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Disease Prevention, Control, and Treatment | Injectable drug for use as Pre-Exposure Prophylaxis, or PrEP, against HIV

Public Health care Education

The first long-acting HIV preventive injectable drug approved

HIV patients now have the first injectable medication for use as Pre-Exposure Prophylaxis, or PrEP, against HIV alternative to pills

The Food and Drug Administration (FDA) has approved the first long-acting injectable medication for use as Pre-Exposure Prophylaxis, or PrEP, against HIV, following its announcement on Monday, according to a media report.

The U.S. Food and Drug Administration approved (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. 

The Center for Disease Control and Prevention (CDC) estimates that as of 2019, there were approximately 285,000 people using PrEP, the massive mainstream of them were gay and bisexual men.

The report further disclosed that while progress have been made in PrEP use over the past several years, only 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed the treatment last year, according to the CDC.

Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said in a statement that the approval of the first drug to prevent HIV, Apretude, that does not involve the use of daily pill, added an important tool in the effort to end the HIV epidemic.

The new preventive drug should be taken once in every two months

The new preventive drug, Apretude, is an injectable given every two months as an alternative to HIV prevention pills, like Truvada and Descovy, which have been shown to reduce the risk of HIV by 99 percent when taken daily.

Rather than as a daily pill, the newly approved drug, Apretude, (cabotegravir) is given to patients every two months.

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Cabotegravir increases PrEP usage and drives down the national HIV rate – a more likely option to HIV than the daily oral medications

The hope is that the newly approved, long-acting injectable — made by ViiV Healthcare, which is majority owned by GlaxoSmithKline — will make adherence easier, help increase PrEP usage and drive down the national HIV rate.

According to NBC News, Two FDA trials analyzing the safety and efficacy of the new drug found that Apretude was more likely to reduce HIV than the daily oral medications — by 69 percent for cisgender men and transgender women who have sex with men and by 90 percent for cisgender women. Apretude’s greater effectiveness was seemingly driven by the superior ease with which study participants kept to the every-other-month routine compared with taking a pill on daily basis.

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Deborah Waterhouse, ViiV Healthcare’s CEO, claimed in a statement that having an option beyond daily oral pills for people who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, was welcoming

She said in a statement, adding that “Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial.”

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66% of all newly HIV diagnosis in the US in 2019 are gay and bisexual, 42% of which are Blacks – CDC

Gay, bisexual and other men who have sex with men accounted for 66 percent of all new HIV diagnoses in the U.S. in 2019, according to the CDC. When the numbers are broken down by race, Black Americans accounted for the highest percentage, representing 42 percent of all new diagnoses that year.

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Welcome preventive and control measure but huge implementation challenge

The managing director of PrEP4All, Kenyon Farrow, an advocacy group that fights to increase access to HIV prevention and treatment, said his organization was definitely happy to see the approval of another HIV prevention and treatment option for people who wanted to use PrEP.

However, he allayed the fear that the implementation of this option would likely take years to make it real for most people.

He lamented the much of the workforce needed to implement this large scale are leaving the medical field due to burnout related to COVID-19 that has already overwhelmed the public health systems as treatment would be administered in clinical settings, not of pharmaceutical benefit.

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Other researched long-acting forms of PrEP put on hold due to safety concerns

Meanwhile, other multiple long-acting forms of PrEP making their way through the research pipeline, requiring twice-per-year dosage have been put on hold since one of such long-acting drug, Merck’s islatravir, has some safety issues after people receiving the drug in clinical trials experienced declining CD4 levels.

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