Federal health officials recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take a daily pill that has been shown to prevent infection with the virus that causes it.
If broadly followed, the advice could transform AIDS prevention in the United States — from reliance on condoms, which are effective but unpopular with many men — to a regimen that relies on an antiretroviral drug.
It would mean a 50-fold increase in the number of prescriptions for the drug, Truvada — to 500,000 a year from fewer than 10,000. The drug costs $13,000 a year, and most insurers already cover it.
The guidelines tell doctors to consider the drug regimen, called PrEP, for pre-exposure prophylaxis, for gay men who have sex without condoms; heterosexuals with high-risk partners, such as drug injectors or male bisexuals who have unprotected sex; patients who regularly have sex with anyone they know is infected; and anyone who shares needles or injects drugs.
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Officials at the U.S. Centers for Disease Control and Prevention (CDC) have long been frustrated that the number of HIV infections in the United States has barely changed in a decade, stubbornly holding at 50,000 a year, despite 30 years of official advice to rely on condoms to block transmission.
Although there is no guarantee that gay men will adopt the drug regime, federal officials say something must be done because condom use is going down. In a CDC survey in November, the number of gay men reporting to recent, unprotected sex rose nearly 20 percent from 2005 to 2011.
Nevertheless, advocates for the drug regime were elated at Wednesday’s announcement.
“This is wonderful,” said Damon Jacobs, a therapist in Manhattan who is HIV negative, has been on the regimen since 2011 and runs a Facebook page promoting it. “When an institution like the CDC makes a statement, it makes a profound difference to the doctors who are ambivalent.”
Dr. Jonathan Mermin, director of the CDC’s national center for AIDS and other sexually transmitted diseases, said the new guidelines should save many lives.
“On average, it takes a decade for a scientific breakthrough to be adopted,” he said. “We hope we can shorten that time frame and increase people’s survival.”
While many antiretroviral drugs could, in theory, be used for the drug regime, the only pill approved for that purpose by the U.S. Food and Drug Administration (FDA) is Truvada, made by Gilead Sciences, of Foster City, Calif. (The company’s Seattle office is home to Gilead’s respiratory research and clinical-development activities.)
Truvada, a mix of tenofovir and emtricitabine, is considered relatively safe with few side effects. Generic versions are made in India, and the drug has become the backbone of AIDS treatment in poor countries.
Common side effects include headache, stomach pain and weight loss. Rare but serious side effects include liver and kidney damage.
Officially, the CDC is endorsing the drug regime only in conjunction with condoms. But health officials say they know that some people will stop using them. Many gay men, including Jacobs, report doing just that.
That raises their risk of catching other diseases, such as syphilis and gonorrhea. But health officials argue that the benefits outweigh the risks.
“Making the perfect the enemy of the good is something we’ve got to get over,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the country’s best-known AIDS doctor. “I strongly support the CDC doing this.”
Syphilis and gonorrhea can usually be cured with antibiotics, but HIV lasts for life and is fatal if left untreated. Even those treated properly often develop early heart disease and other problems.
Since 2010, three separate studies using Truvada have shown that, when taken daily, it can vastly reduce the chances of infection. That held true for gay men, heterosexual couples and drug injectors. In the study of gay men, known as iPrEx, men whose blood tests showed they had taken their pill every day were 99 percent protected.
The new guidelines say patients should have an HIV test before starting the regimen to make sure they are not already infected. (Prophylaxis involves doses of two drugs, but anyone with the disease should be on triple therapy.)
Patients should be retested every three months to be sure that they are still HIV-negative, that they are not developing side effects to the drug, and that they have not caught any other sexually transmitted diseases.
While many AIDS specialists endorse the drug regime, it has not caught on among doctors as a whole. A survey of 1,175 infectious-disease specialists in the United States and Canada published in December showed that 74 percent supported the drug regime, but only 9 percent had actually prescribed it.
Also, the drug regime has not caught on among gay men, who are, by far, the largest risk group.
By analyzing pharmacy databases, Gilead has tried to track how many Truvada prescriptions are for the preventive drug regime, rather than AIDS treatment. As of last September, the company said, it knew of only 2,319 — of whom 49 percent were women.
Advocates said there were several reasons there had been little clamor for the drug regime. First, while many doctors prescribe statins as prophylaxis against heart attacks, for example, only AIDS specialists think about prescribing AIDS drugs as prophylaxis. But uninfected gay men have no reason to see AIDS specialists and usually see general practitioners if they see doctors at all.
Also, Truvada is expensive. However, private insurers and state Medicaid programs have, thus far, generally covered such prescriptions, and Gilead has a program covering copays and giving Truvada to the uninsured.
“In my experience, it’s a simple process to get the meds approved,” Daskalakis said.
Another reason is that Gilead does not advertise Truvada for prophylaxis, even though the FDA in 2012 approved Truvada for that use. Nor does Gilead advertise Truvada for treatment, for which the FDA approved Truvada in 2004.
A company spokeswoman said it had no plans to do so, but it does make grants to gay organizations that espouse the drug regime.
Michael Weinstein, president of the AIDS Healthcare Foundation, has called Truvada a “party drug” and argued that the drug regime would encourage men to avoid condoms and, thus, increase the infection rate. He called the release of the guidelines “a shameful chapter in the history of the CDC.”