• Antiviral therapy · Jan 2016

    Clinical Trial

    Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies.

    • Marianne Martinello, Margaret Hellard, David Shaw, Kathy Petoumenos, Tanya Applegate, Jason Grebely, Barbara Yeung, Laurence Maire, David Iser, Andrew Lloyd, Alexander Thompson, Joe Sasadeusz, Paul Haber, Gregory J Dore, and Gail V Matthews.
    • Viral Hepatitis Clinical Research Program, The Kirby Institute, UNSW Australia, Sydney, NSW, Australia. mmartinello@kirby.unsw.edu.au.
    • Antivir. Ther. (Lond.). 2016 Jan 1; 21 (5): 425-34.

    BackgroundIndividuals with recent HCV infection may benefit from shortened duration therapy. These studies evaluated the efficacy and safety of response-guided regimens with pegylated interferon-α2a and ribavirin for people with recent HCV infection.MethodsParticipants with recent hepatitis C (duration of infection ≤18 months) enrolled in the ATAHC II (pegylated interferon-α2a ± ribavirin) and DARE-C I (pegylated interferon-α2a, ribavirin and telaprevir) studies were included for analysis. Treatment duration was response-guided (ATAHC II: 8, 16, 24 or 48 weeks; DARE-C I: 8, 12 or 24 weeks) and dependent on time to first undetectable HCV RNA using Roche Taqman HCV RNA testing. The primary efficacy end point was sustained virological response at 12 weeks (SVR12) by intention-to-treat. Logistic regression analyses were used to identify predictors of SVR.ResultsA total of 82 participants (62% HIV-positive) were enrolled in ATAHC II (treated, n=52) and 14 (79% HIV-positive) in DARE-C I. The predominant modes of HCV acquisition were injecting drug use (ATAHC II 55%, DARE-C I 36%) and sexual intercourse with a partner of the same sex (ATAHC II 39%, DARE-C I 64%). SVR12 was 71% in both ATAHC II (37/52) and DARE-C I (10/14) with 56% in ATAHC II receiving shortened therapy (8 or 16 weeks). SVR was associated with a rapid virological response (odds ratio 10.80; P=0.001).ConclusionsThe majority of participants were able to receive short duration response-guided therapy with pegylated interferon-α2a and ribavirin. Response-guided therapy for recent hepatitis C infection could be considered in the absence of available interferon-free therapies. ClinicalTrials.gov registry (ATAHC II: NCT01336010; DARE-C I: NCT01743521).

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