October 3, 2001
AIDS activists from the Treatment Action Group (TAG) today endorsed Gilead Sciences application for accelerated approval of Viread brand tenofovir disoproxil fumarate (TDF) for use in combination antiretroviral therapy in adults infected with HIV. Today the Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee will review Gileads application.
Tenofovir is the first in a new class of anti-HIV drugs, the nucleotide analogues, and is active against the HIV reverse transcriptase gene. Taken once a day, tenofovir is active against both drug-resistant and drug-sensitive HIV. To date there is little clinical toxicity associated with the drug.
TAG Antiviral Project Director Yvette Delph, M.D. said, "We salute Gilead Sciences for conducting its pivotal efficacy studies in heavily pre-treated individuals. This is something we have been asking industry to do for years. Over 50% of people taking antiretovirals are already resistant to many approved drugs, and they will need a potent drug with favorable toxicity and resistance profiles -- such as tenofovir -- to help them construct a potent new regimen."
Some at the FDA have questioned why the drug should be approved for treatment of all adults with HIV infection when the data mostly concentrate on heavily pre-treated individuals. TAG Senior Policy Director addressed this issue by pointing out that "FDA has approved new antiretrovirals for use in combination since 1995. Gilead has a phase III study in drug-naive individuals which will yield efficacy data in early 2002. The drug is clearly safe in both drug-naive and drug-experienced patients. If it is potent in drug-experienced patients it is likely to be even more potent in untreated individuals. It has a favorable safety and resistance profile. After years of asking industry to study new drugs in treatment-experienced individuals it would be perverse to penalize them for doing so."
TAGs policy statement and review of the data on tenofovir DF are available. In addition, the Gilead data and FDA analyses are available at http://www.fda.gov/ohrms/dockets/ac/01/briefing/3792b1.htm.
Founded in 1992, the Treatment Action Group (TAG) fights to find a cure for AIDS and to ensure that all people living with HIV receive the necessary treatment, care, and information they need to save their lives. TAG focuses on the AIDS research effort, both public and private, the drug development process, and our nations health care delivery systems. We meet with researchers, pharmaceutical companies and government officials, and resort when necessary to acts of civil disobedience, or to acts of Congress. We strive to develop the scientific and political expertise needed to transform policy. TAG is committed to working for and with all communities affected by HIV.