AEGiS-WSJ: Panel Backs Boehringer Drug As Treatment for Resistant HIV: Advisers to FDA Conclude Urgent Need for Tipranavir Outweighs Safety Concerns

Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.

Panel Backs Boehringer Drug As Treatment for Resistant HIV: Advisers to FDA Conclude Urgent Need for Tipranavir Outweighs Safety Concerns

Wall Street Journal - May 20, 2005
Jennifer Corbett Dooren And Jeanne Whalen, Staff Reporters of THE WALL STREET JOURNAL

A Food and Drug Administration panel backed a new drug to treat HIV in patients who have become resistant to other drugs, despite safety concerns.

The drug, tipranavir, made by a unit of German-based Boehringer Ingelheim GmbH, is a protease inhibitor aimed at blocking HIV replication. If tipranavir is approved, it would be used in combination with Abbott Laboratories's Norvir. Physicians also could add other drugs to the treatment regimen.

"We feel the need for this drug in this patient population is high and the risks are certainly present," said Janet Englund, a pediatric infectious-disease expert in Seattle, who headed the FDA panel of outside experts. The panel voted 11 to 3 in favor of a question that asked whether it believed tipranavir was safe and effective for drug-resistant HIV patients. The vote essentially recommends to the FDA that it approve the drug.

The FDA is considering tipranavir, which would be sold under the brand name Aptivus, under an accelerated review system aimed at getting life-saving drugs on the market faster. The agency is expected to make a decision by around June 22.

Panel members and the FDA said they were concerned about possible liver damage and adverse interactions of the drug with other commonly used drugs such as cholesterol-lowering and diabetes medications. They also said they were concerned about an increased incidence of rash in females, who comprised just 15% of patients in clinical studies of the drug.

Still, panel members said there is a great need for new treatments for HIV/AIDS patients who are no longer responding to many of their medications. Boehringer Ingelheim is continuing to study the drug to address many of the concerns raised by the panel.

Protease inhibitors are used with two or three other classes of drugs as part of a "cocktail" used to treat HIV, the virus that causes AIDS, which destroys a person's immune system.

Charlie Hicks, an HIV researcher at Duke University Medical Center who helped lead the tipranavir clinical studies, said the drug is the most significant protease inhibitor to come before the FDA in several years.

Data presented by Boehringer Ingelheim showed that patients receiving tipranavir combined with Norvir responded better than patients who were treated with a cocktail of other antiviral drugs. Many patients in the two key clinical trials of tipranavir had become resistant to about 12 other HIV/AIDS medications.

Some of the patients in the clinical trials of tipranavir also are being treated with Fuzeon, a drug sold by Swiss-based Roche Holding AG and Trimeris Inc. of Durham, N.C. Fuzeon is the only fusion inhibitor on the market and it works by blocking HIV from moving into healthy cells in the body's immune system. The FDA noted that when Fuzeon was added to the tipranavir combination "the treatment effect was even more significantly greater than if [Fuzeon] was not used."

In many HIV-infected patients, the virus stops responding to treatment over time, in part because many patients have a hard time adhering to their treatment regimens since several commonly used drugs cause significant gastrointestinal problems like diarrhea and nausea. When patients interrupt their treatment schedules, it gives HIV time to mutate, physicians say.

HIV most commonly is spread by sexual contact. About 950,000 Americans and some 40 million people world-wide currently are infected with HIV, according to federal government estimates.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com and Jeanne Whalen at jeanne.whalen@wsj.com

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