FDA Approves Boehringer Ingelheim's Protease Inhibitor Aptivus to Treat Drug-Resistant HIV

FDA on Wednesday approved Boehringer Ingelheim's protease inhibitor Aptivus to be used in combination with Abbott Laboratories' Norvir for HIV/AIDS patients who have become resistant to other drugs, Reuters reports. Boehringer on Wednesday said Aptivus -- known generically as tipranavir -- will be available at pharmacies nationwide within two weeks (Reuters, 6/23). Protease inhibitors work by blocking the action of an enzyme that cuts HIV proteins into the shorter sections that the virus needs to replicate (Kaiser Daily HIV/AIDS Report, 5/4). Although FDA has approved eight other protease inhibitors, most HIV/AIDS patients develop resistance to the drugs at some time. Boehringer said it hopes to gain approval of Aptivus from E.U. regulators by the end of this year, according to Andres Barner, the company's head of research (Reuters, 6/23).

Safety Concerns
An FDA advisory panel last month supported Aptivus' approval but called for more data from long-term studies on Aptivus' effects on the liver and cholesterol levels. Although the panel expressed safety concerns about Aptivus, it said there is a great need for new treatments for HIV/AIDS patients who are not responding to other drugs (Kaiser Daily HIV/AIDS Report, 5/20). Boehringer said there are multiple ongoing clinical trials testing the safety and efficacy of Aptivus, including Phase II and Phase III trials involving HIV-positive children and adults who have not taken any other antiretroviral drugs, according to a Boehringer release. The company recommends that physicians perform liver function testing at initiation of Aptivus therapy and frequently monitor the levels, as well as take caution in prescribing the drug to HIV-positive people who are co-infected with hepatitis B or hepatitis C or have other liver problems (Boehringer Ingelheim release, 6/23).

Back to other news for June 23, 2005