HEALTH
FDA Approves Injectable PrEP
Shot shows stronger effi cacy than daily pill at preventing HIV
BY MATT TRACY
The US Food and Drug
Administration (FDA)
has approved a bimonthly
injectable form
of PrEP to prevent HIV infection,
adding yet another tool in the fi ght
against HIV/AIDS nine years after
the agency fi rst authorized daily
PrEP pills.
The injectable PrEP regimen
— intended to prevent HIV transmission
through sex, not injection
drug use — begins with one shot in
back-to-back months before shifting
to bi-monthly jabs. Patients
also have the option of testing their
body’s tolerance of the injectable
drug, known as Apretude, by taking
it orally for four weeks before
moving to the shots.
The FDA’s approval of Apretude
follows the emergence of studies
showing strong effi cacy for the
shots in comparison to PrEP pills,
which are already approximately 99
percent effective at preventing HIV
through sex, according to the CDC.
The injections will be available for
at-risk adults and adolescents who
weigh at least 77 pounds.
One study involving 4,566 cisgender
men and transgender
women who have sex with men
concluded that Apretude was 69
percent better at preventing infection
than Truvada, a daily HIV
prevention pill. A separate study
featuring 3,224 cisgender women
who received Apretude injections
found that their risk of HIV infection
was 90 percent less than
those who took Truvada. In both of
the studies cited by the FDA, participants
were given oral Apretude
for up to fi ve weeks.
The shots are getting approved
less than a year after the FDA
rubber-stamped a once-per-month
treatment injection for individuals
living with HIV.
According to the Centers for Disease
Control and Prevention, 69
percent of new diagnoses in 2019
were among men who have sex
with men, while straight individuals
represented 23 percent of new
diagnoses. Seven percent of new
The Food and Drug Administration’s approval of injectable PrEP marks another step in the fi ght against
HIV/AIDS.
diagnoses were among those who
inject drugs and trans folks made
up about two percent.
Those between the ages of 25
and 35 represented the greatest
share of new HIV diagnoses in
2019, with 13,127 — nearly twice
as many as the 7,147 new diagnoses
among people between the ages
of 35 and 44. Twenty-six percent of
new HIV diagnoses in the US were
among Black individuals.
The bi-monthly shots could be
easier to maintain than daily pills
for PrEP. Some areas — including
New York City and San Francisco
— have outlined guidelines for a
“PrEP on Demand” or “2-2-1” approach
in which patients can take
PrEP pills around sexual schedules
instead of daily.
“This injection, given every two
months, will be critical to addressing
the HIV epidemic in the US,
including helping high-risk individuals
and certain groups where
adherence to daily medication has
been a major challenge or not a
realistic option,” Dr. Debra Birnkrant,
director of the Division of
Antivirals in the FDA’s Center for
Drug Evaluation and Research,
said in a written statement.
The additional PrEP options
could be useful in the government’s
broader campaign to expand
HIV prevention medication.
Just 25 percent of those who are
ideal candidates for PrEP have a
prescription, which is still 22 percent
REUTERS/ANDREW KELLY
improvement from 2015, according
to the FDA.
Nonetheless, advocates are
speaking out about potential hurdles
associated with injectable
PrEP. It could be years before the
general public has wide access to
the shots, according to Kenyon Farrow,
the managing director of advocacy
and organization for PrEP4All,
which advocates for PrEP access.
“We are defi nitely happy to see
the FDA approval of another option
for people who want to use PrEP,”
Farrow said in a written statement.
“The long-acting injectable
taken as a shot six times a year
may be a great choice for people
who struggle with adherence to
a daily pill or intermittent (2-1-1)
pill use. But just as with the longacting
injectable for treatment that
was approved one year ago, we
anticipate the implementation of
this option will likely take years to
make it real for most people. Due to
COVID, public health systems are
already overburdened and much of
the workforce needed to implement
this large scale are leaving the fi eld
due to burnout.”
The injectable PrEP is being produced
by Viiv Healthcare, which is
owned by GlaxoSmithKline, Pfi zer,
and Shionogi. Viiv Healthcare
plans to begin shipping Apretude
to wholesalers and distributors
within the United States early next
year. It has not been approved outside
of the country.
Those who plan to take Apretude
will be required to undergo
HIV testing prior to every shot.
The drug contains labels warning
consumers that individuals who
have received the injections after
becoming HIV-positive have been
found to have drug-resistant HIV
variants, so there is an emphasis
on ensuring those who receive injections
are indeed HIV-negative.
“Because it will need to be administered
in clinical settings, it
won’t be treated as a pharmacy
benefi t by payers, but instead as
a medical benefi t, which will take
time to implement the proper coding
for billing, as well as education
and training for nurses who will
likely bear the brunt of the work to
implement,” Farrow added.
Those who take PrEP orally already
have access to generic options
and the Biden administration
earlier this year directed insurers
to provide PrEP at no extra cost,
though not all Americans are covered.
PrEP4All hopes the injectable
PrEP will soon be covered without
cost sharing.
In the meantime, Farrow said
the injectable PrEP “will likely require
prior authorization by most
PrEP users, making it even harder
to access for most people since the
generic TDF/FTC is a fraction of
that price.”
Study participants who received
Apretude reported side effects such
as back pain, fatigue, fever, headache,
injection site reaction, myalgia,
and rash, according to the CDC.
Further developments surrounding
injectable PrEP could be
forthcoming. Gilead announced
last year that it was evaluating a
drug called lenacapavir to be used
as an injectable PrEP option administered
once every six months,
and Carl Schmid, a member of the
Presidential Advisory Council on
HIV/AIDS and the executive director
of the HIV+Hepatitis Policy Institute,
expressed optimism about
that during an interview with Gay
City News in November. There
are also discussions underway,
Schmid said, about a once-per-year
implant to prevent HIV infection.
December 30, 2021 - January 12, 2 4 022 | GayCityNews.com
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