HIV-1 Integrase Inhibitor Safe, Potent in Advanced HIV

Raltegravir may become an important part of salvage therapy in advanced HIV

FRIDAY, April 13 (HealthDay News) -- Raltegravir, an experimental HIV drug that targets the integrase enzyme, appears promising in a randomized phase II trial of treatment-resistant patients, according to a report in the April 14 issue of The Lancet. The drug is under development by Merck Research Laboratories in North Wales, Penn.

Beatriz Grinsztejn, M.D., of the Evandro Chagas Clinical Research Institute/Oswaldo Cruz Foundation in Rio de Janiero, Brazil, and colleagues assessed the safety and efficacy of raltegravir when added to optimized background combination therapies in 178 patients with advanced HIV who were failing their existing therapies. Patients received placebo or 200, 400 or 600 mg of raltegravir twice daily with background treatment for 24 weeks.

At 24 weeks, patients who received raltegravir showed a 98 percent drop in HIV RNA, on average, compared with 45 percent among their counterparts in the placebo group. Moreover, the number of CD4 cells was also increased in patients taking the novel HIV drug. Raltegravir was safe and well-tolerated in most study participants.

"If no long-term unexpected side-effects or resistance issues emerge, raltegravir will have a major role in salvage therapy," write Pedro Cahn, M.D., Ph.D., and Omar Sued, M.D., of the Fundación Huesped in Buenos Aires, Argentina, in an editorial.

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