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Raltegravir may be effective for adolescents with HIV
Raltegravir may be safe and well-tolerated for patients with HIV aged 12 to 18 years, according to results of a new study presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. The study’s findings indicated that efficacy rates among patients in this age group may be similar to those in treatment-experienced adults.
Lisa Frenkel, MD, professor in the pediatric infectious diseases program at the University of Washington, presented the results.
Eligible patients had HIV RNA levels >1,000 copies/mL, were naive to integrase inhibitors and excluded individuals with hepatitis B or C virus. Other antiretroviral therapy (ART) treatments were optimized at entry or within 10 days of entry into the study.
There were two stages in the trial. Stage 1 involved dose finding, including analysis for intensive pharmacokinetics and safety. Patients in the stage 1 program were switched to 400 mg raltegravir twice daily if they were not already receiving this dose.
“The first part of this study involved a dose escalation,” Frenkel said. Stage 2 involved extended follow-up.
Primary endpoints included achieving and maintaining >1-log decreases from baseline or viral loads =400 copies/mL and on-study treatment at week 24.
There were 22 patients in the stage 1 program and 47 patients in the stage 2 program. Intent-to-treat efficacy data were available for 43 patients overall.
By week 24, 74% of patients achieved success (95% CI, 59%, 86%). A viral load level of =50 copies/mL was achieved by 56% of patients (95% CI, 40%, 71%).
Fourteen of the 69 patients experienced grade 3+ toxicities; four of those cases were determined to have been related to raltegravir use.
“In adolescents who failed other therapies, generally this rate of success is very good,” Frenkel said. “We have figured out a dose that is good for youth, given that individuals of his age excrete drugs much faster than adults.” -by Rob Volansky