Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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July 2, 2004 - Wall Street Journal
Marilyn Chase, marilyn.chase@wsj.com
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.
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