Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study

MS Sulkowski, WJ Fessel, A Lazzarin, J Berenguer, N Zakharova, H Cheinquer, P Côté, D Dieterich, A Gadano, G Matthews, JM Molina, C Moreno, JA Pineda, F Pulido, A Rivero, J Rockstroh, D Hernandez, F McPhee, T Eley, Z LiuP Mendez, E Hughes, S Noviello, P Ackerman

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Daclatasvir (DCV) is a potent, pangenotypic, hepatitis C virus (HCV) non-structural protein 5A inhibitor with low potential for drug interactions with antiretroviral therapy (ART). We evaluated the safety and efficacy of DCV plus peginterferon alfa-2a/ribavirin (PegIFN/RBV) in HIV-1/HCV genotype-1-coinfected patients. METHODS: AI444043 (NCT01471574), an open-label, Phase III, single-arm, response-guided treatment (RGT) study included 301 patients. They received DCV doses of 30, 60 or 90 mg once daily (depending on concomitant ART), plus weight-based RBV (
Original languageEnglish
Pages (from-to)188-198
Number of pages11
JournalHepatology International
Volume11
Issue number2
DOIs
Publication statusPublished - 2017

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