Biotechnology firm Gilead Sciences on Monday announced that FDA has granted priority review status for a fixed-dose drug combination (FDC) pill that would include its antiretroviral drugs Viread and Emtriva, Reuters reports (Reuters, 5/17). FDC antiretroviral drugs combine two or more different medicines into one pill that is taken as few as two times a day. Generic FDCs that combine three medications into one pill can cost as little as $140 per person per year (Kaiser Daily HIV/AIDS Report, 4/29). Viread, which is known generically as tenofovir, is FDA-approved for use as a treatment for HIV infection. The drug has been shown to boost immune response and lower viral levels in the bloodstreams of patients who are resistant to other antiretrovirals (Kaiser Daily HIV/AIDS Report, 2/6). Viread currently is available as a once-daily 300 milligram tablet. Emtriva also has been approved for marketing by FDA and currently is available currently as a once-daily 200 milligram capsule (Gilead release, 5/17). The FDC will include 300 milligrams of Viread and 200 milligrams of Emtriva and will be administered with at least one other antiretroviral drug, Reuters reports. Gilead said it had submitted its new drug application for the Viread/Emtriva combination to FDA on March 12, and the company expected a decision by Jan. 12, 2005, based on a traditional review, which usually takes about 10 months, according to Reuters. However, under the priority review, FDA will consider the application within six months, and a decision is expected by Sept. 12, 2004.

Bristol-Myers Squibb, Merck
Gilead's announcement came one day after the drug maker said it is working with Bristol-Myers Squibb and Merck to develop an FDC using BMS' Sustiva, which is known generically as efavirenz and is marketed by Merck in some foreign markets as Stocrin, according to Reuters (Reuters, 5/17). Gilead CFO John Milligan said that discussions between the three companies began in late 2003 with the intention of creating a combination pill that would be "available at no profit in poor nations ravaged by AIDS," according to the Los Angeles Times. He added that the three drug makers are "optimistic" about an agreement, although researchers still are unsure whether a one-pill combination of the three drugs is "technically possible," the Times reports (Gellene, Los Angeles Times, 5/18).

HHS "Fast-Track" Program
Gilead's announcement also came one day after HHS Secretary Tommy Thompson at a news conference in Geneva announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs -- including FDCs -- to African and Caribbean nations covered under the President's Emergency Plan for AIDS Relief. The expedited process is meant to encourage drug makers to produce FDCs to simplify delivery of drugs in remote areas in hard-hit countries and ensure the drugs' safety. Although the World Health Organization has established a prequalification review system and approved certain generic FDC drugs, U.S. officials wanted to ensure that the drugs would not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use. The expedited review process will apply to new products that combine HIV/AIDS drugs that are already FDA approved into a fixed-dose pill and to new co-packaging of existing treatments. FDA guidance for the review process outlines four scenarios for the review of different FDC and co-packaged products. The agency also has provided a list of currently approved antiretroviral drugs that officials believe have sufficient clinical safety and efficacy data supporting their use as in combination therapies (Kaiser Daily HIV/AIDS Report, 5/17).

Mixed Reviews
Thompson's announcement received "mixed reviews" from AIDS and public health advocates and lawmakers, the New York Times reports (McNeil, New York Times, 5/18). U.N. Special Envoy for HIV/AIDS in Africa Stephen Lewis said that the administration's new review process is an "unexpected and excellent move" (Boseley, Guardian, 5/18). Rep. Henry Waxman (D-Calif.) said that he was "disappointed that the plan does not involve cooperation with the World Health Organization," adding, "We need to see the fine print before we can tell if the new process will actually improve access to these affordable, effective drugs." A WHO official speaking on the condition of anonymity said, "Although the United States has not exactly been in love with our prequalification process, they are now going to do exactly the same. If they want to create a parallel structure and do a good job, that's fine." He added that Thompson's claims that the review process could take as little as two to six weeks were "question[able]," according to the Times. WHO's prequalification process "takes a minimum of three months ... even if everything is perfect," the WHO official said. FDA Center for Drug Evaluation and Research Deputy Director Mark Goldenberger said that "two weeks would be at the extreme short end." He added that the two-week review time likely would apply to reviews for co-packaging drugs, according to the Times (New York Times, 5/18). International Association of Physicians in AIDS Care President and CEO Jose Zuniga said that the administration's decision to offer fast-track approval for FDCs is the "[r]ight thing to do." He added that although the U.S. government did not accept WHO prequalification for medications used in PEPFAR -- which "caused some postponement of rolling out this initiative in the most efficient and cost-effective manner possible" -- allowing FDA to fast-track FDCs is "an acceptable compromise, but only if the agency acts with all possible speed" (IAPAC release, 5/17).

