Boehringer Ingelheim has launched Aptivus (tipranavir), a protease inhibitor indicated for use, with low-dose ritonavir as a pharmacokinetic enhancer, for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.

Aptivus is available as soft capsules containing tipranavir 250mg.

The Summary of Product Characteristics for Aptivus states that when deciding to initiate treatment with the drug (in combination with low-dose ritonavir), careful consideration should be given to patients' treatment history and the patterns of mutation associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus.

The recommended dose of tipranavir is 500mg, co-administered with ritonavir 200mg, twice daily. The capsules should be taken with food.

Aptivus should be used with caution in patients with mild hepatic impairment (Child-Pugh Class A) and should be avoided in patients with moderate to severe impairment (Child-Pugh Class B or C).

Marketing approval for Aptivus was granted on the basis of two phase III studies involving highly pre-treated patients (median number of prior antiretroviral agents = 12) with virus resistant to protease inhibitors.

The SPC states that the development of resistance to tipranavir is slow and complex. The drug maintains significant antiviral activity against most HIV-1 clinical isolates showing post-treatment decreased susceptibility to other protease inhibitors that are available currently. Greater than 10-fold resistance to tipranavir is uncommon (<2.5 per cent of tested isolates) in viruses obtained from highly treatment experienced patients who have received multiple peptidic protease inhibitors.

View Aptivus drug record

Further information: Boehringer Ingelheim Ltd

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