Adebisi Alimi is an LGBT advocate, former AVAC PxROAR Europe member and a 2014 Aspen New Voices Fellow. This article first appeared in Project Syndicate.

In October, two groups researching the effectiveness of a potential breakthrough drug in the fight against HIV did something unusual. They announced that the therapy they were testing, an antiretroviral drug called Truvada, had proved effective enough to end the randomized phases of the trials, and that they were offering the pill to all of the studies’ participants.

The researchers found that gay men who take Truvada, in addition to using condoms when they have sex, were significantly less likely to contract HIV. This is further evidence of the effectiveness of pre-exposure prophylaxis (PrEP), a technique by which people who are HIV-negative use antiretroviral drugs to protect themselves from infection. In 2011, a trial funded by the Gates Foundation found that straight couples using Truvada reduced the risk of transmitting HIV by 73 percent.

Those fighting to prevent the spread of HIV/AIDS thus have a new tool in their arsenal. The question now is how best to deliver it to those who need it most: gay men in developing countries.

This summer, the World Health Organization took an important step to that end, recommending PrEP for all gay men and men who have sex with men, making it the first major international health organization to do so. The WHO estimates that increased use of PrEP could reduce HIV infections by up to 25 percent over the next decade among men who have sex with men (this category includes anyone with elevated risk, not just those who identify as gay).

But an important obstacle remains: the legal predicament of gay men in much of the developing world. In countries like Nigeria, where anti-homosexuality legislation has recently been approved, those following the WHO’s new PrEP guidelines could find themselves subject to imprisonment.

The climate of officially sanctioned homophobia in Nigeria has already set back the fight against AIDS. In 2006, a study found that 13 percent of men who have sex with men in Nigeria were HIV-positive, compared to 4.5 percent of all Nigerians. By 2012, the HIV rate among men who have sex with men had jumped to 17 percent. Meanwhile, an increasing number of men reported encountering homophobia at healthcare centers, making them less likely to seek help.

The consequences could not be more serious. Two years ago, a young HIV-positive Nigerian man contacted me on Facebook to tell me about his monthly ordeal at the clinic. The nurse at the hospital spent more time lecturing him on the evils of homosexuality than telling him about the drugs he was taking and their possible side effects. The man, a third-year medical student, told me that he had decided to stop going to the clinic. When I asked how he would continue treatment, he said that he had a friend abroad who could get him the drugs. Less than two years later, I saw a Facebook update announcing his death.

My Facebook friend is not the only one who has paid the price for Nigeria’s homophobia. A preliminary report from the Solidarity Alliance Nigeria, a coalition of gay, lesbian, bisexual, and transgender (LGBT) organizations, details a huge decrease in the use of HIV services by men who have sex with men in the six months following the enactment of the anti-gay legislation. The decrease ranges from 40 percent in Lagos – Nigeria’s most cosmopolitan city – to 70 percent in Kano, a predominantly Muslim state.

Nigerians living with HIV must do more than just fight the infection; they also must brave social stigma, weather discrimination by secular and religious institutions, and now, potentially, face threats from the legal system. In this environment, the promise of PrEP begins to dim, as the risks of seeking treatment outweigh the potentially life-saving benefits.

The story is similar in Uganda. Last spring, as legal persecution of gays there mounted, the government raided an HIV clinic and withheld its operating license for providing care and support to HIV-positive men who have sex with men.

As an African activist with more than ten years of experience in the fight against HIV, I hope that the WHO will build on its important first step of advising the use of PrEP. That means initiating a public conversation with countries like Nigeria, Uganda, Gambia, and Russia on the importance of inclusion in the battle against HIV.

The WHO should make it clear that while it may not be advocating for LGBT political rights, it is determined to ensure that all those who can benefit from PrEP are able to access the necessary drugs, without fear of legal consequences. Researchers, drug companies, and human-rights campaigners must take up the fight to ensure that PrEP is made available – without risk – to those who need it most.

Over the last few weeks the PrEP for HIV prevention field has been boosted by positive news from two ongoing research studies in Europe: PROUD and IPERGAY. In each study, use of TDF/FTC (brand name Truvada) for PrEP reduced risk of HIV acquisition. The exact numbers behind the recent announcements are not yet available (in each case the data was reviewed by the trial’s independent data safety and monitoring board and will not be available more widely until published or presented, which is expected in early 2015 for both), but daily and “on-demand” (taken before and after sex) TDF/FTC as PrEP were effective at reducing risk in gay men and other men who have sex with men.

A lot has been written about these promising advances and what the announcements mean for regulatory approvals and PrEP access in Europe, the effectiveness of “on-demand” versus daily PrEP and the mounting evidence of PrEP’s utility as an important HIV prevention option. 

