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IL-2 Fails to Boost CD4 Cells, But T-20 Proves Effective in Severely Immunocompromised HIV Patients: Presented at CROI By Ed Susman BOSTON, MA -- February 7, 2008 -- Enfuvirtide (T-20) proved better at increasing CD4-positive cell counts in severely immunocompromised patients with HIV infection compared with treatment with interleukin-2 (IL-2), according to a 1-year study presented here at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). "IL-2 failed to increase CD4[-positive cell counts] in severely immunocompromised patients with multiple therapeutic failures," said Jean-Paul Viard, MD, Infectious Disease Specialist, Centre Hospitalier Universitaire Necker, Paris, France. "Use of T-20, even on a poorly optimized background, was highly associated with success, underlining the importance of using a new drug family in salvage therapy." Researchers sought to determine if immune system recovery could be improved by adding IL-2 to the regimen in patients with low CD4-positive cell counts who had already progressed despite different antiretroviral therapies. Dr. Viard and his colleagues recruited 56 patients with CD4-positive cell counts that were no greater than 200 cells/mm3. For enrollment, patients had to have a viral load that exceeded 10,000 copies/mL and a genotypic score based on available genotypic results showing two or fewer active drugs in their regimen. Patients were randomized to receive an optimized background treatment alone or in combination with 8 subcutaneous cycles of IL-2 4.5 MUI twice daily for 5 days, from week 2 to 42. Twenty-eight patients were randomized to each arm of the study. "Background regimen was optimized as much as possible according to genotypic score, and enfuvirtide was added in patients naive to the injected entry inhibitor," Dr. Viard said in his poster presentation on February 6. Average age of patients was 46 years, and median baseline CD4 cell count was 63 cells/mm3. About 43% of patients had a genotypic score of 0, meaning none of the background drugs were effective. Background treatment could be optimized in 23 patients, with enfuvirtide being the only active drug in 9 of the patients. Treatment could not be optimized in 33 patients, whose regimens remained unchanged except for the addition of enfuvirtide in those who had never had the drug. After 1 year of treatment, the proportion of patients with with CD4-positive cell counts of 200 cells/mm3 or higher was 14% in the IL-2 arm and 18% in the control arm (P = 1.00). The proportion of patients with an increase in CD4-positive cell counts of at least 50 cells/mm3 was 25% in the IL-2 arm and 32% in the control arm (P =.56). HIV viral load did not change significantly from baseline in either arm of the study. However, Dr. Viard said that in multivariate analysis, optimization with enfuvirtide was the only factor associated with immunologic success. The percentage of patients who had increased CD4-positive cell counts to more than 200 cells/mm3 was 50% among patients taking enfuvirtide and 2.5% if enfuvirtide was not in the regimen (P =.004). An increase of at least 50 CD4-positive cells/mm3 occurred in 75% of patients on enfuvirtide and in 5% of patients not taking enfuvirtide (P <.001). [Presentation title: Immunological Success Is Predicted by Enfuvirtide but Not Interleukin-2 in Immunocompromised Patients, Final Results of the ANRS 123 ETOILE Randomized Trial. Abstract 703] E-mail this page to a friend or colleague! To print, use this version