Press room ... 2001 archive

Project Inform Lauds Approval of
New Drug for Treatment of HIV

October 3, 2001

San Francisco, CA—An advisory committee to the U.S. Food and Drug Administration (FDA) recommended approval of the new drug tenofovir (Viread) for the treatment of HIV disease by a slim margin of a 9 to 7 vote. The committee recommended only a narrow label indication of the drug, restricting it to use people with advanced-stage HIV disease with resistance to other drugs. The FDA usually follows the recommendations of its advisory committees but is not bound to do so. The sponsor, Gilead Sciences of Redwood City, California, had asked that the drug be approved for wide use in treating HIV disease, the same label indication given to almost all AIDS drugs for the last several years.

Project Inform is deeply disappointed that the committee instead recommended this narrow indication. Martin Delaney, Founding Director of Project Inform, said that "While we're happy to see the drug approved, this narrow indication is major mistake and one of the least logical positions I've ever seen taken by an FDA advisory committee. For the last several years, all other drugs for HIV have been granted wide label indication, even though many were far more toxic than this drug. Most of the earlier drugs were tested only in early stage patients just beginning treatment, yet they were given approval for all stages of the disease."

Project Inform asserts that if the FDA follows the committee's recommendation in this regard, it would signal a major change in FDA policy and would in effect punish the sponsor for doing something both the FDA and AIDS activists had asked of them, namely to first study the drug in patients who were running out of options.

"This recommendation," Delaney said, "simply makes no sense and takes away physicians' rights to use a medication in the way they feel proper. The committee is trying to practice medicine. In the entire history of HIV medicine, every drug that works in later stages of disease has been found to work even better in earlier stages when treatment is indicated. There are no exceptions to this." Project Inform intends to protest the committee's recommendation and will urge the FDA to reject it and instead grant the same broad indications given to all other AIDS drugs.

Project Inform believes that Tenofovir is an important drug for several reasons. It remains active even in people who have had extensive experience with other anti-HIV drugs of this class and developed resistance to them. Secondly, it appears to have an excellent safety profile, possibly the best yet seen of any anti-HIV drug. Finally, it is taken only once a day, thus helping to simplify the overall treatment regimen taken by people with HIV. Simpler regimens result in better adherence and thus better performance by the drug. Safety data are currently only available for up to a year of use and it's always possible that some side effects may appear later. Still, Project Inform believes the drug sets a new standard for safety in the first year of use and so far gives no indication that any long-term toxicity will develop.

Ben Cheng, Director of Antiviral Information at Project Inform, attended the FDA hearing in Washington, DC and comments, "This is the first time we've seen a drug developed initially in people with advanced disease and a long prior history of using of other anti-HIV treatments. Yet even in this difficult setting, the drug proved its value. We applaud Gilead's decision to focus on the needs of people who might otherwise be running out of options. But this drug may be equally important for use in earlier stages of disease due to its low toxicity, ease of use and strong barrier against development of resistance. The decision about when to use it should be left in the hands of doctors and their patients. That's why the issue of the broad vs. narrow label indication is so important and why we strongly reject the committee's recommendation."

Anne Donnelly, Public Policy Director of Project Inform raised the issue of price. "We recently met with Gilead to discuss the cost of this drug. At the meeting, a number of the directors of State AIDS Drug Assistance Programs (ADAP) who advise the FAIR Pricing Coalition, an activist coalition, pointed out how inadequate funding is already causing State ADAPs to restrict or limit programs. Some are being forced to put people on waiting lists. This is completely unacceptable. Solving the problem will require both increased federal and state funding and the lowest possible price for anti-HIV drugs. We're waiting to see what Gilead will charge and hope they will be good corporate citizens. If not, it may affect the ability of some states to put this important new drug on their formularies, thus restricting access. It doesn't matter how good a drug is if people can't afford it." Donnelly also worried that the narrow indication, which will result in restricted sales at least for a while, might encourage the company to set a higher price because of the smaller market opportunity. "We look forward to hearing what Gilead has in mind."

Ben Cheng concluded, "A wide, general indication for the treatment of HIV disease, like that given for almost all other anti-HIV drugs, is the best solution for both patients and their healthcare providers. Setting a low, fair price consistent with that of other drugs in this class is the best way for Gilead to compete in the marketplace". He continued, "Gilead has worked sensitively and cooperatively with the community while developing this drug. They should not now be ‘punished' with a narrow indication as a consequence of first testing the drug in advanced patients with drug resistance. But that is exactly what will happen if the committee's recommendation is followed."