FDA approves injectable PrEP treatment

Yesterday, the U.S. Food and Drug Administration announced that it has approved the first-ever injectable HIV prevention treatment. 

It seems as though recently that injectables may be changing the game of HIV treatment, as well as prevention. Earlier this year, the FDA also approved ViiV Healthcare’s Cabenuva, which is the first long-acting injectable HIV regimen.

Now, the next treatment, called Apretude by GlaxoSmithKline, will be available for anyone who is considered “at-risk” for HIV infection. At-risk individuals must also weigh at least 77 pounds, per the treatment guidelines. 

The treatment will be administered as two injections, which will be given one month apart. After the first round of injections, patients will then be given injections every two months. Patients will also be allowed to begin the treatment orally for the first four weeks if they are concerned about how they will tolerate the injections. 

HIV prevention medication has been around since the approval of Gilead’s Truvada pill, which was approved for use as pre-exposure prophylaxis in 2012, allowing gay and bisexual men, and other people at high risk for HIV infection, an easy and effective way to prevent it. However, the FDA tells us that a daily pill regimen is not as easy as some may think. 

“PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication,” said the FDA press release. “Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.”

The FDA has also stated that, while the usage of PrEP as a HIV prevention method has increased in recent years, it still remains relatively low. This is because it is only currently prescribed to about 25% of the 1.2 million recommended users. 

Apretude has been approved by the FDA after two randomized, double-blind trials, first including HIV-negative men and trans women, and cis women in the second trial. The injection does come with some potential side effects, including injection site reactions, headache, fever, fatigue, back pain, myalgia and rash.