Roche will discontinue the US sale and distribution of Fortovase, the soft-gel formulation of the HIV protease inhibitor saquinavir, due to the continued availability of the Invirase 500 mg tablet formulation, effective from February 15, 2006.
Roche has taken this action due to a significant decline in the demand for Fortovase as well as in response to the updated HIV treatment guidelines from the US Department of Health and Human Services (DHHS), which no longer recommend Fortovase as a component of a preferred or alternative initial treatment regimen. Roche first announced the discontinuation of Fortovase in May 2005 to allow physicians and patients adequate time to consider a transition to boosted Invirase or alternative treatment options, and to give pharmacists and wholesalers sufficient lead time to adjust their stock, states the company release.
"The Fortovase formulation of saquinavir no longer meets the demands of convenience and tolerability expected by patients today. In keeping with our research focus to optimise delivery of current therapies and develop novel treatments for people living with HIV/AIDS, we have determined that it is time to focus our resources on the availability of Invirase, which offers significant improvements in convenience and GI tolerance. We have taken great care to plan this discontinuation in such a manner as to allow physicians and patients adequate time to consider and transition to boosted Invirase or other therapies," said Frederick Schmid, vice president, virology/HIV, Roche.
Invirase in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection. Ritonavir is manufactured by Abbott Laboratories.