Almost exactly six years ago, researchers published findings from the first study to show that a pill a day could drastically reduce the risk of HIV infection. This was tantalising evidence that “pre-exposure prophylaxis”, or PrEP, could be one more way to protect people against the virus.
In the subsequent two years, multiple trials confirmed the result among different populations. In some cases, the pill, which consists of two of the antiretroviral (ARV) drugs people with HIV use to control the virus in their bodies, reduced the chances of HIV infection by more than 90%.
But such studies also confirmed a basic reality: drugs, like condoms, only work when used correctly and consistently. The evidence in clinical trials was clear: when PrEP is not taken consistently, as prescribed, it becomes less effective. Moreover, these studies highlighted that younger people — both young women and young men — had more difficulty adhering. But when PrEP is taken correctly it significantly reduces the risk of HIV infection. So we must figure out how to deliver PrEP — and help adherence — among those who need it most.
Scaling up PrEP, along with other prevention options, for those most at risk of HIV can help to bring the numbers of new infections down. But it is important to do this in parallel with programmes that aim to achieve the United Nations’ 90-90-90 targets: by 2020, 90% all people with HIV will need to know their HIV status, 90% of all HIV-positive people will have to be on ARV therapy and 90% of all people on ARVs would have achieved viral suppression. In other words, ARVs would have drastically reduced the amount of HIV in their bodies.
Communities are beginning to talk about PrEP, and demand it. Health providers, policy makers and governments have started to support programmes with work, money and leadership.
In 2012, the United States Food and Drug Administration approved a two-in-one pill combining the ARVs tenofovir and emtricitabine, also known as Truvada, for PrEP. In 2015, regulators in Kenya and South Africa followed suit with approval and the World Health Organisation (WHO) recommended oral PrEP for all people at substantial risk of HIV infection.
Does all this mean there’s going to be more PrEP in sub-Saharan Africa, and fewer new infections, in the near future? Not exactly, or at least, not yet.
This is because paper policies aren’t programmes. As countries revise their own ARV guidelines to align with the new WHO recommendations of the immediate offer of treatment for all people living with HIV and PrEP for those at substantial risk, many countries are including both recommendations in their national adaptations.
But this doesn’t imply countries have clear plans or funding to deliver PrEP yet. Although several countries have PrEP in their ARV guidelines, far fewer have developed PrEP guidance — the more detailed, intervention-specific roadmap for deciding who should get PrEP, what tests and counselling messages should go with it and how doctors should approach the ongoing health monitoring, and support for people who are taking it. To adopt PrEP into national guidelines without then moving onward to specific guidance that identifies how best to deliver the strategy to populations who need it would be a huge error.
Some countries have made progress with this. In July, Kenya launched its new guidelines on the use of ARVs for treatment and prevention with oral PrEP, in the form of pills, fully integrated. Although PrEP is not yet included in the current South African ARV guidelines, it is enshrined in the country’s response in a number of ways, including approval in 2015 by the Medicines Control Council for Truvada to be used for as PrEP. PrEP has also been included in the health department’s national strategic plan for HIV, sexually transmitted infections and tuberculosis, and the Southern African HIV Clinicians Society published expanded PrEP guidelines in early 2016.
From guidance, we need to move to programmes. This is where we will gain invaluable information about how, and for whom, PrEP will work in the real world. In June, South Africa formally launched its national PrEP programme at a number of clinics that serve sex workers.
But we need to remember: oral PrEP, in the form of an HIV prevention pill, is a new option. It hasn’t been delivered at national scale anywhere in the world. Even in the United States, where PrEP was approved over four years ago, large-scale programmes, marketing campaigns and broad access are only just beginning. We’re still in the learning stage — figuring out how to deliver counselling messages that support choice and that help people stay on PrEP, especially those at greatest risk. We must ensure gender equity in access: getting PrEP to women who are old young, pregnant or using contraceptives, gay men and other men who have sex with men, and to transgender women.
We are also aware of the dangers. And there are many. Chief among them is that PrEP could be launched in a way that dooms it to fail. Public health history is littered with examples of innovations that didn’t reach the people who needed them most, in a timely and effective manner.
The hepatitis B vaccine was originally targeted at specific populations who were already stigmatised, so the vaccine also became stigmatised. The female condom was introduced without supportive programming in most countries — and then when women didn’t embrace it, the public health establishment largely declared that it had failed. The list goes on and on.
So now, before it is too late, we must chart a course that avoids these pitfalls. We must, first and foremost, move with speed.
A fascinating session with current PrEP users and programme implementers at the recent Aids 2016 conference in Durban showed how much we are already learning from current PrEP programmes. The take-home message from that session was clear: “PrEP is not perfect. It is not easy. It is not for everyone. It is not for always. It will not end HIV — or, of course, the underlying social and structural issues — on its own. But we won’t end the epidemic without it.”
Mitchell Warren is the executive director of AVAC, a US-based HIV advocacy organisation that does extensive work in South Africa.