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| FDA approved Apretude injection as the first HIV prevention |
The FDA has
announced the approval of the first injectable drug to be used for HIV
prevention called Apretude. This new drug should be administered every two
months as an option for HIV prevention just as Truvada and Descovy. These prior
drugs are effective to reduce the risk of HIV by almost ninety-nine percent if
taken daily. Apretude was found to be more likely to lower HIV than daily oral
drugs in two FDA trials examining its safety and efficacy — by 69 percent for
cisgender males and transgender women who had sex with men and by 90 percent
for cisgender women. Apretude's improved efficacy was presumably caused by the
ease with which research participants adhered to the every-other-month routine
versus taking a pill every day.
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Debra
Birnkrant, head of the FDA's Center for Drug Evaluation and Research, said in a
statement. "This injection, administered every two months, will be
important to managing the HIV epidemic in the United States, especially
assisting high-risk persons and some populations whose adherence to daily
medicine has been a huge difficulty or is not a realistic option." While
PrEP use has increased in recent years, according to the Centers for Disease
Control and Prevention, just 25% of the 1.2 million persons for whom PrEP is
advised were administered the treatment last year. According to the CDC, over
285,000 people were using PrEP in 2019, with the vast majority of them being
gay and bisexual men. The newly licensed, long-acting injectable — manufactured
by ViiV Healthcare, which is majority-owned by GlaxoSmithKline — is expected to
improve adherence, increase PrEP use, and drive down the national HIV rate.
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Apretude is
studied as an HIV prevention trial program that includes large numbers of transgender
women and black men who never had sex. According to the CDC, males who had sex
with men accounted for 66 percent of all new HIV diagnoses in the United States
in 2019. When the data is broken down by race, Black Americans have the
greatest percentage, accounting for 42 percent of all new diagnoses that year. As
things stand, insurers will not be compelled to cover the full cost of the new
injectable version of PrEP, which has a list price of $3,700 per dosage and
will be available to wholesalers and specialty distributors in the United States
in early 2022.
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PrEP4All, an
advocacy group that works to promote access to HIV prevention and treatment,
said its managing director, Kenyon Farrow, is "certainly delighted to see
the FDA approval of another alternative for folks who wish to utilize PrEP."
However, he expressed concern that implementation of this choice will likely
take years to make it real for the majority of people. As a result of COVID,
public health systems are already overcrowded, and much of the labor required
to conduct this large-scale program is departing the sector due to burnout. As
it will need to be administered in clinical settings, payers will treat it as a
clinical benefit rather than a pharmacy benefit. Meanwhile, several more
long-acting variants of PrEP are making their way through the research
pipeline, requiring treatment as little as twice a year.
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