Medical Advocates for Social Justice
Conference Abstract
from the
2nd IAS Conference on HIV and Pathogenesis
Paris, France

July 14-17, 2003
 

 

Analysis of Virological Response of Enfuvirtide in TORO:
Implications for Patient Management

Montaner J1, DeMasi R2, Delehanty J2, Chung J3,
Gafoor Z2, Salgo M3 on behalf of the TORO 1 and
TORO 2 study groups.
1 University of British Columbia, Vancouver, Canada
2 Trimeris, NC, USA;
3 Roche, NJ, USA

 

Share this Abstract with a Colleague
 

Background:
Enfuvirtide (ENF) is an HIV-1 fusion inhibitor, a new class of approved antiretroviral (ARV) that targets HIV-1 gp41 thereby inhibiting HIV fusion to the host cell. The safety and efficacy of ENF plus an optimised background (OB) regimen through 24 weeks of treatment has been established in two pivotal studies, TORO 1 and TORO 2. We evaluated virological response with the objective of providing guidance for clinical practitioners on the effective use of ENF + OB.

Methods:
Triple-class experienced patients with plasma HIV-1 RNA >5,000 copies/mL selected an OB regimen of 3–5 ARVs based on prior history and baseline (BL) genotypic and phenotypic resistance. The percentages of patients with plasma HIV-1 RNA <50 and <400 copies/mL were summarized by randomized treatment arm. Exploratory multiple logistic regression analyses were used to assess the prognostic value of baseline and treatment factors on virological response, and subgroup analyses were performed to confirm the findings.

Results:
995 patients (ENF + OB: 661; OB: 334) were included in the ITT population (defined as randomized, received at least one dose of study drug and had at least one post-baseline assessment). At 24 weeks, the percentage of patients with plasma HIV-1 RNA <50 and <400 copies/mL were 22.8% and 37.4 % for ENF + OB vs. 9.0% and 16.2% for OB, respectively. The likelihood of virological suppression <400 copies/mL was higher for ENF + OB patients that were: healthier (CD4+ >100 cells/mm3 vs <100 cells/mm3; OR=3.0, 95% CI=(2.1, 4.2)); less ARV experience (<10 prior ARVs vs. >10 ARVs; OR=1.8, 95% CI=(1.2, 2.7)); and had more active drugs in their OB (>2 vs. <2; OR=2.6, 95% CI=(1.8,3.7)).

Conclusions:
While the comparative efficacy of ENF + OB over OB alone has previously been established, these results suggest that the virological response to ENF + OB therapy is directly related to the activity of the background regimen and improved responses were observed in less advanced and less-experienced patients.

Main New/Newsworthy Enfuvirtide Main Page IAS Conference Index      


Analysis of Virological Response of Enfuvirtide in TORO:
Implications for Patient Management
A Medical Advocates for Social Justice Update