Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial
Author:
Fichtenbaum Carl J1ORCID, Ribaudo Heather J2, Leon-Cruz Jorge2, Overton Edgar T3, Zanni Markella V4, Malvestutto Carlos D5, Aberg Judith A6, Kileel Emma M4, Fitch Kathleen V4, Van Schalkwyk Marije7, Kumarasamy Nagalingeswaran8, Martinez Esteban9, Santos Breno Riegel10, Joseph Yvetot11, Lo Janet4, Siminski Sue12, Melbourne Kathleen13, Sponseller Craig A14, Desvigne-Nickens Patrice15, Bloomfield Gerald S16, Currier Judith S17, Hoffmann Udo18, Douglas Pamela S19, Grinspoon Steven K4, Curran Adrian, Baranauskas Adrienne, Wilkin Aimee, Abrams-Downey Alexandra J, Eckard Allison Ross, Wurcel Alysse G, González-Cordón Ana, Paez Armando, Sha Beverly E, Santos Breno, Yoshida Carina Beppu, Rolle Charlotte-Paige, Somboonwit Charurut, Funk Connie, Gómez-Ayerbe Cristina, Frank Cynthia, Nixon Daniel E, Skiest Daniel J, Choi David, Mushatt David M, Rial-Crestelo David, Perez Deborah K, Burke Deirdre J, dos Santos Desirée V G, Jayaweera Dushyantha T, Gardner Edward M, DeJesus Edwin, Connick Elizabeth, Lam Emerline G, Hecker Emily J, Kallas Esper G, Martinez Esteban, Waters Evan, Rhame Frank, Sattler Fred R, Wang Gary P, Enrile Seedhom Helen May, Tavares Isabel C F, Stapleton Jack T, Bennet Jaclyn, Brock James B, Scott James, Forcht Janet, Lama Javier R, Valencia Javier, Brumfield Jennifer K, Brumfield Jennifer K, Portilla Joaquin, Kumar Jonathan, Navarro Jordi, Pinto Jorge A, Castro Jose G, Bernardino Jose I, Casado Jose L, Madruga José Valdez, Baraiaetxaburu Josu, Berenguer Juan, Aberg Judith A, Currier Judith S, Tashima Karen T, Ho Ken, Costa Laura V L, Perez Latorre Leire, Mohapi Lerato, López-González L, Fantry Lori E, Domínguez-Domínguez Lourdes, Martín-Carbonero Luz, Cornelissen Lynne M, Jain Mamta K, Masiá Mar, Lacerda Marcus V G, Saumoy Maria, Van Schalkwyk Marije, Villalobos-Hernández Marina, Mall Mark, Kubat Maureen E, Carreres Melissa, Frank Michael, Kozal Michael J, De la Peña Mireia, Salomon Nadim, Kumarasamy Nagalingeswaran, Kosashunhanan Natapol, Mogashoa Ntebo D, Lance Okeke Nwora, Mukwekwerere Pamela G, Sugandhavesa Patcharaphan, Vizcarra Pilar, Kumar Princy N, Weinman Renee, Novak Richard M, Chaudhary Rina, Dawson Rodney, Bedimo Roger, Chinchay Romina, Pillay Sandy, Bares Sara H, Badal-Faesen Sharlaa, Walmsley Sharon L, Perez-Frontera Sigrid, Middleton Sondra, Mayer Stockton, Adams Suzanne L, Lalloo Umesh G, Estrada Vicente, Watson Vicky, Chiang Victor, Curran Adrian, Baranauskas Adrienne, Wilkin Aimee, Abrams-Downey Alexandra J, Eckard Allison Ross, Wurcel Alysse G, González-Cordón Ana, Paez Armando, Sha Beverly E, Santos Breno, Yoshida Carina Beppu, Rolle Charlotte-Paige, Somboonwit Charurut, Funk Connie, Gómez-Ayerbe Cristina, Frank Cynthia, Nixon Daniel E, Skiest Daniel J, Choi David, Mushatt David M, Rial-Crestelo David, Perez Deborah K, Burke Deirdre J, dos Santos Desirée V G, Jayaweera Dushyantha T, Gardner Edward M, DeJesus Edwin, Connick Elizabeth, Lam Emerline G, Hecker Emily J, Kallas Esper G, Martinez Esteban, Waters Evan, Rhame Frank, Sattler Fred R, Wang Gary P, Enrile Seedhom Helen May, Tavares Isabel C F, Stapleton Jack T, Bennet Jaclyn, Brock James B, Scott James, Forcht Janet, Lama Javier R, Valencia Javier, Brumfield Jennifer K, Brumfield Jennifer K, Portilla Joaquin, Kumar Jonathan, Navarro Jordi, Pinto Jorge A, Castro Jose G, Bernardino Jose I, Casado Jose L, Madruga José Valdez, Baraiaetxaburu Josu, Berenguer Juan, Aberg Judith A, Currier Judith S, Tashima Karen T, Ho Ken, Costa Laura V L, Perez Latorre Leire, Mohapi Lerato, López-González L, Fantry Lori E, Domínguez-Domínguez Lourdes, Martín-Carbonero Luz, Cornelissen Lynne M, Jain Mamta K, Masiá Mar, Lacerda Marcus V G, Saumoy Maria, Van Schalkwyk Marije, Villalobos-Hernández Marina, Mall Mark, Kubat Maureen E, Carreres Melissa, Frank Michael, Kozal Michael J, De la Peña Mireia, Salomon Nadim, Kumarasamy Nagalingeswaran, Kosashunhanan Natapol, Mogashoa Ntebo D, Lance Okeke Nwora, Mukwekwerere Pamela G, Sugandhavesa Patcharaphan, Vizcarra Pilar, Kumar Princy N, Weinman Renee, Novak Richard M, Chaudhary Rina, Dawson Rodney, Bedimo Roger, Chinchay Romina, Pillay Sandy, Bares Sara H, Badal-Faesen Sharlaa, Walmsley Sharon L, Perez-Frontera Sigrid, Middleton Sondra, Mayer Stockton, Adams Suzanne L, Lalloo Umesh G, Estrada Vicente, Watson Vicky, Chiang Victor,
Affiliation:
1. Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA 2. Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA 3. Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA 4. Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA 5. Division of Infectious Diseases, Ohio State University Medical Center, Columbus, Ohio, USA 6. Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA 7. Family Centre for Research with Ubuntu, Division of Adult Infectious Diseases, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa 8. Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, India 9. Hospital Clinic and University of Barcelona, Barcelona, Spain 10. Infectious Diseases Service, Hospital Nossa, Senhora da Conceição/GHC, Porto Alegre, Brazil 11. Les Centres GHESKIO, Port-au-Prince, Haiti 12. Frontier Science and Technology Foundation, Amherst, Massachusetts, USA 13. HIV Medical Sciences, Gilead Sciences, Foster City, California, USA 14. Kowa Pharmaceuticals America, Montgomery, Alabama, USA 15. National Heart, Lung and Blood Institute, Baltimore, Maryland, USA 16. Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA 17. Division of Infectious Diseases, University of California-Los Angeles, Los Angeles, California, USA 18. Cardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA 19. Duke University Medical Center, Durham, North Carolina, USA
Abstract
Abstract
Background
Patterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.
Methods
The REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40–75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.
Results
A total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45–55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447–826/ µ L), and the median duration of prior ART use, 9.5 years (5.3–14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.
Conclusions
There were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.
Clinical Trials Registration
NCT02344290.
Funder
National Institutes of Health National Heart, Lung, and Blood Institute National Institute of Allergy and Infectious Diseases
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Immunology and Allergy
Cited by
10 articles.
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