Efficacy and Safety of Tipranavir Coadministered with Ritonavir in HIV-1-Infected Children and Adolescents: 5 Years of Experience
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2014-04-01
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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.
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Pediatric Infectious Disease Journal. Philadelphia: Lippincott Williams & Wilkins, v. 33, n. 4, p. 396-400, 2014.