New Aptivus launched in Europe for resistant HIV
pharmafile | November 9, 2005 | News story | Sales and Marketing |Â Â Â
Boehringer Ingelheim's new treatment for patients with drug-resistant HIV has been approved by the EMEA.
The prevalence of drug-resistant HIV is a growing problem globally and Aptivus (tipranavir) has been fast-tracked by European regulators to meet the need.
The drug is a non-peptidic protease inhibitor (NPPI) and will be given to highly pre-treated patients with virus resistance to multiple protease inhibitors.
The approved twice-daily dose of Aptivus is 500mg taken with 200mg of ritonavir, a protease inhibitor which, according to trial data, boosts the therapeutic effect of Aptivus.
"Aptivus is a significant breakthrough for the many patients who have been on HIV therapy and are in need of powerful treatment options to help manage their disease," said professor Margaret Johnson of the Royal Free Hospital, London.
Aptivus, which was granted a similar accelerated approval in the US this year, is already being prescribed outside the US on a named patient basis.
Its European approval follows data from two trials, RESIST-1 and RESIST-2, involving over 1,500 patients.
The trials showed that a higher percentage (41.2% against 18.9%) of HIV-positive patients taking the Aptivus and ritonavir combination achieved a treatment response than those taking a low-dose ritonavir-boosted comparator protease inhibitor (CPI).
The results also showed that adding Roche's fusion inhibitor Fuzeon (enfuviritide) to the combination resulted in a 90% drop in viral load compared with patients not receiving Fuzeon.
Roche said Fuzeon and Aptivus represented a potent combination and that new guidelines supported the use of the drugs.
The Department of Health and Human Services in the US recently recommended the treatment goal of achieving suppression of the virus to levels that make it undetectable in the blood for these patients.
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