Tipranavir (Aptivus) approved in US
On June 22, 2005, the US Food and Drug Administration (FDA) granted accelerated approval of a new protease inhibor, tipranavir (Aptivus). Tipranavir, co-administered with 200 mg of ritonavir, is indicated for adult patients who are highly treatment-experienced or have HIV-1 strains resistant to multiple PIs.
The approval of tipranavir/r is based on 24-week results from of two controlled phase III studies previously reported in HTB (RESIST 1 and 2). A statistically greater percentage of HIV-positive patients taking tipranavir/r achieved treatment response versus the comparator group (40% vs 18%). Treatment response was defined as a confirmed 1 log or greater decrease in HIV RNA from baseline.
The approved dose of tipranavir is 500 mg taken with 200 mg of ritonavir, twice daily with food. Taking the drug with food improves absorption.
Source: FDA listlesrve and Boehringer Ingelheim PR