Inside News

• FDA Approves Gilead's Once-Daily NRTI, Emtriva
• CDC: Doctors Should Not Use Two-Month Rifampin/Pyrazinamide Regimen for LTBI
• DHHS Releases Revised ARV Guidelines; Hopes to Make Drug Selection Easier
• Lamivudine + Abacavir + Tenofovir Arm of Study Halted Due to Early Virologic Non-Response
• New Guidelines Available for HIV Drug Resistance Testing

FDA Approves Gilead's Once-Daily NRTI, Emtriva

The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences' once-daily nucleoside reverse transcriptase inhibitor (NRTI), Emtriva (emtricitabine), to be used in combination with other antiretroviral medications to treat HIV. Emtriva works by blocking an enzyme necessary for HIV replication. Gilead gained approval for its other once-daily NRTI, Viread (tenofovir), and is developing a combination pill containing both drugs, which it hopes will be available in 2005. The U.S. wholesaler acquisition cost for Emtriva is $252.83 for 30 capsules (one month of therapy). Emtriva is available in pharmacies now. (Reuters, 7/2/03.)

CDC: Doctors Should Not Use Two-Month Rifampin/Pyrazinamide Regimen for LTBI

The two-month combination therapy using rifampin and pyrazinamide to treat latent TB infection (LTBI) can cause severe liver damage and death, and should not be used, according to a study from the Centers for Disease Control and Prevention (CDC). In data collected from January 2000 to June 2002, the CDC received reports of 48 patients with LTBI who experienced severe liver injury after receiving the two-drug treatment. Eleven patients died. The CDC recommends using a nine-month regimen of isoniazid as the preferred treatment. The rifampin/pyrazinamide regimen should be used only if the potential benefits outweigh the risk for severe liver injury and death associated with it. (CDC MMWR 2003;52;(31):735-739.)

DHHS Releases Revised ARV Guidelines; Hopes to Make Drug Selection Easier

The U.S. Department of Health and Human Services (DHHS) has released an updated version of the Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents. The new version, which contains a list of suggested combination regimens for the initiation of antiretroviral therapy, is expected to make the selection of appropriate treatment easier. Based on the results of clinical trials and expert opinion, the suggested regimens are classified as "preferred" or "alternative." The guidelines are available at www.aidsinfo.nih.gov, or can be ordered by calling 1-800-448-0440. (National Institutes of Health Press Release, 7/14/03.)

Lamivudine + Abacavir + Tenofovir Arm of Study Halted Due to Early Virologic Non-Response

GlaxoSmithKline has notified health care providers of a high rate of early virologic non-response in clinical study ESS30009, which was studying therapy-naive adults receiving once-daily combination therapy with lamivudine (3TC), abacavir (ABC), and tenofovir (TDF). Based on the results, the company recommends that 3TC, ABC, and TDF not be used as sole therapy for HIV; that any patients taking this combination be closely monitored and considered for modification of the therapy; and that any use of the combination with other antiretroviral agents be closely monitored for signs of treatment failure. (AEGiS news service, 7/25/03.)

New Guidelines Available for HIV Drug Resistance Testing

New guidelines on the use of resistance testing have been published by the American arm of the International AIDS Society (IAS-USA). The guidelines were created by an international panel of researchers convened in 2002, and includes information on how HIV develops resistance to different HIV drugs; highlights the importance of key mutations; discusses the different types of resistance tests available; and makes recommendations for their use in pregnancy and other situations. The guidelines were initially published in the July 1, 2003 issue of Clinical Infectious Diseases, and are also available for download on the IAS-USA Web site, www.iasusa.org. (AEGiS news service, 7/21/03.)

Back to the HEPP Report September 2003 contents page.