1965. Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients With Chronic Hepatitis C Virus Genotypes 1–6 and Human Immunodeficiency Virus-1 Co-Infection: An Integrated Analysis of Two Phase 3 Clinical Trials

BACKGROUND: People co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV)-1 may be treated for HCV without special considerations apart from drug interactions with antiretroviral therapies (ART). The once-daily, all-oral, ribavirin-free, pangenotypic combination of glecaprevir (identified by AbbVie and Enanta) and pibrentasvir has shown high sustained virologic response at post-treatment Week 12 (SVR12) in HCV mono-infected patients. We evaluated the safety/efficacy of glecaprevir/pibrentasvir in patients co-infected with HCV/HIV-1. METHODS: Data were pooled from two Phase 3 trials for treatment-naïve and -experienced patients co-infected with HCV genotypes (GT) 1–6/HIV-1 without cirrhosis or with compensated cirrhosis who received glecaprevir/pibrentasvir for 8 or 12 weeks. Virologic response, adverse events (AEs), and laboratory abnormalities were evaluated. RESULTS: Across the two trials, 152 patients without cirrhosis and 16 with compensated cirrhosis received glecaprevir/pibrentasvir for 8 and 12 weeks, respectively. Baseline demographics are shown in Tables 1 and 2. The overall intention-to-treat (ITT) SVR12 rate was 98.2% (165/168), with no virologic failures among non-cirrhotic patients treated for 8 weeks; mITT rate (excluding non-virologic failures) was 99.4% (167/168). Reasons for nonresponse were breakthrough (n = 1; patient with incomplete study drug adherence), premature study drug discontinuation (n = 1), and missing SVR12 data (n = 1). Safety analyses included the additional 18 non-cirrhotic GT1-infected patients treated for 12 weeks (all achieved SVR12). AEs occurring in ≥5% of patients were fatigue, headache, nausea, and nasopharyngitis. Serious AEs and AEs leading to discontinuation were rare; none were related to study drug. Grade 3 or higher laboratory abnormalities were infrequent. All patients maintained HIV-1 suppression (<200 copies/mL) during treatment. CONCLUSION: Glecaprevir/pibrentasvir was highly efficacious and well tolerated in patients co-infected with HCV GT1–6/HIV-1 without or with cirrhosis following 8 or 12 weeks of treatment, respectively, and could be the first 8-week pangenotypic treatment option for HCV/HIV-1 co-infected patients without cirrhosis. [Image: see text] DISCLOSURES: J. K. Rockstroh, Gilead, Abbott, AbbVie, BMS, Bionor, Cipla, Janssen, Merck, ViiV: Consultant, Grant Investigator, Research Contractor and Scientific Advisor, Consulting fee, Research grant, Research support and Speaker honorarium. S. R. Bhagani, AbbVie, BMS, Gilead, Janssen, Merck, ViiV: Board Member, Consultant, Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. C. Orkin, AbbVie, Abbott, Boehringer Ingelheim, BMS, Gilead, GSK, Janssen, ViiV: Grant Investigator and Research Contractor, Research grant and Research support. R. Soto-Malave, AbbVie, Janssen, Merck: Consultant, Grant Investigator, Research Contractor and Scientific Advisor, Consulting fee, Research grant and Research support. K. Lacombe, AbbVie, BMS, Gilead, Janssen, Merck: Board Member, Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. Z. Zhang, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. S. Wang, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. F. Mensa, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. R. Trinh, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options.