Background: To evaluate the long-term (up to week 292) safety, efficacy and tolerability of ritonavir-boosted tipranavir in HIV-1-infected pediatric patients. Long-term follow up of patients enrolled in the randomized, open-label pediatric trial (1182.14/PACTG1051).
Methods: HIV-1-infected pediatric patients (2–18 years) who participated in the PACTG 1051 trial were followed for ritonavir-boosted tipranavir-based regimen efficacy, safety and tolerability through week 292.
Results: In patients <12 years of age, 51/62 (82%) were receiving drug at week 48 and 13/62 (21%) at week 288. Among adolescents (12–18 years of age), 35/53 (66%) were receiving drug at week 48 and 2/53 (4%) at week 288. Among patients 2 to <6 years of age, 18/25 (72%) had viral loads <400 copies/mL at week 48. By week 292, 9/25 (36%) of patients had viral loads <400 copies/mL. Among older patients, week 48 responder rates were 35% (13/37 of patients 6 to <12 years of age) and 32% (17/53 of patients 12 to 18 years of age). By week 292, 6/37 (16%) of those 6 to <12 years of age and 2/53 (4%) of those 12 to 18 years of age had viral loads <400 copies/mL. Overall safety and tolerability profiles were best for children who initiated treatment between 2 and <6 years of age. Drug-related adverse events (investigator defined) were similar across all age groups (55–65%).
Conclusions: Pediatric patients who begin treatment at the earlier ages, and who are stable on a ritonavir-boosted tipranavir-based regimen at week 48, generally continue to demonstrate good safety, tolerability and virologic efficacy profiles up to 292 weeks of treatment.
From the *Connecticut Children’s Medical Center, Division of Pediatric Infectious Diseases and Departments of Pediatrics and Immunology, University of Connecticut School of Medicine, Hartford, CT; †Fundación Huésped, Buenos Aires, Argentina; ‡Instituto de Infectologia Emílio Ribas; §Department of Pediatrics, University of São Paulo Medical School, São Paulo, Brazil; and ¶Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT.
Accepted for publication August 7, 2013.
The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors and were fully responsible for all content and editorial decisions, and were involved at all stages of article development. This study was funded by Boehringer Ingleheim Pharmaceuticals, Inc. and Drs. Robinson, Jelaska and Mikl are employees of Boehringer Ingleheim Pharmaceuticals, Inc. Writing and editorial support was provided by José L. Walewski, PhD of Envision Scientific Solutions, which was contracted and compensated by BIPI for these services. The authors have no other funding or conflicts of interest to disclose.
Address for correspondence: Juan C. Salazar, MD, MPH, Pediatrics and Immunology, Connecticut Children’s Medical Center, 282 Washington Street, 2-L, Hartford, CT 06106. E-mail: JSalazar@nso1.uchc.edu.