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Accelerated approval granted for protease inhibitor

BOEHRINGER INGELHEIM Accelerated approval granted for protease inhibitor

This non-peptidic protease inhibitor (PI) inhibits the virus-specific processing of the viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, thereby preventing the formation of mature virions. Tipranavir received accelerated approval on June 22, 2005, to be coadministered with 200 mg of ritonavir (Norvir, Abbott) for combination antiretroviral treatment of HIV-1-infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors.

Efficacy. The efficacy of tipranavir was evaluated in 2 ongoing, randomized, controlled, open-label, multicenter studies in HIV-positive, triple antiretroviral class experienced patients (N=1,159). Patients received either tipranvir coadministered with 200 mg of ritonavir plus an optimized background regimen (OBR) or a ritonavir-boosted PI (lopinavir, amprenavir, saquinavir, or indinavir) plus an OBR and were subsequently assessed for treatment response at 24 weeks. The proportion of patients in the tipranavir group characterized as virological responders (confirmed at least 1 log10 HIV-1 RNA below baseline) was 40% compared with 18% in the comparator PI group. The proportion of virological failures in the tipranavir group was 54% compared with 79% in the comparator PI group.

Dosing. The recommended dose of tipranavir is 500 mg (two 250-mg capsules), coadministered with 200 mg of ritonavir, twice daily.

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