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.
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.