Journal Article

Switch from Enfuvirtide to Raltegravir in Virologically Suppressed Multidrug-Resistant HIV-1-Infected Patients: A Randomized Open-Label Trial

Nathalie De Castro, Joséphine Braun, Isabelle Charreau, Gilles Pialoux, Laurent Cotte, Christine Katlama, François Raffi, Laurence Weiss, Jean-Luc Meynard, Yazdan Yazdanpanah, Constance Delaugerre, Isabelle Madelaine-Chambrin, Jean-Pierre Aboulker and Jean-Michel Molina

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 49, issue 8, pages 1259-1267
Published in print October 2009 | ISSN: 1058-4838
Published online October 2009 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/605674
Switch from Enfuvirtide to Raltegravir in Virologically Suppressed Multidrug-Resistant HIV-1-Infected Patients: A Randomized Open-Label Trial

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  • Infectious Diseases
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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 <400 copies/mL who were receiving enfuvirtide-based regimens were randomized 1:1 to maintain enfuvirtide or to switch to raltegravir. The primary efficacy end point was the cumulative proportion of patients with virologic failure, defined as a confirmed plasma HIV-1 RNA level ⩾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 (d=0.01%; 95% confidence interval, −6.7 to 6.8) and 1.2% and 0%, respectively, in the on-treatment analysis (d=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.

Journal Article.  4468 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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