[Ip-health] Wall Street Journal: Generic AIDS Pill Gets Acceptance

[thiru@cptech.org]

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http://online.wsj.com/article/0,,SB108871313014153230,00.html?mod=world_news_whats_news

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Generic AIDS Pill Gets Acceptance

Drug Made in India Costs
Less Than Brand Names;
Study Covered Six Months
By MARILYN CHASE
Staff Reporter of THE WALL STREET JOURNAL
July 2, 2004; Page B3

An AIDS study has validated the safety and efficacy of a popular
generic-drug regimen made in India, raising the stakes in the effort to
provide affordable treatments to epidemic-ravaged Africa.

In the first such study of a generic AIDS drug, published this week in the
British journal the Lancet, researchers from Africa, Europe and the U.S.
said the combination pill Triomune, made by CiplaLtd. of India, was safe
and effective in a six-month study of 60 patients with HIV/AIDS in
Cameroon.

The study found that blood levels of the AIDS virus plunged to
undetectable levels in 80% of study patients, which the study's lead
author said is comparable with similar brand-name treatments. The
beneficial white blood cells of the immune system called Cd4 cells rose
moderately. Safety was excellent, with only one patient withdrawing due to
side effects, according to the physicians organization Doctors Without
Borders, a co-sponsor of the study.

Triomune contains a fixed dose of three generic AIDS drugs: nevirapine,
stavudine and lamivudine. The drug combination has been approved as safe
and equivalent to its branded counterpart by the World Health
Organization. However, two other Cipla generic products were suspended
from the WHO program because of deficiencies in documentation. The action
didn't affect Triomune, a spokeswoman for the researchers said.

Controversy over generic AIDS drugs has been raging for several years as
health groups scramble to distribute treatments in developing countries.
Triomune costs $20 a month compared with $35 a month for brand-name drugs.
In addition to reducing the price of the three drugs, the Triomune regimen
reduces the number of pills to two from six a day.

U.S. AIDS-drug procurement initiatives have favored brand-name drugs but
recently allowed generics to submit applications for market approval. This
study, while encouraging, isn't likely to end the controversy because the
study was short and didn't include a control group.

"I'm not naive. I know this won't change the purchasing policy of the
U.S.," said Rachel Cohen of Doctors Without Borders. "The bottom line is
that a controlled study wasn't necessary. The regimen was already proven
efficacious and safe under the WHO prequalification program," she said.
"But given the political and ideological arguments being waged,
investigators thought it necessary to carry out the study. It makes it
impossible to argue that such drugs aren't safe and effective."

Eric Delaporte, senior author of the Lancet study, said the benefits
observed using Triomune were comparable with success seen in developed
countries using brand-name versions of the triple-drug therapy. This
erases any scientific doubt over the use of generics in the developing
world, he says.

The study was conducted at two hospitals in Yaounde, Cameroon, by Dr.
Delaporte and Christine Laurent of the University of Montpellier, France,
and collaborators at the French National Agency for Research on AIDS,
Doctors without Borders in Switzerland, the University Hospital Center of
University Bichat Claude Bernard in Paris. Their African collaborators
included the Pasteur Center of Yaounde, the Mobile Laboratory of Health
and Hygiene in Yaounde, and the National AIDS Program of Cameroon.

Write to Marilyn Chase at marilyn.chase@wsj.com