1. Daclatasvir/peginterferon lambda-1a/ribavirin in patients with chronic HCV infection and haemophilia who are treatment naïve or prior relapsers to peginterferon alfa-2a/ribavirin.
- Author
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Santagostino, E., Pol, S., Olveira, A., Reesink, H. W., Erpecum, K., Bogomolov, P., Xu, D., Critelli, L., Srinivasan, S., and Cooney, E.
- Subjects
RIBAVIRIN ,HEMOPHILIACS ,CHRONIC hepatitis C ,HEPATITIS C virus ,PATIENTS ,THERAPEUTICS - Abstract
Aim This study explores the potential role of a novel interferon-containing regimen for treatment of patients with chronic hepatitis C ( CHC) and underlying haemophilia. Methods This trial ( NCT01741545) was an open-label, non-randomized phase 3 study, which included adult haemophiliacs with hepatitis C virus ( HCV). Patients with HCV genotypes ( GT)-2 or -3 were treated with Lambda- IFN/ribavirin ( RBV)/daclatasvir ( DCV) for 12 weeks (cohort A). Patients with HCV GT-1b or -4 were treated with Lambda- IFN/ RBV/ DCV for 12 weeks, followed by Lambda- IFN/ RBV for an additional 12 weeks (cohort B). The primary endpoint was the proportion of patients with a sustained virologic response at post-treatment follow-up week 12 ( SVR12). Clinical development of Lambda- IFN was discontinued during this trial leading to study termination before a 24-week post-treatment follow-up was obtained for all participants. Results Overall, 51 patients were treated (cohort A, n = 12; cohort B, n = 39). The proportion of patients achieving SVR12 was 92% in cohort A and 90% in cohort B. Therapy was generally well tolerated. The most common adverse events ( AEs) were related to elevations in serum transaminases and/or bilirubin. Five serious AEs, four discontinuations due to AEs, and no deaths were reported. The rate of grade 3-4 bilirubin elevations was 17-18% across cohorts. Conclusion Lambda- IFN/ RBV/ DCV treatment demonstrated a high SVR rate and was generally well tolerated with a safety profile consistent with expectations for this special patient population. This study supports use of DCV as part of a combination treatment regimen for haemophiliacs with CHC. [ABSTRACT FROM AUTHOR]
- Published
- 2016
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