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UK PrEP study completes enrolment
pilot stage of the PROUD study – the UK's study of HIV pre-exposure prophylaxis
(PrEP) in gay men – is now fully enrolled, having reached its target of 550
participants by the end of April. The trial investigators have applied for
funding to expand PROUD into a full-scale efficacy trial with 2300
participants. A final decision on this is expected in November, meaning that
any expansion will not start recruiting until spring 2015.
PROUD is a two-year study with
participants randomised either to take Truvada daily for two years or to
take it only during the second year. The aim of deferring PrEP for half of the
participants for a year is that, because it is not a placebo-controlled trial and
all those taking PrEP will know they are on active drug, the trial can take a
true measurement of whether people change their sexual risk behaviour once they
know they are taking PrEP.
data – on the baseline characteristics of participants – was released at the Third Joint
Conference of BHIVA (British HIV Association) with BASHH (British Association
for Sexual Health and HIV) in April. The average age of the 443
participants with data was 35.5 years with a quarter of them were aged 29 or
below. Eighty per cent of participants were white and nearly 60% were
graduates. Participants reported a median of ten anal sex partners in the last
three months and used condoms with half to three-quarters of partners. A third
of participants’ partners were known to have HIV but at least 80% of these were
on HIV treatment.
were asked why they didn’t use condoms when they didn’t. Most gave several
different reasons but the most common reason was “It’s much more enjoyable
without a condom” (given by two-thirds of participants. No fewer than 40% of participants
had used post-exposure prophylaxis (PEP) in the 12 months before joining the
study and 21% had used it more than once.
participants reported high levels of drug use: half had used mephedrone or
similar, 43% GHB, 35% cocaine and 24% methamphetamine.
Expanded HIV testing may find more acute infections as well as late ones
HIV testing into local hospitals and primary care may not only find more people
who have lived with HIV for a long time without knowing it, but may also find
more people who have only recently acquired HIV, a pilot study from Vancouver
in Canada has found.
project evaluating a programme of expanded HIV testing took place between
October 2011 and June 2013. This involved instituting routine HIV testing for
all admissions to the three acute care hospitals serving Vancouver and also
routine testing of patients in primary care: in the latter case over 500
primary care physicians signed up to the pilot scheme.
resulted in an expansion of tests in hospitals from about 500 a month before
October 2011 to 2500 a month in October 2012, and an expansion of tests in
primary care from 650 a month during 2011 to 2000 a month in the first half of
2013. There were over 73,000 tests performed in the last six months of the
pilot compared with 38,000 in any six-month period in 2008-10.
of people diagnosed with HIV in hospitals doubled during the pilot, from 11 in
2010 to 30 in 2012 and 27 in 2013. While the 0.2% of people diagnosed in
primary care, and in hospital outpatients, roughly matches the prevalence of
HIV in the general population in British Columbia, the proportion diagnosed in
hospital admissions was 0.5%.
expected, the hospital pilot picked up on considerably more late presenters:
the proportion of people diagnosed with a CD4 count below 200 cells/mm3
was 35%, compared with 12% in other centres. However, and unexpectedly, it also
detected more people in the acute stage of infection: these formed 25% of the
total, compared with 15%.
be because people with acute HIV may not suspect their symptoms have anything to
do with HIV, especially if they have recently tested negative.
'Chemsex' not common in London gay men; more so in men with HIV
recent report from London finds that the use of drugs such as crystal methamphetamine,
mephedrone and GHB/GBL during sex (so-called ‘chemsex’) was still a minority
behaviour even in the London boroughs of Lambeth, Southwark and Lewisham, which
have the highest concentration both of gay men and of men with HIV of any part
of the UK.
A recent analysis
of figures from the large EMIS
(European MSM Survey) study found that 1142 men from these London boroughs
had answered the survey. Of these, approximately 10% had used mephedrone or
GHB/GBL in the last month and 5% had used crystal meth – and these drug use
figures were about double those in gay men in other parts of London.
of men had injected any drug in the last year. However, two-thirds of those who
had injected drugs were men living with HIV, as were more than two-thirds of
those taking crystal meth, implying that, in this area, as many as one in five
men with HIV might be injecting and one in four taking crystal meth.
