AIDS 2008 – Mexico City 3-8 August 2008 - XVII Internationnal AIDS Conference

Late Breaker Track B Session 1	THAB03

Organiser:

Type:

Oral Abstract Session

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Venue:

SR 1 (6090)

Interpretation:

None

Time:

12:45 - 14:15, 07.08.2008

Code:

THAB03

Co-Chairs:

Julio Montaner, Canada
Papa Salif Sow, Senegal

Click here to see a webcast of this session on kaisernetwork.org

Presentations in this session:

12:45
THAB0301
Abstract
Powerpoint (712 KB) A randomized, double-blind, placebo-controlled, multicenter trial of pregabalin vs placebo in the treatment of neuropathic pain associated with HIV neuropathy
Presented by David Simpson, United States
D.M. Simpson¹, T.K. Murphy², E. Durso-De Cruz², P. Glue², E. Whalen²
¹Mount Sinai Medical Center, New York, United States, ²Pfizer Global Pharmaceuticals, New York, United States

13:00
THAB0302
Abstract Cost-effectiveness of programmatic models for provision of antiretroviral therapy in resource-limited settings
Presented by Joseph Babigumira, United States
J. Babigumira¹, A. Sethi², K. Smyth², M. Singer²
¹University of Washington, Pharmacy, Seattle, United States, ²Case Western Reserve University, Epidemiology, Cleveland, United States

13:15
THAB0303
Abstract ACTG 5202: shorter time to virologic failure (VF) with abacavir/lamivudine (ABC/3TC) than tenofovir/emtricitabine (TDF/FTC) as part of combination therapy in treatment-naïve subjects with screening HIV RNA ³100,000 c/mL
Presented by Paul Sax, United States
P. Sax¹, C. Tierney², A. Collier³, M. Fischl⁴, C. Godfrey⁵, N. Jahed⁶, K. Droll², L. Peeples², L. Myers⁷, G. Thal⁸, J. Rooney⁹, B. Ha¹⁰, W. Woodward¹¹, E. Daar¹²
¹Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, United States, ²Harvard School of Public Health, Boston, United States, ³University of Washington School of Medicine, Seattle, United States, ⁴AIDS Clinical Research Unit, University of Miami School of Medicine, Miami, United States, ⁵National Institute of Allergy and and Infectious Diseases, Division of AIDS, Bethesda, United States, ⁶ACTG Operations Center, Social & Scientific Systems Inc., Silver Spring, United States, ⁷Frontier Science & Technology Research Foundation Inc., Amherst, United States, ⁸Bristol-Myers Squibb, New York, United States, ⁹Gilead Sciences, Inc., Foster City, United States, ¹⁰GlaxoSmithKline, Research Triangle Park, United States, ¹¹Abbott Laboratories, Abbott Park, United States, ¹²Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, United States

13:30
THAB0304
Abstract
Powerpoint (110 KB) Abacavir/lamivudine (ABC/3TC) shows robust virologic responses in ART-naïve patients for baseline (BL) viral loads (VL) of ³100,000c/mL and <100,000c/mL by endpoint used in ACTG5202
Presented by Keith Pappa, United States
K. Pappa¹, J. Hernandez², B. Ha¹, M. Shaefer², C. Brothers², Q. Liao³
¹GlaxoSmithKline, Infectious Diseases MDC, U.S. HIV Collaborative Studies, Research Triangle Park, NC, United States, ²GlaxoSmithKline, Infectious Diseases MDC, U.S. HIV, Research Triangle Park, NC, United States, ³GlaxoSmithKline, MDC BDS-Infectious Diseases, U.S., Research Triangle Park, NC, United States

