The Food and Drug Administration has approved the first three- in-one antiretroviral pill for use by the U.S.-sponsored plan for AIDS treatment, something the White House’s acting global AIDS coordinator said Tuesday should greatly improve treatment for AIDS patients in poor countries.
Although it is not yet clear how much money it will save, having patients take only one pill twice a day “should facilitate better therapies and better adherence,” said the coordinator, Dr. Mark Dybul.
The agency posted the approval of the drug on its website Friday. It approved the three-in- one pill, made by an Indian generic drug company, for patients in countries helped by the President’s Emergency Plan for AIDS Relief.
Under that plan, the United States is now the largest provider of antiretroviral drugs in the world, paying for treatment for 561,000 patients in Africa, Asia and the Caribbean.
The Global Fund for AIDS, Malaria and Tuberculosis, the second-largest provider, pays for about 541,000 patients, Dybul said, although there is some overlap in countries where both agencies work. The United States also pays one-third of the Global Fund’s budget.
The pill, made by Aurobindo Pharma of Hyderabad, India, combines three common first-line drugs, AZT, 3TC and NVP, which are also known as zidovudine, lamivudine and nevirapine and sold in the United States as Retrovir, Epivir and Viramune.
Dybul said he was pleased that the new pill did not contain D4T, also known as stavudine and Zerit, which is another common first-line drug, but more toxic than the others. In poor countries, where it is harder to do frequent blood and liver tests, toxicity can be harder to control.