In a long-expected move, federal health authorities recently recommended that people “at substantial risk” of becoming infected with human immunodeficiency virus (HIV) take a daily medication to prevent that from happening. The new guidelines, spearheaded by the Centers for Disease Control and Prevention (CDC), are expected to lead to a substantial increase in the numbers of HIV-negative men and women who seek out the medication as a form of self-protection—an approach known as pre-exposure prophylaxis, or PrEP. The guidelines should also help to ease the concerns of primary care physicians; many are unfamiliar with the new prevention strategy, and others are reluctant to prescribe medications for healthy patients (with good reason, generally).
There are an estimated 50,000 new HIV infections annually in the U.S., a number that has held steady for years, to the frustration of public health officials. An HIV vaccine has been notoriously difficult to create, with many promising candidates having failed in human trials. Aside from abstinence, condoms have for decades provided the only effective means of preventing transmission—and they can break or slip off. While many gay men used condoms religiously during the worst years of the epidemic, today’s generation has come of age viewing HIV infection as one of many chronic, debilitating—but not necessarily fatal—illnesses. So they are more likely to forego condoms, just like straight men.
So when studies showed that a pharmaceutical already approved for HIV treatment was highly protective against infection if taken daily, public health experts and advocates hailed the findings. Two years ago, the Food and Drug Administration (FDA) endorsed this method when it approved the drug—Truvada, a combination of two antiviral medications—for use in preventing HIV infection.
The number of people taking Truvada for prevention is estimated to be in the low thousands, according to early data from Gilead, which makes the drug; so far, insurance companies have been willing to cover most of the costs. But the slow pickup has disappointed many in the HIV prevention field, who hoped that HIV-negative gay men, in particular, would seek out the medication. In the Gilead data, about half of those taking Truvada for prevention were women; researchers speculated that many of them were likely involved in relationships with HIV-positive men.
“The uptake is so low with PrEP right now, and it’s been frustrating for some of us who really believe it could benefit so many people," said Jeff Berry, the editor of Positively Aware, an HIV treatment magazine published by TPAN, a Chicago-based HIV/AIDS service organization. “The guidelines will help to reinforce that it’s one more tool they can use to help reduce risk.” One major HIV services organization, the Los Angeles-based AIDS Healthcare Foundation, has vigorously protested efforts to promote PrEP, warning that gay men are unlikely to stay adherent to the medication and also unlikely to continue to use condoms. That would be a recipe for potential disaster, with the possibility of Truvada-resistant strains of HIV arising and being spread among people believing they were protected from infection.
Other HIV and AIDS organizations accuse the foundation of fear-mongering and misrepresenting the scientific data. Studies to date suggest that gay men on Truvada maintain their levels of condom use; although anecdotal reports suggest that at least some gay men on Truvada reduce their use of condoms. It is also true that medication adherence was a problem in the early clinical trials, but those currently on PrEP know that it works and might therefore be more motivated to follow the regimen. Some gay men remain cautious about the new strategy and have urged health care providers to closely monitor whether patients are actually taking the medication as prescribed.
The new guidelines recommend PrEP for gay men who don’t always use condoms, men and women in relationships with HIV-positive people or who have sex with people at risk for HIV and injection-drug users. And while the recommendations promote continued condom use even with PrEP, they implicitly acknowledge that many people are unlikely to follow that advice.
“The guidelines recognize that some people are just not going to use condoms and that it’s better to get them on PrEP,” said Ken Mayer, M.D., a professor of medicine at Harvard University and the medical research director at Fenway Health, a community center in Boston with many lesbian and gay patients. “PrEP is not a panacea, but it is now clearly part of the pantheon of HIV prevention.”