No gay men got HIV in PrEP study. None.

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Sorry, PrEP naysayers. The results are in, and science is winning. Whether you would use Truvada as a pre-exposure prophylactic or not, it successfully prevented every last potential HIV transmission in a real-world study of gay men.

It comes amid a firestorm of rhetoric informing the individual personal decisions that sexually active gay men must make about using the drug. But the piece of the debate over whether PrEP works is being shut down yet again by a study out this week by a major insurer and 657 of its HIV-negative clients. All but four of them were gay men.

The study is notable for the sheer sample size and for its look at some men who engaged in sexual behaviors considered the most risky for transmitting HIV. Researchers followed the men from 2012 through February 2015.

None of the clients contracted HIV. No new HIV infections. None. Zero.

The news is being hailed as the most reassuring for PrEP to date. Until now, we’ve only been aware of a moderately high PrEP success rate. But in those studies, adherence to the drug regimen was hit and miss, and they were cut short due to ethical concerns of giving some men a placebo that did nothing to curb infections.

But it’s not all butt sex and rainbows in the study, according to the New York Times. The study was observational rather than clinical – subjects self-reported their regimens, and blood samples weren't taken to ensure that they were taking their daily dose. And as some critics feared, the gay men studied did use condoms less often and contracted other STIs.

Most other sexual infections, while potentially dangerous, can be cured with antibiotics. H.I.V. cannot, though it can be controlled with antiretroviral drugs taken for life.

“This is very reassuring data,” said Dr. Jonathan E. Volk, an epidemiologist for the insurer, Kaiser Permanente of San Francisco, and the study’s lead author. “It tells us that PrEP works even in a high-risk population.”

Observational studies like this one are not considered as scientifically rigorous as randomized clinical trials in which some participants receive a placebo. …

After starting PrEP, half of them became infected with syphilis, gonorrhea or chlamydia within a year.

Volk tells the Times that increases in those diseases among gay men was already on the rise, and that even among the most high-risk group in the U.S. – because hey, HIV rates are dropping, unless you're gay or young and gay – PrEP should be considered a reliable line of defense.

The new study also lacked a control group taking placebo or no drug regimen to prevent HIV, a co-author tells HIV Plus.

“Without a control group, we don’t know if these STI rates were higher than what we would have seen without PrEP,” stressed co-author Julia Marcus. “Ongoing screening and treatments for STIs, including hepatitis C, are an essential component of a PrEP treatment program.”

As work continues in clinical and real-world settings, add this latest news to your arsenal of information. Whether you’re like this Atlantan who wouldn’t touch PrEP with a 10-foot pole, or more like these local guys who think access to PrEP should be Gay Priority No. 1 while you enjoy your butt sex and Truvada too, it’s increasingly ridiculous to cling to the belief that PrEP is a “party drug” used as an excuse to engage in risky behaviors.

[New York Times | HIV Plus | Clinical Infectious Diseases]


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