Injectable PrEP Could Be Approved in 2022 (Cabotegravir)

Pre-exposure prophylaxis (or PrEP) regime

Currently, Pre-exposure prophylaxis (or PrEP) regime involves taking oral medication daily to help prevent getting HIV only. PrEP is highly effective for preventing HIV when taken as prescribed.

The approved PrEP pills in the market now are Truvada (tenofovir disoproxil fumarate/emtricitabine) and Descovy (tenofovir alafenamide/emtricitabine).

New Drug Application for Injectable Cabotegravir for Pre-Exposure Prophylaxis (PrEP)

The Food and Drug Administration (FDA) has accepted ViiV Healthcare’s New Drug Application for injectable cabotegravir for pre-exposure prophylaxis (PrEP) and granted it priority review status, according to an announcement from ViiV. ViiV Healthcare is a global specialist HIV company owned by GlaxoSmithKline (GSK)

An FDA decision is expected by the end of January 2022. If approved by FDA, cabotegravir would be the first injectable option for PrEP.

Currently, Cabotegravir is a drug by the U.S. Food and Drug Administration (FDA) for HIV treartment only. It is approved as part of a long-acting injectable two-drug regimen with rilpivirine.

There are two recent studies showed that long-acting cabotegravir injections work even better than PrEP pills.

In both trials, cabotegravir injections were safe and well-tolerated. The most common side effect was injection site reactions, including pain, redness, or swelling. While a majority of participants reported such reactions, few stopped treatment for this reason. 

The advantage of the injections appears to be attributable to better adherence compared with pills.

What Makes Injectable PrEP More Effective?

Researchers are still speculating as to why injectable HIV PrEP could be delivering such significantly better results. One of the theories pinpoints a really intriguing reason for the potential failure of oral PrEP and that’s poor adherence. When blood samples were taken from some of the volunteers, researchers found out that the level of medications in their blood were in no way indicative of taking the recommended at least four pills per week. In other words, people often forget to take their meds.

Learn more: Injectable HIV PrEP delivers better results than oral PrEP 

References:

https://clinicaltrials.gov/ct2/show/NCT02720094
https://www.nejm.org/doi/10.1056/NEJMoa2101016
https://clinicaltrials.gov/ct2/show/NCT03164564
https://www.poz.com/article/injectable-prep-much-effective-daily-truvada-recent-trial-1
https://viivhealthcare.com/en-gb/media/press-releases/2020/may/global-hiv-prevention-study-to-stop-early-after-viiv-healthcares/