Study Identifies ‘Ideal’ AIDS Drug Regimen; Includes Same Drug Types Found in Indian Generic FDCs, Study Author Says
The "ideal" antiretroviral drug combination for new patients includes two nucleoside reverse transcriptase inhibitors and one non-nucleoside reverse transcriptase inhibitor, according to a study in the April 29 issue of the New England Journal of Medicine, the New York Times reports. This drug combination -- known colloquially as "two nukes plus a non-nuke" -- has been produced in fixed-dose combination pill form since 2001 by Indian generic drug companies and is the same combination of drug classes that the World Health Organization has recommended since 2002 for use in developing countries, according to the Times (McNeil, New York Times, 5/4). Dr. Roy Gulick, director of the HIV clinical trials unit at Weill Cornell Medical College in New York, and colleagues tested the effectiveness of three antiretroviral drug regimens in the initial treatment of 1,147 HIV-positive people. The regimens included a triple-nucleoside treatment containing zidovudine, lamivudine and abacavir; a regimen containing the nucleosides zidovudine and lamivudine and the non-nucleoside efavirenz; and a regimen containing the triple-nucleoside combination plus efavirenz (Gulick et al., New England Journal of Medicine, 4/29). The researchers selected the drugs in an attempt to find an ideal drug regimen that avoided the use of protease inhibitors, which are effective but can cause liver damage and shifts in body fat that can cause malformations, according to the Times. Patients on the triple-nucleoside combination did so poorly that they were taken off the regimen before the study was completed, the Times reports.
The study found that 89% of patients on the zidovudine-lamivudine-efavirenz combination had undetectable viral levels after 32 weeks, compared with 79% of the patients on the zidovudine-lamivudine-abacavir regimen. The authors concluded that the drug combinations containing one non-nucleoside and two or three nucleosides were more effective than the triple-nucleoside combination in the initial treatment of HIV. Some AIDS experts said that the study also shows that "three-in-one" FDC pills manufactured by Indian generic drug companies -- which contain the two nucleoside, one non-nucleoside combination -- are more effective than any of the three-in-one combination pills currently manufactured in the United States, such as GlaxoSmithKline's triple-nucleoside Trizivir, according to the Times. Most of the three-in-one Indian generic drugs include zidovudine and lamivudine, the same drugs used in the study, and nevirapine, a non-nucleoside that a recent study published in the Lancet found to be equivalent to efavirenz, which was used in the NEJM study. The study "reinforces the point" that the combination recommended by WHO for use in developing nations is appropriate for rich countries as well, Gulick said.
The Philadelphia Inquirer on Tuesday profiled Ranbaxy Laboratories, the largest pharmaceutical company in India (Maykuth, Philadelphia Inquirer, 5/4). Ranbaxy produces the FDC Triviro, which combines stavudine, lamivudine and nevirapine into one pill that is taken twice a day (Kaiser Daily HIV/AIDS Report, 4/9).