PMID- 30977945 OWN - NLM STAT- MEDLINE DCOM- 20200710 LR - 20231019 IS - 1365-2893 (Electronic) IS - 1352-0504 (Print) IS - 1352-0504 (Linking) VI - 26 IP - 8 DP - 2019 Aug TI - Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. PG - 951-960 LID - 10.1111/jvh.13110 [doi] AB - Although direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection are highly efficacious and safe, treatment initiation is often limited in patients with neuropsychiatric disorders due to concerns over reduced treatment adherence and drug-drug interactions. Here, we report adherence, efficacy, safety and patient-reported outcomes (PROs) from an integrated analysis of registrational studies using the pangenotypic DAA regimen of glecaprevir and pibrentasvir (G/P). Patients with chronic HCV genotypes 1-6 infection with compensated liver disease (with or without cirrhosis) receiving G/P for 8, 12 or 16 weeks were included in this analysis. Patients were classified as having a psychiatric disorder based on medical history and/or co-medications. Primary analyses assessed treatment adherence, efficacy (sustained virologic response at post-treatment week 12; SVR12), safety and PROs. Among 2522 patients receiving G/P, 789 (31%) had a psychiatric disorder with the most common diagnoses being depression (64%; 506/789) and anxiety disorders (27%; 216/789). Treatment adherence was comparably high (>95%) in patients with and without psychiatric disorders. SVR12 rates were 97.3% (768/789; 95% CI = 96.2-98.5) and 97.5% (1689/1733; 95% CI = 96.7-98.2) in patients with and without psychiatric disorders, respectively. Among patients with psychiatric disorders, SVR12 rates remained >96% by individual psychiatric diagnoses and co-medication classes. Overall, most adverse events (AEs) were mild-to-moderate in severity with serious AEs and AEs leading to G/P discontinuation occurring at similarly low rates in both patient populations. In conclusion, G/P treatment was highly efficacious, well-tolerated and demonstrated high adherence rates in patients with chronic HCV infection and psychiatric disorders. CI - (c) 2019 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd. FAU - Back, David AU - Back D AD - University of Liverpool, Liverpool, UK. FAU - Belperio, Pamela AU - Belperio P AUID- ORCID: 0000-0002-6435-7450 AD - U.S. Department of Veterans Affairs, VA Palo Alto Healthcare System, Palo Alto, California. FAU - Bondin, Mark AU - Bondin M AD - AbbVie Inc, North Chicago, Illinois. FAU - Negro, Francesco AU - Negro F AD - University of Geneva, Geneva, Switzerland. FAU - Talal, Andrew H AU - Talal AH AUID- ORCID: 0000-0002-5565-7515 AD - Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, New York. FAU - Park, Caroline AU - Park C AD - AbbVie Inc, North Chicago, Illinois. FAU - Zhang, ZhenZhen AU - Zhang Z AD - AbbVie Inc, North Chicago, Illinois. FAU - Pinsky, Brett AU - Pinsky B AD - AbbVie Inc, North Chicago, Illinois. FAU - Crown, Eric AU - Crown E AD - AbbVie Inc, North Chicago, Illinois. FAU - Mensa, Federico J AU - Mensa FJ AD - AbbVie Inc, North Chicago, Illinois. FAU - Marra, Fiona AU - Marra F AD - University of Liverpool, Liverpool, UK. LA - eng SI - ClinicalTrials.gov/NCT02243280 SI - ClinicalTrials.gov/NCT02243293 SI - ClinicalTrials.gov/NCT02604017 SI - ClinicalTrials.gov/NCT02640482 SI - ClinicalTrials.gov/NCT02640157 SI - ClinicalTrials.gov/NCT02636595 SI - ClinicalTrials.gov/NCT02642432 SI - ClinicalTrials.gov/NCT02651194 SI - ClinicalTrials.gov/NCT02446717 SI - ClinicalTrials.gov/NCT02738138 PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190520 PL - England TA - J Viral Hepat JT - Journal of viral hepatitis JID - 9435672 RN - 0 (Aminoisobutyric Acids) RN - 0 (Antidepressive Agents) RN - 0 (Antiviral Agents) RN - 0 (Benzimidazoles) RN - 0 (Cyclopropanes) RN - 0 (Lactams, Macrocyclic) RN - 0 (Pyrrolidines) RN - 0 (Quinoxalines) RN - 0 (Sulfonamides) RN - 2WU922TK3L (pibrentasvir) RN - 9DLQ4CIU6V (Proline) RN - GMW67QNF9C (Leucine) RN - K6BUU8J72P (glecaprevir) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Aminoisobutyric Acids MH - Antidepressive Agents/therapeutic use MH - Antiviral Agents/*therapeutic use MH - Benzimidazoles/*therapeutic use MH - Cyclopropanes MH - Female MH - Genotype MH - Hepacivirus/genetics MH - Hepatitis C, Chronic/complications/*drug therapy MH - Humans MH - Lactams, Macrocyclic MH - Leucine/analogs & derivatives MH - Liver Cirrhosis/complications/drug therapy MH - Male MH - Mental Disorders/complications/*drug therapy MH - Middle Aged MH - Proline/analogs & derivatives MH - Pyrrolidines MH - Quinoxalines/*therapeutic use MH - Sulfonamides/*therapeutic use MH - Sustained Virologic Response MH - Treatment Adherence and Compliance MH - Young Adult PMC - PMC6852431 OTO - NOTNLM OT - chronic hepatitis C OT - drug interactions OT - mental disorders OT - sustained virologic response OT - treatment adherence and compliance COIS- 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, Merck, Janssen and Viiv. 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, Genfit, Center for AIDS Research, Patient-Centered Outcomes Research Institute (PCORI); Advisor: AbbVie, Merck, Abbott Diagnostics, Chronic Liver Disease Foundation; Speaker's Bureau: Chronic Liver Disease Foundation. Mark Bondin, Caroline Park, ZhenZhen Zhang, Brett Pinsky, Federico Mensa, Eric Crown are employees of AbbVie, Inc and may hold stock or stock options. EDAT- 2019/04/13 06:00 MHDA- 2020/07/11 06:00 PMCR- 2019/11/13 CRDT- 2019/04/13 06:00 PHST- 2018/09/28 00:00 [received] PHST- 2019/01/13 00:00 [revised] PHST- 2019/02/11 00:00 [accepted] PHST- 2019/04/13 06:00 [pubmed] PHST- 2020/07/11 06:00 [medline] PHST- 2019/04/13 06:00 [entrez] PHST- 2019/11/13 00:00 [pmc-release] AID - JVH13110 [pii] AID - 10.1111/jvh.13110 [doi] PST - ppublish SO - J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.