France approves PrEP: so do South Africa and Kenya
France has become the first country outside the US, and the first country with a centrally organised, fully reimbursable health system, to approve pre-exposure prophylaxis (PrEP). PrEP became fully reimbursable from the beginning of 2016. The French Minister of Health, Marisol Touraine, said: “Given the level of efficacy of this approach, which has been recognised by all national and international scientific experts in the battle against HIV and AIDS, I take financial responsibility for this treatment, which can contribute to complete our global strategy against HIV.”
PrEP will be available, according to the published criteria, "to individuals who cannot, for diverse reasons, use condoms systematically and who belong to groups where HIV incidence is very high."
In separate developments, the national medicines agencies of South Africa and Kenya also authorised the use of PrEP, though they are simply licensing it rather than providing it for free via the national healthcare system.
Comment: Congratulations to France for being the first country in the world to offer PrEP essentially free to those who need it, though there remain many practical issues around how it will be offered. One of the reasons France was first is that there was strong community involvement and discussion about PrEP since well before the beginning of the Ipergay PrEP study, and an active role for France's chief HIV NGO, AIDES, and other organisations. In the UK, there was community involvement from the start of PROUD but it was much less structured organisationally and some prominent NGOs preferred to take a sceptical line on PrEP until study results were published. The UK now needs to work with other European countries that are struggling to find ways to include PrEP within their healthcare systems.
HIV diagnoses continue to increase in gay men across Europe, and in heterosexuals in the east
The annual report by the European Centre for Disease Control and Prevention (ECDC) shows that the annual number of new HIV diagnoses is increasing across the entire region from western Europe to central Asia. This is driven partly by continued increases in diagnoses in gay men and other men who have sex with men in western and central Europe. However, three-quarters of HIV diagnoses last year were in eastern Europe and 60% in a single country, Russia. In Russia, which has the highest HIV diagnosis rate per head of population in the region, the increase is partly explained by an increase in testing, but is also due to an increase in infections via heterosexual sex. One in 40 Russian men aged 30 to 34 now has HIV and one in 70 women; annual diagnoses have doubled since 2005, while at the same time the number of new diagnoses due to drug injection has fallen, in Russia and in every other country in Europe.
In western Europe the general HIV infection rate has fallen, largely owing to fewer diagnoses in people from high-incidence countries and in people who use drugs, but infections in gay men and other men who have sex with men continue to rise in all but a few countries. The UK now has the highest number of both new and cumulative HIV infections of any large country in western Europe. Having said that, in the UK and many other countries, the continued increases in diagnoses are at least partly due to slow increases in the proportion of gay men who test for HIV and the frequency with which they do it. But true HIV incidence at best appears to be flat, with, according to the UK's own 2015 annual report, 2800 gay men a year acquiring HIV in the UK.
In central Europe – in the band stretching from Poland in the north to Turkey in the south – HIV prevalence and the rate of new diagnoses remains low but there are signs of a new epidemic among gay men and other men who have sex with men, with new diagnoses increasing by anything between threefold and 20-fold in the last decade. As a result, HIV infections in general in some countries such as Poland, Hungary and Bulgaria have more than doubled.
There are some successes: a Europe-wide fall in HIV in people who inject drugs, as noted, with big falls in diagnoses in some countries such as Estonia; falls in mother-to-child transmission throughout; signs of stabilisation in Europe’s second worst-affected country, Ukraine; and a stabilisation or slight fall in HIV infections in the general population in western Europe. But in general, Europe as a region is still failing to control HIV, notably in men who have sex with men, while in Russia a generalised epidemic threatens, more similar to those seen in African countries.
Comment: The continued high rate of HIV infections in gay men in the west and alarming increases in central Europe are an indictment of public health providers that have never really worked closely enough with the gay community about HIV, and an LGBT political establishment that has been more reluctant to take on HIV as a political issue than in the US. Continued stigma, not to say violence, against gay men further east is a factor too, of course. In Russia, it is important to stress that HIV prevalence and incidence varies hugely across this vast country, and that even in Russia mother-to-child transmission is being contained, which was also a 'first point of entry' for concerted HIV programmes in Africa. A recent Kremlin-level meeting on HIV in Russia is one sign that Russia is at last taking its HIV epidemic seriously, though it is a pity it has taken a rise in heterosexual HIV infections, rather than the previous disastrous epidemic in people who inject drugs and prisoners, to do that.
