Denmark has first evidence of treatment as prevention working in gay men in a high-income country

A study of people diagnosed with HIV in Denmark has provided the first unambiguous evidence of a link between high rates of viral suppression in gay men and falling HIV incidence (the proportion of men who acquire HIV each year).

The researchers say that HIV incidence among gay men in Denmark is now so low that it approaches the one per 1000 annual incidence rate that the World Health Organization has set as the threshold for eventually eliminating the HIV epidemic.  The HIV incidence rate is now 0.14% per year, or 1 in 700 gay men acquiring HIV annually. They estimate that the percentage of gay men and other men who have sex with men (MSM) who have HIV, are taking treatment and have an undetectable viral load is now 72.1% – very close to the 72.9% that UNAIDS’ 90/90/90 target sets for ending the HIV epidemic.

The researchers estimate that the number of MSM with HIV who are undiagnosed fell from about 1400 in 1995 to just over 600 in 2013. The researchers were able to calculate that the absolute number of MSM infected in Denmark per year declined from 117 in 1994 to 70 in 2013. They note that incidence only started decreasing when the proportion of all HIV-positive MSM on treatment (including the undiagnosed) rose to more than 35%.

One important finding is that though incidence fell, it did not fall by as much as diagnoses. And the transmission rate rose – the number of times each MSM with a detectable viral load passes on HIV. This is probably due to increased levels of risk behaviour, and also a concentration of that risk behaviour into a shrinking pool of high-incidence gay men.

Comment: The researchers also show that incidence stayed flat at 80 infections per year once the proportion of MSM on antiretroviral treatment (ART) rose above 55%. It then started to decrease further when the proportion rose above 70%. This could be because the transmission rate was increasing during this time, and the effect of ART only started to compensate with really high numbers on ART. It’s likely that a greater proportion of people in a population with a high level of HIV risk behaviour and biological vulnerability needs to achieve undetectable viral load before incidence starts falling than in a population with lower levels of risk behaviour. This could explain why, in KwaZulu Natal, in one of the few other studies to show a direct correlation between the proportion of people with a suppressed viral load and HIV incidence, incidence started falling when treatment coverage reached 30%, but that incidence is still increasing in countries like the UK with the same viral suppression rates as Denmark. Some researchers have calculated that it could take viral suppression rates of as high as 90% to started bringing incidence down in the UK, in the absence of PrEP (pre-exposure prophylaxis) or positive behaviour change.

Cost is biggest barrier to PrEP in Europe, ECDC report declares

A meeting at the European Centre for Disease Control (ECDC) in Stockholm, in April, heard that cost was regarded as the biggest barrier to the adoption of HIV pre-exposure prophylaxis (PrEP) by European countries. Many regarded significant price reductions in the drugs used as a pre-condition for adopting PrEP.

The ECDC held the meeting to discuss considerations for PrEP implementation throughout Europe and invited clinicians, researchers, epidemiologists, community advocates and, significantly, representatives from various countries’ Ministries of Health – the people who would make recommendations on PrEP to their governments.

As part of the preparation for the meeting, the ECDC also collaborated with the gay social network site Hornet on a survey about PrEP. Despite the survey only being online for three days (23-25 April), 8543 men answered it. A quarter of these were from France, 22% from the UK, and 10% from Russia, where Hornet is the most widely used gay social app. Excluding respondents from France, a high proportion of respondents – one in ten – said they were taking PrEP, and 69% said their health provider was aware of this fact. The most common way (47%) of obtaining PrEP was online and 22% said they got it from their doctor.

There was a quite different pattern in France, which started providing PrEP through its healthcare system at the end of last year. Here, 68% of people received PrEP from their doctor and only 8% were buying it online.

In France, 60 clinics are now offering PrEP. In the first three months of the programme’s operation, 437 people had started PrEP through the healthcare system.

Jean-Michel Molina presented an analysis of the first 249 people accessing PrEP at the Paris St Louis clinic. All but one were gay men, 86% were French nationals, most were employed and had completed secondary education and 72% were single. About 75% chose intermittent PrEP and 25% daily.

The ECDC also conducted a survey of 31 European countries and found that 17 had demonstration projects of PrEP either in progress or planned.

When asked: “What issues are limiting or preventing the implementation of PrEP in your country?”, by far the most common issue cited was cost. Twenty-one countries considered the cost of PrEP drugs as a highly important limiting factor; and the second most important limiting factor was the cost of service delivery, which 11 countries considered highly important.

Comment: This was a very interesting meeting, catching attitudes among European healthcare providers in the process of changing. The full report is worth reading. However, there is still a long way to go before provision of PrEP through the healthcare system, following the lead of France, is adopted or even seen as desirable or possible by many more countries. Running a demonstration project seems a more common tactic, though these are primarily NGO initiatives. It was emphasised by a number of health ministry delegates that there is still entrenched opposition to PrEP within some European health ministries for both political and financial reasons.

