No
women
taking
long-acting
cabotegravir
(Apretude)
for
HIV
pre-exposure
prophylaxis
(PrEP)
developed
an
HIV
infection
despite
short
delays
before
some
maintenance
injections,
according
to
a
U.S.
study
of
routine
clinical
care.
There
were
no
cases
of
incident
HIV
over
a
median
follow-up
of
13
months
among
315
women
who
started
cabotegravir
in
2021-2024
as
part
of
the
OPERA
longitudinal
cohort.
No
HIV
transmissions
occurred
despite
less-than-perfect
adherence
to
the
cabotegravir
regimen:
88%
of
1,193
maintenance
injections
overall
were
delivered
on
time,
with
late
injections
occurring
a
median
8
days
late.
Ultimately,
44%
of
women
had
at
least
one
delayed
maintenance
injection,
Laura
Armas-Kolostroubis,
MD,
of
the
AIDS
Healthcare
Foundation
in
Dallas,
Texas,
reported
at
the
International
AIDS
Conference.
“The
great
news
is
that
none
of
the
women
on
cabotegravir
PrEP
acquired
HIV
during
the
study
period
despite
ongoing
sexual
transmission
risk
—
demonstrating
that
PrEP
works,”
Armas-Kolostroubis
said.
“This
study
demonstrates
the
high,
real-world
effectiveness
of
cabotegravir
for
HIV
PrEP
in
cisgender
and
transgender
women
in
the
U.S.”
“We
know
that
the
life
of
our
patients,
particularly
women,
is
very
complicated,
and
the
delays
in
clinical
treatment
may
be
due
to
family
reasons,
work,
and
other
factors,”
Armas-Kolostroubis
said.
Despite
delays,
she
said,
“don’t
discard
the
possibility
of
continuing
PrEP
—
stress
that
this
is
a
very
effective
method.”
Approved
for
PrEP
in
2021,
long-acting
injectable
cabotegravir
is
indicated
for
use
in
adolescents
and
adults
weighing
at
least
35
kg
(~77.2
lbs)
who
are
at
risk
for
HIV-1
acquisition.
Long-acting
injectable
cabotegravir
PrEP
is
administered
as
a
monthly
injection
for
the
first
2
months,
then
every
2
months
afterwards.
Despite
the
treatment
gaps
observed,
women’s
return
to
cabotegravir
suggests
a
continuing
interest
in
the
drug
as
a
PrEP
option,
Armas-Kolostroubis
noted.
“This
pattern
of
interruptions
and
resumptions
may
reflect
how
the
need
for
PrEP
evolves
over
time,
as
true
risk
—
or
perception
of
risk
—
changes,”
she
said.
“They
might
feel
at
risk
for
a
little
while,
then
they
trust
their
partner
—
and
then
when
they
break
up,
they
come
back
and
get
back
in
care.”
Of
note,
long-acting
lenacapavir
(Yeztugo)
PrEP
had
not
yet
been
approved
during
the
study.
Lenacapavir
is
positioned
to
further
boost
PrEP
uptake
and
persistence
given
its
twice-yearly
administration.
The
OPERA
cohort
tracks
more
than
172,000
people
with
HIV,
911,000
people
without
HIV,
and
86,000
who’ve
received
PrEP.
In
the
present
analysis,
researchers
included
cisgender
or
transgender
women
age
18
years
or
older
who
started
PrEP
from
December
2021
to
December
2024.
Among
5,330
women
who
started
any
PrEP
in
that
period,
6%
initiated
cabotegravir
PrEP;
80%
started
daily
oral
tenofovir
disoproxil
and
emtricitabine
(Truvada)
and
14%
started
daily
oral
tenofovir
alafenamide
fumarate
and
emtricitabine
(Descovy).
The
median
age
of
the
315
individuals
initiating
cabotegravir
was
28
years,
43%
were
Black,
32%
were
transgender,
and
43%
had
a
BMI
of
at
least
30
kg/m2.
Cabotegravir
reached
a
different
population
than
oral
PrEP
options
did,
Armas-Kolostroubis
observed.
A
greater
percentage
of
women
on
cabotegravir
were
transgender
(32%)
than
among
those
on
oral
PrEP
(19%),
while
more
women
on
the
long-acting
injectable
received
Medicaid
(38%)
than
those
on
oral
PrEP
(8%).
Most
women
who
chose
cabotegravir
were
compliant
with
the
drug’s
initiation
and
maintenance
regimen.
Among
the
study’s
315
women,
80%
received
the
cabotegravir
initiation
sequence
of
two
monthly
injections
and
were
followed
for
a
median
13
months
afterward.
Among
the
252
who
completed
treatment
initiation,
83%
had
at
least
one
maintenance
injection,
with
a
median
of
four
maintenance
injections
among
the
group.
More
than
half
of
women
(56%)
had
all
of
their
subsequent
maintenance
injections
every
2
months
on
time,
and
those
who
didn’t
had
a
median
of
only
one
late
injection.
Additionally,
89%
of
those
who
didn’t
get
a
maintenance
injection
on
time
had
a
short
delay
of
less
than
31
days
that
didn’t
require
a
cabotegravir
restart.
While
38%
of
women
who
received
at
least
one
maintenance
injection
discontinued
cabotegravir
PrEP
therapy,
25%
of
them
resumed
injections
a
median
of
31
weeks
after
their
last
injection.
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