Sixth International Congress

Drug Therapy in HIV Infection


17-21 November, 2002
Glasgow, UK

Print this article
Enfuvirtide (T-20) in combination with an optimized background (OB) regimen vs OB alone: week 24 response among categories of baseline (BL) demographics, treatment experience, and HIV antiretroviral (ARV) resistance

Joep Lange1, A Lazzarin2, B Clotet3, D Cooper4, J Reynes5, K Arasteh6, M Nelson7, C Katlama8, H-J Stellbrink9, J-F Delfraissy10, J Chung, M Salgo, on Behalf of The TORO 2 Study Group11, R Demasi, J Delehanty12
Int Cong Drug Therapy HIV 2002 Nov 17-21;6:Abstract No. PL14.3

Enfuvirtide (T-20; ENF) is the first in a new class of HIV antiretrovirals, the fusion inhibitors, which targets HIV gp41 and blocks the virus from entering the host cells. The phase III study TORO 2 (T-20 vs Optimized Regimen Only) was conducted in Europe and Australia. Patients with ≥ 3 months prior experience with three classes of ARVs, and HIV-1 RNA ≥ 5,000 copies/mL selected an optimized background (OB) regimen of three to five ARVs based on prior history and BL genotypic and phenotypic viral resistance. Patients were randomized 2:1 to ENF (90 mg SC BID) + OB or OB alone. A total of 504 patients represented the intent-to-treat (ITT) population. Median BL HIV-1 RNA was 5.1 log10 copies/mL, and CD4 count was 98 cells/mm3. Patients had been exposed to an average of 12 ARVs over a mean period of 7.6 years. Approximately 90% of patients had virus with five or more primary ARV mutations at baseline. At 24 weeks the change from BL in viral load (ITT, LOCF) was -1.43 log10 copies/mL for ENF + OB, and -0.65 log10 copies/mL for OB alone (p<0.0001). Responder analyses (≥ 1 log drop, <400 and <50 copies/mL) were statistically significant favoring the ENF group. This presentation will extend primary analyses to demonstrate consistency of ENF HIV-1 suppression through subgroup analysis of parameters of demographics (age, gender, race), baseline characteristics (HIV viral load, CD4+ cell count, genotypic sensitivity, phenotypic sensitivity), ARV experience, primary mutations affecting the three classes of ARV agents, and other factors.

Enfuvirtide when used in combination with an OB regimen provided consistently superior viral suppression compared to OB alone in highly ARV-experienced patients within predefined sub-populations and virological subgroups, as well as for the overall population.

Presenting author: Joep Lange

Download Conferences Abstracts

1 IATEC Amsterdam, Netherlands.

2 San Raffaele Scientific Institute, Milan, Italy.

3 IrsiCaixa Foundation, Hospital Germans Trias i Pujol, Barcelona, Spain.

4 NCHECR, Sydney, Australia/

5 CHU Gui de Chauliac, Montpellier, France.

6 EPIMED, Vivantes Auguste-Viktoria Hospital, Berlin, Germany.

7 Chelsea & Westminster Hospital, London, United Kingdom.

8 Pitie-Salpetriere Hospital, Paris, France.

9 Universitätskrankenhaus Eppendorf, Hamburg, Germany.

10 Hopital Bicetre, Paris, France.

11 Roche, New Jersey, USA.

12 Trimeris Inc, North Carolina, USA.

2002-11-17
PL14-3

Copyright © 2002 - The Gardiner-Caldwell Group, Ltd.. All Rights Reserved. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Sixth International Congress on Drug Therapy in HIV Infection, c/o The Gardiner-Caldwell Group Ltd, part of The Thomson Corporation, Peakside House, Alder Court, Tytherington Business Park, Tytherington, Cheshire SK10 2XG, UK - Tel: +44 (0)1625 668000, Fax: +44 (0)1625 668121 Email: hiv6@gardiner-caldwell.com

This information is designed to support, not replace, the relationship that exists between you and your doctor. ©1980, 2005. AEGiS.