One of the strategies that are proving effective in preventing the transmission of HIV, the virus that causes AIDS, is the so-called pre-exposure prophylaxis (PrEP). PrEP involves taking a daily pill of antiretroviral medications, such as Truvadato reduce the risk of contracting HIV. It is highly effective if taken correctly, reducing the risk of infection by 99%. It is recommended for people at high risk of exposure to HIV, such as those with HIV-positive partners or those who engage in unprotected sexual practices.
However, its effectiveness decreases considerably when it is not taken consistently.
To alleviate this situation, the use of other guidelines has been tested, requiring less compliance on the part of the patient. One of them is the biannual injection of a medication, lenacapavirwhose data are presented in a study published in ‘The New England Journal of Medicine‘.
The clinical trial financed by the pharmaceutical company Gilead (Purpose-2), led by doctors from the Emory University and the Grady Health Systemindicate that a biannual injection of this drug offers a 96% reduction in the risk of infection, making it more effective than oral PrEP.
For Colleen Kelleylead author of the study and professor at Emory University School of Medicine, “This is a considerable and profound advance in medicine.especially for those whose circumstances do not allow them to take a daily oral medication, as well as for populations most affected by HIV.
In this phase III clinical trial, 99% of participants in the lenacapavir group did not contract HIV, and only two infections occurred in a total of 2,179 people. In comparison, nine infections were recorded in the PrEP group (1,086 people). The study also showed a greater adhesion to the injection than to the daily pill.
According to Kelley, the injection is more effective, as many people abandon oral PrEP due to the difficulty of adhering to a daily treatment. The shot, given only twice a year, is especially helpful for those with limited access to health care.
The inclusion of racially, ethnically, and gender diverse participants in the trial was key, as it represented the populations most affected by HIV.
Ethnic variety
The trial groups were composed of cisgender men and gender diverse people in 88 locations in Peru, Brazil, Argentina, Mexico, South Africa, Thailand and the US.
According to the work, the same populations that are disproportionately affected by HIV are those with limited access to PrEP or they may have difficulty taking antiretroviral medication consistently, underscoring the need for more options.
Valeria Cantos, principal investigator of the clinical trial at Grady, highlighted the importance of conducting trials that include populations that are truly representative of the patients Grady cares for.
“We are not reaching all the people we need to reach with current HIV prevention interventions,” Kelley says. For those who cannot take daily pills, injectable drugs can really offer incredible effectiveness and be a game changer in helping them stay HIV negative.”
Since the phase III clinical trial has been completed and submitted to the US health authorities (FDA) for consideration, Kelley expects Lenacapavir to be approved for commercial use in 2025.
The challenge, says Carlos del Río, from Emory University, “is to implement and make available these tools equitably; “Only then will we see a dramatic decline in new HIV infections, both locally and globally.”
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