Hope overshadowed – the US PrEP Summit

The US National HIV PrEP Summit, which took place in early December in San Francisco, was one of the most extraordinary HIV meetings I have ever been to.

This first-ever gathering of 600 people involved in PrEP (pre-exposure prophylaxis) provision in the USA (plus 25 non-US scholarship recipients, mainly from Europe) was already designed to be something different from the standard HIV ‘discover-test-treat’ conference. But fate then intervened to make it happen at an extraordinary time – in between the US election and Donald Trump’s inauguration. The election result totally changed the conference’s atmosphere and meaning.

The PrEP summit was designed as an event of celebration and hope. Its structure, its speakers, even the way the plenary room was designed and the way the speakers dressed, all conveyed one message: we are all in this together, and PrEP really is the game-changer we have been looking for.

Plenary talks were given in the round, from a low stage in the centre of the room. So were panels, with discussants sitting in white designer chairs. Slides were shown, but in the corners of the room behind our heads, so people looked at the speaker instead.

The atmosphere was more akin to gay men’s prevention conferences in the 1990s than treatment conferences. There was little sense of hierarchy or experts-versus-learners. One prominent presenter came out as having just started PrEP, to warm applause. Workers for stern-sounding federal bureaus were hard to tell from community spokespeople. Discussions were facilitated by an ‘MC’, the activist Ken Williams, better known as the blogger ‘Ken Like Barbie’, who has no federal job to lose.

The conference audience was also notably different. A majority of attendees were women, about 50% were black, and flamboyant rather than conservative gayness was much on show. There was also a large, conspicuous and involved trans* contingent, mainly women but some men.

So, had Hillary Clinton won, this meeting would have been a celebration of the success of a new HIV prevention paradigm and a showcase of projects to make PrEP work better and extend it to more people.

Instead, the predominant feeling was one of trepidation. The most obvious sign of this was that media were not allowed entry. I got in as a PrEP advocate but colleagues from the community press were told there would be no media presence. Although tweeting from the meeting was allowed, it was requested that no presenter working for any federal agency should be quoted directly. Originally, presentations were to be published online and some were. Now all have been taken down, leaving only the programme.

The result in my case is that this can’t be written as the usual Aidsmap-style summary. I can only rely on the presentations I did manage to salvage and fragmentary notes and tweets taken at the time.

The summit’s convenor, Paul Kawata of the National Minority AIDS Council (NMAC), gave a long, impassioned and off-the-cuff opening speech where he described the anxiety of the current moment and the big unknowns of the Trump administration.

“The HIV sector has been good at working with Democratic administrations,” he said. “But we’re not so good at making friends with Republican ones.”

It is clear they can be related to and influenced; otherwise, one of the most important initiatives in the whole history of HIV, PEPFAR (The President's Emergency Plan for AIDS Relief), would never have been started by George W Bush. But whether Donald Trump will be as persuadable or well-disposed to an intervention with as much built-in controversy as PrEP remains to be seen. One possible chink of light is that Vice-President Mike Pence, as Indiana State Governor, was the person forced to permit needle and syringe exchange when confronted by an HIV outbreak among white, rural heroin users. But the signs are few that he or his president will be as well disposed to urban blacks, and Trump has already drastically cut federal agency jobs.

The difference that the Obama administration and the Affordable Care Act (‘Obamacare’) brought to the HIV sector in the USA was underlined dramatically by the head of an HIV/STI programme for one of the Southern states. The ACA had led to the proportion of people in the state who had no health insurance falling from 18 to 12%, but there was a much more dramatic difference for people with HIV: the proportion of people in the state’s AIDS Drugs Assistance Programme (ADAP) who had no health insurance had shrunk from 70% in 2012 to 27% in 2016. As a result, the percentage of HIV-positive people who were virally suppressed on antiretroviral therapy had risen from 70% to 82%. How much of this gain could be lost under the new administration?

PrEP – the state of play

A speaker from the US Office of National AIDS Policy told us that the current US HIV/AIDS strategy includes a target of full access to PrEP services by 2020 “for those for whom it is appropriate and desired, with support for adherence” and increased use of PrEP is one of the three new progress indicators installed in 2016, alongside an increase in HIV viral suppression rates and a decrease in stigma. The actual target is a sixfold increase in PrEP use. If that means relative to the level of use at the time the revised strategy was adopted in July 2015, which would have been about 25,000, that would mean 150,000 – a level which may possibly already have been reached.

