Children

Tipranavir, co-administered with ritonavir, was approved for marketing in the US in 2008 for use in patients aged two to 18 years. Dosing by body surface is tipranavir at 375mg/m2 and 150mg ritonavir/m2.  Dosing by weight is 14mg/kg co-administered with ritonavir 6/mg/kg twice daily. This dose should not exceed a dose of tipranavir 500mg with ritonavir 200mg twice daily. If a patient has toxicity and HIV that is not resistant to more than one protease inhibitor, the dose may be reduced.

Major toxicities are diarrhoea, nausea, fatigue, headache, rash and vomiting. Rash is more common in children than it is in adults. Laboratory abnormalities include elevated liver enzymes, cholesterol, and triglycerides. Boosted tipranavir is best tolerated when taken with food.

The oral solution contains vitamin E in quantities higher than the US FDA reference daily intake (RDI) so supplemental vitamin E in amounts greater than that found in a standard paediatric vitamin should not be used. The oral solution must be used within 60 days of the bottle being opened.1 Capsules should be refrigerated if they will not be deplete within two months. 

Tipranavir given with 200mg ritonavir has resulted in fatal and non-fatal intracranial haemorrhage in adults. The drug should be used with caution in anyone with an elevated bleeding risk.

Paediatric use of boosted tipranavir was approved based on results from PACTG 1051 clinical trial. These showed that, in 115 HIV-positive children aged between two and 18 years, a dose of 290/115mg/m2, or the higher dose of 375/150mg/m2, resulted in viral loads less than 50 copies/ml in 35% of the children after 48 weeks. This was coupled with CD4 cell count increases of 157 and 96 cells/mm3 respectively. All but three of the children were treatment-experienced, with the older children having a median of 17 protease inhibitor-associated mutations.2

An earlier study had reported on the safety and efficacy of tipranavir at a dose of 290mg/m2 tipranavir boosted by 115mg/m2 ritonavir.3

References

  1. Panel on antiretroviral therapy and medical management of HIV-infected children Guidelines for the use of antiretroviral agents in pediatric HIV infection. August 16, 2010; pp1-219. Available at http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf (accessed November 13, 2010)., 2010
  2. Salazar JC Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS 22(14): 1789-1798, 2008
  3. Sabo JP et al. Population pharmacokinetic assessment of systemic steady-state tipranavir concentrations for HIV+ pediatric patients administered tipranavir / ritonavir: BI 1182.14 and PACTG 1051 study team. 13th Conference on Retroviruses and Opportunistic Infections, Denver, abstract 687, 2006
Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.