Made in India, the ideal ‘cocktail’ for AIDS


A three-year study of AIDS drugs has identified what the research leaders believe is the ideal triple-therapy cocktail for new patients.

The successful cocktail, known colloquially as “two nukes plus a nonnuke,” is the same one that the World Health Organization has been recommending in poor countries since 2002. It is also the same combination that Indian suppliers of generic drugs have been
putting in three-in-one pills since 2001.

Another drug cocktail examined in the study – a “three-nuke combination” – did so poorly that patients were taken off it. The failed cocktail is the only one made as a three-in-one pill by any Western pharmaceutical company.

The study, its authors said, suggests that patients who have never been on AIDS drugs should be started on a combination of two nucleoside reverse transcriptase inhibitors (“nukes”) and a nonnucleoside reverse transcriptase inhibitor (“nonnuke”).

Currently, U.S. and European doctors prescribe many different mixes of the 20 drugs approved for fighting AIDS infections, and shift the mixes as patients develop resistance or side effects.

The study of 1,147 patients, published in the April 29 issue of The New England Journal of Medicine, looked for an ideal regimen for new patients that avoided protease inhibitors. Those drugs are effective and often prescribed by Western doctors, but they can
damage the liver or shift body fat into unsightly humps.

The study was begun before any drugs in the two newest classes of AIDS drugs, fusion inhibitors and integrase inhibitors, were approved.

AIDS experts said a second conclusion from the study was that the three-in-one pills offered by generic drugmakers from India were better for new patients than any of those sold or planned by Western drug companies.

The study “reinforces the point” that the type of cocktail recommended for poor countries by the World Health Organization is right for rich countries as well, said the study’s lead author, Dr. Roy Gulick, director of the HIV clinical trials unit at Weill Cornell
Medical College in New York City.

The latest guidelines from the National Institutes of Health for U.S. doctors recommend starting new patients either on the same two-nukes-plus-a-nonnuke regimen that the WHO recommends, or a two-nukes-plus-a-protease-inhibitor regimen.

Most of the Weill Cornell study’s 1,147 patients were nonwhite and 19 percent were women, Gulick said, so the study’s conclusions should be applicable worldwide.

The AIDS expert who led the committee that formulated the WHO guidelines, Dr. Scott Hammer, chief of the division of infectious diseases at Columbia Presbyterian Medical Center, said the WHO made its 2002 recommendation because the combination worked well and
the drugs were generally cheap.

Besides their toxicity problems, he said, protease inhibitors were expensive because only companies that held patents on the drugs made them, and some of the medications required refrigeration, which is impossible to guarantee in, for example, rural Africa.
In the new study, the cocktail that worked best was a mix of the “nukes” AZT and lamivudine plus the “nonnuke” efavirenz. After 32 weeks on the cocktail, 89 percent of the patients had almost undetectable levels of virus in their blood. The cocktail that did
less well was a mixture of AZT and lamivudine plus abacavir. After 32 weeks, only 79 percent of the patients had low levels of virus.

That cocktail is sold by GlaxoSmithKline as a three-in-one pill under the name Trizivir.

Most of the study was paid for and monitored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

The report by Human Rights Watch, a nongovernmental organization based in New York, states that while the Philippines shares many of the risk factors of other countries, Filipinos are more vulnerable because 85 percent of them adhere to a religion, Roman Catholicism,
“whose leadership objects to the use of condoms for any purpose.”



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