The Food and Drug Administration has accepted for Priority Review the New Drug Application for long-acting cabotegravir injection for HIV pre-exposure prophylaxis (PrEP).
The application is supported by data from the phase 2b/3 HPTN 083 (ClinicalTrials.gov Identifier: NCT02720094) and HPTN 084 (ClinicalTrials.gov Identifier: NCT03164564) trials, which evaluated the efficacy and safety of long-acting injectable cabotegravir for HIV PrEP.
HPTN 083 included men who have sex with men and transgender women who have sex with men (N=4566). HPTN 084 enrolled women who were at increased risk of HIV acquisition (N=3223). In both trials, patients received either cabotegravir intramuscularly every 8 weeks or daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) 200mg/300mg.
Results from the HPTN 083 trial showed that cabotegravir was 69% (95% CI, 41-84) more effective than FTC/TDF in preventing HIV acquisition among the study population (incidence rate: 0.38% [95% CI, 0.20-0.66] in the cabotegravir group vs 1.22% [95% CI, 0.86-1.66] in the FTC/TDF group).
In the HPTN 084 trial, cabotegravir was found to be 89% (95% CI, 68-96) more effective than FTC/TDF in preventing HIV acquisition among the study population (incidence rate: 0.21% [95% CI, 0.06-0.526] in the cabotegravir group vs 1.86% [95% CI, 1.3-2.57] in the FTC/TDF group).
As for safety, the most common adverse reactions reported were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, and abdominal pain.
“In the United States, fewer than 25% of those who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options,” said Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare. “We believe new options like investigational cabotegravir long-acting for PrEP will help play a significant role in our collective efforts to end the HIV epidemic.”
A Prescription Drug User Fee Act (PDUFA) target date of January 24, 2022 has been set for the application.
- FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV. News release. ViiV Healthcare. Accessed September 28, 2021. https://www.businesswire.com/news/home/20210928005590/en/FDA-grants-Priority-Review-to-ViiV-Healthcare%E2%80%99s-New-Drug-Application-for-cabotegravir-long-acting-for-prevention-of-HIV.
- ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV. News release. ViiV Healthcare. May 4, 2021. Accessed September 28, 2021. https://viivhealthcare.com/en-us/us-news/us-articles/2021/viiv-healthcare-initiates-rolling/.