WASHINGTON,
United
States
—
The
United
States
has
approved
the
world’s
only
twice-a-year
shot
to
prevent
HIV,
the
first
step
in
an
anticipated
global
rollout
that
could
protect
millions
–
although
it’s
unclear
how
many
in
the
U.S.
and
abroad
will
get
access
to
the
powerful
new
option.
While
a
vaccine
to
prevent
HIV
still
is
needed,
some
experts
say
the
shot
made
by
Gilead
Sciences
—
a
drug
called
lenacapavir
—
could
be
the
next
best
thing.
It
nearly
eliminated
new
infections
in
two
groundbreaking
studies
of
people
at
high
risk,
better
than
daily
preventive
pills
they
can
forget
to
take.
“This
really
has
the
possibility
of
ending
HIV
transmission,”
said
Greg
Millett,
public
policy
director
at
amfAR,
The
Foundation
for
AIDS
Research.
Condoms
help
guard
against
HIV
infection
if
used
properly
but
what’s
called
PrEP
—
regularly
using
preventive
medicines
such
as
the
daily
pills
or
a
different
shot
given
every
two
months
—
is
increasingly
important.
Lenacapavir’s
six-month
protection
makes
it
the
longest-lasting
type,
an
option
that
could
attract
people
wary
of
more
frequent
doctor
visits
or
stigma
from
daily
pills.
But
upheaval
in
U.S.
healthcare
—
including
cuts
to
public
health
agencies
and
Medicaid
—
and
slashing
of
American
foreign
aid
to
fight
HIV
are
clouding
the
prospects.
Millett
said
“gaping
holes
in
the
system”
in
the
U.S.
and
globally
“are
going
to
make
it
difficult
for
us
to
make
sure
we
not
only
get
lenacapavir
into
people’s
bodies
but
make
sure
they
come
back”
twice
a
year
to
keep
up
their
protection.
Gilead’s
drug
already
is
sold
to
treat
HIV
under
the
brand
name
Sunlenca.
The
prevention
dose
will
be
sold
under
a
different
name,
Yeztugo.
It’s
given
as
two
injections
under
the
skin
of
the
abdomen,
leaving
a
small
“depot”
of
medication
to
slowly
absorb
into
the
body.
People
must
test
negative
for
HIV
before
getting
their
twice-a-year
dose,
Gilead
warned.
It
only
prevents
HIV
transmission
—
it
doesn’t
block
other
sexually
transmitted
diseases.
Some
researchers
who
helped
test
the
shot
advise
cold
packs
to
counter
injection-site
pain.
Global
efforts
at
ending
the
HIV
pandemic
by
2030
have
stalled.
There
still
are
more
than
30,000
new
infections
in
the
U.S.
each
year
and
about
1.3
million
worldwide.
Only
about
400,000
Americans
already
use
some
form
of
PrEP,
a
fraction
of
those
estimated
to
benefit.
A
recent
study
found
states
with
high
use
of
PrEP
saw
a
decrease
in
HIV
infections,
while
rates
continued
rising
elsewhere.
About
half
of
new
infections
are
in
women,
who
often
need
protection
they
can
use
without
a
partner’s
knowledge
or
consent.
One
rigorous
study
in
South
Africa
and
Uganda
compared
more
than
5,300
sexually
active
young
women
and
teen
girls
given
twice-yearly
lenacapavir
or
the
daily
pills.
There
were
no
HIV
infections
in
those
receiving
the
shot
while
about
2
percent
in
the
comparison
group
caught
HIV
from
infected
sex
partners.
A
second
study
found
the
twice-yearly
shot
nearly
as
effective
in
gay
men
and
gender-nonconforming
people
in
the
U.S.
and
in
several
other
countries
hard-hit
by
HIV.
Ian
Haddock
of
Houston
had
tried
PrEP
off
and
on
since
2015
but
he
jumped
at
the
chance
to
participate
in
the
lenacapavir
study
and
continues
with
the
twice-yearly
shots
as
part
of
the
research
follow-up.
“Now
I
forget
that
I’m
on
PrEP
because
I
don’t
have
to
carry
around
a
pill
bottle,”
said
Haddock,
who
leads
the
Normal
Anomaly
Initiative,
a
nonprofit
serving
Black
LGBTQ+
communities.
“Men,
women,
gay,
straight
–
it
really
just
kinds
of
expands
the
opportunity
for
prevention,”
he
added.
Just
remembering
a
clinic
visit
every
six
months
“is
a
powerful
tool
versus
constantly
having
to
talk
about,
like,
condoms,
constantly
making
sure
you’re
taking
your
pill
every
day.”
Gilead
said
the
U.S.
list
price,
meaning
before
insurance,
is
$28,218
a
year,
which
it
called
similar
to
some
other
PrEP
options.
The
company
said
it
anticipated
insurance
coverage
but
also
has
some
financial
assistance
programs.
Most
private
insurers
are
supposed
to
cover
PrEP
options
without
a
co-pay
although
the
Supreme
Court
is
considering
a
case
that
could
overturn
that
requirement.
Congress
also
is
considering
huge
cuts
to
Medicaid.
And
while
community
health
centers
still
are
an
option,
the
Trump
administration
has
largely
dismantled
HIV
prevention
work
at
the
Centers
for
Disease
Control
and
Prevention
that
would
normally
get
the
message
to
vulnerable
populations
who’d
qualify
for
the
shot,
said
Carl
Schmid
of
the
nonprofit
HIV+Hepatitis
Policy
Institute.
Schmid
worries
the
shot
won’t
meet
its
potential
because
“we’re
basically
pulling
the
rug
out
of
HIV
prevention
and
testing
and
outreach
programs.”
Gilead
also
has
applications
pending
for
the
twice-yearly
shot
in
other
countries.
Last
fall,
the
company
signed
agreements
with
six
generic
drug
makers
to
produce
low-cost
versions
of
the
shot
for
120
poor
countries
mostly
in
Africa,
Southeast
Asia
and
the
Caribbean.
Gilead
plans
to
make
enough
shots
to
supply
2
million
people
in
those
countries,
at
no
profit,
until
the
generics
are
available,
said
company
senior
vice
president
Dr.
Jared
Baeten.
Winnie
Byanyima,
executive
director
of
UNAIDS,
said
in
a
statement
the
price
is
still
too
high.
If
it’s
unaffordable,
she
said,
“it
will
change
nothing.”
And
HIV
experts
worry
the
arrangements
Gilead
has
made
to
reduce
costs
in
some
countries
leave
out
middle-income
countries
like
some
in
Latin
America.
“Everyone
in
every
country
who’s
at
risk
of
HIV
needs
access
to
PrEP,”
said
Dr.
Gordon
Crofoot
of
Houston,
who
helped
lead
the
study
in
men.
“We
need
to
get
easier
access
to
PrEP
that’s
highly
effective
like
this
is.”
–
AP