- Marionville mayor ‘kind of agreed’ with Kansas City shooter’s views
- Rev. Al Sharpton’s Easter message: Politically ‘crucified’ Obama has risen again
- Supreme Court to weigh challenge to ban on campaign lies
- UNICEF launches ‘Mr. Poo’ mascot in India to curb public defecation
- Teen taking selfie by train: ‘Wow, that guy just kicked me in the head’
- Goodbye, Afghanistan — hello, Africa: Air Force to shift as U.S. exits Middle East
- Iran mulls ban on vasectomies, decrease on abortions to bolster population
- CNN op-ed claims right-wingers ‘more deadly than jihadists’
- Classes resume at high school rocked by stabbings
- ABC News accuses Center for Public Integrity of stealing Pulitzer-winning work
FDA approves once-daily HIV pill
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.
By John R. Bolton
Reality calls for attaching Gaza to Egypt and the West Bank to Jordan
- 'Culture of intimidation' seen in Nevada ranch standoff
- Rand and Ron Paul ride to the rescue for Bundy in Nevada standoff with feds
- Atheists rush to stage Easter display: 'Jesus Christ is a myth'
- Removal of military gear limits options for U.S., NATO in Ukraine
- CNN op-ed claims right-wingers 'more deadly than jihadists'
- U.S. Navy to turn seawater into jet fuel
- Army goes to war with National Guard, seizes Apache attack helicopters
- Nevada Bundy ranch standoff could leave dirt on Harry Reid reputation
- CARSON: Recovering Tocqueville's vision of American exceptionalism
- GOP writes legislation to deny Attorney General Eric Holder his salary
Celebrity deaths in 2014
Top 10 handguns in the U.S.