Apretude, a new drug approved by the FDA this week, is an injection that has proven to be significantly more effective at reducing the risk of sexually-acquired HIV.

Apretude, a new drug approved by the FDA this week, is an injection that has proven to be significantly more effective at reducing the risk of sexually-acquired HIV. / ViiV Healthcare

A long-awaited development to help stop the spread of HIV and AIDS was approved by the U.S. Food and Drug Administration this week, and scientists are calling it a game-changer.

The drug, called Apretude but also known as cabotegravir, is an injection that has proven to be significantly more effective at reducing the risk of sexually-acquired HIV. Before the FDA approval on Monday, the more common way to take pre-exposure prophylaxis, commonly known as PrEP, was through a daily pill.

Now, an injection only needed once every eight weeks could help mitigate the social stigma of HIV and prevent its spread.

"This new medication, cabotegravir, is a game changer," Kenneth Mayer, medical research director at Fenway Health in Boston, one of the sites where it was tested in clinical trials, told NPR.

Officials at the FDA say the injection is a more realistic option for groups where taking a daily pill was more of a challenge. Issues such as poverty, depression, other medical disorders and sometimes just plain forgetfulness, can make it hard to stick with medication on a daily basis.

"This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., 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 at the FDA, said in a statement.

Taking PrEP as an oral pill has actually been highly effective in recent years. The FDA says that in 2020, about 25% of people for whom PrEP was recommended were ultimately prescribed it, compared to just 3% in 2015.

But what makes the injection such a game-changer is not just that it can be easier to adhere to — it's also more effective.

Clinical trials showed that Apretude taken by cisgender men and transgender women who have sex with men had 69% less risk of getting infected with HIV. For cisgender women, they had 90% less risk.

Mayer points out, though, that during the trials, there were some individuals who didn't like the experience of the injection and stopped their treatment, so the new drug may not be an across the board solution for everyone.

But it's still a significant step, not only for curbing the spread of HIV in the U.S., but also in Africa, where 1 million of the 1.7 million people who contracted HIV in 2019 live.

On study of cabotegravir in sub-Saharan Africa, conducted before the pandemic, was considered so effective that researchers ended the trial earlier than anticipated.

Dr. Anthony Fauci, who has worked on HIV/AIDS research for decades, called it a "major advance."

"One of the stumbling blocks in our prevention [efforts against HIV] has been the inconsistency or lack of efficacy of pre-exposure prophylaxis in those who need it the most," Fauci said. "Namely young women, particularly those in southern Africa."

Now, with FDA approval of the drug in the United States, it could pave the way for its use in lower-income countries.

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Tags: FDA drug approval  PrEP  FDA  HIV