423. Efficacy and Hepatic Safety of Rilpivirine (RPV; TMC278) in Treatment-nave, HIV-1-infected Patients Co-infected with Hepatitis B and/or C: Pooled 96-week Analysis of the Phase III ECHO and THRIVE Trials
Session: Poster Abstract Session: HIV - Antiretroviral Therapy
Friday, October 21, 2011
Room: Poster Hall B1
Handouts
  • IDSA HEP BC Poster Hires.pdf (862.2 kB)
  • Background: RPV has demonstrated durable, non-inferior efficacy to efavirenz (EFV), and a more favorable tolerability profile vs EFV in the pooled Phase III ECHO (NCT00540449) and THRIVE (NCT00543725) trials at 96 weeks. We report results from a pooled analysis of patients (pts) co-infected with hepatitis B and/or C virus (HBV/HCV) in these trials.

    Methods: Treatment-nave pts were randomized 1:1 to receive either RPV 25mg qd (N=686) or EFV 600mg qd (N=682), in combination with TDF/FTC (ECHO) or TDF/FTC, AZT/3TC or ABC/3TC (THRIVE). Pts with proven HBV (surface antigen positive) and HCV (antibody positive confirmed by RNA) infection were eligible if AST and ALT were <5 x upper limit of normal at screening. All pts with baseline HBV/HCV assessments were included. 

    Results: Co-infection data were available at baseline for 670 (97.7%) and 665 (97.5%) pts in the RPV and EFV groups, respectively. Virologic and CD4 cell responses were comparable between monoinfected treatment groups (Table); co-infected pts in the RPV group had lower responses than EFV pts, likely because of a higher rate of discontinuations (D/Cs) not related to virologic failures or AEs in the RPV group. There were no clinically significant differences in hepatic toxicity between RPV and EFV pts, as measured by hepatic AEs, D/Cs for hepatic AEs or treatment-emergent rises in ALT/AST and bilirubin; the frequency of hepatic AEs and laboratory abnormalities was higher in co-infected pts in both treatment groups compared to monoinfected pts. The overall rate of D/Cs due to hepatic AEs was low.

    Conclusion: While lower virologic response rates were observed in co-infected pts in the RPV group than in the EFV group, this may be due to the higher proportion of pts in the RPV group who discontinued for non-AE reasons. Data should be interpreted with caution because of the low pt numbers in this subgroup. Hepatic AEs were higher overall in co-infected pts than monoinfected pts, but there were no clinically significant differences between the RPV and EFV groups.

     


    Subject Category: H. HIV/AIDS and other retroviruses

    Judith Feinberg, MD1, Ezio Baraldi, MD2, Robert Finlayson, MB, BS3, Jorge Rodriguez, MD4, Hans-Jrgen Stellbrink, MD5, Edmund Wilkins, MD6, Simon Vanveggel, MSc7, Marita Stevens7 and Katia Boven, MD8, (1)University of Cincinnati School of Medicine, Cincinnati, OH, (2)TrialTech Clinical Research, Pretoria, South Africa, (3)Taylor Square Private Clinic, Sydney, Australia, (4)Orange Coast Medical Group, Newport Beach, CA, (5)ICH Study Center, Hamburg, Germany, (6)North Manchester General Hospital, Manchester, United Kingdom, (7)Tibotec BVBA, Beerse, Belgium, (8)Tibotec Inc., Titusville, NJ

    Disclosures:

    J. Feinberg, Tibotec Therapeutics: Grant Investigator, Scientific Advisor and Speaker, Consulting fee, Research grant and Speaker honorarium
    Bristol Myers Squibb: Grant Investigator, Scientific Advisor and Speaker, Consulting fee, Research grant and Speaker honorarium
    Merck and Co: Scientific Advisor and Speaker, Consulting fee and Speaker honorarium
    GlaxoSmithKline/Viiv: Grant Investigator, Scientific Advisor and Speaker, Consulting fee, Research grant and Speaker honorarium
    Roche: Grant Investigator, Research grant
    Tobira (pending): Grant Investigator, Research grant

    E. Baraldi, Tibotec: Investigator, Contract research fees

    R. Finlayson, Janssen Cilag: Scientific Advisor, Consulting fee
    Merck: Scientific Advisor, Consulting fee
    Viiv Healthcare: Scientific Advisor, Consulting fee
    BNS: Scientific Advisor, Consulting fee

    J. Rodriguez, Tibotec: Research Contractor and Speaker's Bureau, Contracted payment for research and Speaker honorarium

    H. J. Stellbrink, Janssen Cilag: Consultant, Investigator, Scientific Advisor and Speaker, Consulting fee, Research support and Speaker honorarium

    E. Wilkins, Gilead: Scientific Advisor, Speaker honorarium
    BMS: Scientific Advisor, Speaker honorarium
    Viiv: Scientific Advisor, Speaker honorarium
    MSD: Scientific Advisor, Speaker honorarium
    Tibotec: Scientific Advisor, Speaker honorarium

    S. Vanveggel, Tibotec-Johnson & Johnson: Employee, Salary

    M. Stevens, Tibotec BVBA: Employee, Salary

    K. Boven, Tibotec: Employee, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.