Cabotegravir Maintains Protective Efficacy in the Setting of Bacterial Sexually Transmitted Infections: A Secondary Analysis of HPTN 083

Meredith E Clement¹, Brett Hanscom², Daniel Haines³, Jose A Bazan⁴, Nuntisa Chotirosniramit⁵, Ryan Kofron⁶, Sharon Mannheimer⁷, Kenneth H Mayer⁸, Mayara Secco Torres Silva⁹, Lydia Soto-Torres¹⁰, Alex R Rinehart¹¹, James F Rooney¹², Andrea Jennings¹³, Kailazarid Gomez-Feliciano¹³, Marybeth McCauley¹³, Beatriz Grinsztejn⁹, Raphael J Landovitz⁶; for HPTN 083 Study Team

Collaborators, Affiliations

Collaborators

for HPTN 083 Study Team:
Sue Ellen Abdalian, Roberto C Arduino, Jose Bazan, Juan Carlos Hinojosa Boyer, Robinson Cabello, Suwat Chariyalertsak, Jesse Clark, Carlos Del Rio, Eileen F Dunne, Carl Fichtenbaum, Ian Frank, Julie Franks, Jorge A Gallardo-Cartagena, Aditya Gaur, Pedro Gonzales, Beatriz Grinsztejn, Roy Gulick, Tran Viet Ha, Christopher Hall, Javier Antonio Valencia Huamani, Christopher Hurt, Jessica Justman, Esper G Kallas, Colleen Kelley, Raphael J Landovitz, Albert Liu, Marcelo H Losso, José Valdez Ramalho Madruga, Manya Magnus, Kenneth Mayer, Keren Middelkoop, Richard Novak, E Turner Overton, Temitope Oyedele, Nittaya Phanuphak, Rachel Presti, Daniel Reirden, Anne Rompalo, Breno Riegel Santos, Omar Sued, Shobha Swaminathan, Cornelius van Dam

Affiliations

¹ Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
² Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
³ Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
⁴ Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
⁵ Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.
⁶ Department of Medicine, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California, USA.
⁷ Department of Medicine, Columbia University, NewYork, New York, USA.
⁸ Department of Medicine, Fenway Health and Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, USA.
⁹ STI/HIV Clinical Research Laboratory, Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro, Brazil.
¹⁰ Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
¹¹ Research and Development, ViiV Healthcare, London, UK.
¹² Medical Affairs, Gilead Sciences, Inc, Foster City, California, USA.
¹³ Network and Collaborative Research Division, FHI 360, Washington D.C., USA.

PMID: 39579334
DOI: 10.1093/cid/ciae572

Cabotegravir Maintains Protective Efficacy in the Setting of Bacterial Sexually Transmitted Infections: A Secondary Analysis of HPTN 083

Meredith E Clement et al. Clin Infect Dis. 2026.

. 2026 Feb 25;82(2):e387-e395.

doi: 10.1093/cid/ciae572.

Authors

Collaborators

for HPTN 083 Study Team:
Sue Ellen Abdalian, Roberto C Arduino, Jose Bazan, Juan Carlos Hinojosa Boyer, Robinson Cabello, Suwat Chariyalertsak, Jesse Clark, Carlos Del Rio, Eileen F Dunne, Carl Fichtenbaum, Ian Frank, Julie Franks, Jorge A Gallardo-Cartagena, Aditya Gaur, Pedro Gonzales, Beatriz Grinsztejn, Roy Gulick, Tran Viet Ha, Christopher Hall, Javier Antonio Valencia Huamani, Christopher Hurt, Jessica Justman, Esper G Kallas, Colleen Kelley, Raphael J Landovitz, Albert Liu, Marcelo H Losso, José Valdez Ramalho Madruga, Manya Magnus, Kenneth Mayer, Keren Middelkoop, Richard Novak, E Turner Overton, Temitope Oyedele, Nittaya Phanuphak, Rachel Presti, Daniel Reirden, Anne Rompalo, Breno Riegel Santos, Omar Sued, Shobha Swaminathan, Cornelius van Dam

Affiliations

¹ Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
² Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
³ Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
⁴ Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
⁵ Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.
⁶ Department of Medicine, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California, USA.
⁷ Department of Medicine, Columbia University, NewYork, New York, USA.
⁸ Department of Medicine, Fenway Health and Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, USA.
⁹ STI/HIV Clinical Research Laboratory, Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro, Brazil.
¹⁰ Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
¹¹ Research and Development, ViiV Healthcare, London, UK.
¹² Medical Affairs, Gilead Sciences, Inc, Foster City, California, USA.
¹³ Network and Collaborative Research Division, FHI 360, Washington D.C., USA.

PMID: 39579334
DOI: 10.1093/cid/ciae572

Abstract

Background: Sexually transmitted infections (STIs) have been shown to facilitate human immunodeficiency virus (HIV) transmission and acquisition. HPTN 083, a global clinical trial, demonstrated superiority of long-acting cabotegravir (CAB-LA) versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for HIV prevention among transgender women and cisgender men who have sex with men. This analysis assessed whether CAB-LA maintained protective efficacy when bacterial STIs (syphilis, rectal/urethral gonorrhea, and chlamydia) were present.

Methods: STI events per 100 person-years were calculated, including by subgroups (age, race/ethnicity, gender, education, treatment arm, drug use, alcohol use, region/country, condom usage, partner number, marital status, baseline STI). Association between baseline factors and STI incidence was modeled using Poisson regression. Cox proportional hazards modeling with STI status as a time-varying covariate was used to evaluate potential interactions between STI status and the relative efficacy of CAB-LA versus TDF/FTC.