One of the clinicians prominent in the San Francisco PrEP programme said that in terms of documented pharmacy prescriptions alone, the number of new starters on PrEP by the end of 2015 was 80,000. How does this compare with the need for PrEP?

One model developed by the CDC researcher Dawn Smith has calculated that one in four sexually active gay men might be sufficiently at risk of HIV to benefit from PrEP (492,000 men). The one in five people who inject drugs who might benefit adds another 115,000. Far fewer people at risk via heterosexual sex might need PrEP – one in 166 women and one in 500 men, the model suggests – but because there are a lot more of them, the number of heterosexual women who might benefit from PrEP nearly equals the number of gay men – 468,000. Add 157,000 heterosexual men and you have nearly 1.232 million people. If 50% of these people actually start PrEP, that is somewhere near a sixfold increase in PrEP use from today. (The model made no separate calculation for trans* people).

The big issue about PrEP, however, and the biggest issue at the conference aside from whether the Trump administration would nip this progress in the bud, was whether PrEP is getting to the right people. We’ll look at how to get it to those 468,000 women later, but at the moment it’s not even getting to the right MSM (men who have sex with men) and in particular black MSM and young ones. In the US, while 13% of the population is African-American, 44% of HIV infections are in this group. But only 10% of those using PrEP have been black. In comparison, 74% of PrEP use is among white people though only 27% of HIV infections are in the white population.

And although it’s clearly crucial to the success of PrEP to get people using it as soon as they start being highly vulnerable to HIV, only 6% of male PrEP users were under 25.

One slightly more promising sign is that the Southern states, which are disproportionately affected by HIV, also have some of the highest rates of PrEP use, with Texas and Florida being two of the top five states numerically in terms of PrEP prescriptions. It was suggested by the speaker that we need a new PrEP ‘cascade’ or continuum of care. This would have six measurable steps – see this report for more:

• The proportion of people at risk of HIV identified as a candidate for PrEP
• The proportion interested in it
• The proportion linked to a PrEP programme
• The proportion starting PrEP
• The proportion staying in the programme
• The proportion achieving adherence and persistence

This would be harder to measure than the HIV care cascade, though, as people can drop out of risk and PrEP use, and then re-enter it, at any point in the cascade.

PrEP – barriers to uptake

Numerous studies are looking at how to increase PrEP knowledge, acceptance, use and adherence among the people who need it most, among young and black MSM, trans* women and men, people who inject drugs and heterosexual men and women.

Among the most interesting findings from these studies were the subjective reasons people don’t use or adhere to PrEP. A common finding is that PrEP candidates do not consider themselves “at high risk” even though they are. One study, for instance, found that 62% of people who declined PrEP in the PrEP Demo Project had had condomless anal sex in the last three months, 28% with more than five partners in the last year, and 43% had had rectal gonorrhoea or chlamydia in the last year. African-Americans were more likely to decline PrEP and if they took it were less likely to have protective drug levels in their blood when these were measured.

Two important reasons for declining or not adhering to PrEP stand out in these studies. One is concern about side-effects: people are still convinced that PrEP is toxic. The other is interesting because it reflects findings from African PrEP studies: people were concerned that if people found they were taking PrEP, it might “out” them as gay (or unfaithful), or people might wrongly assume they had HIV.

Young men in the ATN113 study with adolescent MSM were particularly likely to say this. Non-adherent participants were more likely to agree with the statements “I worry others will see me taking pills and think I am HIV positive” and “I’m concerned people will know I have sex with other men because I’m taking PrEP.” Exposure is more likely to be an issue if people are young and/or poor, not least because they are more likely to share living and sleeping space. They are also more likely to be mobile and unstably housed.

It is possible, however, to help young MSM achieve high adherence to PrEP: the EPIC study in Chicago, for instance, achieved protective levels of the drug among 84% of MSM aged 18-29 after 36 weeks.

Health care providers' attitudes may also present a barrier to uptake, as in this poll of medical students’ attitudes from the Research for Prevention conference in Chicago. Another study in press finds that clinical providers still have an unjustified degree of concern about the possible side-effects of PrEP (75% said these were a worry) with resistance, a very rare consequence of PrEP, also cited by 60%. In contrast, only 40% thought that increased sexual risk-taking was an issue.

Studies are underway to evaluate the use of electronic health records to identify people at increased risk of acquiring HIV; of basing PrEP clinics at community pharmacies; of mobile apps such as NURX to facilitate PrEP uptake; and of self-sampling and PrEP home delivery. 

