Tipranavir expanded access programme begins in US

This article is more than 20 years old. Click here for more recent articles on this topic

Boehringer Ingelheim today announced the opening of the tipranavir Expanded Access Programme (EAP) in the United States. The programme will provide access to the company’s experimental protease inhibitor tipranavir for eligible HIV-infected patients who are not enrolled in the ongoing tipranavir clinical studies, who have demonstrated protease inhibitor (PI) resistance, and who need tipranavir to construct a viable treatment regimen.

For more information about the program, healthcare professionals treating HIV-infected patients may obtain information by calling 1-888-524-8675 or visiting www.tpv.com. Physicians must register at this site in order to obtain further information.

The tipranavir EAP in the U.S. is available to HIV-infected patients at least 18 years old, who are triple-antiretroviral class-experienced with at least two previous PI-based regimens, and have documented PI-resistance. Eligibility is not dependent upon viral load or CD4+ cell count.

Glossary

protease inhibitor (PI)

Family of antiretrovirals which target the protease enzyme. Includes amprenavir, indinavir, lopinavir, ritonavir, saquinavir, nelfinavir, and atazanavir.

treatment-experienced

A person who has previously taken treatment for a condition. Treatment-experienced people may have taken several different regimens before and may have a strain of HIV that is resistant to multiple drug classes.

named patient basis prescribing

A means of access to an unlicensed drug, in which a doctor requests supplies from its manufacturer for a specific individual.

fusion inhibitor

Anti-HIV drug targeting the point where HIV locks on to an immune cell.

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

The U.S. EAP is part of a larger, international early access initiative, which will provide tipranavir to several thousand treatment-experienced patients worldwide. Tipranavir is already available on a named patient basis under the same conditions as the US expanded access programme.

Twenty four week results of two large trials of tipranavir in highly treatment-experienced patients with some resistance to protease inhibitors were presented recently at international conferences. The studies, RESIST 1 & 2, showed that patients treated with tipranavir/ritonavir were significantly more likely to have viral load below below 400 copies at week 24 than patients receiving other ritonavir-boosted protease inhibitors, especially if they started to take the fusion inhibitor T-20 (enfuvirtide) at the same time as tipranavir.