The patient must follow certain guidelines, such as seeing a doctor every three months and, most importantly, being consistent, in order for oral drugs that prevent new HIV infection to be effective.
Truvada® and other daily oral antiretrovirals, often known as PrEP (pre-exposure prophylaxis), are very successful at preventing HIV infection, but only if taken as prescribed. When taken inconsistently, Truvada’s effectiveness is significantly reduced.
A twice-yearly injection of Lenacapavir, however, offers a 96% lower risk of infection overall, according to the results of a recent Gilead-funded clinical trial (Purpose-2) conducted by doctors at Emory University and Grady Health System. This makes the injection far more effective than the daily oral PrEP.
Their findings were published in the journal The New England Journal of Medicine.
Seeing these high levels of efficacy – at almost 100% — in an injectable that people only have to take every six months is incredible,
This is a considerable and profound advancement in medicine, especially for people whose circumstances don’t allow them to take a daily oral medication, and for those among populations disproportionately impacted by HIV.
Colleen Kelley
99% of patients in the Lenacapavir group did not contract HIV in the randomized, double-blind, Phase III clinical trial evaluating the effectiveness of the two drugs. Just two of the 2,179 patients in the Lenacapavir group contracted HIV during the trial. This is comparable to nine new HIV infections out of 1,086 individuals in the Truvada®group. According to the experiment, people were more likely to stick with the injection than the daily oral tablet.
What we see over time is that about half of people who start taking daily oral PrEP stop within a year due to various factors,
Having an effective injectable that is only needed twice annually is very significant for people who have trouble accessing healthcare or staying adherent to daily, oral pills.
Colleen Kelley
The clinical trial’s inclusion of volunteers from a variety of racial, ethnic, and gender backgrounds was noteworthy since it represented populations that were disproportionately affected by HIV in real time. For instance, at 88 locations in Peru, Brazil, Argentina, Mexico, South Africa, Thailand, and the United States, the trial groups included both cisgender men and gender nonconforming individuals.
The study concludes that more choices are needed because the same people that are disproportionately affected by HIV are also the ones that have limited access to PrEP or may find it difficult to take the oral antiretroviral drug on a regular basis. According to the analysis, cisgender gay men accounted for over half of all new HIV infections in the country in 2022, with Black or Hispanic people accounting for 70% of these cases.
Having clinical trials that include populations that are truly representative of the patients that Grady serves is crucial, according to Valeria Cantos, MD, associate professor in the School of Medicine at Emory University, doctor at Grady Memorial Hospital, and principal investigator for the clinical trial at the Grady research site.
At Grady, our focus is on increased representation of underserved and vulnerable populations, acknowledging and addressing the distrust towards research held by some community members due to prior abuses or neglect of these populations by research institutions in the past,
Grady is an established, trusted research site because of its commitment to equity.
Valeria Cantos
Bilingual staff workers sought and enrolled trial participants who spoke only Spanish, and medical documents were available in Spanish at the Grady clinical trial site. Additionally, according to Cantos, the site recruited participants that are typical of the groups that Lenacapavir would most effectively help. The clinical experiment was supported by 88 sites, including Grady, the Hope Clinic, and Emory Midtown Hospital.
We are not reaching everyone we need to reach with our current HIV prevention interventions, such as those who are disproportionately impacted by HIV and health care disparities,
For people that are unable to take the daily oral pills, the injectable agents can really give incredible efficacy and be a game changer in helping them stay HIV negative.
Colleen Kelley
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The results of this study add to the armamentarium of novel tools for HIV prevention. Long acting antiretrovirals offer new hope for those who are not able to take oral medications,
The challenge is now to roll out and make these tools available and accessible in an equitable way only then we will see new HIV infections dramatically decreased locally and globally.
Carlos del Rio
Source: Emory University – News
Journal Reference: Kelley, Colleen F et al. “Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons.” The New England journal of medicine, 10.1056/NEJMoa2411858. 27 Nov. 2024, DOI: 10.1056/NEJMoa2411858
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