One in ten
men were concerned about their drug use. In contrast, 93% of men drank alcohol
– the most popular drug of all – and 25% were concerned about their drinking.
interviews with 30 men who had had ‘chemsex’ in the past year, one-third of
them living with HIV, 30% (nine men) reported injecting drugs, but all reported
safe injecting practices. Men split roughly into three groups: men living with
HIV who had taken a decision to have condomless sex with other HIV-positive men
(serosorting), although they sometimes assumed the HIV status of partners
rather than ascertaining it; a group of largely HIV-negative men who in the
main maintained non-risky sexual practices despite using drugs; and a group of
men who did feel they were not in control of the risks they took when
the figures show that ‘chemsex’ is still a minority pursuit in gay men, it is
associated with significant health impacts. Another
recent report from London, where UK-acquired cases of the serious gut infection
shigella have increased 8-fold since 2005, largely in gay men, found that a
third of a group of 42 gay men recently diagnosed with the bug reported
injecting drugs and three-quarters reported recreational drug use. Nearly
60% had HIV and 88% had not heard of shigella until they got it.
can cause severe diarrhoea, and 30% of those diagnosed had gone to hospital
emergency departments because of their symptoms. Four individuals were admitted
to hospital. Shigella can be cured with antibiotics.
HIV diagnoses in French gay men up 14%, mainly due to more testing
data from France show that 2600 gay men there were diagnosed with HIV in 2012.
This 14% increase on the previous year is far larger than the long-term rate of
increase in diagnoses, which had been rising at about 3% a year since 2003.
have not been rising in heterosexual people; there were 3500 heterosexual cases
diagnosed in 2012, half of them in people born in sub-Saharan Africa.
there is clearly ongoing transmission among gay men, a large proportion of the
increase is due to more testing, public health officials said. Incidence assays
showed that 47% of gay men were diagnosed within a few months of their
infection in 2012, up from 42% in 2011 – a sign of more frequent testing. It is
estimated that 29% of all individuals living with undiagnosed HIV in France
acquired their HIV in the last year.
study has estimated that 83,000 people acquired HIV in France between 2000 and
2010 and that 29,000 of those (35%) remain undiagnosed. It is estimated that
nearly 3% of gay men, 0.6% of people who inject drugs, 0.4% of non-French native heterosexuals
and 0.03% of French-born heterosexuals has HIV.
HIV genital viral load: undetectable in women on treatment, can vary hourly in men
unresolved issue in HIV prevention science is what level of viral load in
genital fluids indicates infectiousness and whether low but detectable viral
load in genital fluids is predictive of transmission.
studies recently have, if anything, added to the complexity of data in this
studies have suggested that viral load in women’s genital secretions may be more
likely to remain detectable even if HIV is undetectable in their blood,
than is the case in men.
US study recently has found the opposite: in a study of 20 non-pregnant,
pre-menopausal women on one particular combination therapy (tenofovir,
emtricitabine and boosted atazanavir: Truvada
plus Reyataz with Norvir) while viral load above 50
copies/ml was measurable in 10.6% of 123 blood samples, it was not detectable
at that level in any sample of cervico-vaginal fluid.
researchers used a sensitive test that could in fact detect much lower levels
of HIV genetic material than this; while this test detected HIV in 59% of blood
samples, it could only find it in 16% of vaginal samples.
study in men provided quite different results. In this, French scientists
found that HIV was detectable in 7.5% of semen samples from men with no
detectable HIV in their blood. The average seminal viral load was 705 copies/ml
and in 3.6% of all samples it was over 1000 copies/ml.
was a nearly significant difference in the likelihood of detectable HIV in
semen according to HIV treatment regimen. In men taking protease
inhibitor-based therapy, HIV was detectable in 29% of samples compared with
7.7% on regimens based on other drug classes.
men were able to provide two different semen samples within an hour. In 9% of
these pairs of samples, HIV was detectable in one sample (average viral load
918 copies/ml) but not the other.
authors cite a figure of 0.03% (one transmission in 3333 occasions of sex) for
the likelihood of transmission from a man with a seminal viral load of 1000
copies/ml, although the recent PARTNER study found no
transmissions from an HIV-positive person on treatment in 44,000 episodes of
anal and vaginal sex.
