Theme: Clinical Research Year: 2018
Background:
Herein we report the integrated efficacy and safety of glecaprevir (NS3/4A protease inhibitor;
developed by AbbVie/Enanta) and pibrentasvir (NS5A inhibitor; coformulated as G/P) from ten
Phase 2/3 studies in patients with psychiatric disorders.
Methods:
Data were pooled from SURVEYOR-I and -II, MAGELLAN-I, ENDURANCE-1, -2, -3, and -4, and
EXPEDITION-1, -2 and -4 studies. Treatment-naive and -experienced patients were classified as
having a psychiatric disorder if they were taking a psychiatric medication at G/P initiation or had a
medical history of a psychiatric disorder. Efficacy was assessed as percent of patients achieving
post-treatment week-12 (SVR12: HCV RNA
concomitantly by patients with psychiatric disorders were antidepressants (396, 50%), opioids
(272, 34%), anxiolytics (244, 31%), antiepileptics (217, 28%), hypnotics/sedatives (159, 20%), and
antipsychotics (117, 15%). Overall SVR12 rates (%, n/N) were 97% for both patients with (97.3%;
768/789; 95% CI=96.2–98.5) and without psychiatric disorders (97.5%; 1689/1733; 95%CI=96.7–
98.2). Among patients with psychiatric disorders, SVR12 rates were >96% regardless of the
number of diagnosed psychiatric disorders or concomitant psychiatric drugs used. Overall, G/P
was well-tolerated in patients with psychiatric disorders with no DAA-related serious adverse
events (0/789) and <1% (5/789) adverse events leading to discontinuation of G/P.
Conclusion: Use of G/P in chronic HCV genotype 1-6 infected patients who were either receiving
concomitant CNS drugs or had a history of a psychiatric disorder was well-tolerated and achieved
high SVR12 rates
Disclosures:
David Back: Advisory board member/speakers bureau and receives honorarium from: Gilead,
Merck, Abbvie, Bristol-Myers Squibb, Janssen; received research grant funding from: Gilead,
Merck, Abbvie, Bristol-Myers Squibb, Janssen; received travel sponsorship from: Abbvie.
Pamela Belperio: Nothing to disclose.
Fiona Marra: Consulting or grants from Abbvie, Gilead, MSD, Janssen, BMS.
Francesco Negro: Advisor to Gilead, AbbVie, Merck. Unrestricted research grant from AbbVie.
Investigator initiated study supported by Gilead.
Andrew Talal: Research grants: AbbVie, Merck, Gilead, Intercept, Conatus, Abbott Laboratories;
Advisor: AbbVie, Merck, Abbott Laboratories.
Mark Bondin, Caroline Park, Yang Lei, Federico Mensa, Eric Crown are employees of AbbVie,
Inc. and may hold stock or stock options.