tipranavir (Aptivus) 100mg/ml oral solution

following an abbreviated submission:

tipranavir 100mg/ml oral solution (Aptivus), in combination with low dose ritonavir is accepted for restricted use within NHS Scotland for combination antiretroviral treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to multiple protease inhibitors.

The marketing authorisation for tipranavir states that it should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options. In adult patients the Scottish Medicines Consortium has restricted tipranavir to patients with a tipranavir mutation score of less than 4 and this restriction should also apply to this licence extension covering children from 2 to 12 years of age. Tipranavir is listed in the British National Formulary for Children for the treatment of HIV infection.