Taiwan harm reduction programme cuts HIV in drug users by 80%
of a comprehensive harm reduction programme has successfully contained the HIV
epidemic among people who inject drugs in Taiwan.
2004, estimated HIV incidence among prisoners with a history of drug use in
Taiwan was 6.44%. Incidence peaked at 18% in 2005. The introduction of the
large-scale harm reduction programme was accompanied by a sharp fall in
incidence. In 2007, it had fallen to 2%. Incidence was just 0.27% in 2010.
viral load also declined among prisoners, from a mean of 93,000 copies/ml in
2006 to a mean of 11,710 copies/ml in 2010. The proportion of people with a
viral load below 1000 copies/ml increased from 21% in 2006 to 40% in 2010.
annual HIV incidence rate among former prisoners who received methadone maintenance
therapy was 0.165% compared with 1.33% a year among former prisoners who did
not receive this therapy. After controlling for potential confounders, the
investigators found that engaging with methadone maintenance programmes reduced
the risk of infection with HIV by 80% and there was a zero HIV incidence rate
among frequent users of needle and syringe exchanges. This compares to an
incidence rate of 0.5% among people who inject drugs who did not use such
HIV prevalence among people who inject drugs in Taiwan increased substantially
between 2004 and 2006. The increase slowed between 2007 and 2009, and fell
slightly in 2010.
Rwanda cuts HIV incidence by 90% as it goes for universal HIV treatment
achievement of high rates of HIV treatment in one African country, Rwanda,
has resulted in HIV diagnoses more than halving and annual incidence falling by
90%, the 2014 Treatment as Prevention
workshop in Vancouver heard last month.
estimated that, in Rwanda, as of this year, 93% of people living with diagnosed
HIV with CD4 counts below 350 cells/mm3 are on antiretroviral
therapy (ART), 59% of all people diagnosed with HIV, and about 40% of everyone
with HIV, diagnosed and undiagnosed. The median CD4 count at diagnosis is now
treatment coverage is still patchy, with some centres reporting 80% coverage of
all diagnosed people and others only 20%; one particularly challenging area is
the slums on the outskirts of the capital, Kigali.
37,000 people tested positive for HIV in 2007: by 2011 diagnoses were down to
23,000 and last year they declined to 13,000. This is despite the number of HIV
tests going up, and would be even more dramatic if it reflected true incidence:
annual incidence of HIV in fact declined nearly tenfold from 0.25% a year in
2004 to 0.03% in 2012.
Other recent news headlines
number of people someone with HIV infects during their life can vary by five
orders of magnitude, the 2014 Treatment as Prevention Workshop heard last month.
This figure, called the reproduction number, or R0, determines
whether an epidemic grows or shrinks: if it is over 1, the epidemic will grow.
A close analysis of the epidemic in one province in Vietnam, where HIV is
rather evenly spread around risk groups (female sex workers, people who inject drugs
and gay men) as well as being present in other women who often acquire HIV from
partners who have been with sex workers. The R0 of different
population groups ranged from 99 in sex workers who also injected drugs to 0.06
in sex-worker clients. It was found that if HIV treatment was in limited
supply, the most efficient treatment-as-prevention strategy would be to
preferentially give it to people who inject drugs as they are connected to most
other risk groups.
the next two years it may become possible to provide portable, non lab-based
viral load tests for low-income countries that cost little more than CD4
counts, the 2014 Treatment as Prevention Workshop heard. With more
people being treated earlier even in poorer countries, it is more important to
find out if treatment is suppressing the virus. Manufacturers’ costs per
portable viral load test are currently 67% higher than lab-based tests because
they cannot use disposable components like reagents in bulk. The actual price
charged to African countries for viral load tests including all equipment
averaged around US$25 per test for lab-based tests and would be at least US$33
for portable tests, but this could be brought down to US$12 per test if samples
were pooled. This is not too much more expensive that the per-test cost of a
CD4 count – about US$7.50.
