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

Activists, individuals at risk of HIV, and clinicians reacted with anger last month when NHS England officials refused to allow a draft policy on pre-exposure prophylaxis (PrEP) to go forward for further consideration.

Senior managers at NHS England announced on 21 March that they should not have been considering running a PrEP programme in the first place, as HIV prevention services are the responsibility of local councils. They argued that if they did fund PrEP, there was a risk that proponents of other interventions that were not funded might make a legal challenge.

The decision, however, was greeted with a legal challenge itself by the National AIDS Trust (NAT), who argued that the incompetence of NHS England in allowing a committee to work for 18 months on a detailed recommendation for a PrEP programme, only to abort it at the last moment, offered no confidence in the legality of the decision.

“It is extraordinary that such legal concerns were only raised at the eleventh hour, after months of work,” commented NAT’s Yusef Azad.

The Local Government Association challenged the idea that cash-strapped local authorities should foot the bill for the antiretrovirals used for PrEP medication. "NHS England's statement is a selective and untenable reading of the [law] and an attempt to create a new and unfunded burden on local authorities”, a spokesperson said.

NHS England did offer £1 million a year for two years to determine the feasibility of local-authority-run ‘pilot projects’, instead of the committee’s recommendation of £16-24 million a year for the first five years of a full PrEP programme. PrEP researchers and HIV policy workers said this offer was both unnecessary – as the PROUD study had already shown that PrEP provided by sexual health clinics was feasible and effective – and inadequate, as it would treat a total of only 500 people compared with the 6000 a year thought necessary by the PrEP committee.

The decision has been greeted with anger by everyone from gay activists to politicians, and activity contesting the decision has involved everything from questions in Parliament to a street demonstration. The latest news at the time of this bulletin was that NHS England have offered a meeting with NAT to discuss its legal challenge and are also having a meeting in late May to discuss how to modify the process of commissioning new treatments and indications in the light of the PrEP debacle.

Comment: The history of HIV has shown that time and again, vital interventions regarded as inadvisable or impossible by officials – such as HIV treatment for low-income countries – have had to be fought for by coalitions of community activists, concerned scientists, and sympathetic politicians. PrEP is the latest. It faces particularly tough opposition as it challenges entrenched ideas about what safer sex consists of, and arouses fears – not supported by the evidence – that it will be the cause of high levels of HIV and sexually transmitted infections in gay men and other affected populations, rather than part of the response to them.

Kidney function decline in people taking Truvada PrEP supports need for monitoring

Older people taking Truvada as PrEP in two major studies experienced some decline in kidney function.

In the iPrEx study, people over 40 were more likely to experience a decline in kidney function, and this was related to how much PrEP they took. The proportion with a clinically significant decrease in kidney function rose from 6% if they took about two doses a week to 24% if they took 6-7 doses. In people under 40, this proportion never rose about 5%, even in people who took seven doses a week.

Another study, the US Demo Project, found similar decreases in older people, but only if they had already started with lower-than-average kidney function.

Together, these findings indicate that while Truvada PrEP is safe for most people, ongoing kidney function monitoring is important to catch any problems that may occur promptly, especially in over-40s.

Comment: Previous studies have tended to find non-significant rates of kidney problems in people taking PrEP, but the findings that people over 40 had considerably higher rates is of concern. It does not mean older people should not take PrEP, as the rates reported would only cause serious effects in a small number of people, but it does mean older people should be monitored.

Long-acting PrEP injection tolerable for male volunteers, but dose adjustment needed

Results have been released from a dose-finding study of a long-lasting, injectable formulation of the HIV drug cabotegravir for use as PrEP.

After taking a daily oral pill of the drug cabotegravir for a month – to weed out side-effects – participants then received three doses, one every 12 weeks, of injectable cabotegravir. This was given as two 2ml injections, one in each buttock.

There were a couple of unexpected findings. Firstly, the rate of absorption of the drug into the body was faster than expected, meaning that an injection will probably have to be given every eight weeks, instead of every 12 weeks as hoped.

Secondly, the duration and severity of pain and other effects of the injections were greater than expected. However, few people dropped out of the study because of them, and three-quarters of participants said they would be happy to continue taking cabotegravir injections as PrEP should it become available. In fact, more people said they preferred the 12-weekly injection to the daily tablet than vice versa.

