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NIH to test long-acting injectable HIV PrEP regimen in women
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An NIH-sponsored phase 3 trial will evaluate long-acting cabotegravir for the prevention of HIV in sexually active women, according to a press release.
The study, HPTN 084, is the first large-scale clinical trial of a long-acting injectable medication for HIV pre-exposure prophylaxis (PrEP) in sexually active women, the NIH said. HPTN 084 will be conducted in sub-Saharan Africa and will evaluate the safety and efficacy of injectable cabotegravir compared with daily oral Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences; TDF/FTC), the only regimen currently licensed for HIV PrEP.
“This new study, driven by African women scientists and volunteers, is testing the efficacy of a new HIV prevention tool for women who need more options for protection,” Anthony S. Fauci, MD, director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), said in a statement. “Taking a daily pill can be challenging for some people. For some women, a long-acting injectable form of protection may be an easier, more desirable and discreet alternative.”
Cabotegravir is an investigational integrase strand transfer inhibitor that ViiV Healthcare is developing for HIV treatment and prevention. The company is currently evaluating a long-acting formulation for intramuscular injection. Last December, the company announced the start of a complementary study, HPTN 083, that compares injectable cabotegravir to TDF/FTC in HIV-uninfected men who have sex with men and transgender women who have sex with men.
According to ViiV, HPTN researchers seek to enroll 3,200 women aged 18 to 45 years from sub-Saharan African countries. The trial is being conducted through a public-private funding collaboration between ViiV, the NIAID and the Bill and Melinda Gates Foundation. Study medications are being provided by ViiV and Gilead.
For more information:
Evaluating the safety and efficacy of long-acting injectable cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women. https://clinicaltrials.gov/show/NCT03164564.
Disclosure: Fauci reports no relevant financial disclosures.