Partial Post-Exposure Protection by Topical Inserts Containing Tenofovir Alafenamide Fumarate/Elvitegravir in a Macaque Model of Rectal Simian HIV (SHIV) Infection

Authors

• Natalia Makarova, Centers for Disease Control and Prevention
• Tyana Singletary, Centers for Disease Control and Prevention
• M. Melissa Peet, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• Kristen Kelley, Centers for Disease Control and Prevention
• Ryan Johnson, Centers for Disease Control and Prevention
• Vivek Agrahari, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• Maria Mendoza, Centers for Disease Control and Prevention
• Yi Pan, Centers for Disease Control and Prevention
• Walid Heneine, Centers for Disease Control and Prevention
• Meredith R. Clark, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• J. Gerardo García Lerma, Macon & Joan Brock Virginia Health Sciences at Old Dominion University
• Gustavo F. Doncel, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• James W. Smith, Centers for Disease Control and Prevention

ORCID

0000-0002-3837-1777 (Agrahari), 0009-0009-9641-1325 (Doncel)

Document Type

Article

Publication Date

2026

DOI

10.1093/infdis/jiaf611

Publication Title

Journal of Infectious Diseases

Volume

233

Issue

4

Pages

e932-e936

Abstract

On-demand topical inserts for HIV prevention may be a good option for people who have a low frequency of sexual activity. We recently demonstrated in a preclinical macaque model that rectal application of inserts containing tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG) conferred protection against SHIV infection (93% efficacy) when applied as pre-exposure prophylaxis 4 hours before SHIV exposure. Here, we show that the same inserts provide significant postexposure protection (82.9% efficacy) when applied 4 hours after SHIV exposure. Our findings further support the ongoing clinical development of TAF/EVG inserts for on-demand HIV prevention.

Rights

This work is written by US Government employees and is in the public domain in the US. Foreign copyright may apply.

Original Publication Citation

Makarova, N., Singletary, T., Peet, M. M., Kelley, K., Johnson, R., Agrahari, V., Mendoza, M., Pan, Y., Heneine, W., Clark, M. R., García-Lerma, J. G., Doncel, G. F., & Smith, J. M. (2026). Partial post-exposure protection by topical inserts containing tenofovir alafenamide fumarate/elvitegravir in a macaque model of rectal simian HIV (SHIV) infection. Journal of Infectious Diseases, 233(4), e932-e936. https://doi.org/10.1093/infdis/jiaf611

Repository Citation

Makarova, N., Singletary, T., Peet, M. M., Kelley, K., Johnson, R., Agrahari, V., Mendoza, M., Pan, Y., Heneine, W., Clark, M. R., García-Lerma, J. G., Doncel, G. F., & Smith, J. M. (2026). Partial post-exposure protection by topical inserts containing tenofovir alafenamide fumarate/elvitegravir in a macaque model of rectal simian HIV (SHIV) infection. Journal of Infectious Diseases, 233(4), e932-e936. https://doi.org/10.1093/infdis/jiaf611