Comment: The fact that the men in this study were prepared to put up with, for some, considerable discomfort in order to be protected against HIV for two to three months highlights the attractiveness of long-acting PrEP as a prevention measure to gay men. It is an interesting contrast to the less positive views expressed in the study of a rectal microbicide (see next story). A parallel trial is happening in women and when this has concluded the final decision will be taken about taking injectable cabotegravir PrEP forward into a fully-fledged effectiveness trial.

‘On-demand’ rectal microbicide gel reasonably acceptable – daily less so

Results presented from a study of using a gel containing the HIV drug tenofovir as a rectal microbicide (used either daily or only if having receptive anal sex), instead of taking a Truvada pill, found that the rate of adverse events of any severity was exactly the same as in oral PrEP for daily use, and somewhat lower during occasional use.

At least 80% adherence was achieved by 94% of people using oral PrEP, 93% of people using the gel before and after sex, but only 83% of those using gel daily.

Participants rated the gel as almost as easy to use as oral PrEP, and said that they would be willing to use the gel again during sex. However, if offered the choice between the gel and the pill as the one PrEP method they could use, most participants chose the pill.

Nonetheless, the researchers feel that the lack of toxicity and relative ease of use justifies taking the microbicide gel forward into an effectiveness study.

Comment: The rectal microbicide had scores for the ‘ease of use’ sub-category that were statistically equivalent to the score for oral PrEP, as long as it was used before and after sex. However its overall satisfaction scores were significantly lower. And all classes of satisfaction score were lower for daily microbicide use. As daily use has not proved popular among either women or gay men, this study should probably be the last that tests whether a microbicide used daily, regardless of sex, is feasible.

Two-thirds of gay men in US have heard of PrEP but only 1 in 20 has used it

Surveys of American gay men show that the proportion who have heard of PrEP jumped from 45% in 2012 to 68% in 2015, with around half of them willing to consider using PrEP. Actual usage is far lower, at 5%. However, it is higher in some cities with large gay populations with high HIV prevalence: 12% in New York, 16% in Washington, DC, and 17% in San Francisco.

Awareness of PrEP, willingness to use PrEP and actual use all increased from survey to survey. In 2012, 45% were aware of PrEP, 39% would consider using it and 0.5% had actually used it (in the previous 12 months).

Comment: It’s not so important to get a lot of gay men using PrEP: the issue is to get the right gay men taking it – those at the highest risk of acquiring HIV (and of passing it on if they get it). So although more than 5% coverage would be welcome, the fact that one in six men in Washington DC and San Francisco are on it is probably more significant. The challenge now is to get it to the men who really need it: gay black men, especially in the southern states. 

Many factors associated with irregular attendance at London HIV clinics

People who miss appointments for HIV care are more likely to have money problems, childcare responsibilities and a history of depression, according to a recent UK study. Poor attendance was more common in women, younger people, the less well-educated, people with memory and concentration problems, and recreational drug users.

There was little evidence that differences in the way services are provided affected engagement with care – probably reflecting the generally high quality of care provided at specialist HIV clinics in the UK.

Nearly 1000 patients attending seven London HIV clinics completed a survey on social factors and their experience of care; 550 were regular attenders, 269 were irregular attenders (had missed at least one appointment) and 164 were classified as non-attenders (had recently disengaged with care for at least a year).

While 27% of regular attenders had children, 34% of irregular attenders and 41% of non-attenders did. Not always having enough money for basic needs was an extremely common problem for regular attenders (51%), but even more so for irregular attenders (65%) and non-attenders (66%).

Finally, whereas a quarter had been diagnosed in the past five years, half were diagnosed more than ten years ago, and having been diagnosed for over ten years was also associated with poor attendance.

Comment: There are few surprises in these data other perhaps than a slight association of poor attendance with length of diagnosis. This could be due to ‘clinic fatigue’ or the effects of ageing. Otherwise, it underlines the fact that in order to best support their patients’ health, clinics need to make special efforts to serve three groups – women, people with low incomes, and people with mental health issues.

Simple outreach on dating websites increases HIV testing rate

A simple online outreach intervention in which a health educator chatted and responded to questions about HIV testing on hook-up websites for gay men significantly increased the HIV testing rate, a study found.

Until now there have been few data to show whether this kind of intervention is effective or not. This is the first randomised trial. The intervention involved a health educator having a presence in chat rooms on Adam4Adam, BlackGayChat, Craigslist and Gay.com.

