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Young gay men can do well on PrEP, but may need more support
Liz Highleyman, 2016-07-21 05:40:00
gay and bisexual men had good adherence to Truvada
for pre-exposure prophylaxis (PrEP) during the first few months of a
demonstration project with close monitoring, but adherence slipped once
follow-up switched from monthly to quarterly, suggesting that young people
using PrEP may require more on-going support.
The results were presented
yesterday by Sybil Hosek of Stroger Hospital in Chicago, on
behalf of the Adolescent Trials Network ATN 113 study team, at the 21st International AIDS Conference (AIDS 2016) taking place this week in Durban, South Africa.
looked at adolescent men who have sex with men, aged 15-17, in six US cities:
Boston, Chicago, Denver, Los Angeles, New Orleans and Philadelphia. A companion
study, ATN 110, enrolled a slightly older group, aged 18-22 years. Hosek reported results from that study last
The studies were designed to provide additional safety data on Truvada (tenofovir/emtricitabine) PrEP in
young gay men; to examine acceptability, patterns of use, rates of adherence
and levels of drug exposure; and to look at changing patterns of sexual behaviour
while on PrEP.
Participants received once-daily Truvada on an open-label basis along with a behavioural risk reduction
intervention and adherence support. The first
three follow-up visits were a month apart (4, 8 and 12 weeks after starting
PrEP), but then went to every three months (24, 36 and 48 weeks). Levels of tenofovir diphosphate
(TFV-DP) were measured in dried blood spots.
were assigned male at birth (not transgender) and HIV-negative at screening, but
were at high risk for infection, for example due to having an HIV-positive
steady partner, condomless sex with HIV-positive or unknown status partners,
exchanging sex for money or drugs, or having had a sexually
transmitted infection (STI). Though they were under 18, parental consent was
not required to join the study.
team approached 2,864 young men for pre-screening between August 2013 and September 2014, but around 500
refused and 2,077 were found to be ineligible. Of the 260 men (9%) deemed
eligible, more than half declined to participate, one was already HIV-positive,
13 had kidney impairment that contraindicated Truvada use and several others were lost or withdrew for other
reasons, leaving 79 enrolled participants. Within this group 32 men
discontinued the study prematurely, mostly due to loss to follow-up.
The mean age of the study group was 16.5 years. Nearly
a third were black, a similar proportion identified as mixed or other
race/ethnicity, 21% were Hispanic/Latino, 14% were white and 3% were Asian. A
majority (58%) identified as gay and 28% as bisexual. They were most
successfully recruited online rather than through gay venues.
Most participants were currently living with their
families, but 15% said they had been kicked out for being gay. The men had two sex
partners during the past month, on average, and 60% reported condomless receptive
anal sex with their last partner; 17% said they had ever been paid for sex and
15% had a positive STI test.
was generally safe and well tolerated. No study participants discontinued PrEP
due to adverse events and there were no abnormal laboratory results, including
kidney function tests. There were three grade 3 adverse events (weight loss)
considered related to the study drugs. Participants underwent DEXA bone density
scans at 48 weeks, but these data are still being analysed and were not
Over the course of the study three young men seroconverted, for an HIV incidence
of 6.41 per 100 person-years (95% CI 4.9-25.8). This is among the highest rates
ever seen in a PrEP programme, and twice the rate in the parallel study of men
Adherence was initially quite good, with a majority
of participants achieving protective TFV-DP levels during monthly visits, but
it decreased after they switched to every thee months.
"At week 24 we started to see a pretty drastic decline in drug levels and
an increase in people not taking the meds at all," Hosek said.
More than 95% of the men had detectable drug
levels and more than half had highly protective levels (at least four doses per
week) during the first three months, but this dropped to about 75% and 32% after
they switched to quarterly follow-up.
There was no clear racial disparity in adherence, as
seen in ATN 110. The most common reasons given for missing doses were being away from
home (32%), being too busy (28%), forgetting (26%), or a change in routine (19%).
Participants with poor adherence were more likely to say they did not like
taking pills or that they were worried others would think they were
HIV-positive or had sex with men if they saw them taking PrEP.
STI incidence declined over the course of the study,
as did sexual risk behaviour - in contrast to the age 18-22 study where these
remained stable. A majority of the men reported condomless sex throughout the study, with
no significant associations between condomless sex and PrEP adherence.
Noting that STI rates were high at the outset, Hosek
said it was difficult to determine the effect of PrEP because many of the young
men had not previously received STI anal swabs and the high rate might be in
part due to more testing during the study.
The safety data in ATN 113 and the effectiveness of
PrEP among young men who took Truvada
consistently are reassuring, though adherence levels during quarterly follow-up
were not what they need to be to ensure adequate protection.
results are important because Truvada
is not yet approved for PrEP for people younger than 18 years. The data will be
presented to the US Food and Drug Administration to support an expanded
The findings, Hosek summarised, show that adolescents
have an urgent need for PrEP - as evidenced by their high rate of new HIV infections
and STIs - and suggested that they may need more frequent adherence support and
strategies than adults.
"Young people may need more time, and we need to
give it to them," Hosek said. "If they want PrEP, we need to help
them make it work."
seeing people who are struggling with using condoms," she added. "PrEP
won't prevent STIs, but at least it's preventing HIV. Let's not stigmatise one of the best prevention options we've
had in a long time."