Atripla, a newly approved fixed-dose 'cocktail' drug for the treatment of HIV and AIDS, is being hailed as a major step forward in combating the disease in the US and elsewhere in the world.

It will also be made available to 15 other countries under PEPFAR, the President's Emergency Plan for AIDS Relief: Botswana, Ethiopia, Guyana, Haiti, Ivory Coast, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia.

Three Pharmas Teaming Up

Atripla contains the active ingredients of three commonly used antiretroviral drugs: Sustiva (efavirenz), manufactured by Bristol-Myers Squibb; and Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate), both manufactured by Gilead.

Merck holds the rights to efavirenz in some parts of the world and will work with the other two pharmaceutical companies to make Atripla available to patients and their doctors, according to the FDA.

The new drug application for the combination pill was placed on the FDA's fast track and was approved in under three months.

In a 10-month study of 244 HIV-positive adults, the three-drug pill significantly reduced the virus and increased the number of infection-fighting CD4 cells in 80 percent of the cases.

Easier Compliance

"Today's approval is a significant example of drug developers and FDA clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in the United States and abroad," said Dr. Andrew C. von Eschenbach, Acting Commissioner of Food and Drugs, in a statement released Thursday.

"The approval of Atripla simplifies the treatment regimen for HIV-1 infected adults," he added, "and will potentially improve the ability of patients to adhere to treatment resulting in long-term effective control of HIV-1."

There are more than 1 million people living with HIV or AIDS in the US; 40,000 new cases are diagnosed annually. Worldwide, almost 40 million people have HIV or AIDS; most of them live in poverty-stricken countries in Africa and Asia. UNAIDS reported that almost the global death toll from the disease reached 3 million in 2005.