Tipranavir (Aptivus) riceve l’approvazione al commercio in Europa

L’inibitore della proteasi Aptivus (Tipranavir, Boehringer Ingelheim ) ha ricevuto l’approvazione al commercio in Europa. L’opinione positiva del CHMP (EMEA) risaliva al 28 luglio.

Il dosaggio raccomandato è TPV/rtv 500/200 mg, bis in die. L’indicazione prevede che esso sia utilizzato nei pazienti pre-trattati che abbiano un ceppo virale di HIV resistente ad alri inibitori delle proteasi.

Di seguito alcune specifiche:

Last week the US Food and Drug Administration issued revised HIV treatment guidelines stating that patients with multi-drug experience should receive anti-HIV therapy with the aim of suppressing viral load as low as possible. In order to achieve this, the guidelines suggest that patients should consider taking a boosted protease inhibitor such as tipranavir/ritonavir together with the fusion inhibitor, T-20 (enfuvirtide, Fuzeon).

The current UK guidelines, issued by the British HIV Association note that the “RESIST-I and II studies provide data that the [protease inhibitor] tipranavir is an active agent for the management of drug-resistant HIV in highly treatment-experienced patients”, and notes that the use of tipranavir along with another active drug, use as T-20 significantly increases the chances of virological suppression.

Side-effects of tipranavir include raised liver enzymes and increased levels of blood fats. Most patients experiencing these side-effects in the RESIST studies did not need to change treatment. Tipranavir is known to interact with other protease inhibitors and with some drugs used to treat infections, such a fluconazole and rifampin. It can also interact with statins and antacids requiring the dose of tipranavir to be increased.