Germany’s Boehringer Ingelheim has been given the go-ahead in Europe to market its non-peptidic HIV protease inhibitor Aptivus (tipranavir).
BI recently launched Aptivus in the USA to treat HIV/AIDS [[24/06/05d]] and has great expectations for the drug. In common with the USA, European approval specifically covers Aptivus’ use in combination with Abbott Laboratories’ Norvir (ritonavir), on the back of data from the RESIST clinical studies, in which patients taking Aptivus plus Norvir experienced a significantly greater treatment response compared to those given a protease inhibitor regimen [[26/10/04f]].
Specifically, Aptivus is approved for use with ritonavir – in combination of other anti-HIV drugs – in patients who have extensive previous experience of antiretroviral therapy and have HIV that is resistant to other protease inhibitors. The approved dose of Aptivus is 500mg taken with 200mg of ritonavir, twice daily.
Meanwhile, Aptivus’ availability in Europe will also provide a boost for Roche, whose HIV fusion inhibitor Fuzeon (enfuvirtide) has shown dramatic efficacy in trials when combined with tipranavir and ritonavir.
Last week, the US Department of Health and Human Services updated its HIV treatment guidelines to suggest that patients who have already been treated with multiple antiretrovirals should receive anti-HIV therapy aimed at suppressing viral load to undetectable levels, rather than simply achieving a ‘significant reduction’. Use of a boosted protease inhibitor such as tipranavir/ritonavir together with Fuzeon is explicitly cited in the guidance [[17/10/05f]].
In addition to its approvals in the USA and Europe, Aptivus has also been registered in Mexico and Switzerland.
