September 26, 2013
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Ritonavir-boosted tipranavir shows long-term promise in children

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Children with HIV who begin treatment early and are stable on ritonavir-boosted tipranavir regimens at week 48 appeared to remain stable up to 292 weeks after beginning treatment, recent data suggest.

Juan C. Salazar, MD, MPH, of Connecticut Children’s Medical Center, and colleagues conducted a long-term follow-up study of children who were enrolled into a randomized phase 1/2a study of the safety and tolerability of a treatment regimen based on tipranavir (Aptivus, Boehringer Ingelheim).

Among the 62 patients younger than 12 years who were included in the trial, 51 were still receiving treatment at week 48; 30 were receiving treatment at week 120; 24 were receiving treatment at week 168; and 13 were still receiving the treatment at week 288.

There were 53 adolescent patients aged 12 to 18 years on the trial. Thirty-five were still receiving treatment at week 48; 17 were receiving treatment at week 120; 10 were receiving treatment at week 168; and two were receiving treatment at week 288.

Among children younger than 6 years, nine of 25 patients had viral loads of less than 400 copies/mL at week 292. Six of 37 patients aged 6 to 12 years had viral loads of less than 400 copies/mL at week 292, as did two of 53 patients aged 12 to 18 years. Safety and tolerability were best for the children aged 2 to 6 years.

“Expanded treatment options for HIV-infected children and adolescents are critical, given that triple-class virologic failure has been reported to be near 12% after 5 years of initial antiretroviral treatment,” the researchers wrote. “[These data] support the long term use of a tipranavir-based regiment in younger HIV-1 infected children.”

Juan C. Salazar, MD, MPH, can be reached at Connecticut Children’s Medical Center, 282 Washington St., 2-L, Hartford, CT 06106; email: JSalazar@nso1.uchc.edu.  

Disclosure: The study was funded by Boehringer Ingelheim, and some of the study researchers are employees of the company.