Efficacy and Safety of Tipranavir Co-Administered with Ritonavir in HIV-1-Infected Children and Adolescents: 5 Years of Experience

Salazar, Juan Carlos; Cahn, Pedro; Della Negra, Marinella; De Aquino, Maria Zilda; Robinson, Patrick; Jelaska, Ante; Mikl, Jaromir

Efficacy and Safety of Tipranavir Co-Administered with Ritonavir in HIV-1-Infected Children and Adolescents: 5 Years of Experience

Date

2014

Authors

Salazar, Juan Carlos

Cahn, Pedro

Della Negra, Marinella

De Aquino, Maria Zilda

Robinson, Patrick

Jelaska, Ante

Mikl, Jaromir

Abstract

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.

Keywords

Tipranavir efficacy, Pediatric HIV, Antiretroviral safety

Citation

Salazar, J. C., Cahn, P., Della Negra, M., De Aquino, M. Z., Robinson, P. A., Jelaska, A., & Mikl, J. (2014). Efficacy and safety of Tipranavir coadministered with Ritonavir in HIV-1-infected children and adolescents. The Pediatric Infectious Disease Journal.