13:45
THAB0305
Abstract Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the SMART study
Presented by Jens Lundgren, Denmark
J. Lundgren¹, J. Neuhaus², A. Babiker³, D. Cooper⁴, D. Duprez², W. El-Sadr⁵, S. Emery⁴, F. Gordin⁶, J. Kowalska⁷, A. Phillips⁸, R. Prineas⁹, P. Reiss¹⁰, C. Sabin⁸, R. Tracy¹¹, R. Weber¹², B. Grund², J. Neaton², SMART/INSIGHT and D:A:D Study Groups
¹Rigshospitalet & University of Copenhagen, Copenhagen, Denmark, ²University of Minnesota, Minnesota, United States, ³Clinical Trials Unit / MRC, London, United Kingdom, ⁴University of New South Wales, Sydney, Australia, ⁵Colombia University, New York, United States, ⁶Veterans Affairs Medical Center and George Washington University, Washington DC, United States, ⁷University of Copenhagen, Copenhagen, Denmark, ⁸Royal Free and University College London, London, United Kingdom, ⁹Wake Forest University School of Medicine, Winston-Salem, United States, ¹⁰Academic Medical Center, Amsterdam, Netherlands, ¹¹University of Vermont, Burlington, United States, ¹²University of Zürich, Zürich, Switzerland

Rapporteur report

Track B report by Omar Sued

Dr Simpson reported the results of the use of pregabiline in the treatment of HIV associated neuropathy. Although the drug was well tolerated (with dizziness and somnolence as the most frequents events) no significant difference with placebo was reported, underling the need of continue looking for more options of treatment.

Dr Babimuira showed a cost effectiveness analysis of three models of ART care provision, facility base care (FBC), vs mobile based care (MBC) and home based care (HBC). They used a Markov model to simulate the expenditures of the three models of provision of care, taking in consideration access, quality of life, and adherence. A ten year the incremental cost of MCC and HBC where higher than for the FBC based approach in resource limited settings. In order to limit the expenditures during the scaling up ARV process, a broad FBC approach should be considered.

Dr Sax presented data of the study A5202, currently ongoing, comparing ABC/3TC and TDF/FTC associated to EFV or ATV. In January 2009 the DSMB found and an excess of virologic failures in the ABC/3TC arm, requesting the un-blinding of the NRTI component. The results of 797 patients followed by a median of 60 week were presented showing a significant shorter time to virologic failure in ABC/3TC arm vs. TDF/3TC and, with 57 failures in the ABC/3TC versus 26 failures in the TDF/FTC arm (HR 2.33). The CD4 increase and CV events were similar between both arms. The blinding of the accompanying drug (EFV or ATV) and the lack of data regarding baseline resistance limit the conclusions of this study.

Having into account these unexpected findings, Dr Pappa presented pooled analysis of the studies in which Epzicom (ABC/3TC) was used as background in order to evaluate the efficacy in patients with VL >100.000 c/mL, and the tolerance. Six randomized randomized trials using Epzicom, and the data from the HEAT study (that compares Epzicom with Truvada) were included. The rate range of patients achieving virologic suppression (<200 c/mL) 48 week was from 87% to 95%, without significant differences between patients with > or < 100.000 c/mL. In adittion HEAT study showed similar safety profile between Epzicom and Truvada, with a surprisingly similar rate of suspected hypersensitivity reaction between arms, and without significant changes in the lipid profile, suggesting that more data is need to determine if there are differences on the efficacy between these NRTI combinations.

Dr Lundgrend presented additional information regarding the association of ABC with cardiovascular disease (CVD). For the presentation, data of patients participating in the SMART study were included. A total of 1019 patients receiving ABC were compared with 643 patients receiving ddI and 2882 patients receiving other NRTIs. Patient from ddI group showed 28% of previous use of ABC vs 7% in the NRTIs, and 39% of patients in ABC where in a 3NRTI regimen vs 6 and 4% in arms ddI and NRTIs. Other characteristics were similar. A 4.3 fold increase risk of myocardial infarction was found with ABC use. Patients on ABC also presented high levels of hs-CRP, IL-6 and amyloid P. However, several limitations - 49% in 3NRTI regimen, a currently considered suboptimal therapy; channeling effect; non randomized trial-, reinforce the need to design randomized trial to address the effect of ABC in CVD.

The organizers reserve the right to amend the programme.