TY - JOUR
TI - High Sustained Virologic Response Rates of Glecaprevir/Pibrentasvir in
Patients With Dosing Interruption or Suboptimal Adherence
AU - Zamor, Philippe J.
AU - Brown, Ashley
AU - Dylla, Douglas E.
AU - Dillon,
AU - John F.
AU - Luetkemeyer, Anne F.
AU - Feld, Jordan J.
AU - Mutimer, David
AU - and Ghalib, Reem
AU - Crown, Eric
AU - Lovell, Sandra S.
AU - Hu, Yiran and
AU - Moreno, Christophe
AU - Nelson, David R.
AU - Colombo, Massimo and
AU - Papatheodoridis, Georgios
AU - Rockstroh, Juergen K.
AU - Skoien, Richard
AU - and Lawitz, Eric
AU - Jacobson, Ira M.
JO - The American Journal of Gastroenterology
PY - 2021
VL - 116
TODO - 9
SP - 1896-1904
PB - Lippincott, Williams & Wilkins
SN - 0002-9270
TODO - 10.14309/ajg.0000000000001332
TODO - null
TODO - INTRODUCTION: Pangenotypic, all-oral direct-acting antivirals, such as
glecaprevir/pibrentasvir (G/P), are recommended for treatment of
hepatitis C virus (HCV) infection. Concerns exist about the impact on
efficacy in patients with suboptimal adherence, particularly with
shorter treatment durations. These post hoc analyses evaluated adherence
(based on pill count) in patients prescribed 8- or 12-week G/P, the
impact of nonadherence on sustained virologic response at post-treatment
week 12 (SVR12), factors associated with nonadherence, and efficacy in
patients interrupting G/P treatment. METHODS: Data were pooled from 10
phase 3 clinical trials of treatment-naive patients with HCV genotype
1-6 without cirrhosis/with compensated cirrhosis (treatment adherence
analysis) and 13 phase 3 clinical trials of all patients with HCV
(interruption analysis). RESULTS: Among 2,149 patients included, overall
mean adherence was 99.4%. Over the treatment duration, adherence
decreased (weeks 0-4: 100%; weeks 5-8: 98.3%; and weeks 9-12: 97.1%)
and the percentage of patients with >= 80% or >= 90% adherence
declined. SVR12 rate in the intention-to-treat (ITT) population was
97.7% (modified ITT SVR12 99.3%) and remained high in nonadherent
patients in the modified ITT population (<90%: 94.4%-100%; <80%:
83.3%-100%). Psychiatric disorders were associated with <80%
adherence, and shorter treatment duration was associated with >= 80%
adherence. Among 2,902 patients in the interruption analysis, 33 (1.1%)
had a G/P treatment interruption of >= 1 day, with an SVR12 rate of
93.9% (31/33). No virologic failures occurred. DISCUSSION: These
findings support the impact of treatment duration on adherence rates and
further reinforce the concept of “treatment forgiveness” with
direct-acting antivirals.
ER -