Aidsmap.com editor and long-time writer and activist Gus Cairns penned a piece for Huffington Post, D-day for the Pill for HIV, noting how these two studies and their show of PrEP effectiveness together mark a turning point in HIV prevention. His cogent analysis is a must-read. 

The US Centers for Disease Control and Prevention notes that the trial announcements are “encouraging” and that they look forward to seeing trial data for more information, particularly from IPERGAY, on dosing and timing required for protection. 

From the HIV R4P conference “live blog”, Emily Bass writes on PrEP for a New Era, describing the new data and the energy around PrEP exhibited at the conference.

PROUD study team statement is available here and the ANRS’ statement on IPERGAY is here.

For the latest on PrEP, visit avac.org/prep.

This was originally published on the What’sUpHIV blog that provided live coverage during HIV R4P 2014.

Maureen Milanga, a staffer at Health GAP in Kenya and an alumna of the AVAC Advocacy Fellows program, presented a poster demonstrating how advocates from Kenya, Zimbabwe and Nigeria were able to influence their countries by strategically raising their voices to increase demand for key interventions. Their work has helped secure a number of significant changes—including global WHO guidelines that recommend early ART initiation for sero-discordant couples regardless of CD4 counts. Demand is also driving expanding attention to the need to deliver post exposure prophylaxis (PEP – ARVs given after a person suspects they have been exposed to HIV) for key populations like sex workers in Zimbabwe and South Africa. There has also been increased effective engagement of communities in trials.

However, a lot still needs to be done to scale up pre-exposure prophylaxis, or PrEP (programs that provide ARVs to HIV-negative people to reduce their risk of HIV infection). This includes additional research, demonstration projects and large scale roll out programs.

It is important to note that advocacy requires appropriate strategy for each country in order to create meaningful change. They need to be given basic facts about the research and the prevention/treatment options for them to influence policy makers. Advocates can then frame arguments that help the policy makers see themselves as beneficiaries of the action—whether by saving costs, lives or earning the respect and alliance of the key constituencies driving change.

This was originally published on the What’sUpHIV blog that provided live coverage during HIV R4P 2014.

It was an exciting morning for pre-exposure prophylaxis (PrEP) using daily oral TDF/FTC (brand-name Truvada). In the morning plenary session, Chris Beyrer, of Johns Hopkins University and president of the International AIDS Society, spoke about HIV prevention in sex workers, gay men and other men who have sex with men. Beyrer pointed out that there is only one country implementing PrEP—the United States—at a national level.

“I can’t wait until the PrEP era begins,” Beyrer said. “Hopefully it is going to be soon.” Beyrer is a staunch human rights advocate—founder and director of the Center for Health and Human Rights at Johns Hopkins—and it is good to hear support for PrEP in the context of a rights-based response. As he noted, there are many concerns in civil society about biomedical interventions like PrEP and ART for treatment and prevention, since the medical establishment is, often, linked with the state—eg governments that may be actively criminalizing and persecuting the very populations who are being targeted with new biomedical strategies. Beyrer’s embrace of both rights and biomedical interventions is exactly what’s needed—and it will be exciting when the PrEP era, as he defines it, begins.

Speaking of the PrEP era, it took a leap forward while the plenaries were taking place, as the French research agency ANRS released a press release announcing that its IPERGAY trial, which had been designed to evaluate intermittent PrEP use, had found evidence of efficacy and was going to end its randomized, placebo-controlled design.

Briefly, this trial was launched after the iPrEx trial of daily oral PrEP showed efficacy in gay men, other men who have sex with men and transgender women. It sought to test intermittent use and had a placebo arm—a design decision that raised ethics questions from the outset, given the evidence of efficacy from iPrEx. The investigators had explained that since PrEP was not available or evaluated in France, the design was warranted. Plenary speaker Brigid Haire, who gave a compelling, nuanced talk on trial ethics and biomedical prevention, mentioned these questions specific to IPERGAY—perhaps at the precise moment that the press release was being released announcing the changes in the trial. (Kudoes to Haire and indeed anyone who isn’t checking email compulsively during conferences…)

In a delicious turn of phrase, Haire referred to the “tantalizing whiff of data” from the UK PROUD study of PrEP in gay men and other MSM. This trial found compelling evidence of efficacy earlier this month—a finding that triggered a review of the IPERGAY protocol. It’s exciting when a field evolves in real time—let’s hope it keeps happening, as fast as Beyrer suggests it should.

Last week, a scheduled interim analysis from the UK PROUD study found that daily oral pre-exposure prophylaxis (PrEP) with TDF/FTC (Truvada) to be “highly protective against HIV for gay men and other men who have sex with men in the UK.”

