Carl J Fichtenbaum1, Heather J Ribaudo2, Jorge Leon-Cruz2, Edgar T Overton3, Markella V Zanni4, Carlos D Malvestutto5, Judith A Aberg6, Emma M Kileel4, Kathleen V Fitch4, Marije Van Schalkwyk7, Nagalingeswaran Kumarasamy8, Esteban Martinez9, Breno Riegel Santos10, Yvetot Joseph11, Janet Lo4, Sue Siminski12, Kathleen Melbourne13, Craig A Sponseller14, Patrice Desvigne-Nickens15, Gerald S Bloomfield16, Judith S Currier17, Udo Hoffmann18, Pamela S Douglas19, Steven K Grinspoon4. 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
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.
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.
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