403. Analysis of Lipid Levels and Neuropsychiatric Events in Treatment-Naïve HIV-1-Infected Adults Treated With Rilpivirine or Efavirenz Over 96 Weeks in ECHO and THRIVE
Session: Poster Abstract Session: HIV - Antiretroviral Therapy
Friday, October 21, 2011
Room: Poster Hall B1
Handouts
  • 18831F IDSA Safety Poster FINAL.pdf (498.2 kB)
  • Background:

    Over 96 weeks in the Phase III, randomized, double-blind ECHO and THRIVE trials, rilpivirine (RPV; TMC278) 25mg qd had non-inferior efficacy vs efavirenz (EFV) 600mg qd in treatment-naïve HIV-1-infected adults. Analyses of pooled lipid levels and neuropsychiatric events are presented.

    Methods:

    Patients were randomized 1:1 to receive RPV or EFV plus TDF/FTC (ECHO) or TDF/FTC, AZT/3TC or ABC/3TC (THRIVE). Adverse events (AEs) and laboratory abnormalities were assessed at each visit.

     

    Results:

    1368 patients were randomized and treated. Significantly greater increases from baseline to Week 96 were seen for EFV vs RPV in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) and high-density lipoprotein (HDL) levels [Figure]. Fewer RPV than EFV patients had TC (31% vs 57%, p<0.0001, Fisher's exact test), LDL-C (28% vs 49%, p<0.0001) and TG (52% vs 63%, p<0.0001) levels above the National Cholesterol Education Program (NCEP) cut off at any timepoint. 82% RPV vs 75% EFV patients had HDL values below the NCEP cut off at ³1 timepoint (p<0.001).

      

    Neuropsychiatric AEs of interest (any cause or grade) were reported in significantly fewer RPV (43%) than EFV (60%) patients (p<0.0001, Fisher's exact test). Treatment-related neurologic AEs of interest occurred in 17% of RPV and 38% of EFV patients (p<0.0001); the most frequently reported AE was dizziness (8% vs 27%; p<0.0001). Treatment-related psychiatric AEs of interest occurred in 16% RPV and 24% EFV patients (p<0.0001); abnormal dreams/nightmares was the most frequently reported AE (8% vs 13%; p=0.0039). Neurologic and psychiatric serious AEs, as well as treatment discontinuations due to a neurologic or psychiatric AE, occurred in only a few patients in either group.

     

    Conclusion:

    Over 96 weeks, RPV 25mg qd was associated with significantly lower increases in TC, LDL and TG and fewer treatment-related neurologic and psychiatric AEs than EFV 600mg qd. Increases in lipid levels were minimal beyond Week 48.

     


    Subject Category: H. HIV/AIDS and other retroviruses

    Michael Sension, MD1, Mariette Botes, MBChB2, Dan Duiculescu, MD, PhD3, Gerd Fätkenheuer, MD4, Eric Florence, MD, PhD5, Claudio Gonsalez, MD6, Chien-Ching Hung, MD, MIH, PhD7, François Raffi, MD, PhD8, Timothy Wilkin, MD, MPH9, Robin Wood, MD, PhD10, Henri Deckx11, Marita Stevens11, Simon Vanveggel, MSc11 and Katia Boven, MD12, (1)Comprehensive Care Center, Fort Lauderdale, FL, (2)MuelMed Hospital, Pretoria, South Africa, (3)and "Dr. Victor Babes" Hospital for Infectious and Tropical Diseases, Bucharest, Romania, (4)University Hospital of Cologne, Cologne, Germany, (5)Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium, (6)Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De São Paulo, São Paulo, Brazil, (7)National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan, (8)University Hospital Hotel Dieu, Nantes, France, (9)Weill Medical College of Cornell University, New York, NY, (10)Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa, (11)Tibotec BVBA, Beerse, Belgium, (12)Tibotec Inc., Titusville, NJ

    Disclosures:

    M. Sension, Gilead: Investigator and Speaker's Bureau, Research support and Speaker honorarium
    Tobotec: Consultant, Investigator and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
    BMS: Speaker's Bureau, Speaker honorarium

    M. Botes, None

    D. Duiculescu, None

    G. Fätkenheuer, Janssen Cilag: Scientific Advisor, Consulting fee
    Gilead: Scientific Advisor, Consulting fee and Speaker honorarium

    E. Florence, Tibotec BVBA: Investigator, Scientific Advisor and Travel grant, Consulting fee, Educational grant and Research grant
    Johnson & Johnson: Investigator and Scientific Advisor, Consulting fee and Research grant

    C. Gonsalez, None

    C. C. Hung, Johnson & Johnson/Tibotec: Investigator, Research support

    F. Raffi, Abbot: Consultant, Consulting fee
    BMS: Investigator, Research grant
    Gilead: Consultant, Consulting fee
    Jansssen: Consultant, Consulting fee

    T. Wilkin, Tibotec: Research Contractor, Research grant

    R. Wood, None

    H. Deckx, Tobotec-Virco: Employee, Salary

    M. Stevens, Tibotect BVBA: Employee, Salary

    S. Vanveggel, Tibotec - Johnson & Johnson: 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.