Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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Miami Herald - June 24, 2005
Fred Tasker, Miami Herald
A powerful new anti-HIV drug was unveiled Thursday to help patients in whom the virus has overcome other drugs and begun to replicate again.
APTIVUS, when used with other drugs, was twice as effective as other drug combinations in 24-week clinical trials of 1,400 patients. The drug, to which the FDA gave accelerated approval Thursday, helped patients who had developed resistance to as many as three other drugs.
Such quick, temporary approval is given when a drug proves to be particularly effective and fills a crucial need for patients.
''This is important to a growing population of HIV patients experiencing drug resistance,'' said Dr. Pete Piliero, senior associate director for virology of the Germany-based drug giant Boehringer Ingelheim Pharmaceuticals.
Such new drugs are important because 1.1 million Americans are living with HIV. The number continues to climb because powerful antiretroviral drugs are keeping HIV patients alive longer, but also because even aggressive prevention and treatment programs have been unable to cut HIV's chronic new-infection rate of about 40,000 per year.
Part of HIV's staying power is its ability to develop resistance to existing drugs. Mutations often happen in patients who fail to adhere to their treatment regimens.
APTIVUS, generically called tipranavir, is in the drug class called protease inhibitors. It must be taken along with APTIVUS/r, another protease inhibitor generically called ritonavir, to be effective. Both drugs work by inhibiting the action of protease, an enzyme needed for HIV to replicate.
''APTIVUS is an important drug; it's one more drug in the armory,'' said Dr. Margaret Fischl, veteran AIDS researcher at the University of Miami. ``But it's similar to existing drugs.''
Serious side effects of APTIVUS include death, liver problems and adverse interaction with some other drugs.
The drug firm said the U.S. Food and Drug Administration had granted accelerated approval to APTIVUS based on 24 weeks of trials.
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