Background. An aggressive therapeutic approach for treatment of HIV in adults consists of combining five or more concurrent antiretrovirals. The clinical benefits of this regimen are often accompanied by increased toxicities. We report the safety and tolerance of multiple drug therapy in HIV-infected children.
Methods. A retrospective chart review was performed to identify HIV-infected children who received ≥5 concurrent antiretrovirals or 4 antiretrovirals plus hydroxyurea. Treatment success was defined as ≥1 log10 decrease in plasma HIV RNA from baseline any time during multiple drug therapy. Toxicities were defined as a >Grade 2 change from baseline in laboratory values.
Results. Twelve patients received multiple drug therapy for 6 months, and 42% of patients continued to receive therapy for at least 1 year. No Grade 3 or 4 toxicities or laboratory abnormalities were reported. Treatment success occurred in 8 (83%) of 12 patients. Adherence was a determining factor in treatment success or failure.
Conclusions. Treatment of HIV-infected children with multiple drug therapy was well-tolerated in this cohort. Treatment success occurred in most patients, with adherence affecting patients’ likelihood of success. Larger controlled clinical trials in this patient population are necessary to determine whether the benefit of this therapeutic approach outweighs potential risks.
From the Division of Clinical Pharmacology (JRK, EPA) and the Division of Infectious Diseases, Department of Pediatrics (MC, RP, DWK, MSS), and the Departments of Pediatric and Maternal Infection (EC, RY) and Microbiology (GMA, RP), University of Alabama at Birmingham, Birmingham, AL; and the Division of General Pediatrics and Adolescent Medicine, The Feinberg School of Medicine, Northwestern University, Evanston, IL (MSS).
Accepted for publication Nov. 25, 2002.
Address for reprints: Grace Aldrovandi, M.D., C.M., Department of Pediatrics, University of Alabama at Birmingham, 845 Nineteenth St. South, Bevill Biomedical Building, Room 559, Birmingham, AL 35294-0019. Fax 205-975-2457; E-mail firstname.lastname@example.org