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
Session: Poster Abstract Session: Clinical Trials
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • ID Week2018_1965_Rockstroh_Integrated CoInfection_encore_v.pres.pdf (2.4 MB)
  • 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 1/2. 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.

     

     

    Jurgen K Rockstroh, MD1, Sanjay R Bhagani, MD2, Chloe Orkin, MBBCh3, Ruth Soto-Malave, MD4, Karine Lacombe, MD, PhD5, Zhenzhen Zhang, PhD6, Stanley Wang, MD, PhD6, Federico Mensa, MD6 and Roger Trinh, MD, MPH6, (1)Universitätsklinikum Bonn, Bonn, Germany, (2)Royal Free London Foundation Trust, London, United Kingdom, (3)The Royal London Hospital, London, United Kingdom, (4)Innovative Care P.S.C, Bayamon, Puerto Rico, (5)Inserm UMR-S1136, Université Pierre et Marie Curie, Hôpital Saint-Antoine, Paris, France, (6)AbbVie Inc., North Chicago, IL

    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 .

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