TY - JOUR
T1 - Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection
AU - REACT study group
AU - Protocol Steering Committee
AU - Coordinating Centre
AU - Site Principal Investigators
AU - Matthews, Gail V.
AU - Bhagani, Sanjay
AU - Van der Valk, Marc
AU - Rockstroh, Juergen
AU - Feld, Jordan J.
AU - Rauch, Andri
AU - Thurnheer, Christine
AU - Bruneau, Julie
AU - Kim, Arthur
AU - Hellard, Margaret
AU - Shaw, David
AU - Gane, Ed
AU - Nelson, Mark
AU - Ingiliz, Patrick
AU - Applegate, Tanya L.
AU - Grebely, Jason
AU - Marks, Phillipa
AU - Martinello, Marianne
AU - Petoumenos, Kathy
AU - Dore, Gregory J.
AU - Marks, Pip
AU - Feld, Jordan
AU - Rockstroh, Jürgen
AU - Amjad, Sophia
AU - Tu, Elise
AU - Tamaddoni, Mahshid
AU - Thurnheer, Maria Christine
AU - Gilleece, Yvonne
AU - Fraser, Chris
AU - Moriggia, Alberto
AU - Lutz, Thomas
AU - Moon, Juhi
AU - Read, Phillip
AU - Kim, Arthur Y.
AU - Ustianowski, Andrew
AU - Cordes, Christiane
AU - Sasadeusz, Joe
AU - Hull, Mark
AU - Braun, Dominique
N1 - Publisher Copyright:
© 2021
PY - 2021/10/1
Y1 - 2021/10/1
N2 - Background & Aims: Shortened duration therapy for acute and recent HCV infection has been shown to be highly effective in several small non-randomised studies with direct-acting antiviral regimens; however, large randomised studies are lacking. Methods: REACT was an NIH-funded multicentre international, open-label, randomised, phase IV non-inferiority trial examining the efficacy of short course (6-week) vs. standard course (12-week) therapy with sofosbuvir-velpatasvir for recent HCV infection (estimated duration of infection ≤12 months). Randomisation occurred at week 6. The primary endpoint was sustained virological response 12 weeks after treatment end (SVR12) in the intention-to treat (ITT) population. A total of 250 participants were due to be enrolled, but on advice of the data safety and monitoring board the study was halted early. Results: The primary analysis population consisted of 188 randomised participants at termination of study enrolment; short arm (n = 93), standard arm (n = 95). Ninety-seven percent were male and 69% HIV positive. ITT SVR12 was 76/93, 81.7% (95% CI 72.4–89.0) in the short arm and 86/95, 90.5% (95% CI 82.7–95.6) in the standard arm. The difference between the arms was -8.8 (95% CI -18.6 to 1.0). In modified ITT analysis, wherein non-virological reasons for failure were excluded (death, reinfection, loss to follow-up), SVR12 was 76/85, 89.4% (95% CI 80.8–95.0) in the short arm and 86/88, 97.7% in the standard arm (95% CI 92.0–99.7; difference -8.3%, p = 0.025). Conclusions: In this randomised study in recent HCV infection, a 6-week course of sofosbuvir-velpatasvir did not meet the criteria for non-inferiority to standard 12-week therapy. Lay summary: In this randomised trial, 188 people with recently acquired hepatitis C infection were randomly assigned to treatment using either a short 6-week course (93 people) or standard 12-week course (95 people) of the hepatitis C treatment sofosbuvir/velpatasvir. There were 9 cases of relapse after treatment with the short course and 2 following the standard course. A shortened course of 6-week therapy for hepatitis C infection appeared to be less effective than a standard 12-week course in people with recently acquired hepatitis C infection. ClinicalTrials.gov Identifier: NCT02625909.
AB - Background & Aims: Shortened duration therapy for acute and recent HCV infection has been shown to be highly effective in several small non-randomised studies with direct-acting antiviral regimens; however, large randomised studies are lacking. Methods: REACT was an NIH-funded multicentre international, open-label, randomised, phase IV non-inferiority trial examining the efficacy of short course (6-week) vs. standard course (12-week) therapy with sofosbuvir-velpatasvir for recent HCV infection (estimated duration of infection ≤12 months). Randomisation occurred at week 6. The primary endpoint was sustained virological response 12 weeks after treatment end (SVR12) in the intention-to treat (ITT) population. A total of 250 participants were due to be enrolled, but on advice of the data safety and monitoring board the study was halted early. Results: The primary analysis population consisted of 188 randomised participants at termination of study enrolment; short arm (n = 93), standard arm (n = 95). Ninety-seven percent were male and 69% HIV positive. ITT SVR12 was 76/93, 81.7% (95% CI 72.4–89.0) in the short arm and 86/95, 90.5% (95% CI 82.7–95.6) in the standard arm. The difference between the arms was -8.8 (95% CI -18.6 to 1.0). In modified ITT analysis, wherein non-virological reasons for failure were excluded (death, reinfection, loss to follow-up), SVR12 was 76/85, 89.4% (95% CI 80.8–95.0) in the short arm and 86/88, 97.7% in the standard arm (95% CI 92.0–99.7; difference -8.3%, p = 0.025). Conclusions: In this randomised study in recent HCV infection, a 6-week course of sofosbuvir-velpatasvir did not meet the criteria for non-inferiority to standard 12-week therapy. Lay summary: In this randomised trial, 188 people with recently acquired hepatitis C infection were randomly assigned to treatment using either a short 6-week course (93 people) or standard 12-week course (95 people) of the hepatitis C treatment sofosbuvir/velpatasvir. There were 9 cases of relapse after treatment with the short course and 2 following the standard course. A shortened course of 6-week therapy for hepatitis C infection appeared to be less effective than a standard 12-week course in people with recently acquired hepatitis C infection. ClinicalTrials.gov Identifier: NCT02625909.
KW - HCV
KW - acute
KW - direct-acting antivirals
KW - recently acquired
KW - short duration
KW - treatment
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U2 - 10.1016/j.jhep.2021.04.056
DO - 10.1016/j.jhep.2021.04.056
M3 - Article
C2 - 34023350
AN - SCOPUS:85111885283
SN - 0168-8278
VL - 75
SP - 829
EP - 839
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 4
ER -