On each website, the health educator created a profile and publicised his availability to answer questions about local HIV testing, including opportunities in bars and other community spaces. He could also answer questions about transmission risks and symptoms. Men using the websites could begin a conversation by sending the health educator a private message.

The study was conducted in four communities in the US situated over 200 miles away from each other. In two of the communities, the intervention was provided and in two it was not.

After the intervention, 64% of those in intervention communities had tested in the previous year, compared with 42% of those in control communities. After adjustment for confounding factors, those in intervention communities were three times more likely to have tested.

Comment: This is an unusually encouraging result for this kind of intervention. It may reflect the skills and training of the health educators, or that the websites used were ones associated with sex-positivity rather than health information.

Other recent news headlines

‘New tenofovir’ PrEP protects monkeys, but tissue levels in humans may be too low

Research suggests that using the new version of tenofovir, tenofovir alafenamide (TAF), as PrEP, could potentially avoid the side-effects of the currently used version, tenofovir disoproxil fumarate (TDF), such as kidney problems and bone mineral loss. But it is not yet known whether it will be equally effective, given that it is distributed differently in the body. Although it protected monkeys in one study, in a human study rectal and vaginal tissue levels of TAF were less than a tenth of TDF levels.

Too little is known about prevention and treatment for transgender people

Transgender women have among the highest rates of HIV infection but little is known about HIV prevalence among trans men, the conference delegates heard in the first-ever plenary talk on this population at the Conference on Retroviruses and Opportunistic Infections (CROI). The conference heard that transgender women had an HIV prevalence rate of 19% – 49 times higher than that of the general population.

African women in London with poor adherence long to stop HIV treatment

A qualitative study with West African women living in London who have difficulties adhering to their HIV treatment has found that many think of HIV treatment as a ‘life sentence’ that they long to escape from. But some women described an improvement in their feelings about the medication over time, talking about the factors that helped them with adherence.

Privacy concerns limit the reach of sexual health messages on social media

The way in which people avoid revealing something about their sexual behaviour or HIV status on social media sites limits the potential of online campaigns according to an evaluation of It Starts with Me, a programme started in 2013 that targets gay men and African people living in England with messages promoting HIV testing and condom use. Users are encouraged to share, like and comment on Facebook posts. Interviewees worried about how engagement with sexual health content on social media would be perceived by others.

This pill prevents HIV – but it’s treated like an illicit drug

from Vocativ

'Adam', a 38-year-old living in Germany, recently began illegally importing drugs. Thanks to a stranger he met on Facebook, he managed to find an online international distributor of his drug of choice in India. He used a forwarding service to route the shipment through the UK so it seemed less suspicious, and then to him in Germany. Adam, who requested a pseudonym to protect his identity, was careful to order no more than 90 pills at a time – just enough to fly under the radar. As much as this might sound like a story of narcotics trafficking, it is far from it. Adam is ordering pills that help prevent a disease: HIV.

Do ethicists hinder HIV prevention research?

from Reuters

Ethics panels may be hindering HIV prevention efforts by requiring gay and bisexual adolescents to get parental consent before taking part in research, experts suggest. Fear over coming out as gay or bisexual may prevent young men from asking their parents for permission to participate in HIV prevention studies. But leaving them out of such studies would likely result in huge gaps in scientific knowledge.

Zero draft 2016 Political Declaration released ahead of High-Level Meeting on Ending AIDS

from UNAIDS

The co-facilitators of the 2016 United Nations General Assembly High-Level Meeting on Ending AIDS have released the zero draft of the 2016 Political Declaration: on the Fast-Track to end AIDS in the age of sustainable development.

The zero draft reflects on the achievements made so far in the response to AIDS. It also sets out a clear agenda to Fast-Track the response by 2020 and put the world on track to end the AIDS epidemic as a public health threat by 2030.

A simple ask in 2016: the UN goal of universal HIV treatment

from i-Base

Last week, the working draft for 2016 UN Political Declaration on HIV/AIDS was released with only a few days for comments. Called the zero draft, like previous statements produced every five years, it is a list of observations, comments and goals. But using the UN Statement as a platform of human rights has become disconnected from the scientific and medical advances in HIV over the last five years. The bulk of the draft document could have been written at any time during the epidemic, certainly most of it could have been written in 2011. There is only one reference to dramatic changes in the WHO 2015 guidelines and only two references to PrEP.