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© Research
Publication : Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Switch from enfuvirtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial

Scientific Fields
Diseases
Organisms
Applications
Technique

Published in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - 15 Oct 2009

De Castro N, Braun J, Charreau I, Pialoux G, Cotte L, Katlama C, Raffi F, Weiss L, Meynard JL, Yazdanpanah Y, Delaugerre C, Madelaine-Chambrin I, Aboulker JP, Molina JM,

Link to Pubmed [PMID] – 19757993

Clin. Infect. Dis. 2009 Oct;49(8):1259-67

BACKGROUND: Among patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection, salvage regimens including enfuvirtide have demonstrated sustained efficacy. Because of reluctance to use subcutaneous injections, raltegravir may be an alternative to replace enfuvirtide within a suppressive regimen. We conducted a prospective, randomized, open-label trial to compare the antiviral efficacy and safety of a switch to raltegravir with the efficacy and safety of continuing enfuvirtide.

METHODS: A total of 170 patients with multidrug-resistant HIV-1 infection and plasma HIV-1 RNA levels or=400 copies/mL, over 24 weeks. The secondary end points mainly involved safety.

RESULTS: The switch to raltegravir was non-inferior to the maintenance of enfuvirtide, with virologic failure rates of 1.2% in both treatment arms in the intention-to-treat analysis (beta = 0.01%; 95% confidence interval, -6.7 to 6.8) and 1.2% and 0%, respectively, in the on-treatment analysis (beta = 1.22%; 95% confidence interval, -5.6 to 8.1). At week 24, 88%-89% of patients in both arms had plasma HIV-1 RNA levels <50 copies/mL. No significant CD4 cell count changes occurred in either arm. Grade 3-4 adverse events and laboratory abnormalities were uncommon and were not different between the treatment arms.

CONCLUSION: A switch to raltegravir was safe, well tolerated, and virologically non-inferior to the maintenance of enfuvirtide in patients infected with multidrug-resistant HIV-1 infection who were receiving suppressive antiretroviral therapy.

CLINICAL TRIALS REGISTRATION: NCT00454337

http://www.ncbi.nlm.nih.gov/pubmed/19757993