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news.The FDA has granted the approval of Aptivus, Boehringer Ingelheim's HIV treatment, to be used in combination with ritonavir. Following the agency's endorsement, Boehringer said it expects to release a capsule formulation of the drug within the next two weeks.
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The FDA approved Aptivus (tipranavir) capsules, an HIV protease inhibitor, to be given with ritonavir for treatment of HIV-1 infected adults.
Ritonavir is also a protease inhibitor; this means the drug blocks the release of the protease enzyme needed by the HIV virus to create new viruses. The two drugs will be taken in combination in order to boost the therapeutic levels of Aptivus. With out this drug cocktail levels of Aptivus will be insufficient to inhibit HIV replication.
The approval is based on 24-week data from ongoing studies conducted by Boehringer. As yet there are no study results demonstrating the effect of Aptivus on clinical progression of HIV-1.
The FDA said the endorsement provides a new therapy for patients with limited treatment options. Aptivus is able to enter infected immune cells and inhibit HIV replication for many strains of HIV that are resistant to other commercially available protease inhibitors.
Drug resistance is one of the major challenges that patients and physicians face in the treatment of HIV. Resistance develops when the virus mutates and is no longer suppressed by drugs that were once effective.