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

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 ( NCT 01741545) 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 ( SVR 12). 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 SVR 12 was 92% in cohort A and 90% in cohort B. Therapy was generally well tolerated. The most common adverse events ( AE s) were related to elevations in serum transaminases and/or bilirubin. Five serious AE s, four discontinuations due to AE s, 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 .