Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial
Gregory J Dore, Jordan J Feld, Alex Thompson, Marianne Martinello, Andrew J Muir, Kosh Agarwal, Beat Mullhaupt, Heiner Wedemeyer, Karine Lacombe, Gail V Matthews, Michael Schultz, Marina Klein, Christophe Hezode, Gerard Estivill Mercade, Danny Kho, Kathy Petoumenos, Philippa Marks, Fernando Tatsch, Ana Gabriela Pires Dos Santos, Ed Gane Show all
Journal of Hepatology | ELSEVIER | Published : 2020
BACKGROUND & AIMS: Direct-acting antiviral (DAA) therapy for HCV has high efficacy and limited toxicity. We hypothesised that the efficacy of glecaprevir-pibrentasvir for chronic HCV with a simplified treatment monitoring schedule would be non-inferior to a standard treatment monitoring schedule. METHODS: In this open-label multicentre phase IIIb trial, treatment-naïve adults with chronic HCV without cirrhosis were randomly assigned (2:1) to receive glecaprevir-pibrentasvir 300 mg-120 mg daily for 8 weeks administered with a simplified or standard monitoring strategy. Clinic visits occurred at baseline and post-treatment week 12 in the simplified arm, and at baseline, week 4, week 8, and pos..View full abstract
This study was an investigator-initiated trial primarily funded by AbbVie.