FDA Approves Once-Daily Combo Drug for HIV–Three-agent Atripla should ease treatment in U.S. and abroad, experts say SATURDAY, July 29, 2006 — The first once-a-day combination drug treatment for people with HIV/AIDS gained approval Wednesday from the U.S. Food and Drug Administration and will soon be available to patients.
The drug, called Atripla, combines Viread (tenofovir), Emtriva (emtricitabine) and Sustiva (efavirenz), to keep the human immunodeficiency virus under control.
Viread and Emtriva are made by Gilead Sciences and are already sold in combination under the brand name Truvada, while Sustiva is made by Bristol-Myers Squibb, the Associated Press reported.
“This is a landmark for those suffering from HIV/AIDS,” Dr. Andrew von Eschenbach, acting FDA commissioner, said during a teleconference. “This can and will fundamentally change the treatment paradigm for those living with HIV/AIDS, not just in the United States, but in the world.”
Just a decade ago, many HIV/AIDS patients were subject to a complicated medication therapy involving dozens of drugs, taken at different times of the day and with cumbersome food restrictions. Some patients were even forced to awake in the middle of the night to comply with the instructions.
The regimen has gradually gotten simpler and simpler until, today, when the one-a-day pill was announced.
One of the biggest benefits will be in terms of patient compliance.
“The idea of a fixed-dose combination has been one of the holy grails of trying to come up with therapies that would be particularly helpful, not only from a medical perspective but from a logistical perspective,” said Dr. Murray M. Lumpkin, FDA’s deputy commissioner for international and special programs. “It’s one thing to have medicine available but it will only be effective when people take it when they’re supposed to over the time frame they’re supposed to, so as to mitigate the rise of resistance viruses.”
Dr. Michael Horberg, director of HIV/AIDS policy at Kaiser Permanente Health Plan in Santa Clara, Calif., had one slight reservation about the new product. “Patients who do not have resistance to either of the three components of this new three-in-one combo will now be able to take HIV medicine as one pill once a day,” he said. “But a goodly portion of patients are already resistant to one of the components and, for them, it is no different than before. Nothing has changed.”
Still, none of that detracts from the drama of the day, Horberg added. “This is a breakthrough and an innovation and, hopefully, it will signal the pattern of drug development in the future,” he said. “Maybe the most significant thing is two disparate companies decided to work together and maybe that’s the best part of this message — that, hopefully, pharmaceutical companies will understand that, for HIV-positive patients, working together benefits everyone.”
Atripla was approved in just three months under the FDA’s fast-track approval program and was based on several trials, including one with 244 patients that directly assessed this product.
The drugs combined in the pill already constitute the most widely prescribed anti-HIV regimen in the United States.
According to The New York Times, other pills that combine three drugs are already available, but those pills need to be taken twice a day.
FDA officials made much of the international implications of the announcement.
The compliance problem, said von Eschenbach, is “particularly an issue in developing countries where people will benefit from a simplified dosing regimen that will make access and compliance far more efficient.”
The pill, added Lumpkin, will also be available for consideration for purchase under the President’s Plan for AIDS Relief.
“There is no new active ingredient, but the fact that people can take one pill once a day will not only meet the medical needs of patients but will meet the logistical needs and, in developing economies, that has been one of the highest hurdles in trying to win the war on HIV/AIDS,” he said.
Dr. Joel Gallant, associate director of the AIDS Service at Johns Hopkins University School of Medicine, in Baltimore, noted, “Today vs. yesterday, we’re at one pill a day vs. two pills a day, which is a nice incremental step.”
“Compared with 10 years ago, where patients were sometimes taking 25 pills a day and up to five divided doses with lots of long-term toxicity, there’s both a real and a symbolic importance to this,” said Gallant, who was involved in the Gilead study looking at the efficacy of Atripla.
Will this be the wave of the future? That remains to be seen, Gallant said.
“Not to say that there aren’t other opportunities to combine drugs, but this is by far the most logical combination,” he said. “Not all the other combinations are quite as amenable. I do hope we will see more of it but it probably won’t be any time soon.”
Officials sidestepped the issue of cost, saying it was ultimately up to the companies, but the AP reported that the new pill will cost $1,150 for a 30-day supply, or the same as for Truvada and Sustiva when purchased separately.
Learn more about HIV treatment from the U.S. National Institutes of Health.
SOURCES: July 12, 2006, teleconference with Andrew C. von Eschenbach, M.D., acting commissioner, U.S. Food and Drug Administration; Murray M. Lumpkin, M.D., deputy commissioner for international and special programs, FDA; Michael Horberg, M.D., director of HIV/AIDS policy, Kaiser Permanente Health Plan, Santa Clara, Calif.; Joel Gallant, M.D., professor of medicine and epidemiology, and associate director of the AIDS Service, Johns Hopkins University School of Medicine, Baltimore; Associated Press, The New York Times