FDA Approves Gilead, Bristol-Myers Squibb Once-a-Day Combination Antiretroviral Pill

Main Category: HIV / AIDS
Also Included In: Immune System / Vaccines
Article Date: 17 Jul 2006 - 1:00 PDT

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FDA on Wednesday as expected approved Gilead and Bristol-Myers Squibb's once daily antiretroviral treatment regimen called Atripla, which combines BMS' Sustiva and Gilead's Truvada into a single pill, for sale and marketing in the U.S., the Washington Post reports (Kaufman, Washington Post, 7/13). The two companies in December 2004 announced that they would collaborate, with the aim of developing the single daily combination antiretroviral drug. Currently, patients undergoing antiretroviral treatment often take several pills daily, sometimes at specific times and under certain conditions. Atripla is the first highly active antiretroviral treatment regimen available in a single, daily pill. It includes Truvada -- which is made of 200 milligrams of emtricitabine and 300 milligrams of tenofovir -- as well as 600 milligrams of Sustiva, known generically as efavirenz (Kaiser Daily HIV/AIDS Report, 7/10). Emtricitabine, tenofovir and efavirenz are reverse transcriptase inhibitors, which often are given to patients newly diagnosed as HIV-positive, the Los Angeles Times reports. Some experts said drug companies are looking to incorporate protease inhibitors, usually given to HIV-positive people who develop resistance to first-line medications, into Atripla, according to the Times (Maugh, Los Angeles Times, 7/13). A clinical trial of 244 HIV-positive adults taking the medications that make up Atripla -- which FDA said can have side effects including headache, dizziness, abdominal pain, vomiting and rash -- found that 80% of patients had a significant reduction in viral loads and marked increase in their number of CD4+ T cells (CQ HealthBeat, 7/12). 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 (Kaiser Daily HIV/AIDS Report, 7/10). About 60% of HIV-positive people who are receiving antiretrovirals in the U.S. are taking Truvada and Sustiva, and 13% of people living with AIDS are taking the drugs, Norbert Bischofberger, Gilead vice president for research and development, said (Russell, San Francisco Chronicle, 7/13). The approval came as a result of FDA's fast-track review program, the Los Angeles Times reports.

Cost, PEPFAR Availability
BMS and Gilead on Wednesday said Atripla will be available for sale within seven business days and a 30-day supply will sell for $1,150.88, the same price as Truvada and Sustiva sold separately (Los Angeles Times, 7/13). The approval means that Atripla can be included in the drugs distributed by the President's Emergency Plan for AIDS Relief (Howard Price, Washington Times, 7/13). However, BMS and Gilead must come to an agreement with Merck on international sales. Merck sells Sustiva under the brand name Stocrin in developing countries, the New York Times reports. Merck Vice President for External Affairs Jeffrey Sturchio said the company has "reached agreement on all the issues with Gilead," and what remains is formalizing the agreement and applying for approval in other countries. Sturchio estimated that Atripla would be available in some developing countries in the coming months and that the price would be approximately equivalent to the sum of prices of the drugs in those countries, the Times reports (Pollack, New York Times, 7/13). Atripla "offers a particularly important advantage for patients in many countries that are most affected by the AIDS epidemic and will also have a major impact in the U.S.," Andrew von Eschenbach, acting commissioner of FDA, said (Corbett Dooren, Wall Street Journal, 7/13). However, the drug might be too expensive for many countries even if it is sold at less than $1 per dose, Kevin DeCock, director of HIV/AIDS programs for the World Health Organization, said, adding, "We have to accept there's no way that treatment can be paid for by these countries on their own" (Sternberg, USA Today, 7/13).

Potential Effect of Approval
Atripla makes it "simpler to stick to the treatment regimen" and thus could curb the emergence of drug resistant strains of the virus, the AP/Forbes reports. John Martin, president and CEO of Gilead, said drug-resistant HIV strains can develop if a person takes less than 95% of their pills, adding, "The fewer pills, the better they are able to achieve that 95% threshold" (Bridges, AP/Forbes, 7/12). Raymond Schinazi, a professor of pediatrics at Emory University and co-discoverer of emtricitabine in 1996, said that the "tremendously powerful drug" has the potential to keep HIV from "escap[ing]," adding that HIV-positive people who take Atripla could "live a lot longer or maybe even a normal life span." Dennis Liottta, a chemistry professor at Emory and another co-discoverer of emtricitabine, said Atripla also could have the potential to prevent HIV infection (Hendrick, Atlanta Journal-Constitution, 7/13). Veronica Miller, director of the Forum for Collaborative HIV Research, said the collaboration between BMS and Gilead could lead to future collaborations on pediatric combination drugs (AP/Forbes, 7/12). However, some researchers and advocates expressed anxiety that the pill could lessen vigilance in HIV prevention, the Baltimore Sun reports. "I'm concerned that people will see the advertisements that say one pill once a day and think that that's easier than wearing condoms," Joel Gallant, associate director of Johns Hopkins AIDS Service, said, adding, "We need to get the message out that it's still a lot better -- it's easier -- to prevent than treat, even with better therapy" (Rockoff, Baltimore Sun, 7/13).

NPR's "Morning Edition" on Thursday reported on FDA's approval of Atripla. The segment includes comments from Jill DeSimone, senior vice president at BMS; von Eschenbach; and Murray Lumpkin, deputy commissioner for international and special programs at FDA (Wilson, "Morning Edition," NPR, 7/13). The complete segment is available online in RealPlayer.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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