US reports falls in new HIV infections in most populations
In contrast to Europe, the rate of new HIV infections has fallen by 20% overall in the US in the last decade, the annual US HIV Prevention Conference in Atlanta heard last month. Diagnoses fell by 35% in heterosexuals, by 40% among women, by 42% in black women, and by 63% in people who inject drugs, relative to 2005. Among gay men it rose by 6% over the decade but stabilised in the last five years. New diagnoses in gay men, however, differed substantially according to race. Over the last decade, the annual number of new diagnoses fell by 18% in white men but increased by 22% in black men and 24% in Latinos. However in the last five years, the new diagnosis rate has levelled off in black gay men and decreased by 2% in young black gay men aged 13 to 24. However, in young Latino gay men diagnoses rose by 16% in the same time period. The number of tests in these groups stayed steady during the same period, showing that the increases and decreases observed are real.
Comment: These contrasted US and European surveillance reports speak for themselves. It is remarkable that the US is now starting to see falls in HIV diagnoses in even the most intractable groups like young black gay men, considering that the proportion of people with HIV with a fully suppressed viral load is still only about 30% nationwide. This may conceal much better achievements, however, in places like San Francisco and New York. Why is the US doing better? It should be too early for PrEP to make a difference, though the renewed climate of discussion about HIV that it has engendered may have helped. There is some evidence that both condom usage rates and serosorting (with genuine discussion and disclosure, rather than 'seroguessing') are higher in the US. But one answer may be the higher testing rates for HIV in nearly all populations.
PrEP programmes continue to report zero HIV infections in the US
A number of programmes providing tenofovir and emtricitabine (Truvada) pre-exposure prophylaxis (PrEP) in the US have found no HIV infections in people who stay on PrEP, the US National HIV Prevention Conference heard last month. However, programmes aimed at the highest risk groups including young people, poor and uninsured people, and African Americans, have found significant lack of engagement in care and loss to follow-up.
In one San Francisco programme involving 600 men using PrEP for over a year, there were no HIV infections and, interestingly, no fall in condom use. In another in Washington state, no infections were seen among 700 men receiving PrEP in a programme originally designed for 200: however this programme, which only pays for drugs and not tests and clinic support, is threatened by running out of funds.
No infections were seen in a programme in Oakland for young African Americans at risk of HIV, even though there were startling levels of undiagnosed HIV and sexually transmitted infections (70% STI prevalence) in those presenting for PrEP. In this programme, which was intended for both men who have sex with men and for women, few women have come forward, and a specific PrEP programme for women is planned. In a couple of other programmes in Philadelphia and in Jackson, Mississippi targeted mainly at poor African Americans, there have been low levels of take-up of, and interest in, PrEP. In Philadelphia, the main problem seemed to be loss to follow-up due to delay between initial assessment and the offer of PrEP while in Jackson, the problem seemed to be mainly that people did not perceive themselves to be at high risk of HIV even though most (78%) were. Worries about side-effects and whether HIV drugs could be mixed with recreational drugs and alcohol also seemed to cause people to leave the programme.
Comment: In a way it is still remarkable that we are seeing such conclusive evidence of effectiveness in PrEP programmes in the US and no 'breakthrough' infections. However, it is also sobering to consider that in order for PrEP to reach its potential in those most vulnerable to HIV – in particular poor, less well-educated and younger gay men from minority ethnic communities – we may need to set up the supportive sexual health and patient support structure they should have had in the first place. And even in the US we are only at the start of finding the women who need PrEP and offering it to them.
HIV drug resistance acquired on PrEP fades rapidly
One concern often expressed about PrEP is whether its use will lead to increased levels of HIV drug resistance, if people inadvertently start taking it when they already have HIV, or acquire HIV while taking inadequate levels of PrEP. A substudy from the Partners PrEP Study, which was conducted between 2009 and 2011, looked at cases of resistance that had arisen in that study. In this large study of 4747 heterosexual couples of different HIV status, while 47 of the HIV-negative partners allocated to the placebo acquired HIV, so did 13 allocated to Truvada (tenofovir/emtricitabine) and 18 allocated to tenofovir alone.
The substudy looked at nine people who were found to carry some drug-resistant strains of HIV, detected using highly sensitive resistance tests. Seven people had resistance to emtricitabine, one to tenofovir, and one to both drugs. Among these nine, five definitely developed resistance during the period they were taking PrEP: four had acute HIV before they started PrEP but had not yet developed antibodies to it, so were started on PrEP mistakenly; in one case the person acquired HIV after being given PrEP, but before starting to actually take it. The other four people were not taking PrEP when they developed resistance (one was on placebo and another not on the drug they developed resistance to), so they probably acquired drug-resistant HIV. In the five people who developed resistance after starting PrEP, the proportion of HIV in their system with resistance mutations fell to zero within six months and stayed at zero thereafter.
