Investigational Anti-HIV Drug to Be Made Available Through Early Access Program

The investigational anti-HIV protease inhibitor amprenavir (Agenerase), formerly known as 141W94, is now available to patients who have not responded to current protease inhibitor-containing regimens through a novel early access program. The program will provide patients and physicians with more protocol options than standard expanded access drug programs previously have offered.

Three Options Available

The early access program for amprenavir was opened to enrollment of patients on September 21 and will include three options for obtaining the drug.

One option will be to enroll in an open-label clinical trial to determine the effect of amprenavir on lipid metabolism (hyperlipidemia and lipodystrophy) in subjects who are experiencing these adverse effects and are responding to current antiretroviral therapy.

A second option will be to enroll in an open-label clinical trial that will evaluate amprenavir or amprenavir combined with a second protease inhibitor in multidrug regimens for patients who have not responded to a protease-containing combination.

A third option is for patients who are not responding to their current therapies and need amprenavir to try to create a viable treatment regimen to meet their individual needs.

Regardless of which option physicians and patients opt for, patients need to have received prior treatment with at least one protease inhibitor in addition to fulfilling other standard criteria. Patients will also be strongly encouraged to start at least one other anti-HIV agent that they have not previously used.

“It is our hope that making Agenerase available through this early access program will enable patients who have failed previous treatment to construct alternative regimens which will fight the virus,” said Lynn Smiley, MD, vice president at Glaxo Wellcome, the company that is developing amprenavir. “Furthermore, by taking this unique approach to an early access program, we hope to capture some clinical information regarding Agenerase that might help guide future antiretroviral treatment decisions.”

Patients can be considered for inclusion in the early access program for amprenavir by having their physicians call 1-800-248-9757. Details of each option, including enrollment criteria, will be provided to physicians seeking to enroll patients into the program. Those patients who qualify for and are enrolled in any one of the three options will be provided amprenavir free of charge during the early access program through their physicians and will be counseled regarding dosing, compliance, and adverse event reporting.

To date, data collected on more than 700 patients receiving amprenavir have suggested that the drug is generally well tolerated with few treatment-limiting adverse events. The most commonly reported adverse events in clinical trials of amprenavir have included nausea, headache, vomiting, rash and perioral parasthesia. Amprenavir is dosed twice daily, once in the morning and once in the evening. In clinical trials, the drug was dosed without regard to food and water.