More Reaction
Africa Action and TransAfrica Forum said in a release that the expedited review process announcement is an "elaborate ruse to stall the use of low-cost generic drugs" in the fight against HIV/AIDS. Africa Action Executive Director Salih Booker said that Thompson's announcement "is a callous manipulation of the truth, when in reality the U.S. government is telling African and Caribbean nations that they cannot use U.S. funds to buy cheaper and easier to use [FDCs] ... that have already been approved by the World Health Organization and accepted by governments throughout Africa and the Caribbean." TransAfrica Forum President Bill Fletcher said that because "the people most affected by AIDS are in Africa and the Caribbean, the White House seems to think that they can continue to place drug company profits before the lives of black patients" (Africa Action release, 5/17). AIDS Responsibility Project Executive Director Abner Mason said in a release that the Bush administration is "creating a solution that will both greatly expand access to critical life saving medications and ensure that Africans receive the same standard of care that we insist on for Americans." Mason, who chairs the President's Advisory Council on HIV and AIDS international subcommittee, added that this "bold step" will allow "those in greatest need to be confident that the medications they receive are safe and effective and backed by assurances from the world's leading regulatory authority" (AIDS Responsibility Project release, 5/17).

Editorials Respond to Announcement

• Akron Beacon Journal: The administration's "change in ... AIDS drug policy promises a better quality of life for millions of patients and significant financial relief for nations burdened by the high cost of fighting the infectious disease," a Journal editorial says. The administration's approach to fighting the "global scourge" of HIV/AIDS has been "frustrating for its ambivalence," and its policies seemed to have been "swayed more often by the interests of U.S. drug makers than the needs of millions of poor patients whose lives would be enhanced by cheaper drugs," the editorial says, concluding, "The announced policy change should go a long way to burnish the administration's image of compassion" (Akron Beacon Journal, 5/18).

• Orlando Sentinel: Prior to the expedited review policy change, the government had been "more a part of the problem than the solution in getting affordable treatments to AIDS patients in Africa" because "[c]umbersome" FDA rules "stood in the way," a Sentinel editorial says. Although Thompson put the plan into effect without waiting for the 60-day comment period to expire, "here's a comment anyway: Good work!" the editorial concludes (Orlando Sentinel, 5/18).

• St. Louis Post-Dispatch: The "abrupt and surprising" policy change announced this week is "good news" and "should blunt criticism of the U.S. policy on AIDS," a Post-Dispatch editorial says. "This welcome change in policy will pay dividends by bringing relief to hundreds of thousands who otherwise would die due to lack of access to cheaper and better AIDS treatment," the editorial concludes (St. Louis Post-Dispatch, 5/18).

The New York Times on Tuesday ran two editorials on the Bush administration's global AIDS policies. Summaries of the editorials appear below:

• "Progress on Pills": Thompson's announcement marks a "stunning change of course" that could "save vast numbers of lives," a Times editorial says. Some health advocates have said that the administration is "piling on an unnecessary level of review ... [b]ut if the administration felt it needed FDA review to ensure safety and efficacy, or even simply to save face, the result can only be beneficial to millions of infected individuals," the editorial concludes (New York Times, 5/18).

• "Opposition to Condoms": Although the decision to fast-track approval for antiretroviral FDCs demonstrates the administration's "enlightenment on AIDS treatment," it has not been "matched in AIDS prevention programs," a Times editorial says. "Spurred by the religious right," the administration channeled one-third of its funding for international HIV/AIDS prevention programs into abstinence programs beginning in 2006, according to the Times. Ambassador Randall Tobias, head of the State Department Office of the Global AIDS Coordinator, has said "numerous" times that condoms are not effective at preventing HIV among the general population, the editorial says, adding, "Mr. Tobias is wrong." Condoms have helped to reduce HIV prevalence in Uganda, Brazil and Zambia, and the administration "is using pseudoscience to justify its decisions," according to the Times. Abstinence programs "alone are insufficient," the Times says, concluding that the administration's "benighted policies put millions at risk" (New York Times, 5/18).

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