New momentum on PrEP, but critical needs are overlooked

July 17, 2014

Originally appeared on the Huffington Post.

Last week, the World Health Organization (WHO) issued new comprehensive guidelines for addressing HIV/AIDS in so-called “key populations” — the current global health lingo for often-marginalized populations that are heavily affected by the AIDS epidemic including gay men and other men who have sex with men, people in prison, people who inject drugs, sex workers and transgender people.

While the guidance had a number of new recommendations, the one that has received — and deserves — the most attention is the recommendation that gay men and other MSM be offered the option of oral PrEP (the use of a daily medication to reduce risk of HIV infection) as part of comprehensive HIV prevention services. It’s the first time that this new strategy has received an unqualified endorsement from WHO, and it is a most welcome development!

Unfortunately, it also highlights the work that global health agencies and funders have, to date, left undone to make the world a place where such a recommendation could be put into practice. It also risks limiting PrEP’s future impact. By inadvertently reinforcing perceptions that this option is just for gay men, the recommendation could slow efforts to deliver it to others, including millions of heterosexual women at risk for HIV.

These new WHO recommendations come two years after that agency issued guidance on PrEP demonstration projects in low-resource settings, and the US Food and Drug Administration (FDA) approved the use of daily Truvada as PrEP in the US.

The 2012 WHO guidance and FDA approval opened a new chapter in the global rollout of this effective prevention strategy, and they sent a critical message: PrEP is real, it works, and it should be made available now. The 2014 WHO recommendation on PrEP for MSM reinforces that message, and that is a good thing.

But PrEP is an option for many people, not only for gay men. (It isn’t for everybody, of course, but that is a decision to be made by individuals and their health providers.) Global health leaders should be working, now, to develop and fund programs to provide access for anyone who can benefit. Oral PrEP should be integrated into comprehensive, high-impact prevention programs for all people at risk internationally, with particular attention to key populations but also for young women and married women who continue to bear the brunt of the epidemic.

WHO needs to quickly issue guidance on PrEP for all of the populations that can benefit. The data are strong enough to warrant this move, as the US Centers for Disease Control and Prevention recently showed with its guidance that recommended that doctors consider oral PrEP for anyone at high risk of HIV infection. State and local health agencies, including in New York State, are currently conducting demonstration studies to figure out how best to get PrEP to those who need it.

Public health history tells us that a broad recommendation can actually help ensure that specific populations get access. When the hepatitis B vaccine was introduced in 1986, it was recommended only for specific populations, which ended up stigmatized the intervention. It wasn’t until it was repositioned as being a health tool for the general population that it took off.

This lesson should be borne in mind, particularly in light of the homophobic climates in many African countries with high rates of new infections in MSM, women and youth. If PrEP is viewed mainly as an option for MSM, country authorities could be resistant to providing access for anyone.

The scientific evidence of PrEP is as strong in other populations, including heterosexual women and men, and people who inject drugs. Clinical trials in multiple countries have shown that people who consistently take PrEP with oral TDF alone or in combination with emtricitabine (FTC), also known as Truvada, can reduce their risk of becoming HIV-infected by 90 percent or more.

Here in the United States, PrEP is gaining momentum, as are efforts to begin to deliver PrEP to all of the populations that can benefit.. And while gay men have been the most vocal users of PrEP so far, others are beginning to benefit. The poignant accounts by PrEP users and providers at and just this week on the cover story of New York magazine offer hope that this new strategy will save and improve many lives, just as researchers and advocates have long hoped.

If the rest of the world follows America’s lead, PrEP could become an important global health success story. It is already being rolled out faster than earlier public health advances, from vaccines to tampons, oral contraceptive pills and the female condom — many of which took decades to get into the field. To realize PrEP’s potential, several specific things need to happen now.

In addition to expanded WHO guidance, Gilead Sciences Inc., the maker of Truvada, needs to move swiftly to secure regulatory approval in countries where PrEP is most needed. This starts with the countries that hosted clinical trials, where, tragically, PrEP is now out of reach. In two of those countries, South Africa and Thailand, Gilead recently filed for approval. This is an important and welcome step but the process needs to happen much faster and in more places. That requires both more aggressive efforts by Gilead and the willingness of national regulatory authorities to quickly review and approve the company’s applications.

Global health programs, including PEPFAR and the Global Fund, need to help countries design PrEP programs that meet the needs of their populations. A key part of this process is to launch large-scale demonstration studies in a wide range of countries and populations. Those studies can help planners understand how best to target PrEP to the people who need it most, and how to address key challenges like ensuring that people adhere to their daily medications. But so far, few of these studies outside the US have been launched or even planned.

Finally, global funders need to put substantial resources into well-planned PrEP programs. In particular, PEPFAR and the Global Fund should make sure that PrEP is not squeezed out by other funding priorities. National health authorities, who are increasingly and importantly taking ownership of their HIV prevention funding, also need to ensure a place for this intervention.

PrEP is not the perfect or only solution to the global AIDS epidemic — in fact, there is not, and never will be, such a silver bullet. We need integrated and sustained combination prevention and treatment programs. And oral PrEP as an option for all people at risk must be part of that. For the millions of people who stand to benefit from oral PrEP, let’s treat it like the advance and opportunity that it is.