The
FDA
expanded
the
approval
of
dolutegravir
tablets
for
oral
suspension
(Tivicay
PD)
to
include
newborns
with
HIV
infections
younger
than
4
weeks
of
age,
the
agency
announced
on
Tuesday.
In
combination
with
other
antiretroviral
therapies
(ARTs),
the
once-daily
treatment
is
indicated
for
babies
weighing
at
least
2
kg
(~4.4
lbs)
who
are
naive
to
an
integrase
strand
transfer
inhibitor
(INSTI).
The
approval
was
supported
by
the
phase
I
IMPAACT
2023
study
and
pharmacokinetic
modeling
data.
The
open-label
trial
included
48
newborns
who
received
dolutegravir
in
addition
to
standard
ART
for
up
to
6
weeks.
With
16
weeks
of
follow-up,
data
showed
that
dolutegravir
levels
among
the
babies
were
similar
to
levels
linked
to
efficacy
in
adults,
along
with
a
safety
profile
consistent
with
treatment
in
older
patients.
“For
too
long,
newborns
living
with
HIV
have
had
too
few
treatment
options
designed
and
studied
to
meet
their
unique
needs,
despite
the
importance
of
starting
treatment
as
early
as
possible,”
said
investigator
Diana
Clarke,
PharmD,
of
Boston
University
School
of
Medicine,
in
a
press
release
from
manufacturer
ViiV
Healthcare.
The
approval
“represents
an
important
advance
for
the
care
of
newborns,
as
early
treatment
with
the
most
effective
therapies
results
in
the
best
possible
outcomes,”
Clarke
noted.
First
approved
in
2013
for
adults
and
kids
12
years
and
older,
dolutegravir
went
on
to
receive
an
indication
for
children
as
young
as
4
weeks.
The
second-generation
INSTI
is
recommended
by
the
World
Health
Organization
as
part
of
first-
or
second-line
ART
regimens
for
children
living
with
HIV.
Of
note,
dolutegravir
tablets
for
adults
aren’t
bioequivalent
with
the
oral
suspension
tablets
for
kids
and
can’t
be
substituted
on
a
mg-per-mg
basis,
the
FDA
cautioned.
The
most
common
moderate
to
severe
adverse
events,
occurring
in
at
least
2%
of
adult
study
participants,
included
insomnia,
fatigue,
and
headache.
Contraindications
noted
in
the
drug’s
labeling
include
coadministration
with
dofetilide
and
previous
allergic
reactions
to
dolutegravir.
Hypersensitivity
reactions
including
rash
and
liver
injury
have
been
reported.
Some
patients
taking
combination
ART
regimens
have
reported
immune
reconstitution
syndrome.
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