[Ip-health] NYT: New AIDS Pill to Treat People in Poor Countries

[Amy Nunn]

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New AIDS Pill to Treat People in Poor Countries


By DONALD G. McNEIL Jr.

Published: July 6, 2006

The Food and
<http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_an
d_drug_administration/index.html?inline=nyt-org>  Drug Administration has
approved the first 3-in-1 antiretroviral pill for use by the
American-sponsored plan for AIDS
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics
/aids/index.html?inline=nyt-classifier>  treatment, something that the White
House's acting global AIDS coordinator said yesterday 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 on 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
<http://topics.nytimes.com/top/news/international/countriesandterritories/un
itedstates/index.html?inline=nyt-geo>  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
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics
/malaria/index.html?inline=nyt-classifier>  and Tuberculosis
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics
/tuberculosis/index.html?inline=nyt-classifier> , the second-largest
provider, pays for about 541,000 patients, Dr. 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
<http://topics.nytimes.com/top/news/international/countriesandterritories/in
dia/index.html?inline=nyt-geo> , 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.

Dr. Dybul said he was also pleased that the new pill did not contain D4T,
also known as stavudine and Zerit, which is another common first-line drug,
but 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 Dr. 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 Bush administration critics feared the money would be
reserved for expensive American and European brand-name drugs. But, defying
those expectations, the program in May 2004 began buying generics and now
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
<http://topics.nytimes.com/top/reference/timestopics/organizations/w/world_h
ealth_organization/index.html?inline=nyt-org>  Organization's drug-approval
process, the president's program requires separate F.D.A. 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 yesterday, but the
company's Web site carried an announcement, dated Monday, saying it was
"delighted to share" that its drug had won F.D.A. approval.

The first 3-in-1 antiretroviral pill was triomune, from Cipla, another
Indian generic company. It won World Health Organization approval in 2002
and is used by nearly 400,000 patients whose drugs are bought by Unicef
<http://topics.nytimes.com/top/reference/timestopics/organizations/u/united_
nations_childrens_fund/index.html?inline=nyt-org> , Doctors Without Borders
<http://topics.nytimes.com/top/reference/timestopics/organizations/d/doctors
_without_borders/index.html?inline=nyt-org>  and other donors.

Dr. Yusuf K. Hamied, the company's chairman, said yesterday that he hoped
for F.D.A. approval shortly for several Cipla products, including triomune.
"Pepfar came on us out of the blue," he said. "We were concentrating more on
the W.H.O., 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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