FDA approves once-daily HIV pill

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The Food and Drug Administration yesterday approved the first once-a-day pill for people living with HIV/AIDS, allowing patients to forgo treatments with multiple drugs and doses.

The new combination drug, called Atripla, combines three widely used antiviral medications for treating HIV/AIDS that have been on the market in this country for three to eight years. Atripla will be available commercially within seven business days.

"The availability of Atripla marks the culmination of 10 years of efforts to simplify dosing while helping to achieve and maintain effective viral suppression for adults infected with HIV-1," said Dr. John Bartlett, an HIV specialist at Johns Hopkins Medical Institutions.

FDA officials said the new drug results from the collaboration of three pharmaceutical firms that recognized the need for simplifying treatment for HIV/AIDS to improve compliance.

"Compliance is as important as therapy itself," Dr. Andrew C. von Eschenbach of the FDA said at a press briefing yesterday. "A decade ago, a patient with HIV took as many as 12 to 15 pills a day. Now they can take one pill once a day -- this is a landmark for those suffering from HIV/AIDS."

Atripla combines the active ingredients Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate).

"All three components have been in use for some time, so their characteristics and effects are well-known," said Dr. Steven Galson of the FDA's Center for Drug Evaluation and Research.

The drugs in Atripla are the most widely prescribed anti-HIV treatments in the U.S.

Eric Miller, a spokesman for Bristol-Myers Squibb Co., a firm involved in the joint venture to develop Atripla, said the wholesale price of the combination therapy is $1,150 for 30 pills. Although retail price is determined by pharmacies, it may be comparable, he said.

When asked whether it would be cheaper to continue taking the three pills contained in Atripla separately, Mr. Miller said "no," because the price "is equivalent to its individual components."

Switching to the combination pill would require insured patients to make just one co-payment.

Sustiva is made by Bristol-Myers Squibb, while Gilead Sciences Inc. makes Viread and Emtriva. Those two companies formed the joint venture to commercialize Atripla in the United States. This is the first such collaboration for an HIV/AIDS medication.

Atripla also will be available for purchase under the President's Emergency Plan for AIDS Relief, which targets 15 developing nations hit hardest by the virus.

In many countries, Merck & Co. Inc. holds the rights to efavirenz. All three companies will work together to make Atripla available for physicians and patients.

Dr. Murray M. Lumpkin, FDA's deputy commissioner for international and special programs, said Atripla especially will be beneficial in countries with "developing economies," because it is impossible to "give large numbers of pills throughout the day" in those conditions.

"Taking one pill once a day will meet both the medical needs and logistical needs of patients" in such settings, Dr. Lumpkin said.