England’s PrEP policy in disarray after NHS U-turn

Activists, individuals at risk of HIV, and clinicians have reacted with anger to an official U-turn on provision of HIV pre-exposure prophylaxis (PrEP). NHS England officials have refused to allow a draft policy on PrEP to go forward for further consideration.

“The UK once had a reputation for being a leader in HIV prevention and that reputation now lays in tatters,” said Will Nutland of activist group Prepster. “NHS England has turned its back on a process that could have significantly contributed to turning the tide of HIV in this country. The decision is ill-conceived, is not based on evidence, and will directly contribute to the on-going sexual ill health of the nation.”

The argument advanced by NHS England for the U-turn is that they shouldn’t have been considering commissioning PrEP in the first place, as HIV prevention services are the responsibility of local authorities. While many think these arguments to be disingenuous, PrEP appears to be a victim of the split of commissioning responsibilities between the NHS and local authorities.

“We are perplexed and deeply concerned by NHS England's decision,” said the British HIV Association (BHIVA), representing clinicians. “This is yet another adverse outcome of the disastrous Health and Social Care Act.” Local authority leaders have rejected the idea that they could foot the bill for the medications used in PrEP without additional funding.

Although NHS England argue that they should not be providing PrEP, they simultaneously offer a sliver of funding for a pilot project. Activists and clinicians rejected this as inadequate to meet the needs of people vulnerable to HIV.

People who are concerned about PrEP and the state of HIV prevention in the UK are urged to write to their MP and ask them to raise the issue with the Secretary of State for Health and also to sign a parliamentary petition.

Chemsex

A survey of 532 HIV-positive gay men attending clinics in England and Wales has found very high rates of ‘chemsex’ and of drug injecting. The survey results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2016) held in Boston in February. The figures are of particular concern because they are not based on users of specialised services for people using drugs, but of people attending HIV clinics who were ready to complete a survey covering many aspects of their health and wellbeing. These data are likely to be more representative than some previously published statistics.

Of the HIV-positive gay men completing the survey, 29% reported chemsex (‘the use of drugs to increase disinhibition and sexual arousal’) in the past year. Furthermore, 10% reported injecting – or being injected with – drugs in a sexual context.

Figures were higher for some subgroups: Londoners, middle-aged (rather than younger) men, men reporting depression.

Users were six times less likely to report always using condoms than other men. They reported 30 sexual partners a year, whereas other men had an average of just under 10. The odds of reporting a sexually transmitted infection or hepatitis infection were much higher than in other men.

Vaginal rings

The results of two studies conducted in four African countries announced at CROI 2016 show that vaginal rings impregnated with an anti-HIV drug were effective at cutting the HIV infection rate in women.

However, the overall effectiveness seen was only moderate, preventing less than a third of infections that would otherwise have happened. The primary reason for this was that the rings had no effect at all in the youngest trial participants, aged 18 to 21 – who also had the highest rates of HIV infection. The rings were more effective in older women, preventing almost two-thirds of infections in women over 25 in one of the two studies.

These poorer-than-expected results could be caused by a combination of factors – intrinsic efficacy of the rings of less than 100%, intermittent use among participants (who tended to take them out for cleaning, especially while menstruating or during sex), and greater vulnerability to HIV infection among young women. But whether these are the reasons for the relatively low levels of adherence and lack of effect seen in young women remains to be seen.

An open-label study – in which participants will know that they are receiving a partially-effective ring and not a placebo – will now take place. The rationale of this is that in some studies, adherence and effectiveness have been higher in people who know they are receiving an active product. If results are promising, then there would be an application for a product licence from early 2017.

