Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin

Jordan J Feld, David E Bernstein, Ziad Younes, Hans Van Vlierberghe, Lois Larsen, Fernando Tatsch, Peter Ferenci, Jordan J Feld, David E Bernstein, Ziad Younes, Hans Van Vlierberghe, Lois Larsen, Fernando Tatsch, Peter Ferenci

Abstract

Background & aims: Some individuals with hepatitis C virus infection treated with direct-acting antivirals require ribavirin to maximize sustained virological response rates. We describe the clinical management of ribavirin dosing in hepatitis C virus-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin.

Methods: We performed a post hoc analysis of patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin for 12 or 24 weeks in six phase 3 trials. Multivariate stepwise logistic regression models assessed predictors associated with ribavirin dose adjustments and with developing anaemia.

Results: Of 1548 patients, 100 (6.5%) modified ribavirin dose due to haemoglobin declines, of which 99% achieved sustained virological response at 12 weeks post-treatment. Median time to first ribavirin dose reduction was 37 days. Low baseline haemoglobin was significantly associated with an increased risk of requiring ribavirin dose modification (odds ratio: 0.618 [0.518, 0.738]; P < .001) and developing anaemia (odds ratio: 0.379 [0.243, 0.593]; P < .001).

Conclusions: Ribavirin dose reductions were infrequent, occurred early in treatment, and did not impact sustained virological response at 12 weeks post-treatment. Patients with low baseline haemoglobin should be monitored for on-treatment anaemia.

Trial registration: ClinicalTrials.gov NCT01716585 NCT01715415 NCT01674725 NCT01767116 NCT01833533 NCT01704755.

Keywords: anaemia; dasabuvir; ombitasvir; paritaprevir; ribavirin.

© 2018 The Authors. Liver International Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Mean (±SE) haemoglobin level declines in patients with or without a ribavirin dose reduction following OBV/PTV/r + DSV + RBV treatment for 12 weeks (A) or 24 weeks (B). The mean plot is shown across time for haemoglobin levels in patients that received ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in six phase 3 trials

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