Glecaprevir/pibrentasvir in chronic HCV: an integrated analysis of patients on concomitant opioids, antipsychotics and cardiovascular medications

Document Type

Conference Proceeding

Publication Date

5-1-2025

Publication Title

J Hepatol

Abstract

Background and aims: Although glecaprevir pibrentasavir (G P) is highly effective and has a well-documented safety profile, co_administration of G P with concomitant medications that are substrates of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1 3 may result in an increased plasma concentration of these drugs. While the effect of G P on the exposures of these concomitant medications is expected to be small, herein we analyze the safety and tolerability of a subset of concomitant medications including antipsychotics (aripiprazole, quetiapine, risperidone, paliperidone, lurasidone, clozapine), cardiovascular agents (statins, beta-blockers, calcium-channel blockers, hypertensives) and opioids (fentanyl, oxycodone and hydrocodone). Method: An integrated pooled analysis was carried out across 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. Results: Among 6547 patients in this analysis, 136 patients were on antipsychotic medications, 219 received statins, 226 hypertensives, 94 beta-blockers and 44 calcium-channel blockers that had potential interactions with G P; however, none of the patients experienced a treatment-related serious adverse event (SAE). Of the 133 patients on opioids with potential interactions, 1 patient experienced a treat_ment-related SAE. Treatment discontinuations due to any AEs were rare with only 1 discontinuation in the antipsychotics class, 3 in the cardiovascular class and 3 in the opioid class. High adherence (>94%, as defined by percentage of tablets taken versus expected) was observed across these specific concomitant medication classes. Sustained virologic response at 12 weeks post-treatment (SVR12) by modified intent-to-treat (ITT; excluding patients who failed to achieve SVR12 due to reasons other than virologic failure) was 99.2% when used concomitantly with antipsychotics, 99.5% with statins, 100% with beta-blockers, calcium channel blockers and antihyper_tensive agents and 96.9% with opioids. Conclusion: This integrated pooled analysis demonstrated that G P when concomitantly administered with medications such as those belonging to the antipsychotic (aripiprazole, quetiapine, risperidone, paliperidone, lurasidone, clozapine), cardiovascular (statins, beta_blockers, calcium-channel blockers, hypertensives) and opioid class, was safe, well tolerated, and demonstrated high efficacy and adherence.

Volume

82

First Page

S851

Last Page

S852

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