USIS Washington File - July 13, 2006
Charlene Porter, Washington File Staff Writer

The FDA July 12 approved Atripla™ tablets, manufactured in an unusual alliance between two major pharmaceutical companies, Bristol-Myers Squibb and Gilead Inc. Atripla™ combines medications previously developed and marketed by the two competing companies.

Atripla™ combines Sustiva® (efavirenz), a Bristol-Myers Squibb product and Truvada®, a Gilead product containing Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate).

"[This] approval is a significant example of drug developers and FDA clearing the way to quickly deliver quality, life-saving HIV-AIDS drugs to people who desperately need them in the United States and abroad," said Andrew C. von Eschenbach, acting commissioner of food and drugs. "Fixed dose combination products are an important tool in improving the quality of health care in developing nations."

One reason HIV/AIDS is such a serious disease is because the virus has the capability to elude the human immune system. In the 25 years since the disease emerged, researchers and pharmaceutical companies developed medications to attack the virus, but found the virus quickly could develop resistance to those medications. A breakthrough discovery came in the early 1990s when researchers found that a "cocktail" of drugs was the most effective, available way to control HIV in the body.

A multidrug regimen is difficult, however, requiring a patient to take multiple pills throughout the day on a strict schedule. Development of a combination drug makes a therapeutic regimen easier to follow, and thus, more likely to be effective.

"The approval of Atripla™ simplifies the treatment regimen for HIV-1 infected adults, and will potentially improve the ability of patients to adhere to treatment resulting in long-term effective control of HIV-1," said Eschenbach in an FDA press release. "This offers a particularly important advantage for patients in many countries that are the most affected by the AIDS epidemic and will also have a major impact in the U.S."

The FDA did its part to speed the movement of the medication to the market, approving the combination drug in only two months. All of Atripla's™ component medications previously had been approved by the agency. The combination form underwent an additional 48-week clinical trial in which 80 percent of participants achieved a marked reduction of the virus level in their systems.

"Patients will now have rapid access to the first once-daily single tablet regimen for the treatment of HIV-1 infection in adults," said John C. Martin, president and chief executive officer of Gilead Sciences in a corporate press release. "We are proud to have worked closely with Bristol-Myers Squibb in this precedent-setting collaboration to simplify therapy for physicians and patients."

Simplicity of therapy also has been an issue of concern in the developing world where HIV/AIDS patients may not have the easy access to the support offered by clinics and medical care providers. Combination drugs are considered an answer to some of those difficulties.

In June, the FDA approved another combination drug, one containing lamivuidine, zidovudine and nevirapin, the active ingredients in previously approved and widely used drugs in anti-retroviral AIDS medications.

Aurobindo Phara Ltd. of Hyderabad, India, applied for approval for this three-in-one drug, which cannot be marketed in the United States where existing patents and exclusivity agreements of the various components prevent the manufacture of a combined drug. International agreements allow these restrictions to be waived if the drug is distributed in nations where the HIV/AIDS epidemic is considered a health crisis.

FDA approval of the drugs means they are available for purchase and distribution in the 15 countries targeted by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the five-year, $15 billion campaign to address the disease.

Officials anticipate that the FDA approval will clear the way for distribution of combination drugs in the near future.

Since its 2003 inception, PEPFAR has been working to institute AIDS programs and begin distribution of life-saving drugs. The program had reached 561,000 people with medication as of May, with a goal of reaching 2 million HIV-infected people by 2008.

PEPFAR also aims to prevent 7 million new infections and to provide humane care for 10 million people in these 15 countries. The program is on track to meet those goals.

PEPFAR targets 15 of the world's nations most severely stricken with AIDS, but a total of 120 nations are receiving U.S. assistance to cope with the pandemic.

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A fact sheet on the U.S. President's Emergency Plan for AIDS Relief is available on the State Department Web site.

For more information on U.S. policies and programs, see HIV/AIDS.

(The Washington File is a product of the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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