Tibotec breakthrough HIV therapy recommended

Tibotec said it anticipates receiving the conditional marketing authorization from the European Commission by early next year.

The positive opinion is based on the efficacy and safety results of two phase II trials. Prezista has been approved for co-administration with 100mg ritonavir in combination with other antiretroviral medicinal products for HIV in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor.

Studies have also shown that Prezista, when used in combination with Roche’s fusion inhibitor Fuzeon, can substantially increase the chances of reaching undetectable viral load, the new treatment goal in HIV.

Previously, it was reasonable for HIV patients to have a detectable viral load as long as their immune system was under control. New guidelines suggest that achieving viral suppression should be the aim of new HIV therapies.

Tibotec is developing a global access program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The global access program for Prezista includes access pricing, registration, medical education for appropriate use and voluntary licensing.