Combined AIDS pill OK'd for use abroad


The Food and Drug Administration has approved the first 3-in-1 anti-retroviral pill for use by the U.S.-sponsored plan for AIDS treatment overseas, something that 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 R. Dybul.

The agency posted the approval of the drug on its Web site Friday evening. It approved the 3-in-1 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 anti-retroviral 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 new 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 is somewhat 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.

The plan Dybul runs, known as Pepfar, was created after President Bush's announcement in his 2003 State of the Union address that he would spend $15 billion over five years to fight AIDS.

At the time, many critics of the Bush administration feared that the money would be reserved for expensive U.S. and European brand-name drugs.

But the program in May 2004 began buying generics and currently pays for 24 generic formulations, including liquid solutions for infants. Also, the major Western companies dropped their prices for poor countries, sometimes as low as the prices of generics.

However, rather than subscribing to the World Health Organization's drug-approval process, the president's program requires separate FDA approval, which has caused delays, even though the agency created a fast-track process and waived its large fees.

No one from Aurobindo could be reached for comment Tuesday, but the company's Web site carried an announcement, dated Monday, saying it was "delighted to share" that its drug had won FDA approval.

The first 3-in-1 anti-retroviral pill was triomune, from Cipla, another Indian generic company. It won WHO approval in 2002 and is used by nearly 400,000 patients whose drugs are bought by UNICEF, Doctors Without Borders and other donors.

Dr. Yusuf K. Hamied, the company's chairman, said Tuesday that he hoped for FDA approval shortly for several Cipla products, including triomune.

"Pepfar came on us out of the blue," he said. "We were concentrating more on the WHO, and we were a little slow catching up."

Nonetheless, he praised his rival Aurobindo, calling it "a totally kosher company" and adding: "As an Indian, I'm proud of them."

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