A testing programme targeting high-risk groups that
was combined with one-off screening for other adults would prevent between 4
and 15% of future infections in the UK, a study has found. The model predicted
that without a scale-up of HIV testing, annual HIV incidence would remain
unchanged in the UK at about 3500 new infections per year. If annual testing of
high-risk groups was instituted along with a one-off national screen it would
prevent up to 23% of future infections. There would be 15,000 new HIV diagnoses
in the first year compared with the 6100 diagnosed in 2013. This targeted
testing approach with one-off testing for others, would provide 80% of the
benefits of a universal HIV test for the whole population, but at only 14% of
the cost over ten years.
Editors' picks from other sources
Syphilis is rising among gay men after being
nearly eliminated in the United States more than a decade ago, according to a
federal study released this month. The US syphilis rate in 2013 was 5.3 cases
per 100,000 people, more than twice the all-time low of 2.1 cases per 100,000
people in 2000, the Centers for Disease Control and Prevention reported. The
majority of patients with the disease, which is treatable, were men who had sex
with other men.
from HIV Justice Network
A man’s 2011 conviction for ‘recklessly’ infecting his ex-girlfriend with genital
herpes (HSV2) was upheld on 8 May. However, his original 14-month sentence was
reduced to three months. The Herpes Viruses Association issued a press release
following today’s verdict which stated: “We are appalled at the court’s failure
to overturn the guilty verdict. Herpes virus transmission should not be in the
legal arena at all.”
from Aeon magazine
In spite of extraordinary research breakthroughs and new
effective treatment and prevention, the HIV epidemic continues to chug along.
There are 50,000 new HIV infections a year in the United States – a steady flow
unchanged since 2007 (the peak was 130,000 a year in the mid-1980s). And the
reasons are not so much medical as they are behavioural, psychological and
from Center for Global Health Policy
Released in December, before the dissolution of Ukrainian
control of Crimea, Lives on The Line, Funding Needs and Impacts of Ukraine’s
National HIV/AIDS Program, 2014-2018, offers a choice of
futures. Stronger efforts over the next four years to reach those most affected
by HIV and with the least access to services, including universal access to
antiretroviral treatment would mean that more than 29,000 people would remain
uninfected who would not have otherwise, and the lives of nearly 40,000 people
would be saved.
Outside the US, most volunteers who participated in the
clinical trial that first proved Truvada prevents
HIV no longer have access to the drug. Peruvian physician Juan Guanira is
indignant that his countrymen have received the brush off where access to PrEP
is concerned. “It is really frustrating what is happening in my country,” he
says, “because we were by far the largest site in the iPrEX study of PrEP. The advocacy process to
introduce the concept of PrEP on the local agenda looks worthless when we see
that even the combination of emtricitabine and tenofovir is not available in
the country for HIV prevention and not even for HIV treatment.”
from Sanofi Pasteur press release
The European Medicines Agency's
Committee for Medicinal Products for Human Use has given a positive opinion for
the HPV vaccine Gardasil to be used
for the prevention of anal cancer and related lesions. This is a big step on
the way towards HPV vaccination for boys becoming standard in Europe, as it
already is in girls. Approximately 6800 new cases of anal cancer occur annually
in Europe, of which around 75-80% are attributable to HPV types 16 and 18,
against which Gardasil offers nearly
100% protection. Over 60% of anal cancers occur in women; in men, the incidence
of anal cancer is higher among men who have sex with men (MSM), especially men living
with HIV. However, a population-based study estimated that 53% of male anal
cancers occurred in heterosexual men.