PrEP and sexually transmitted infections

Among the most important issues brought up by opponents of the expansion of PrEP is that there are very high rates of sexually transmitted infections (STIs) among people using PrEP. This is certainly the case: in the first year of the Kaiser Permanente PrEP cohort study, no PrEP user caught HIV but 50% caught an STI, 33% a rectal STI, 28% gonorrhoea and 5.5% syphilis (these figures are more recent than those in this report). The syphilis rate in the PrEP Demo Project was 12.4%. One US study found that MSM using PrEP were 11.2 times more likely to be diagnosed with chlamydia, 25 times more likely to be diagnosed with gonorrhoea, and 44.6 times more likely to be diagnosed with syphilis versus MSM not using PrEP.

The question is whether PrEP is encouraging people to drop condoms and leading to rises in STI rates – or whether the ‘right’ people, with already high STI incidence, are the ones choosing to take PrEP. Some studies do report that people began to have more condomless sex after starting PrEP. The programme at the STRUT clinic in San Francisco, for instance, showed that the proportion saying they were having more condomless sex increased from 16% at their month 1 visit after starting PrEP to 48% at their month 12 visit. The French Ipergay study reported an immediate drop in the proportion of participants using a condom when the study went open-label. The question is whether this will make much difference, given that 93% of men in the STRUT PrEP programme were already having condomless sex when they joined.

One interesting new model shown at the summit, though as yet unpublished, predicts that if PrEP led to a change whereby gay men started having HIV and STI check-ups at least once every six months, while STI diagnoses would rise in the first year, they would then start decreasing owing to the regularity of diagnosis of STIs, some of which might otherwise have gone untreated for considerable periods of time. Even if men only had six-monthly check-ups over the next few years, average STI incidence would decline from 5.5% to 3% a year if regular check-ups were six-monthly and would fall to 2% a year if they were three-monthly.

PrEP adherence and insurance coverage

The ability to continue taking PrEP while still at risk is crucial, and in the US, several HIV infections have happened in people who were forced to discontinue PrEP because of loss of insurance coverage. In the Kaiser Permanente cohort this happened to two people; at the Fenway Clinic in Boston, four of the six recent infections in their 663 patients prescribed PrEP from 2011-2014 were in people who had not planned to discontinue PrEP. In a couple of cases, the non-adherence that led to HIV infection was clearly due to depression, but in the other two cases of infection, it was due to problems with public health insurance. In the SPARK demo project in New York City, 75% of people in the study remained on PrEP after a year, but among the 25% who did stop, only half had announced that they planned to stop. And in the US Demo Project, one-third of participants experienced a gap in their PrEP medication, with many being due to lack of health insurance and inability to afford co-pays.

Reaching new and vulnerable groups

What about those 468,000 women in need of PrEP? While at the start of 2013, of 1451 people who had started PrEP in the previous three months, nearly half were women, of 12,630 starting PrEP in the first three months of 2016, only 10% were women. While more than 15 times as many men started PrEP in 2016 than in 2013, the increase among women was only 72%. And yet the need is clearly there; in one study of women who had male partners with HIV, 40% said that their partner was not virally undetectable.

The question is, what medical setting is best for assessing women? Only 4% of family planning providers had ever prescribed PrEP to women and in one survey, 64-75% of family planning providers said they were uncomfortable about educating women about PrEP and prescribing it. And yet 60% of women of reproductive age access care through US family planning programmes, and HIV prevention is listed as a core task of family planning clinics.

One initiative from the Midwest states, a partnership of four existing HIV prevention organisations, has trained more than 600 providers from Planned Parenthood clinics so far. Washington DC is the first city that has developed an HIV programme, PrEPForHer, specifically to increase PrEP awareness among black women.

This is just one example of a plethora of PrEP awareness campaigns whose posters and materials livened up the conference and gave the impression of a tremendous new wave of energy in the field of HIV prevention. The workshop that featured the family planning training project also featured PrEP projects for trans* people in Los Angeles, adolescents in Chicago, Asian-Americans in San Francisco and native Americans in the rural West, not to mention well-established campaigns like PlaySure in New York and PrEP4Love in Chicago.

HIV social scientist Sarit Golub of Hunter College in New York concluded the summit with a rousing closing plenary speech in which she encouraged clinicians and prevention workers to stop seeing people purely in terms of risk behaviour.

“People don’t indulge in risk behaviour. They indulge in intimacy, pleasure, and trust behaviour. Even in love behaviour if they're lucky,” she said. “Doctors don’t say to people ‘I won’t prescribe you statins because you might go out and eat a cheeseburger’,” she added. “We have to stop treating people as targets and start treating them as priorities.”