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FDA gives green light to the first injectable HIV prevention drug

FILE - This Thursday, Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. FDA officials on Tuesday, Nov. 17, 2020, allowed emergency use of the first rapid coronavirus test that can be performed and developed entirely at home.
Jacquelyn Martin/AP
The FDA recently approved the first injectable drug for HIV prevention.

After years of research, the Federal Drug Administration (FDA) has recently announced the approval of Apretude, the first injectable HIV prevention treatment to replace the daily pill regime.

Developed byViiV Healthcare, the medicine is injected bi-monthjly. Dr. Kimberly Smith, head of research and development, said this treatment was worth the wait.

“ I do think this is (a) game changing medicine, and if we can do something that changes the trajectory of the HIV pandemic, then my life's work will certainly feel worth it,“ she said.

Currently, the only PrEP (pre-exposure prophylaxis) medication approved was a daily pill, which can be difficult to take consistently.

The shift from a bottle of more than 30 pills to a bi-monthly injection, allows individuals to receive an equal or a potentially better form of protection.

“(This is) 3 to 9 times better than oral Truvada,” Dr. Smith said, comparing the results of the trials.

Tres Brown, a community manager with the Dallas-based Resource Center, an agency that helps people living with HIV/AIDS, is excited about increasing accessibility to these drugs.

“Having an injectable option might mean they might adhere to it a little bit more, they need options because keeping up with your medication can be a little bit harder when you don’t have a regular place,” Brown said.

Medical officials have found people of color are disproportionately effected by HIV while also being the least studied during trial testing. Smith said it’s about trust.

“We had all of the community involved in it … it breaks all the myths that you can’t enroll a study and have appropriate representation from people of color, that stereotype has got to go,” she said.

Apretude was studied in one of the most diverse and comprehensive HIV preventional trials. The study included some of the largest numbers of transgender women and Black men who have sex with men, according to ViiV Healthcare.

“I feel thrilled that we have this product to bring to the U.S. to impact the U.S. epidemic,” Smith said.

Now that Apretude has gotten the OK from the FDA, local clinics and qualified institutions may see distribution as soon as early 2022.

Got a tip? Email Solomon Wilson at You can follow Solomon on Twitter @SolomonSeesIt.

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Solomon Wilson is KERA's Marjorie Welch Fitts Louis Fellow. He focuses on covering racial equity, women’s rights, socioeconomic disparities and other evolving issues of social justice in our community.