HIV prevention drug Truvada studied in new clinical research project

The HIV prevention drug Truvada, approved last summer by the Food and Drug Administration, is considered by many to be a game-changer in the fight against HIV and AIDS. But some worry it could have unintended consequences.

In a new clinical research project, Whitman-Walker Health is studying the impact of the drug and interest in the local gay community.

For many years, doctors have used Truvada to treat HIV+ patients after infection. But now, they're prescribing it to HIV- patients in high risk groups: sex workers, men who have unprotected sex with men, those who have a partner living with HIV.

Thirty-year old study participant Kyle Murphy works in HIV advocacy. He hopes participating in the research project will reduce the stigma surrounding HIV and the drug.

“I am a sexually active gay man who is single so obviously I need to take every precaution that I can,” Murphy said. “People assume that if you're taking [Truvada] you have to be promiscuous or you have to be a sex worker. But I view it as something – just an extra step that you can take. It's sort of like taking your vitamin in the morning.”

Murphy is one of 100 men in the Whitman-Walker Health pre-exposure prophylaxis or "PreP" study. It is being funded by the NIH Division of AIDS and Truvada manufacturer Gilead.

Whitman-Walker Health’s Director of Clinical Research, Dr. Richard Elion said, “The levels that [Truvada] builds up in the bloodstream and in certain parts of the body that may be exposed to HIV seem to be high enough that in patients who actually take their medicine on a regular basis, it's effective 97 to 99 percent of the time.”

But some critics, including the AIDS Healthcare Foundation, worry the drug – if and when not taken properly – will result in less condom use and more HIV transmission.

"We're concerned about the public health implications and also the cultural implications. The idea that hundreds of thousands of gay men taking this medication is going to bring down infection rates is just a fallacy,” said AHF President Michael Weinstein.

But Dr. Elion argues this drug is just one more tool in the prevention tool kit. “We would not have 50 to 60,000 new cases [of HIV] each year if everybody was using condoms,” said Elion. “Do I think it is a good idea to use condoms? It's a great idea. Does everybody do it? No way.”

In the D.C. gay community, most seem to support PreP drugs.

Arlington resident Joshua Swain said, “Any kind of protection would be good. Any argument against it would be like arguing against condom use, because it would increase sexual activity.”

District resident Eligio Aguirre said, “I think it's a good thing for people with a partner who is infected.”

Pushing back against the criticism, Murphy said he still uses condoms even while taking Truvada. When the study ends he is not sure how long he will use the medication. For now, he likes the peace of mind it brings him.

“If you have a slip up, if you make a mistake, it's just an added level of security and safety,” he said.

The study will wrap up in December 2014, but Whitman-Walker Health officials are already looking at extending the research project.

The Truvada pill is taken once a day. It costs about $11,000 to $14,000 a year. However, it is covered by Medicaid and most insurers.

Nausea is the most common side effect, especially in the first few months of taking Truvada. There is also an increased risk of bone thinning and kidney problems associated with the drug.