GLECAPREVIR/ PIBRENTASVIR IN CHRONIC HCV: AN INTEGRATED ANALYSIS OF PATIENTS ON MULTIPLE CONCOMITANT MEDICATIONS

Document Type

Conference Proceeding

Publication Date

10-9-2024

Publication Title

Hepatology

Abstract

Background: The safety of direct acting antivirals (DAAs) can be impacted by drug-drug interactions (DDIs). This integrated analysis of phase 2 and phase 3 studies uses the pangenotypic DAA regimen of glecaprevir and pibrentasvir (G/P) to analyze the efficacy and safety of glecaprevir/pibrentasvir (G/P) in the presence of multiple co-morbidities and concomitant medications. Methods: An integrated pooled analysis was carried out across twenty-one (21) randomized controlled clinical trials in patients with chronic HCV genotype 1-6 infection with or without compensated cirrhosis receiving G/P for 8, 12 or 16 weeks that were on concomitant medications. Primary analyses assessed safety and efficacy (sustained virologic response at post-treatment week 12; SVR12). Patients were stratified for analysis by number of concomitant medications, age > 65yrs, having a co-morbidity and use of injectable and other drugs (PWUD). Results: Among 6569 patients in this analysis, 1170 (17.8%) were age > 65yrs, 2049 (31.2%) had a psychiatric disorder, 300 (4.6%) had a cardiovascular disorder, 1786 (27.2%) had HIV-HCV co-infection, and 2049 (31.2%) were PWUD. 2705 patients were on > 3, 1638 patients were on > 5, 439 patients were on > 10, 138 patients were on > 15 and 59 patients were on > 20 concomitant medications. High efficacy of G/P (mITT SVR12) was observed overall (98.6%) including in patients on > 20 (98.2%) concomitant medications. Treatment emergent serious adverse events (TESAEs) occurred at low rates (overall 2.5%, range (2.4-5.1%) across all patient populations, with the most frequently reported SAE being infections, injuries/procedural complications and neoplasms. The majority of the TESAEs were considered unrelated to G/P with only 0.1% possibly related to G/P. Treatment related TESAEs in patients on > 1 concomitant medication were rare (0.1%, range0- 0.2%). Grade 3 elevations in alanine aminotransferase (ALT) or bilirubin were uncommon (0.5%, 0.1%) in the overall population as well as in patients > 65yrs of age (0.2, 0.4%), those with psychiatric comorbidities (0.5, 0.2%), cardiovascular comorbidities (0.7. 0.4%), HIVHCV co-infection (0.4, 0.1%), and PWUD (0.6, 0.1%). There were no patients with both Grade 3 ALT and Grade 3 bilirubin elevations. Conclusion: This integrated pooled analysis confirms the safety, tolerability and high efficacy of G/P in chronic HCV patients on as many as > 20 multiple concomitant medications, > 65 years of age, those with comorbidities and PWUD.

Volume

80

First Page

S372

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