3/26)) than without (38% [21%-58%] (11/29), p=0.01). Conclusions: Unsuccessful first-line short-course therapy did not compromise retreatment with sofosbuvir/ledipasvir/ribavirin (100% SVR12). SVR12 rates were significantly increased when ultrashort treatment varied between 4-7 weeks rather than 4-6 weeks. Ribavirin significantly reduced resistance emergence in those failing first-line therapy. ISRCTN Registration: 37915093 (11/04/2016).
AU  - Cooke,GS
AU  - Pett,S
AU  - McCabe,L
AU  - Jones,C
AU  - Gilson,R
AU  - Verma,S
AU  - Ryder,SD
AU  - Collier,JD
AU  - Barclay,ST
AU  - Ala,A
AU  - Bhagani,S
AU  - Nelson,M
AU  - Ch'Ng,C
AU  - Stone,B
AU  - Wiselka,M
AU  - Forton,D
AU  - McPherson,S
AU  - Halford,R
AU  - Nguyen,D
AU  - Smith,D
AU  - Ansari,A
AU  - Dennis,E
AU  - Hudson,F
AU  - Barnes,EJ
AU  - Walker,AS
DO  - 10.12688/wellcomeopenres.16594.2
PY  - 2021///
SN  - 2398-502X
TI  - Strategic treatment optimization for HCV (STOPHCV1): a randomised controlled trial of ultrashort duration therapy for chronic hepatitis C.
T2  - Wellcome Open Res
UR  - http://dx.doi.org/10.12688/wellcomeopenres.16594.2
UR  - https://www.ncbi.nlm.nih.gov/pubmed/34405118
VL  - 6
ER  -
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