Recent Breakthroughs in HIV Research

Key Takeaways

Thanks to recent strides in human immunodeficiency virus (HIV) research, the prevention and treatment of this deadly infection have entered a period of remarkable innovation. In the past two years, researchers and regulators have advanced novel therapeutic modalities, long-acting formulations, and vaccine strategies that could dramatically reshape the future of HIV care. For healthcare professionals, these developments underscore the importance of staying current through accredited HIV continuing education and CME opportunities. The following overview highlights recent breakthroughs from the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and leading peer-reviewed journals such as The New England Journal of Medicine (NEJM), Science, and Nature Immunology.

Research & Breakthroughs

The FDA approved subcutaneous lenacapavir (brand: Yeztugo) for HIV pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35 kg, establishing the first twice-yearly PrEP option in the U.S. (capsid inhibitor class). See the FDA approval letter and prescribing information for details on indication, dosing, and boxed warnings.

The NEJM reported that twice-yearly lenacapavir prevented HIV acquisition with very high efficacy in men who have sex with men and gender-diverse individuals (PURPOSE 2), complementing earlier data in cisgender women.

NIH summarized randomized data showing LAI cabotegravir/rilpivirine superior to oral ART among people with prior adherence barriers; Clinical Infectious Diseases reported real-world outcomes supporting effectiveness in this population.

Two Phase I trials (IAVI G002/G003) showed mRNA-encoded nanoparticles can reliably activate broadly neutralizing antibody (bnAb) precursor B cells, validating a long-pursued vaccine strategy and mapping a stepwise immunization pathway.

A first-in-human trial demonstrated robust VRC01-class responses in blood and lymph nodes after germline-targeting immunization, strengthening the biologic plausibility of multi-step bnAb vaccine regimens.

The National Institute of Allergy and Infectious Diseases reviewed the expanding role of broadly neutralizing antibodies for HIV cure, remission, and treatment strategies, including their capacity to neutralize diverse variants and enhance immune responses.

The Centers for Disease Control and Prevention’s clinician guidance synthesizes practical steps for oral and long-acting PrEP delivery (screening, follow-up, sexually transmitted infection management). The World Health Organization’s guideline recommends LAI cabotegravir as an additional option for populations at substantial risk, with implementation considerations.

Phase III data presented at CROI 2025 evaluated switching virologically suppressed patients to doravirine/islatravir vs. continuing standard regimens, reporting non-inferiority; peer-reviewed publication is pending, but trial synopses in The Lancet HIV summarize key findings.

This NEJM perspective highlights the rapid advance of long-acting antiretrovirals for both prevention and treatment while flagging equity and access as decisive determinants of public-health impact. 

Recap 

The past two years of HIV research have ushered in transformative advances in medicine, from twice-yearly PrEP and LAIs to vaccine priming and antibody-based HIV cure research. These achievements demonstrate not only scientific progress but also renewed momentum toward ending the HIV epidemic. For clinicians, staying informed through accredited HIV CME programs ensures readiness to integrate new therapies into practice, improve adherence and prevention strategies, and deliver equitable, stigma-free care to all patients.