Comment: Partners PrEP is the only randomised, placebo-controlled study of PrEP that had a large enough number of HIV infections and high enough adherence in participants to be able to answer this question. As such the results are relatively reassuring. Overall it looks as if resistance acquired due to taking PrEP during acute HIV infection fades rapidly and does not imperil future treatment success.
Australian study shows that gay men have many types of sexual relationship and classic monogamy is uncommon
A large internet study from Australia shows that gay men have a wider variety of relationships than previously thought and mix different kinds of relationships more freely. The 'Monopoly' study found that gay men tend not to fall into the two commonly used categories: men who are in a 'relationship' and are largely monogamous, and men who do not have a committed relationship and have casual sex. The study reported on a third, large category of gay men (42%) who had regular sex with partners they might feel friendship towards but who they did not regard as a 'boyfriend' or partner, even though in some cases they were the only person they had sex with. The term preferentially used by respondents for this kind of partner was 'fuckbuddy'. Equally, 36% had a 'boyfriend' (i.e. an emotionally and domestically committed relationship) but of those nearly half also had ‘fuckbuddies’ and/or casual sex. And of the 40% who reported having casual sex, a third also had a boyfriend and a third had a ‘fuckbuddy’. Only 14% of respondents were strictly monogamous. Young gay men were more likely to have only one partner, but actually less likely to regard that partner as a 'boyfriend'.
In a separate, qualitative study of young gay men in Australia, young men expressed a desire to enjoy the opportunities of ‘non-committal’ sex while they were still young along with a wish for someone to settle down with later. Monogamy was not thought of as an HIV prevention strategy but rather as something that put more meaning into life and protected them from the excesses of the gay scene.
Whether someone was a 'boyfriend' was determined by domestic rather than sexual arrangements, such as living together. In terms of issues relevant to HIV, 80% of men in a committed relationship and 56% with a primary ‘fuckbuddy' said they knew their partner's HIV status. Condomless sex was the rule rather than the exception with partners in a committed relationship: 63% said they never used condoms and even 46% who had other regular partners did not use condoms with their primary partner. Forty per cent of those with 'fuckbuddies' always used condoms with their regular partners but 30% never used them.
Comment: This survey shows that gay men's relationships are considerably more complex than have hitherto been described and the researchers comment that some of the findings show why men who acquire HIV are more likely to have been infected by a 'fuckbuddy' or regular friend rather than a boyfriend or one-off encounter. In particular "regular" is not the same as "emotionally committed" and the researchers comment that "The current use of a simple binary that counterposes 'regular' against 'casual' partner is problematic if it is presented as 'regular=safe' versus 'casual=risky'".
Barcelona study predicts who will need PrEP
A study from Barcelona has been able to isolate specific factors in gay men that predict a high likelihood of HIV infection over the following year. This is important as it might serve as a set of criteria that could be used in evaluating who might benefit most from PrEP.
The Barcelona Checkpoint sexual health clinic saw 5430 gay men between 2009 and 2014 but the present study excludes those in a steady committed relationship, those who had fewer than ten partners in the previous six months, and those who said they ‘always’(as opposed to usually, sometimes or never) used condoms. The study included only those in the remainder for whom there was complete data on self-reported condom use, STI diagnoses, partner numbers and sex role (exclusively 'top' versus 'bottom' or versatile). This group comprised 739 men.
Among these men only ones who, in the last six months, had been exclusively the insertive partner, had ‘usually’ used condoms and had not had an STI had an HIV incidence rate over the following year of less than 3%, which is the threshold over which the World Health Organization suggests PrEP might be cost-effective. For the stricter HIV annual incidence rate of 5%, which studies suggest might be the threshold for PrEP to be cost-saving in the UK, the group who had more than ten partners in the last six months and who said they ‘sometimes, rarely or never’ used condoms had an HIV incidence over the following year over this figure, and even those who said they ‘usually’ used condoms but had over 20 partners in the last six months.
Comment: This is an important study because it offers a way to answer an almost unanswerable question. PrEP is only cost-saving if used by those at very high risk of HIV. But how can we determine what someone’s future risk of HIV will be if they do not take PrEP? This study goes a long way towards suggesting a set of risk factors, though it would be interesting to repeat it in gay men with fewer than ten partners in the last six months, and also in women.
For African migrants in France, destitution shapes sexual behaviour and HIV risk
A study from France has found that one-third of African migrants living with HIV acquire HIV after they arrive in France. The data, from 2464 migrants arriving between 2012 and 2013, show that women who acquired HIV after living in France were more likely to have casual partnerships than those who did not and were four times more likely to have transactional sex, while men were nearly twice as likely to have paid for sex. Unstable housing particularly raised the risk of HIV for both men and women but there was a gender split in terms of financial destitution: financial hardship raised the risk of HIV in women but men with more financial resources were more likely to pay for sex or have multiple and overlapping relationships.
