TY  - JOUR
A1  - Brown, Ashley
A1  - Welzel, Tania Mara
A1  - Conway, Brian
A1  - Negro, Francesco
A1  - Bräu, Norbert
A1  - Grebely, Jason
A1  - Puoti, Massimo
A1  - Aghemo, Alessio
A1  - Kleine, Henning
A1  - Pugatch, David
A1  - Mensa, Federico J.
A1  - Chen, Yaozhu J.
A1  - Lei, Yang
A1  - Lawitz, Eric
A1  - Asselah, Tarik
T1  - Adherence to pan‐genotypic glecaprevir/pibrentasvir and efficacy in HCV‐infected patients: A pooled analysis of clinical trials
T2  - Liver international
N2  - Background & Aims: Adequate adherence to hepatitis C virus (HCV) treatment is believed to be a key component of treatment success because non‐adherence can potentially result in treatment failure and the emergence of resistant viral variants. This analysis assessed factors associated with non‐adherence to glecaprevir/pibrentasvir (G/P) therapy and the impact of non‐adherence on sustained virological response at post‐treatment week 12 (SVR12) rates in HCV genotype (GT) 1‐6‐infected patients.
Methods: Adherence was calculated by pill counts at study visits during treatment, and defined as having a lowest treatment adherence of ≥80% and ≤120% at each study visit. Exploratory logistic regression modelling assessed predictors of non‐adherence to G/P therapy. SVR12 rates by treatment adherence were assessed in the intent‐to‐treat (ITT) population and modified ITT (mITT) population, which excludes non‐virological failures.
Results: Overall, 97% (2024/2091) of patients were adherent to G/P therapy at all consecutive study visits. Alcohol use was the only baseline characteristic independently associated with non‐adherence to G/P therapy (OR: 2.38; 95% CI: 1.13‐5.01; P  = .022). In the mITT population, overall SVR12 rates were high both in patients who were adherent to G/P therapy and those who were not (99% [1983/2008] and 95% [58/61] respectively; P  = .047). Corresponding SVR12 rates in the ITT population were 98% (1983/2024) and 87% (58/67) respectively.
Conclusions: Most patients adhered to G/P therapy. SVR12 rates were high both in patients who were adherent to G/P treatment and those who were not. Patient education on treatment adherence should remain an important part of HCV treatment.
Clinical trials registration: NCT02604017, NCT02640482, NCT02640157, NCT02636595, NCT02642432, NCT02651194, NCT02243293, NCT02446717.
KW  - G/P
KW  - adherence
KW  - glecaprevir
KW  - hepatitis C virus
KW  - pibrentasvir
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/54300
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-543003
SN  - 1478-3231
N1  - This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
VL  - 40
IS  - 4
SP  - 778
EP  - 786
PB  - Wiley-Blackwell
CY  - Oxford
ER  -