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

Background. Among patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infec-tion, 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 ( ; 95 % confidence interval,6.7dp 0.01