November 22, 2024

FDA Approval of Long-Acting Injectable Drug Marks Pivotal Expansion of HIV Prevention Options

Up until today, the only FDA-licensed medications for HIV pre-exposure prophylaxis (PrEP) were daily oral pills including the HIV drugs tenofovir and emtricitabine. These medications are extremely reliable at avoiding HIV when taken daily as prescribed. The 2 trials discovered that both HIV avoidance techniques were safe and extremely efficient, but injectable cabotegravir was more effective than daily oral PrEP at avoiding HIV acquisition.
The HPTN 083 and HPTN 084 trials were sponsored by NIAID and carried out by the NIH-funded HIV Prevention Trials Network (HPTN).

Scanning electron micrograph of an HIV-infected H9 T cell. Credit: NIAID
On December 20, 2021, the U.S. Food and Drug Administration revealed its very first approval of a long-acting HIV avoidance medication. FDA has actually authorized the medication for usage by grownups and teenagers weighing at least 35 kgs who are at danger of sexually getting HIV.
An approximated 34,800 individuals in the United States got HIV in 2019, the most recent year for which information are offered. Guy who make love with men, transgender women who make love with males, and Black cisgender ladies are amongst those disproportionately affected by HIV in this country.
Till today, the only FDA-licensed medications for HIV pre-exposure prophylaxis (PrEP) were daily oral tablets including the HIV drugs tenofovir and emtricitabine. When taken daily as prescribed, these medications are extremely reliable at preventing HIV. Nevertheless, taking a tablet daily while feeling healthy can be tough. Long-acting injectable cabotegravir PrEP is a less regular, more discreet HIV avoidance option that might be preferred for some individuals.

The FDA approval is based on information mostly from 2 NIH-supported scientific trials, HPTN 083 and HPTN 084. The two trials found that both HIV prevention techniques were extremely reliable and safe, but injectable cabotegravir was more effective than daily oral PrEP at preventing HIV acquisition.
The HPTN 083 and HPTN 084 trials were sponsored by NIAID and performed by the NIH-funded HIV Prevention Trials Network (HPTN). NIAID and ViiV Healthcare co-funded both trials; the Bill & & Melinda Gates Foundation also supported HPTN 084. HPTN is co-funded by NIAID, the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of NIH.
NIAID supports and carries out research study– at NIH, throughout the United States, and worldwide– to study the reasons for infectious and immune-mediated illness, and to establish better ways of avoiding, diagnosing and dealing with these illnesses.
About the National Institutes of Health (NIH): NIH, the countrys medical research agency, consists of 27 Institutes and Centers and is an element of the U.S. Department of Health and Human Services. NIH is the main federal firm carrying out and supporting fundamental, medical, and translational medical research study, and is investigating the causes, treatments, and treatments for both typical and rare diseases.