HIV Digest	HIV Digest Archive

Last month, the US Food and Drug Administration approved Boehringer Ingelheim's protease inhibitor Aptivus for use with Norvir, made by Abbott Laboratories, in treating adults with drug-resistant HIV. The German drug maker said Aptivus, or tipranavir, should be available in US pharmacies within two weeks.

Though eight protease inhibitors are currently approved in the United States, most patients eventually develop resistance. Two major Boehringer-funded clinical trials showed Aptivus was more effective than other HIV drugs when used in combination with Norvir. According to Boehringer, almost 40 percent of patients taking Aptivus with Norvir responded well, compared with about 21 percent of those taking Norvir with Abbott's Kaletra.

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An FDA advisory panel in May supported the approval of Aptivus but said more safety studies were needed on its long-term effects on cholesterol levels and the liver. One early study demonstrated initial liver toxicity in healthy patients taking Aptivus, and later data showed 10 percent of people taking it had liver problems, compared with 3 percent for similar drugs. In a statement, Boehringer said patients taking Aptivus should be followed closely by clinical and laboratory monitoring. The drug is still being studied in drug-intolerant adults as well as in children.

Editor's Note: from Reuters