A new generic pill that combines three widely used AIDS drugs in a single dose has been approved by the FDA for distribution in 15 hard-hit countries.

The drug, which is manufactured by Aurobindo Pharma, based in Hyderabad, India, contains three antiretrovirals that are widely used in the treatment of AIDS: Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine).

Unavailable in the US

The World Health Organization (WHO) considers all three medications as first-line therapies for AIDS. They account for approximately 50 percent of the drugs taken by AIDS patients.

Fifteen countries -- those deemed to be most affected by the AIDS pandemic -- have been earmarked for distribution of the new pill under the Bush Administration's $15 billion AIDS relief program known as "PEPFAR" (President's Emergency Plan For AIDS Relief).

Because there are existing patents on the individual components of the cocktail tablet, it cannot be sold in the US.

Possible Side Effects

The recommended regimen for the lamivudine-zidovudine-nevirapine tablet is one pill twice a day following an initial two-week treatment with the individual components taken individually, the FDA says in a statement.

Each ingredient of this generic tablet is currently approved to treat HIV-1 infected adults in combination with other antiretroviral agents.

The safety and effectiveness of the combination of lamivudine-zidovudine-nevirapine in lowering the viral load and increasing the CD4+ cell has been demonstrated in previously conducted adequate and well-controlled studies of the individual ingredients being used together for treatment, said the FDA.

The labeling of the combination drug includes a Medication Guide (patient labeling) and a boxed warning that the product's use can cause liver failure, severe rash, and lactic acidosis (buildup of an acid in the blood).