High Sustained Virologic Response Rates of Glecaprevir/Pibrentasvir in Patients With Dosing Interruption or...

Area of Science:

• Hepatology
• Virology
• Pharmacology

Background:

• Direct-acting antivirals (DAAs) like glecaprevir/pibrentasvir (G/P) are recommended for hepatitis C virus (HCV) treatment.
• Concerns exist regarding the efficacy of shorter treatment durations with DAAs in patients with suboptimal adherence.

Purpose of the Study:

• To evaluate adherence rates in patients receiving 8- or 12-week G/P treatment for HCV.
• To assess the impact of nonadherence and treatment interruptions on sustained virologic response at post-treatment week 12 (SVR12).
• To identify factors associated with nonadherence to G/P therapy.

Main Methods:

• Post hoc analyses of pooled data from 10 phase 3 clinical trials for adherence and 13 phase 3 trials for interruptions.
• Adherence was assessed by pill count in treatment-naive patients with HCV genotypes 1-6 without cirrhosis or with compensated cirrhosis.
• SVR12 was evaluated in the intention-to-treat (ITT) and modified ITT populations.

Main Results:

• Overall mean adherence was high (99.4%), though it decreased over treatment duration.
• SVR12 rates remained high (97.7% in ITT, 99.3% in modified ITT) and were robust even in nonadherent subgroups (<90% adherence: 94.4%-100%; <80% adherence: 83.3%-100%).
• Psychiatric disorders were associated with <80% adherence, while shorter treatment duration correlated with ≥80% adherence. Treatment interruptions (≥1 day) in 33 patients resulted in a 93.9% SVR12 rate with no virologic failures.

Conclusions:

• Glecaprevir/pibrentasvir treatment demonstrates high efficacy and is forgiving of nonadherence and treatment interruptions.
• Shorter treatment durations may positively influence patient adherence to G/P therapy.
• These findings support the use of G/P for HCV treatment across various adherence levels.