Abstract
Background & AimsAdequate 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.MethodsAdherence 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.ResultsOverall, 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.ConclusionsMost 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 registrationNCT02604017, NCT02640482, NCT02640157, NCT02636595, NCT02642432, NCT02651194, NCT02243293, NCT02446717.
Highlights
Most (67% [45/67]) patients who were non‐adherent to G/P therapy had a lowest treatment adherence of 120% on at least one study visit
In the modified ITT (mITT) population, which excludes patients with non‐virological failure, there was a marginally significant difference in overall sustained virological response at post‐treatment week 12 (SVR12) rates between patients who were adherent and those who were non‐adherent to G/P therapy (Figure 1B)
The frequency of treatment‐ emergent adverse event (TEAE) was numerically higher in patients who were non‐adherent to G/P therapy versus those were who adher‐ ent (78% [52/67] vs 67% [1350/2024] respectively); the corresponding frequencies of TEAEs that were considered by the study investigator as having a reasonable possibility of being re‐ lated to study drug were similar
Summary
In response to the high burden of chronic hepatitis C virus (HCV) disease, the World Health Organization has set a goal of eliminat‐ ing chronic HCV infection as a major global public health threat by 2030.1 Well‐tolerated, simple, short‐duration, pan‐genotypic direct‐ acting antiviral (DAA) regimens with high cure rates as measured by sustained virological response at post‐treatment week 12 (SVR12) will play an important role in realizing this goal.[2,3,4] Adequate adher‐ ence to 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.[5]. Patients without cirrhosis treated for 8 weeks[22] and 96% (297/308) in patients with compensated cirrhosis treated for 12 weeks (treat‐ ment duration was 16 weeks for HCV GT3‐infected patients with prior treatment experience with interferon [IFN]/ pegylated IFN, rib‐ avirin and/or SOF [PRS] and HCV GT1‐infected patients with prior treatment experience with a non‐structural [NS] protein 5A and/or NS3/4A protease inhibitor).[23] This analysis assessed factors associated with non‐adherence to G/P therapy and the impact of non‐adherence on SVR12 rates in HCV GT1‐6‐infected patients who were enrolled in eight phase 3 clinical trials
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