First 3-Antiretroviral Drug Combo Tablet Approved for HIV-1 Infection

The FDA has approved Atripla, the first combination antiretroviral tablet that contains the active ingredients of the 3 most widely used antiretroviral drugs-lamivudine (Epivir), zidovudine (Retrovir), and nevirapine (Viramune). This fixed-dose product is a stand-alone tablet replacing the need for a 3-drug regimen for the treatment of HIV-1 infection in adults.

This signifies a new approach to HIV treatment that simplifies the burden of the drug regimen for this disease and should increase patient compliance. It will be commercially available in the United States through a joint venture between Bristol-Myers Squibb and Gilead Sciences, and in some areas by Merck. It is also being considered for purchase and distribution in 15 other countries under the president’s Emergency Plan for AIDS Relief.

The recommended regimen is 1 tablet twice daily following an initial 2 weeks of treatment with each of the 3 components individually. “This new option, a fixed-dose combination of a tablet containing lamivudine, zidovudine, and nevirapine, simplifies the treatment of HIV-1, which is a stumbling block for many individuals who find it difficult to maintain a regimen requiring the use of several drugs,” said Michael O. Leavitt, secretary of the Department of Health and Human Services.