FDA Expected To Approve Gilead, Bristol-Myers Squibb Once-a-Day Combination Antiretroviral PillFDA is expected as soon as this week to approve Gilead and Bristol-Myers Squibb's once daily antiretroviral treatment regimen that combines BMS' Sustiva and Gilead's Truvada into a single pill, the New York Times reports (Pollack, New York Times, 7/9). The two companies in December 2004 announced that they would collaborate with the aim of developing the single daily combination antiretroviral drug. Currently, antiretroviral treatment requires patients to take several pills daily, sometimes at specific times and under certain conditions. If approved, the once daily combination pill would be the first highly active antiretroviral treatment regimen available in a single, daily pill. The pill submitted for approval includes Truvada -- which is made of 200 milligrams of emticitabine and 300 milligrams of tenofovir -- as well as 600 milligrams of Sustiva, known generically as efavirenz. The application asks that the combination be approved to treat HIV-1 infection in adults, according to the companies (Kaiser Daily HIV/AIDS Report, 4/28). The price and name of the drug has not yet been revealed, though officials at both companies suggest it might cost roughly the same as Sustiva and Truvada, which combined cost about $14,000 per person annually in the U.S., the Wall Street Journal reports. According to the Journal, FDA said it will expedite the approval applications for the combination drug in as little as two to six weeks (Hamilton, Wall Street Journal, 7/10). Sustiva and Truvada are the most widely prescribed antiretroviral treatment regimen in the U.S., and physicians and securities analysts predict that most people currently taking the drugs separately will switch to the new combination pill, according to the Times. It is less certain how many people taking other antiretroviral combinations will switch. Some people might be intolerant of the side effects caused by Sustiva and Truvada, and some already might have become resistant to one of the antiretrovirals in the new pill, the Times reports. The agency has until October to act but is expected to do so sooner, in part because the government has encouraged companies to collaborate to create simpler HIV/AIDS drugs, the Times reports (New York Times, 7/9).
According to the Journal, large scale use of the new, single-dose combination therapy could "slow the spread and evolution" of the HIV pandemic by reducing the chance that an HIV-positive person forgets to take a dose of the drug therapy. Drug-resistant HIV strains can emerge when people skip doses of their treatment regimen. Although the new, single-dose pill could be a "significant" development in the U.S. and other industrialized nations, it is "potentially groundbreaking for Africa and the rest of the developing world," according to the Journal (Wall Street Journal, 7/10). Access to a single-pill antiretroviral treatment "could be especially important" in developing countries, where HIV-positive people often have less access to medical care, the Times reports. BMS and Gilead said they will "sharply reduc[e]" the price of the combination pill in developing countries, according to the Times (New York Times, 7/9). Because BMS and Gilead sell antiretrovirals at a not-for-profit price in developing countries, the treatment would cost about $600 per person annually, the Journal reports. This is more than four times the cost of a generic triple-combination pill that already is available and consists of older antiretrovirals, according to the Journal (Wall Street Journal, 7/10). It is unclear how much treatment adherence will improve with a once-daily pill as opposed to regimens requiring two pills daily, the Times reports (New York Times, 7/9).
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the once daily antiretroviral treatment regimen "makes the burden of taking pills much less than having to take them multiple times a day" (ABC News, 7/9). "Certainly in the African setting, it will have a huge impact," Tom Coates, an AIDS prevention expert at the David Geffen School of Medicine at the University of California- Los Angeles, said. "If you can get good viral-load suppression in a population, you're going to get lower transmission of the virus," he added (Wall Street Journal, 7/10). According to Fauci, "Another thing that is important is that it will likely be the same price as the drugs are now when sold separately, and they're making it available to developing nations at low cost" (ABC News, 7/9). Some HIV/AIDS advocates warn that any disruption to the supply of antiretrovirals might hasten the development of drug resistant HIV strains, according to the Journal (Wall Street Journal, 7/10).