Future PrEP

The Conference on Retroviruses and Opportunistic Infections (CROI 2016) included several studies looking into possible future ways to deliver PrEP, as alternatives to pills containing tenofovir and emtricitabine (Truvada). The most important of these studies are those into vaginal rings, described above. In addition:

  • TAF, the new version of tenofovir – which has less impact on the kidneys and bones – is distributed differently in the body, which could mean that it won’t be suitable for PrEP. Concentrations in rectal and genital tissues in women were lower than expected.
  • The CCR5 inhibitor maraviroc (Celsentri) could have a role in PrEP when used alongside either of the component drugs in Truvada but is not potent enough to act as PrEP in itself. Maraviroc is of interest because it has few side-effects and few problems with resistance.

Transgender people

“There is probably no population that is both more heavily impacted [by HIV] and less discussed around the world than transgender people,” Susan Buchbinder of the San Francisco Department of Public Health told CROI 2016.

A meta-analysis of 39 studies from 15 countries found that transgender women had an HIV prevalence rate of 19% – 49 times higher than that of the general population. Three studies that estimated annual incidence, or new infections, reported rates of 1.2 to 3.6% a year.

But there are hardly any data on transgender men. The HIV statistics published by Public Health England do not include specific figures for transgender people, although this may be about to change.

Factors that increase trans people’s vulnerability to HIV include stigma, fear of disclosure, sexual networks that include more people with HIV, poverty, lack of employment opportunities which leads many trans women to engage in sex work, unstable housing, violence, problems accessing health care, drug use, and mental health issues such as depression.

Also, hormone therapy could potentially cause changes in rectal or vaginal mucosa that increase susceptibility to HIV. There is also the possibility that hormones might interact with PrEP – and trans women’s concern about this may be one factor behind sometimes low adherence to PrEP.

In England, hardly any prevention programmes have begun to understand and engage with the needs of trans men or trans women.

The safety of PrEP

One of the studies at CROI 2016 that was most widely reported was a case study of a man in Canada who became infected with a multidrug-resistant strain of HIV despite apparently consistent adherence to PrEP. The case provides a useful reminder that no prevention method is 100% accurate but the fact that this is the first case report among the tens of thousands of people now taking PrEP shows that it is very rare.

The man had been on PrEP for two years and appeared to have good adherence on the basis of the frequency of pharmacy refills and of analysis of drug levels inside red blood cells. At a regular check-up, he was diagnosed with acute HIV infection. A drug-resistance test showed that he had HIV with complete resistance to emtricitabine and moderate resistance to tenofovir (the two drugs in Truvada).

The conference also heard more about the impact of Truvada PrEP on the kidneys and bones – the two most important potential side-effects. Some people over the age of 40 and some people with pre-existing kidney problems experienced declines in kidney function. The findings indicate that while Truvada PrEP is safe for most people, ongoing kidney function monitoring is important to promptly catch any problems that may occur, especially in the over-40s.

Another study found that any loss of bone mineral density experienced while taking PrEP recovered within a few months of stopping PrEP.

Scaling up testing and treatment

Interventions aimed at improving the proportion of people diagnosed with HIV, linked to care and remaining on treatment were a major theme at this year's conference. Several large programmes in African countries are testing the feasibility of offering testing and treatment at a very large scale, essential for achievement of the 90-90-90 target of 90% diagnosed, 90% of diagnosed people on treatment and 90% of those on treatment virally suppressed. 

Early findings from the large PopART study in Zambia and South Africa showed that after one round of household-based testing, linkage to care and offer of immediate antiretroviral treatment, 90% of adults knew their HIV status and 71% of adults diagnosed with HIV were on treatment. Progress was a little slower than hoped, with people generally taking a few months to begin HIV treatment. When the study is complete it will tell us whether this test-and-treat approach has an impact on new HIV infections in the study communities.

Botswana is already close to reaching the 90-90-90 target and is ahead of the United States and most European countries in its efforts to improve treatment coverage, the conference heard. Based on a random sample of households in the country, it appears that 83% of people living with HIV know their status, 87% of those diagnosed are taking treatment and 96% of those on treatment have an undetectable viral load.

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