US Recommends Daily Pill to Prevent AIDS Infections

Federal health officials recommended on 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 bisexuals; patients who regularly have sex with anyone they know is infected; and anyone who shares needles or injects drugs.

Officials at the US Centers for Disease Control and Prevention 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 PrEP, federal officials say something must be done because condom use is going down. In a recent CDC survey, the number of gay men admitting to recent, unprotected sex rose nearly 20 percent from 2005 to 2011.

Nevertheless, advocates for PrEP were elated at Wednesday's announcement.

"This is wonderful," said Damon L Jacobs, a therapist who 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 PrEP, the only pill approved for that purpose by the U.S. Food and Drug Administration is Truvada, made by Gilead Sciences.

 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 PrEP only in conjunction with condoms. But health officials say they know that some people will stop using them. Many gay men, including Jacobs, admit to doing just that.

That raises their risk of catching other diseases, like 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 S. Fauci, director of the National Institute for 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 PrEP, 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 PrEP, but only 9 percent had actually prescribed it.

"There's a lot of inertia among doctors - and a strong statement from the CDC will be pretty valuable for overcoming that," said Dr. Demetre C. Daskalakis, an AIDS specialist at Mount Sinai Hospital in New York who has many patients on the drug.

Also, PrEP 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 PrEP, 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 PrEP. 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 co-pays 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 PrEP.

Not advertising helps Gilead avoid controversy. Michael Weinstein, president of the AIDS Healthcare Foundation, has called Truvada a "party drug" and argued that PrEP 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."

That debate has played out on gay websites, where men favoring PrEP are often stigmatized as "Truvada whores." (The term was coined in a 2012 Huffington Post article, whose author has since publicly regretted his stance.)

"People are reacting out of fear," Jacobs said. "Gay men who embraced the condom message and survived the trauma of 30 years ago have PTSD. This is a paradigm shift, and people don't like change."

Recently, a backlash against the backlash has emerged with a few men proudly wearing "Truvada Whore" T-shirts, just as others once proudly wore "Queer" or "HIV Positive" ones.

Adam Zeboski, a test counselor for the San Francisco AIDS Foundation, makes and sells "Truvada Whore" T-shirts to raise money for the foundation.

"People are both very supportive and very offended," he said. "By reclaiming the 'Truvada Whore' term, we're taking the power away from those who use it against us."

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