The
FDA
approved
the
combination
of
bictegravir
and
lenacapavir
(Bixlenvo)
for
adults
with
virologically
suppressed
HIV-1
infection,
Gilead
Sciences
announced
Thursday.
The
once-daily
single
tablet
contains
75
mg
of
the
integrase
strand
transfer
inhibitor
(INSTI)
bictegravir
and
50
mg
of
the
capsid
inhibitor
lenacapavir.
The
treatment
is
indicated
in
adults
with
HIV-1
RNA
levels
less
than
50
copies
per
mL
who
are
switching
from
a
stable
antiretroviral
regimen
and
have
no
resistance
to
the
two
drugs.
“The
approval
is
a
significant
advancement
in
HIV
treatment,
especially
for
individuals
unable
to
benefit
from
guideline-recommended
single-tablet
regimens
due
to
challenges
like
pre-existing
resistance
or
tolerability,”
said
Chloe
Orkin,
MBBCH,
MSc,
of
Queen
Mary
University
of
London,
in
a
Gilead
Sciences
statement.
“It
expands
tailored,
simplified
dosing
to
people
whose
needs
were
not
fully
met
by
existing
single-tablet
therapies.”
The
FDA
based
its
decision
on
two
phase
III
clinical
trials,
ARTISTRY-1
and
ARTISTRY-2.
ARTISTRY-1
included
557
people
with
virologically
suppressed
HIV
on
complex
oral
regimens.
Among
those
randomized
to
switch
to
the
single-tablet
bictegravir-lenacapavir
combination,
0.8%
had
HIV-1
RNA
levels
of
50
copies
or
more
per
mL
after
48
weeks
of
treatment
compared
with
1.1%
of
those
who
remained
on
their
complex
regimen.
There
was
no
detected
resistance
to
the
two
drugs
in
the
single
tablet
after
treatment.
Adverse
events
were
comparable
between
the
two
study
arms,
including
serious
adverse
events.
In
ARTISTRY-2,
the
bictegravir-lenacapavir
combination
pill
was
noninferior
to
combination
bictegravir,
emtricitabine,
and
tenofovir
alafenamide
(Biktarvy).
After
48
weeks,
1.3%
of
those
who
switched
to
bictegravir-lenacapavir
had
HIV-1
RNA
of
50
or
more
compared
with
1.0%
who
remained
on
the
three-drug
pill.
Drug-related
adverse
event
rates
were
similar
between
the
two
treatment
groups,
with
no
serious
drug-related
adverse
events.
Under
the
approved
indication,
patients
begin
a
2-day
initiation
regimen
of
one
tablet
of
bictegravir-lenacapavir
plus
two
tablets
of
300-mg
lenacapavir
(Sunlenca)
followed
by
a
maintenance
regimen
of
one
tablet
of
bictegravir-lenacapavir
once
daily.
Tablets
may
be
taken
with
or
without
food.
The
drug’s
label
warns
that
bictegravir-lenacapavir
shouldn’t
be
given
with
dofetilide
or
strong
CYP3A
inducers,
nor
should
it
be
given
with
other
antiretroviral
medications
to
treat
HIV-1
infection.
The
most
common
adverse
reactions
were
headache,
nausea,
and
diarrhea.
Oral
lenacapavir
is
being
studied
in
other
therapeutic
combinations
for
suppressed
HIV.
Weekly
oral
lenacapavir
with
islatravir
matched
daily
oral
standard-of-care
regimens
in
patients
with
virologically
suppressed
HIV,
according
to
two
phase
III
trials
presented
at
the
International
AIDS
Conference
in
Rio
de
Janeiro
this
year.
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