RESEARCH TRIANGLE PARK – The US Food and Drug Administration has approved the first injectable medication for pre-exposure prophylaxis (PrEP) to lower the risk of getting HIV through sex, it announced Monday. The drug has roots in North Carolina.

ViiV Healthcare, which is majority owned by drug giant GlaxoSmithKilne, has a major R&D operation in RTP.

“This is a medicine that has largely been developed at ViiV’s US headquarters in RTP – with clinical studies conducted by the HIV Prevention Trials Network. It’s also based in Durham,”  ViiV spokeswoman Melinda Stubbee said.

Dr. Kimberly Smith, the head of research and development, and global medical development leader for the drug, Dr. Alex Rinehart, are based in RTP.

“We were incredibly excited about this approval. We think it’s going to be a gamechanger,” Rinehart said.

Rinehart told WRAL News on Tuesday that they had worked on the drug for nine years, including four years of clinical trials conducted in nearly 8,000 people in populations around the world.

“People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills. That’s why ViiV Healthcare is proud 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,” said Deborah Waterhouse, CEO of ViiV Healthcare, in a statement.

“With Apretude, people can reduce the risk of acquiring HIV with as few as six injections a year,” Waterhouse continued.

The hope is that an injectable drug, given every two months at a doctor’s office, will appeal to those at risk for HIV exposure but who may have been uncomfortable filling a prescription at a pharmacy or unwilling to commit to a daily pill.

“I think it’s going to change a lot of things and make things a lot easier for folks who are in need of PreP services,” said Matt Martin, grassroots advocacy manager at NC AIDS Action Network.

Apretude chould be on the market as soon as next month, Rinehart said. A price for the treatments has yet to be established.

A closeup of the HIV virus. (ViiV Healthcare image)

Apretude is approved for adults and teens who are at risk of getting HIV through sex and who weigh at least 77 pounds. It’s given first as two shots a month apart, and every two months afterward.

Trials showed reduced the number of new HIV infections in men and transgender women by 69%. In those born female, Apretude reduced new HIV infections by up to 92%.

ViiiV Healthcare ‘long-acting injectable has the potential to be a game-changer for HIV prevention’

PrEP was previously available only in the form of pills, Truvada and Descovy, and only Truvada was approved for use by women.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Dr. Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.

Approval of the new drug “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,” Birnkrant added.

An estimated 34,800 new cases of HIV were diagnosed in 2019, the latest year for which federal statistics are available. That’s down from 37,800 in 2015. Data from the Centers for Disease Control and Prevention show that in 2020, PrEP was recommended for about 1.2 million people, but only a quarter got a prescription for it.

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Because of a risk of drug-resistant HIV variants, Apretude is only for people who test negative for HIV immediately before starting the drug and before each injection. The label also includes warnings about hypersensitivity reactions, liver damage and depressive disorders.

FDA OKs monthly HIV treatment from ViiV Healthcare, which has major RTP presence,

CNN contributed to this report.