For oral medications that prevent a new HIV infection to be effective, the patient must take certain steps, including attending doctor visits every three months and, most importantly, being consistent.
These daily oral antiretrovirals, more commonly known as PrEP (pre-exposure prophylaxis), such as Truvada®, are extremely effective for HIV prevention, but only if taken daily as directed. Truvada’s effectiveness is greatly compromised when taken inconsistently.
However, results from a recent Gilead-funded clinical trial (Purpose-2) led by physicians at Emory University and Grady Health System indicate that a twice-yearly injection of Lenacapavir offers a 96% reduction in the risk of infection in overall, making the injection significantly safer. more effective than daily oral PrEP. The findings were recently published in the New England Journal of Medicine.
“Seeing these high levels of efficacy (almost 100%) in an injectable that people only have to take every six months is incredible,” says Colleen Kelley, MD, lead author of the study and professor at Emory University School of Medicine. . “This is a considerable and profound advance in medicine, especially for people whose circumstances do not allow them to take a daily oral medication, and for those who belong to populations disproportionately affected by HIV.”
In the randomized, double-blind, phase III clinical trial comparing the effectiveness of the two drugs, 99% of participants in the lenacapavir group did not develop an HIV infection. During the trial, only two participants in the Lenacapavir group, consisting of 2,179 people, contracted HIV. This compares with nine new HIV infections in the Truvada group, which had 1,086 people. The trial showed that adherence to the injectable was greater than that to the daily oral pill.
Kelley, also co-director of the Emory Center for AIDS Research and Associate Dean for Emory Research at Grady, adds that while PrEP is incredibly effective at preventing infections, part of what made the shot more effective in the clinical trial were the challenges. associated with compliance with a daily oral pill.
“What we see over time is that about half of the people who start taking oral PrEP daily stop taking it within a year due to a variety of factors,” Kelley says, referring to disparities in health care in general. . “Having an effective injectable that is only needed twice a year is very important for people who have trouble accessing health care or complying with daily oral pills.”
The inclusion of racially, ethnically, and gender diverse participants in the clinical trial was notable because it was representative of populations disproportionately affected by HIV in real time. For example, test groups were composed of cisgender men and gender diverse people at 88 sites in Peru, Brazil, Argentina, Mexico, South Africa, Thailand, and the United States.
According to the study, the same populations that are disproportionately affected by HIV are the same populations that have limited access to PrEP (or may have difficulty consistently taking oral antiretroviral medications), which ultimately highlights the need for more options. The study also indicates that more than half of new HIV infections nationwide in 2022 occurred among cisgender gay men, and 70% of them among black or Hispanic people.
Valeria Cantos, MD, associate professor at Emory University School of Medicine, physician at Grady Memorial Hospital, and principal investigator of the clinical trial at the Grady research site, emphasized the importance of having trials that include truly representative populations of the patients. which Grady serves.
“At Grady, our focus is on greater representation of vulnerable and underserved populations, recognizing and addressing the mistrust of research that some community members have due to past abuse or neglect of these populations by research institutions in the past. “says Cantos. “Grady is an established and trusted research site because of its commitment to equity.”
At the Grady clinical trial site, medical materials were available in Spanish, and bilingual staff members recruited and enrolled Spanish-only trial participants. Cantos also indicated that the site enrolled participants who are representative of the populations that would benefit most from Lenacapavir. In addition to Grady, Hope Clinic and Emory Midtown Hospital were among the 88 sites that supported the clinical trial.
“We are not reaching all the people we need to reach with our current HIV prevention interventions, such as those who are disproportionately affected by HIV and health care disparities,” Kelley says. “For people who can’t take daily oral pills, injectable agents can really provide incredible efficacy and be a game-changer in helping them stay HIV negative.”
Since the Phase III clinical trial has been completed and submitted to the FDA for consideration, Kelley is hopeful that Lenacapavir can be approved by 2025 for commercial use.
“”The results of this study add to the arsenal of novel tools for HIV prevention. Long-acting antiretrovirals offer new hope for those who cannot take oral medications,” says Dr. Carlos del Río, chair of the Department of Medicine at Emory University School of Medicine. “The challenge now is to implement and manufacture these tools. available and accessible equitably, only then will we see a dramatic decline in new HIV infections locally and globally,” adds del Río, also co-director of the Emory Center for AIDS Research.