Opt-out HIV testing in a hospital emergency department may cost less than managing two patients with undiagnosed HIV

Opt-out HIV testing in accident and emergency departments in areas of high HIV prevalence in the UK is likely to save the National Health Service (NHS) money by avoiding expensive inpatient admissions for individuals with unexplained and deteriorating illnesses, the British HIV Association spring conference heard.

An analysis from King’s College Hospital in south London, where one in 250 of the local population has undiagnosed HIV, found that providing HIV testing to all patients attending their emergency department in 2014 would have identified 138 new cases. A testing uptake of 50% or 75% would have identified 69 or 104 cases. Providing the tests would have cost £245,000 or £160,000 respectively.

But late diagnosis of HIV also costs money. Fifteen people diagnosed in 2014 had attended the hospital’s emergency department in the five years before their eventual diagnosis. When they were diagnosed, most were severely immunosuppressed, with median CD4 cell counts of 61 cells/mm3.

The total cost of inpatient stays and outpatient investigations for these 15 patients, due to late presentation, was estimated to be £336,000. The cost of this avoidable medical care was therefore greater than the cost of a testing programme.

Comment: This illustrates clearly that in relatively high-prevalence areas, offering HIV testing to people presenting at hospital emergency departments will save money. How do we actually achieve a high uptake of HIV testing in routine clinical practice? A companion study from St Thomas’s Hospital, in the same high-prevalence area of south London, found that simply reorganising the order form for blood tests so it included an HIV test as a default option, resulted in an increase in the percentage of emergency patients tested from 2% to 61%. Patients were informed that HIV testing was routine but could be refused. Of 172 people with a positive result, 68 did not know they had HIV and 13 had dropped out of care.

Which men stand to benefit most from access to PrEP?

New data from the UK’s PROUD study have identified the characteristics of the men who are most likely to benefit from PrEP. Analysis of the baseline sexual characteristics of men in the half of participants who deferred PrEP for a year, and who acquired HIV during that time, showed that a rectal sexually transmitted infection (STI) and reporting recent unprotected anal sex with two or more partners were associated with extremely high HIV incidence rates – even higher than the 9.1% a year rate in the overall deferred arm.

A total of 253 men assigned to the deferred arm were included in the analysis. There were 20 new HIV infections in this group. Twelve men who acquired HIV were diagnosed with a rectal STI when they started the study; their HIV incidence rate was 17.4 per 100 person-years. This is an extraordinarily high rate, implying that over half the men in this group would have HIV within four years if it was maintained. Eighteen men who acquired HIV reported recent unprotected receptive anal intercourse, and six of these individuals had unprotected receptive sex with two or more partners. They had an annual incidence rate of 13.6%.

Comment: These figures are significant because they contribute to the evidence base on who should be offered PrEP: something NHS England has just committed itself to revisiting. PrEP would recoup its costs, even at current drug prices and in a relatively short time, if offered to groups with such high incidence rates. If the main block to PrEP in Europe is cost, then factors such as incident STIs, partner numbers and PEP use can guide clinicians to the people who most need it – though the door should always be left open to people with none of these factors but still at high risk, such as people with serodiscordant partners not on treatment.

Risk of sexual transmission of HIV may persist during first six months of ART

A small risk of HIV transmission to sexual partners persists for six months after the initiation of antiretroviral therapy, investigators from the Partners PrEP study confirm. This study, carried out in Uganda and Kenya, recruited HIV-positive people not yet eligible for treatment and their HIV-negative partners, and randomised the HIV-negative partner to receive either tenofovir, Truvada or a placebo.

Nearly 1600 serodiscordant heterosexual couples were included in the analysis. When the partner with HIV started antiretroviral therapy (ART), this was accompanied by a fall in the risk of transmission, but the risk persisted during the first six months of treatment. No transmissions were observed once patients had been taking treatment for over six months.

There was evidence that couples were having unprotected sex during this initial six-month period. Incidence of pregnancy was 4.4% during that period and sex without condoms was reported at 10.5% of study visits.

Comment: This is a reminder that HIV-positive people taking ART do not immediately become non-infectious. However, the small number of infections (only two in partners definitely on treatment) means that the incidence figures have to be treated with caution. It is also worth noting that this analysis was restricted to couples in the trial’s placebo arm, i.e. where the HIV-negative partner did not receive PrEP. In the arm where the HIV-negative partner took Truvada, HIV infections were reduced by 75% and none came from a partner who had started HIV treatment.

American gay men’s use of condoms has been falling for a decade, regardless of serosorting or PrEP

There has been a long-term decline in condom use by gay men in the United States, according to researchers from the US Centers for Disease Control and Prevention (CDC). Condom use began to fall long before PrEP became available, and condom use has declined regardless of partners’ HIV status – showing that the fall in condom use is not due to ‘serosorting’ (people not using condoms with partners who have the same HIV status).

