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

Newer Antiretroviral Agents	TUAB01

Organiser:

Type:

Oral Abstract Session

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Venue:

SR 1 (6090)

Interpretation:

None

Time:

11:00 - 12:30, 05.08.2008

Code:

TUAB01

Co-Chairs:

Pedro Cahn, Argentina
Sharon Walmsley, Canada

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

Presentations in this session:

11:00
TUAB0101 Introduction and background
Sharon Walmsley, Canada

11:05
TUAB0102
Abstract
Powerpoint (663 KB) Sustained antiretroviral efficacy of raltegravir as part of combination ART in treatment-naive HIV-1 infected patients: 96-week data
Presented by Martin Markowitz, United States
M. Markowitz¹, B.-Y. Nguyen², E. Gotuzzo³, F. Mendo⁴, W. Ratanasuwan⁵, C. Kovacs⁶, H. Wan², H. Campbell², R. Isaacs², H. Teppler², and the Protocol 004 Part II Study Team
¹Aaron Diamond AIDS Research Center, Rockefeller University, New York, United States, ²Merck Research Laboratories, West Point, United States, ³Hospital Nacionale Cayetano Heredia, Lima, Peru, ⁴Hospital Nacionale Edgardo Rebagliati, Lima, Peru, ⁵Siriraj Hospital, Bangkok, Thailand, ⁶Canadian Immunodeficiency Research Collaborative, Toronto, Canada

11:20
TUAB0103
Abstract
Powerpoint (181 KB) TMC278 (rilpivirine), a next-generation NNRTI, demonstrates long-term efficacy and tolerability in ARV-naïve patients: 96-week results of study C204
Presented by Mario Santoscoy, Mexico
M. Santoscoy¹, P. Cahn², C. Gonsalez³, W. Hao⁴, A. Pozniak⁵, P. Shalit⁶, S. Vanveggel⁷, K. Boven⁸
¹Hospital Carlos Mac Gregor IMSS, Mexico City, Mexico, ²Hospital Juan A Fernández and Fundación Huesped, Buenos Aires, Argentina, ³Hospital das Clíncias, Pinheiros, Brazil, ⁴Beijing You’an Hospital, Beijing, China, ⁵Chelsea and Westminster NHS Foundation Trust and PKR/SSR, London, United Kingdom, ⁶Swedish Medical Center, Seattle, United States, ⁷Tibotec BVBA, Mechelen, Belgium, ⁸Tibotec Inc, Yardley, United States

11:35
TUAB0104
Abstract
Powerpoint (761 KB) A prospective, randomized, open label trial of efavirenz versus lopinavir/ritonavir based HAART among antiretroviral therapy naïve, HIV infected individuals presenting for care with CD4 cell counts <200/mm3 in Mexico
Presented by Juan Sierra Madero, Mexico
J. Sierra Madero¹, A. Villasis¹, P. Mendez², J.L. Mosqueda³, I. Torres⁴, F. Gutierrez⁵, I. Juarez⁶, M. Magaña⁷, C. Ramos⁸, L. Perez Saleme⁹, L.E. Soto Ramirez¹, V. Dias Lima¹⁰, F. Belaunzaran¹, J. Montaner¹⁰
¹INCMNSZ, Infectious Diseases, Mexico, Mexico, ²HGZ #53, IMSS, Mexico, Mexico, ³Hospital General de Leon, Mexico, Mexico, ⁴Hospital General de Puebla, Puebla, Mexico, ⁵HGZ #72, IMSS, Mexico, Mexico, ⁶HGZ#25, IMSS, Mexico, Mexico, ⁷HGZ #1 IMSS, SLP, Mexico, Mexico, ⁸HGZ #29, IMSS,, Mexico, Mexico, ⁹Centro Médico Nacional Siglo XXI, IMSS, Mexico, Mexico, ¹⁰The BC-Centre for Excelence in HIV/AIDS, Division of AIDS, Vancouver, Canada

11:50
TUAB0105
Abstract
Powerpoint (390 KB) Resistance profile of patients failing first line ART in Malawi when using clinical and immunologic monitoring
Presented by Mina Hosseinipour, Malawi
M. Hosseinipour¹, J.J. van Oosterhout², R. Weigel³, J. Nelson⁴, S. Fiscus⁴, J. Eron⁴, J. Kumwenda²
¹UNC Project, Lilongwe, Malawi, ²Malawi College of Medicine, Blantyre, Malawi, ³Lighthouse Clinic, Lilongwe, Malawi, ⁴University of North Carolina, Chapel Hill, United States

12:05
TUAB0106
Abstract
Powerpoint (549 KB) Safety profile of apricitabine, a novel NRTI, during 24-week dosing in experienced HIV-1 infected patients
Presented by Susan Cox, Australia
S. Cox¹, S. Moore¹, J. Southby¹, A. Alsumde²
¹Avexa Ltd, Melbourne, Australia, ²Avexa Ltd, San Francisco, United States

Rapporteur report

Track B report by Omar Sued

This session adressed newer ARV drug, but quite few new data on new agents were presented.

Dr. Markowitz, from Protocol 004, presented the 96 week data of raltegravir combined with TDF and FTC in first line therapy. Raltegravir arm results were comparable to TDF-3TC-EFV arm, with similar and sustained rate of viral suppression (83 vs 84%) and continued immune recovery (221 vs 232 CD4) since week 48. Of 6 patients failing raltegravir, only 2 showed raltegravir related mutations. Safety profile was favorable to raltegravir, with less drug related adverse events (due to high CNS adverse effects in EFV arm) and neutral impact in the lipid profile with raltegravir (in constrast with mild increase in cholesterol in EFV arm). An unexplained increase in CPK levels (6.3% in raltegravir arm vs. 2.6 in efavirenz) should keep our eye on in post-marketing. These data are encouraging to consider raltegravir based HAART as a potential first line therapy option.

Dr Santoscoy, from study C204 team, presented the 96 week data on rilpivirine, a new NNRTI currently in phase III development at a 25 mg dose. This drug shows high efficacy and sustained virological response at a similar rate than efavirenz. However, rilpivirine showed a lower rate of rashes, CNS adverse events and lipid levels increase. Unfortunately, no data about resistance mutations, in particular those associated to etravirine, were presented.

Susan Cox showed that apricitabine, a new NRTI that showed to be effective in patients with M184V and NRTI mutations, was safe and well tolerate, with low drug related adverse events (mostly gastrointestinal). These data support the evaluation of this drug as a NRTI to be used in second line therapy.

Dr Sierra-Madero presented the results of a Mexican study comparing lopinavir/ritonavir vs efavirenz in HIV naïve advanced patients (<200 cell/mm3). Although independent funding limited the sample size, the results were almost similar to the ACTG5142 study in terms of virological suppression, immune recovery and resistance patterns, supporting the use of NNRTI based HAART even in very advanced patients.

The most worrisome data came from Dr. Hosseinipour presentation. In this study 94 samples of 96 patients failing to a first line regimen (d4T-3TC-NVP) showed high rates of pan nucleoside resistance in Malawi. Resistance to 3TC was present in 81%, to first generation NNRTIs in 93% and pan-nucleoside resistance in 17%. According these data, between 22-50% of patients had no fully active drugs in the recommended second line backbone, highligthing the need to re-evaluate the definition of clinical or immunological criteria to change therapy in low resources settings.

The key message of this session was that the incorporation to the market of these new drugs can impact in the recomended ARV regimens providing new drugs in the treatment of multi-drug resistant patients and also can add more alternative options to first-line regimens.

The organizers reserve the right to amend the programme.