Pre-exposure prophylaxis may be a way to help control the HIV epidemic, but many say the drug will promote unsafe sex, is too expensive and may have side effects

DAVID TAFFET | Staff Writer

In November 2010, researchers released a study that found that HIV-negative men who took the anti-retroviral drug Truvada consistently and dramatically lowered their chances of contracting HIV.

But soon after, the AIDS Healthcare Foundation in Los Angeles published an ad in several newspapers — including Dallas Voice — disputing the results.

Among other concerns mentioned, they are afraid that men will stop using condoms if the drug is approved as pre-exposure prophylaxis, or PrEP.

A letter supporting the research was circulated and signed by 170 AIDS organizations. None of those was from Dallas, but several from Houston are on the list of supporters.

Dr. Robert Grant is the lead investigator of the Truvada study. The research was done independently of the drug manufacturer Gilead.

Although the company contributed the medication used in the study at no charge, Gilead had no other input.

Both those taking a placebo and those taking Truvada increased their condom use during the study. But the group that used Truvada consistently showed 72 to 95 percent more protection than those who only practiced safe sex.

Those who skipped a daily dosage were as unprotected as those who were on placebo.

In response to critics, Grant said that with counseling, condom usage should actually increase.

The AIDS Healthcare Foundation charged that condom usage would decrease with PrEP. They believe that many men would take the daily pill thinking that they would be protected from contracting HIV.

There is also concern that for those who use Truvada as a preventive medicine and then contract HIV, fewer treatment options would be available to control HIV. Representatives of the foundation questioned whether those who contract HIV after using Truvada as a prophylaxis might develop resistance to the drug.

Dr. Nick Bellos of Dallas, who has treated people with HIV since early in the epidemic, said he is pleased to see the PrEP study results.

“I think it’s promising. It does look like it could be beneficial,” Bellos said.

Although he said his long-term preference is for a vaccine, Bellos considers the PrEP treatment to be a step in the right direction.

Still, he said, he would like to see more research that shows the benefits of PrEP.

Dr. Louis Sloan of North Texas Infectious Disease Consultants at Baylor is less optimistic. He said he is concerned about the side effects associated with using Truvada, noting that even if only 3 percent of patients experienced kidney failure, that number was high when simple condom use is effective.

AIDS Arms Executive Director Raeline Nobles said that her agency will be doing some PrEP trials.

Nobles said that while she is also concerned about decreased condom usage, she thinks some situational PrEP usage might be extremely helpful in controlling the spread of the virus.

Grant suggested that some people who use Truvada as a prophylaxis will use it situationally. He said someone coming out of a long-term relationship might begin PrEP until they become more comfortable with safer-sex practices.

A couple who has recently begun a relationship may use PrEP until they feel enough time has passed for them to both be tested as negative. Or the negative member of a sero-discordant couple may use the preventive medication to maintain his negative status.

A heterosexual couple trying to get pregnant when one of the partners is positive is another short-term situational use of the medication.

Among other things, the AIDS Healthcare Foundation charges that the Truvada study shows that the drug is less effective than condom use. They wrote that the study did not replicate real world experience, pointing out that participants were counseled monthly, which doesn’t translate into the way most people would take the drug.

Another concern is cost. The current price of Truvada is $45 per pill, which is more than $16,000 annually. Insurance doesn’t cover the cost of a flu shot, an annual preventive vaccine that costs less than a single Truvada, and there are questions over whether insurance companies would cover the cost of a daily preventive medication.

They also question whether uninfected men are likely to take preventive pills daily for the rest of their lives. A quick, unscientific poll of 10 single gay men, some in the Dallas Voice office, showed that only three in 10 would.

As questions remain, however, PrEP studies continue, including one at Dallas’ AIDS Arms, that could answer some of them.