1. Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial
- Author
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Marije van Schalkwyk, Edgar T. Overton, Steven K. Grinspoon, Nagalingeswaran Kumarasamy, Carl J. Fichtenbaum, Janet Lo, Judith A. Aberg, Esteban Martínez, Judith S. Currier, Patrice Desvigne-Nickens, Craig A. Sponseller, Breno Santos, Markella V. Zanni, Sue Siminski, Gerald S. Bloomfield, Pamela S. Douglas, Heather J. Ribaudo, Kathleen Melbourne, Kathleen V. Fitch, Yvetot Joseph, Jorge Leon-Cruz, Carlos Malvestutto, Reprieve Investigators, Emma M Kileel, and Udo Hoffmann
- Subjects
Male ,REPRIEVE ,CD4-CD8 Ratio ,CD4 cell count ,Integrase inhibitor ,Supplement Articles ,HIV Infections ,Logistic regression ,Medical and Health Sciences ,law.invention ,Randomized controlled trial ,law ,Interquartile range ,cardiovascular disease ,Immunology and Allergy ,Randomized Controlled Trials as Topic ,Biological Sciences ,Middle Aged ,Corrigenda ,Infectious Diseases ,Anti-Retroviral Agents ,6.1 Pharmaceuticals ,HIV/AIDS ,Female ,Infection ,Adult ,medicine.medical_specialty ,antiretroviral therapy ,Clinical Trials and Supportive Activities ,Microbiology ,pitavastatin calcium ,statins ,CD4/CD8 ratio ,Clinical Research ,Internal medicine ,REPRIEVE Investigators ,medicine ,Humans ,business.industry ,Prevention ,HIV ,Evaluation of treatments and therapeutic interventions ,CD4 Lymphocyte Count ,Clinical trial ,Regimen ,Good Health and Well Being ,Cross-Sectional Studies ,business ,Body mass index - 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.
- Published
- 2020