A staggering 36.7 million people worldwide are living with HIV
, a virus that targets CD4 cells in the body that help the immune system fight off a number of harmful infections. Once an individual acquires HIV, the individual has it for life, which is why preventive measures are so crucial, particularly for high risk populations. However, an announcement made by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) may bring a game-changer in the fight against HIV.
The first large-scale Phase III clinical trial of cabotegravir, an injectable drug designed to deliver effective HIV prevention, was launched on Tuesday, according to a press release
. With this study, researchers hope to find out if long-acting cabotegravir—to be injected once every 8 weeks—is as effective as Truvada in preventing HIV in men who have sex with men (MSM) and transgender women who have sex with men.
Currently, Truvada—comprised of the drugs emtricitabine and tenofovir disoproxil fumarate—is “the only licensed PrEP regimen” to which individuals are required to receive each day in the form of an oral tablet. With this study, researchers hope to provide another preventive option for those at risk that may be easier to adhere to than Truvada.
In the press release, Anthony S. Fauci, MD, director of NIAID, said, “We urgently need more HIV prevention tools that fit easily into people’s lives. Although daily oral Truvada clearly works for HIV prevention, taking a daily pill while feeling healthy can be difficult for some people. If proven effective, injectable cabotegravir has the potential to become an acceptable, discreet and convenient alternative for HIV prevention.”
The study, dubbed HPTN 083, is the result of a collaborative effort between: NIAID, ViiV Healthcare, Gilead Sciences, Inc., and the HIV Prevention Trials Network (HPTN). HPTN 083 will enroll 4,500 high-risk MSM and transgender women who have sex with men, aged 18 or older. The participants will come from 45 sites in Argentina, Brazil, India, Peru, South Africa, Thailand, the United States, and Vietnam. Researchers estimate that the results of the study will be available in 2021.