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NIH Record - National Institutes of Health

NIH Celebrates FDA Approval of Injectable Drug for HIV Prevention

Enlarged view of HIV-infected H9 T cell

Scanning electron micrograph of an HIV-infected H9 T cell

Photo: NIAID

The FDA recently approved a long-acting HIV prevention medication. Developed by ViiV Healthcare, cabotegravir is injected once every 2 months. FDA has approved the medicine for use by adults and adolescents weighing at least 77 pounds who are at risk of sexually acquiring HIV. 

This milestone marks a vital expansion of available biomedical HIV prevention options. An estimated 34,800 people in the U.S. 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, which remain a highly effective option. Long-acting injectable cabotegravir PrEP is a less frequent, more discreet HIV prevention option.

The FDA approval is based on data primarily from two NIH-supported clinical trials, HPTN 083 and HPTN 084, each conducted in multiple countries. 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. HPTN 084 enrolled more than 3,200 cisgender women. 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.

Both trials were sponsored by NIAID and ViiV Healthcare, and conducted by the NIH-funded HIV Prevention Trials Network (HPTN). The Bill & Melinda Gates Foundation also supported HPTN 084.

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