Comment: One factor that particularly stood out for women was that poverty and unstable housing raised the risk of sexual harassment and assault as well as transactional sex. Making sure immigrants have stable housing and access to the resources needed not just for things like food but also for travel and official documents can help reduce their risk of HIV.
Other recent news headlines
Large UK study shows low rates of HIV testing, even among those who think they are at risk of HIV
A major household survey of adults in the UK shows that, even among people who perceive themselves to be at risk of HIV, only 14% had recently taken an HIV test. While people with riskier sexual behaviour and people who were aware of their vulnerability to HIV were more likely to take a test than other people, a majority in this group had never taken an HIV test. Very few men who have sex with men (MSM) followed the recommendation that they take an HIV test.
Gay men starting to use crystal meth usually increase their sexual risk taking
A study which followed the same group of gay men over several years has found that individuals who have started to use crystal meth tend to have riskier sexual behaviour than they had in previous years. While this doesn’t definitively demonstrate a causal link, the study also suggests that crystal methamphetamine has a greater impact on sexual behaviour than other drugs.
WHO issues recommendations on linkage to care, retention, to help bring HIV treatment to all
The World Health Organization (WHO) has issued new recommendations on how to organise services in order to promote linkage to care and retention in care as part of its new guidelines recommending antiretroviral treatment for all adults and adolescents. The recommendations on antiretroviral treatment and for pre-exposure prophylaxis (PrEP) for people at substantial risk of HIV infection were announced in September 2015. In December, WHO made a series of new recommendations on service delivery. These are designed to maximise linkage to care and retention in care as part of efforts to expand access to antiretroviral treatment to ensure that 90% of people diagnosed with HIV infection are on treatment by 2020.
Many more people could benefit from PrEP but not enough doctors are aware, says CDC
One-quarter of gay and bisexual men in the US and one-fifth of people who inject drugs could benefit from Truvada PrEP, according to a recent report from the US Centers for Disease Control and Prevention (CDC). But a nationwide survey found that one-third of US healthcare providers still have not heard about PrEP. “PrEP isn't reaching many people who could benefit from it, and many providers remain unaware of its promise,” said CDC Director Tom Frieden. “With about 40,000 HIV infections newly diagnosed each year in the US, we need to use all available prevention strategies.”
Editors' picks from other sources
Three potential barriers to HIV PrEP
from Pharmacy Times
Grindr for Equality – the men’s health advocacy arm of Grindr, the world’s largest gay social network – conducted a survey to measure users’ understanding of the availability of Truvada as PrEP. The poll followed an American Academy of HIV Medicine (AAHIVM) survey of 324 regional HIV care providers on their PrEP prescribing habits. Both the AAHIVM survey and Grindr poll revealed that adherence, knowledge and access all posed barriers to the full availability and use of PrEP.
Gonorrhoea 'could become untreatable'
from BBC Health
Gonorrhoea could become an untreatable disease, England’s top doctor warns, amid concerns some pharmacies are not prescribing for it properly. Dame Sally Davies has written to all GPs and pharmacies to ensure they are prescribing the correct drugs after the rise of “super-gonorrhoea” in Leeds.
HIV prevention fatigue: programme engages men who have heard it all before
from BETA blog
With the HIV epidemic well into its fourth decade, many gay and bisexual men in their 30s, 40s and 50s have spent much of their adult lives being bombarded with HIV and safer sex messages. And as a result, they can get tired of hearing and thinking about it. The research community has a name for this: prevention fatigue, described as an attitude that HIV prevention messages, programmes, outreach, or counselling services have become tiresome. An innovative programme in San Francisco acknowledges and addresses prevention fatigue, while helping gay and bisexual men improve sexual health and wellbeing. Called ‘Bridgemen’, it carefully weaves education and discussions about sex and health into events that bring men together socially and for community service projects.
Women PrEPare
from Positively UK
A new report looking at the findings and evaluation of the Women PrEPare workshop that took place in London in July 2015, bringing together 30 women living with HIV from around the UK to look at HIV treatment and its use in prevention and how it specifically affects women.
Dallas Buyers Club: the real-life version based in south London (video from UK Channel 4 news)
from You Tube
Many sexually active gay men are buying a generic version of an antiretroviral HIV drug from India over the internet.
Landmark Irish Cabinet decision backs drug-injecting centres
from Irish Examiner
The Cabinet made legal history on 16 December by giving the green light for a State-backed facility where the injection of illegal drugs will be permitted.