The announcement of these results was quickly followed by articles in the two UK newspapers: the Independent reporting that the study had “dramatically sped up” plans for the NHS approve PrEP, while the Daily Mail reporting that “NHS England have set up a group looking into the viability offering Truvada.”

The NHS is the world’s largest publicly funded health service providing free care for anyone who is a UK resident. The next step for TDF/FTC as PrEP would be “adoption” by the NHS, which would make this strategy available to all UK residents via programs subsidized and staffed by the UK government health service. This adoption process has no equivalent in the US or elsewhere, including Africa, where multiple different agencies advise, control and fund healthcare. For example, in the United States, the Food and Drug Administration approved a prevention indication for TDF/FTC and the Centers for Disease Control and Prevention has recommended it, but availability is via private insurance, Medicaid and demonstration projects.

Now both countries could be at the forefront of delivering PrEP through very different health systems.

The possibility for this PrEP strategy in the UK is a welcome advance, especially to those following the PrEP discussion in Europe. Until now European governments and agencies have been slow to consider PrEP. Earlier this year, two days after their sister agency in US issued guidelines on PrEP use, and a few months before that the WHO endorsed PrEP for MSM and discordant couples, the European Centre for Disease Prevention and Control (ECDC) issued a brief cautionary comment on PrEP. The WHO strongly recommended men who have sex with men be offered tenofovir-based oral PrEP. The ECDC comment in contrast vacillated, articulating questions about cost and concerns about side effects, potential for drug resistance and condom migration that experience and research have shown so far to be of manageable or minimal impact.

For those interested in seeing whether PrEP might work in Europe, the ECDC guidance was interpreted as European ambivalence or hostility toward PrEP. The ECDC statement was the first normative guidance since the 2012 European Medicines Agency (EMA) guidance, and one could be forgiven for thinking that Europe would be very, very late to PrEP, if they arrived at all.

Despite the tone of ECDC comment, the PROUD study could trigger real action. There is even some cause to believe that Europe could overtake the United States in PrEP implementation.

Europe needs PrEP. Europe has a major epidemic among gay men and other men who have sex with men. Recent data in Western and Central Europe shows that the number of HIV diagnoses among gay men and other men who have sex with men increased by 33% between 2004 and 2011.

But PrEP requires integration into primary care systems, and many European countries have good health system infrastructure. One of the key challenges of PrEP uptake in the United States is developing systems and educating providers to deliver PrEP. Several European countries have that infrastructure and payor systems integrated into those structures already.

Cost is the principal objection to PrEP, and Truvada’s patent is good only until 2021 in the US but 2018 in Europe. So this PrEP strategy could go to generic pricing in Europe three years earlier than the US.

European advocates are organizing. Early advocacy is already happening in France, Germany and the United Kingdom. At the Melbourne AIDS conference in July, advocates from Belgium, France, Italy, Germany, Greece, Netherlands, Portugal, Spain and United Kingdom met to discuss the state of PrEP implementation in their countries. There, the consensus was that not much was happening on PrEP in Europe. But now, things may start to change.

Europe wasn’t involved in the early PrEP efficacy trials, but the interim results from the PROUD open label study validated the protective effect of a daily oral PrEP strategy provided in the context of comprehensive HIV prevention. At the same time, the recent news from PROUD raises questions about the future of IPERGAY, an ongoing placebo-controlled trial that is designed to test if oral TDF/FTC for PrEP taken on an intermittent or ‘on demand’ basis (as compared to daily use in the other studies) reduced risk of infection among gay men and other MSM. The trial is currently ongoing in France and Canada and may also expand to Germany.
Advocates on both sides of the Atlantic have questioned the use of a placebo arm in IPERGAY since the FDA approved daily Truvada for prevention last July. As French and other European regulators, however, have yet to approve the use of Truvada as PrEP, therefore it is not currently available for prevention, only treatment. In a recent discussion of the PROUD results, IPERGAY investigators indicated that the trials independent data review board would be communicating with the analogous body for the PROUD study to share confidential information about the trial data. This step could lead to changes in the IPERGAY protocol.

Efficacy data are one piece of the PrEP puzzle. Acceptability and perceived benefits are also key—though harder to measure. Here, too, the data from daily PrEP are promising. At the Melbourne Conference, Kimberly Koester presented on people’s experiences taking PrEP in the iPrEx OLE study. The most striking finding was not the absence of condom migration. It was that fear before, after and during sex was a part of these men’s lives:

“So, in general, the anxiety, the HIV anxiety, is gone. I won’t say it’s gone-gone. But it’s not in the front of my head as it used to be, where I was obsessively worried about it while sex was happening.”

Losing that fear is a message that will resonate in Europe, and sooner than we think.