The PrEP Debate: More Bloviating Than Fact

WEDNESDAY, May 21 — As more and more people become aware of the little blue HIV prevention pill, there is going to be more push back from opponents. Don’t be fooled by their dire warnings, delivered like Cassandra of old.

Pre-exposure prophylaxis (PrEP) may in fact be the single most important advancement in HIV prevention since condoms were recommended in 1983. The intervention involves taking the anti-HIV drug Truvada on a daily basis to prevent infection with HIV. It’s 90 percent or better in efficacy in preventing a new infection when it is taken daily.

It’s so effective, in fact, the U.S. Centers for Disease Control — the nation’s leading public health authority — has unleashed a major public relations push to bring awareness to the drug’s benefits. Last week, it released broad new guidelines on prescribing it that could result in 500,000 or more Americans getting on the drug.

But there are detractors to this drug. Their arguments generally are based in the construct that PrEP will lead gay men, in particular, to throw caution and condoms to the wind, resulting in dramatically higher STI rates. Some argue the drug is too toxic for people who don’t have HIV to take daily.

Despite their claims, these detractors simply do not have the science to back up their claims. They have fears.

For those who argue that condoms will be passé, the evidence simply does not suggest that. An analysis of information from the iPrEx study – which was a broad study of 2,499 men who have sex with men in several countries on the efficacy of taking Truvada to prevent HIV – researchers found there was no increase in partners or incidents of condomless sex. In a the Journal PLOS One, researchers concluded, “There was no evidence of sexual risk compensation in iPrEx. Participants believing they were receiving FTC/TDF had more partners prior to initiating drug, suggesting that risk behavior was not a consequence of PrEP use.”

“This study further confirms the original findings of iPrEx, which indicated not only that PrEP is a safe and effective tool for reducing HIV transmission, but also that it reduced so-called risk behavior,” Kyle Murphy, assistant director of communications at the National Minority AIDS Council in Washington wrote in an email in December about the study findings. “Hopefully fears around potential risk compensation and now be put to rest and our community can focus instead on how best to scale up this exciting intervention. Infections continue to rise among gay and bisexual men, especially young black gay men and we should be utilizing every tool at our disposal to reverse that trend.”

Some point to the recommendation to use condoms in conjunction with PrEP as evidence that the condoms are actually preventing transmissions. This is inaccurate. Project Inform, an advocacy group focused on HIV treatment and prevention, says that simply is not the case.

"Although everyone reported 'bottoming' (receptive anal sex) in the previous six months without a condom, most people reported using condoms more often during the study,” the group writes in its explanatory report on PrEP. “Given that high-risk sexual behaviors were still quite common, and given that condom use was the same in both the Truvada and placebo groups, it is highly likely that Truvada, and not just condoms, had a lot to do with how effective the pill prevented new infections."

The condoms are recommended in large part to prevent infection with other sexually transmitted infections. Infection with other STIs can increase the likelihood of infection with HIV. Syphilis, for instance, increases the transmission of HIV by 2.5 times. And let’s be clear, STI rates have been climbing in the men who have sex with men communities for at least a decade. In Michigan, including here in Ingham, we have seen several outbreaks of syphilis.

Condom use is not as wide spread an adopted prevention option as we would like to believe. A recent report from the CDC concluding: "The percentage of MSM [men who have sex with men] reporting unprotected anal sex at least once in the past 12 months increased from 2005 to 2011, from 48 percent in 2005, to 54 percent in 2008, and 57 percent in 2011. This trend was statistically significant among self-reported HIV-negative or unknown status MSM…but not statistically significant for self-reported HIV-positive MSM." Other studies have found half of men who have sex with men reported not using condoms in their last sexual episode. Let’s also be clear, if the condoms all the time message worked, we would not be stubbornly stuck on a plateau of new infections at 50,000 Americans a year, would we?

And while condoms are certainly a recommendation for taking PrEP, it is not a requirement. PrEP without condoms can reduce infection possibilities dramatically.

Opponents want to focus on condoms because it is what we have preached as prevention since the mid-80s. And they worked, for those who used them. In fact, they saved many lives in the late 80s and early 90s. Many of those who are screeching about the risk of tossing condoms out the window, lived through that time. Their commitment to condoms is admirable, but times have changed. Condoms are no longer the only – or even the most effective – way to prevent HIV infection, and empowering people to make choices for their own bodies is what we need to do to stop this epidemic.

The other issue that will be raised as a fear specter in relation to Truvada is the drug and its effects. This comes in two different, albeit related arguments. The first argues that if people on Truvada do not take the drug daily and end up infected, they will help the virus develop resistance to Truvada. The science simply does not support this claim.

The National Institute of Allergy and Infectious Disease, part of the National Institutes of Health, reports on the iPrEx study findings related to resistant virus. “Additionally, no drug resistance occurred among individuals who became HIV-infected during the course of the study. There were three cases of emtricitabine [one of the two drugs that make up Truvada] resistance (one participant in the placebo group; two participants in the active drug group), but these cases occurred among individuals who were HIV-infected at the time of enrollment. Their HIV infections were so recent that they were detected by standard HIV antibody testing.”

The second argument related to the drug opponents will make is that using the drug exposes a person to the risk of dangerous side effects. Many will point to lactic acidosis, but what they don’t note is that this is rare, but serious, side effect. It is also, interestingly, a potential side effect of Tylenol. No one is calling for an end to Tylenol use that I can find.

And the fact is, iPrEx found very little by way of side effects for those taking Truvada during the study. Some reported stomach upset issues, which resolved after several weeks on the drug. And some had mild elevations in kidney function measures. When those with the kidney issues stopped using the drug, the problems resolved. There was not a single case of lactic acidosis reported in the study.

At the end of the day, adoption of this drug to prevent HIV is going to be a personal decision. A person who doesn’t want to take it, shouldn’t have to. At the same time, a person who does, should have unfettered access to compassionate medical care and the drug. The debate about taking the drug should be based in facts, not scare tactics. PrEP can revolutionize the way we address HIV in the U.S., but only when we are ready to accept the science and have a rational discussion which is not about shaming gay, bisexual and other men who have sex with men as well as transwomen because we have an agenda to dictate which prevention interventions are morally acceptable and which aren’t.