Cabotegravir extended-release suspension, a long-acting integrase inhibitor, was approved by the U.S. Food and Drug Administration (FDA) on 20 December 2021. It is administered through an intramuscular injection by a health care worker every 2 months and can be offered to adults and adolescents weighing at least 35 kilograms to reduce the risk of sexually acquired HIV.
This announcement follows the results of 2 randomized controlled trials for cabotegravir extended-release, both of which demonstrated it to be highly effective in reducing HIV acquisition risk: first in May 2020 the HPTN 083 trial among men who have sex with men and transgender women, and in November 2020 among women in sub-Saharan Africa.
The FDA is the first regulatorily body to approve long-acting cabotegravir for HIV prevention as it applies to people in the United States of America. "It is hoped that regulatory approval will be forthcoming in other countries particularly in low- and middle-income settings to provide the option of another effective HIV prevention choice," says Dr Meg Doherty, Director of WHO's Global HIV, Hepatitis and STI Programmes. "There is also urgent need for implementation projects in LMIC to better understand the safe and acceptable delivery of injectable prevention."
WHO continues to follow the HIV prevention pipeline closely and has started the process to develop guidelines for long-acting prevention approaches in early 2022. WHO will also continue to support countries and partners as they consider how to include long-acting cabotegravir safely and effectively in their strategic mix of HIV prevention options.
WHO is also working with Unitaid who is at the forefront of developing implementation science projects in South Africa and Latin America where long-acting cabotegravir will be offered as an HIV prevention options. This will be key to answering some of the outstanding safety issues, implementation challenges and understanding peoples preferences among HIV prevention choices.
