Statement—NIH Celebrates FDA Approval of Long-Acting Injectable Drug for HIV Prevention

Cross-posted from NIAID Newsroom

Approval Marks Pivotal Expansion of HIV Prevention Options in the United States

Yesterday the U.S. Food and Drug Administration announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months. FDA has approved the medicine for use by adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquiring HIV. This milestone marks a vital expansion of biomedical HIV prevention options available to people in the United States. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, thanks and congratulates everyone who led, conducted and participated in the research that led to this important development.

An estimated 34,800 people in the United States acquired HIV in 2019, the most recent year for which data are available. Men who have sex with men, transgender women who have sex with men, and Black cisgender women are among those disproportionately affected by HIV in this country.

Until today, the only FDA-licensed medications for HIV pre-exposure prophylaxis (PrEP) were daily oral pills containing the HIV drugs tenofovir and emtricitabine. These medications are highly effective at preventing HIV when taken daily as prescribed. However, taking a pill daily while feeling healthy can be challenging. Long-acting injectable cabotegravir PrEP is a less frequent, more discreet HIV prevention option that may be more desirable for some people.

The FDA approval is based on data primarily from two NIH-supported clinical trials, HPTN 083 and HPTN 084. Both trials compared the safety and effectiveness of a PrEP regimen containing long-acting injectable cabotegravir with a regimen of daily oral PrEP. HPTN 083 enrolled more than 4,500 cisgender men who have sex with men and transgender women who have sex with men in Argentina, Brazil, Peru, South Africa, Thailand, the United States and Vietnam. HPTN 084 enrolled more than 3,200 cisgender women in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda and Zimbabwe. The two trials found that both HIV prevention methods were safe and highly effective, 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 conducted 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.