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Title: Tipranavir Approved in Europe for Suppression Treatment of HIV
URL: http://www.pslgroup.com/dg/2204A6.htm
Doctor's Guide
April 28, 2008

INGELHEIM, Germany -- April 28, 2008 -- The European Commission has given full marketing authorisation to tipranavir (Aptivus) for the suppression of HIV in highly treatment-experienced patients who have developed resistance to other protease inhibitors.

The decision to grant full marketing authorisation was taken on the evidence of 2 large, multicentre pivotal trials that compared the superiority of tipranavir across several efficacy measures with that of a group of comparator protease inhibitors boosted with ritonavir. Treatment response rates over 156 weeks were nearly 3 times higher in the patients assigned to tipranavir compared with those taking ritonavir (20.9% vs 7.5%, respectively). Response rates were markedly higher for those patients who also started a new class of HIV therapy.

The data also demonstrated that tipranavir enabled treatment-experienced patients to achieve and sustain undetectable viral loads. This efficacy prompted European authorities to remove the "exceptional circumstances" restriction on the marketing authorisation, which was previously granted in 2005.

One patient from Frankfurt, Germany, who has been treated with nearly all the 22 currently available drugs for the treatment of HIV, said, "This full approval is good news for treatment-experienced patients like me. It gives us the confidence that our therapies have passed the rigorous tests demanded of them. With drugs like tipranavir available to us, we can, regardless of our treatment experience, aim for an undetectable viral load."

Currently, phase 2 and 3 studies in paediatric and other populations are fully enrolled and ongoing.

The most commonly reported side effects of at least moderate intensity included diarrhoea, nausea, vomiting, and abdominal pain. Fever, fatigue, headache, bronchitis, depression, and rash also occurred. Elevated transaminase, cholesterol, and triglyceride levels were more frequent in patients taking tipranavir than in those assigned to the ritonavir-boosted comparator group. Only in a minority of cases was treatment discontinued.

Tipranavir also has received US marketing authorisation by the Food and Drug Administration and was launched in June 2005; it was granted traditional approval in late 2007. Additional marketing authorisations from other countries have been received or are expected.

SOURCE: Boehringer Ingelheim GmbH

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