Findings: Among 3859 participants, overall STI incidence rate was 50.7 infections/100 person-years. STIs were diagnosed in 1562 (40.5%) participants; 79% of STIs occurred in 25% of the participants. STI incidence was not different by preexposure prophylaxis arm. In the final multivariable model, age, region, race, education level, marital status, and baseline STI were associated with incident STI (P < .05). HIV incidence was lower with CAB-LA versus TDF/FTC with or without STIs (hazard ratios 0.37 and 0.31, respectively), with no significant interaction between STIs and the HR for HIV incidence (P = .75).

Conclusions: In a large preexposure prophylaxis trial with high STI incidence, CAB-LA maintained robust protective efficacy relative to TDF/FTC in the setting of bacterial STIs.

Keywords: CAB-LA; HIV prevention; bacterial sexually transmitted infections; efficacy; long-acting PrEP.

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Conflict of interest statement

Potential conflicts of interest . M. E. C. reports research grants from Gilead Sciences and ViiV Healthcare, and consulting fees from ViiV Healthcare and FHI360. J. A. B. reports receiving consulting fees from Gilead Sciences. K. H. M. reports research grants from Gilead Sciences, ViiV Healthcare, and Merck, and serving on advisory boards for Gilead Sciences, ViiV Healthcare, and Merck. A. R. R. reports being an employee of and holding stock interest in ViiV Healthcare. J. F. R. reports being an employee of and holding stock interest in Gilead Sciences. B. G. reports receiving consulting fees from Gilead Sciences, Merck, and ViiV Healthcare. R. J. L. reports receiving consulting fees from Gilead Sciences, RedQueen Therapeutics, Merck, and ViiV Healthcare. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. HPTN 083 Study Team Members. Sue Ellen Abdalian (New Orleans Adolescent Trials Unit CRS, USA); Roberto C. Arduino (Houston AIDS Research Team (HART) CRS, USA); Jose Bazan (Ohio State University CRS, USA); Juan Carlos Hinojosa Boyer (Association Civil Selva Amazonica (ACSA) CRS, Peru); Robinson Cabello (Via Libre CRS, Peru); Suwat Chariyalertsak (CMU HIV Prevention CRS, Thailand); Jesse Clark (UCLA Vine Street Clinic CRS, USA); Carlos del Rio (Ponce de Leon Center CRS, USA); Eileen F. Dunne (Silom Community Clinic CRS, Thailand); Carl Fichtenbaum (Cincinnati CRS, USA); Ian Frank (Penn Prevention CRS, USA); Julie Franks (Harlem Prevention Center CRS, USA); Jorge A. Gallardo-Cartagena (CITBM CRS, Peru); Aditya Gaur (St. Jude Children's Research Hospital CRS, USA); Pedro Gonzales (San Miguel CRS, Peru); Beatriz Grinsztejn (IPEC CRS, Brazil); Roy (Trip) Gulick (Weill Cornell Chelsea CRS, USA); Tran Viet Ha (Yen Hoa Health Clinic CRS, Vietnam); Christopher Hall (East Bay AIDS Center (EBAC) CRS, USA); Javier Antonio Valencia Huamani (Barranco CRS, Peru); Christopher Hurt (Chapel Hill CRS, USA); Jessica Justman (Bronx Prevention Research Center CRS, USA); Esper G. Kallas (Centro de Pesquisas Clínicas IC-HCFMUSP CRS, Brazil); Colleen Kelley (Hope Clinic of the Emory Vaccine Center CRS, USA); Raphael J. Landovitz (UCLA Care Center CRS, USA); Albert Liu (Bridge HIV CRS, USA); Marcelo H. Losso (Hospital JM Ramos Mejia CRS, Argentina); José Valdez Ramalho Madruga (Centro Referencia e Trienamento DST/AIDS CRS, Brazil); Manya Magnus (George Washington University CRS, USA); Kenneth Mayer (Fenway Health (FH) CRS, USA); Keren Middelkoop (Groote Schuur HIV CRS, South Africa); Richard Novak (UIC Project WISH CRS, USA); E. Turner Overton (Alabama CRS, USA); Temitope Oyedele (AYAR at CORE CRS, USA); Nittaya Phanuphak (Thai Red Cross AIDS Research Centre (TRCARC) CRS, Thailand); Rachel Presti (Washington University Therapeutics (WT) CRS, USA); Daniel Reirden (Children's Hospital Colorado CRS, USA); Anne Rompalo (Johns Hopkins University CRS, USA); Breno Riegel Santos (Hospital Nossa Senhora da Conceição CRS, Brazil); Omar Sued (Fundación Huésped CRS, Argentina); Shobha Swaminathan (New Jersey Medical School CRS, USA); Cornelius van Dam (Greensboro CRS, USA); Hong Van Tieu (New York Blood Center CRS, USA).

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Cabotegravir Maintains Protective Efficacy in the Setting of Bacterial Sexually Transmitted Infections: A Secondary Analysis of HPTN 083

Collaborators

Affiliations

Cabotegravir Maintains Protective Efficacy in the Setting of Bacterial Sexually Transmitted Infections: A Secondary Analysis of HPTN 083

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Grants and funding

LinkOut - more resources

Full Text Sources

Miscellaneous