In 2005, 29% of HIV-negative men reported sex without a condom, rising to 40.5% in 2014. The overall trend was similar for HIV-positive men: in 2005, 34% reported sex without a condom, rising to 44.5% in 2014.

Condomless sex with a partner of the same HIV status rose from 21 to 27% in HIV-negative men and from 19 to 25% in HIV-positive men. With partners of different or unknownHIV status it rose from 8 to 13% in HIV-negative men and from 15 to 19% in HIV-positive men.

The only hint of adjustment for HIV status is that in HIV-positive men, taking the insertive role in condomless sex with partners of unknown or different HIV status did not increase, while taking the receptive role did, suggesting a degree of ‘seropositioning’ (taking the role less likely to transmit HIV).

The rising trend of sex without a condom was seen both in HIV-positive men taking HIV treatment (which reduces the risk of onward transmission, regardless of condom use) and in men not taking HIV treatment. "Our data suggests that condom use has decreased among MSM and that the trends are not explained by serosorting, seropositioning, PrEP use or HIV treatment,” the researchers conclude.

Comment: The same long-term decline in condom use has been seen in other high-income countries, including the UK, where the proportion of men reporting condomless sex during the previous year has been slowly increasing since 1995, from a historic high during the ‘AIDS years’. It is disappointing that here, as in other surveys, viral load appears to have no influence over condom use. As for PrEP, even in 2014 only 3.5% of the HIV-negative men surveyed were taking it, and the degree of usage that might significantly influence condom behaviour has only started happening in the US in the last year.

Other recent news headlines

Two million people with HIV started treatment in 2015

At least two million people worldwide started antiretroviral treatment in 2015 alone, and 17 million people are now taking antiretroviral therapy, up by a third since 2013. Eastern Europe and Central Asia remains the area with the world’s lowest treatment coverage.

First data on uptake of HIV self-testing in the UK

Between April 2015 and February 2016, almost 28,000 people have paid £29.95 for a kit allowing them to test for HIV at home, according to a presentation at the British HIV Association conference. Three-quarters of BioSure’s 27,917 sales have been to men and have been concentrated in non-urban areas.

Australian surveys highlight importance of support from other men with HIV in declines in risk behaviour in newly diagnosed men

Two successive Australian surveys conducted over the last few years have found that in the immediate aftermath of diagnosis, gay men considerably reduce the number of partners they have sex with and also reduce the amount of condomless sex they have with partners of unknown HIV status. The only factor associated with a higher likelihood of reductions in HIV risk behaviour was peer support from other men with HIV (and not from anyone else).

In Option B+, side-effects and needing time to think are key reasons for not taking HIV medication

A study of women in Malawi who chose not to start HIV treatment during pregnancy, or who interrupted their treatment, has found that needing more time to think, concerns about partner support, and side-effects were important reasons for declining to take HIV treatment. While these themes have appeared in other studies of non-adherence to HIV treatment in other settings, they seem to be especially significant in the context of Option B+. One of the most important findings was that women attributed feelings of sickness to the antiretroviral drugs rather than to the effects of pregnancy. Some also expected the ARVs to make them feel healthier and concluded they were not worth taking then they did not.

Bold new Political Declaration on Ending AIDS adopted in New York

from UNAIDS

United Nations Member States agree to reach ambitious new targets by 2020, pledging to leave no one behind and end the AIDS epidemic as a public health threat by 2030.

Cultural sensitivities obstacle at UN AIDS conference

from New York Times

No one at the high-level United Nations conference devoted to ending the AIDS epidemic by 2030 denies serious scientific and financial challenges remain, but cultural sensitivities may prove the toughest stumbling block on the way to achieving that goal. A number of gay and transgender groups were excluded from attending the three-day-long conference by countries who objected to their presence and nations squabbled over references in a final statement to topics involving gay sex and intravenous drug use.

East Europe & Central Asia: Let's not lose track! – EECA communities position on HIV situation in the region

from AIDS Foundation East West (AFEW)

As leaders of the HIV response gather in New York on June 8-10 for the 2016 High-Level Meeting on HIV/AIDS, civil society networks of the EECA region prepared the “East Europe & Central Asia: Let’s not lose track” report to draw attention to the catastrophic situation in our region and solutions that would enable us to catch up to the rest of the world on the track to move towards ending AIDS and achieving Strategic Development Goals by 2030.

End AIDS by 2030? Not Without Harm Reduction

from Huffington Post

People who inject drugs are among those who have been left furthest behind by the global response to HIV. Responding to the HIV risks linked to unsafe injecting is imperative if we truly hope to end AIDS.

BHIVA statement on 31 May NHS update on commissioning and provision of PrEP for HIV prevention

from BHIVA

While NHS England continues to hide behind spurious legal arguments, 17 people a day are diagnosed with HIV in the UK, most of them in England.