Viral Load Status Before Switching to Dolutegravir-Containing Antiretroviral Therapy and Associations With Human Immunodeficiency Virus Treatment Outcomes in Sub-Saharan Africa

Author:

Romo Matthew L1,Edwards Jessie K2,Semeere Aggrey S3,Musick Beverly S4,Urassa Mark5,Odhiambo Francesca6,Diero Lameck7,Kasozi Charles8,Murenzi Gad9,Lelo Patricia10,Wyka Katarzyna1,Kelvin Elizabeth A1,Sohn Annette H11,Wools-Kaloustian Kara K12,Nash Denis1,

Affiliation:

1. Department of Epidemiology and Biostatistics & Institute for Implementation Science in Population Health, CUNY Graduate School of Public Health and Health Policy, City University of New York, New York, New York, USA

2. Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

3. Infectious Diseases Institute, Makerere University, Kampala, Uganda

4. Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, Indiana, USA

5. National Institute for Medical Research, Mwanza, Tanzania

6. Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya

7. School of Medicine, College of Health Sciences, Moi University, Eldoret, Kenya

8. Masaka Regional Referral Hospital, Masaka, Uganda

9. Rwanda Military Hospital, Kigali, Rwanda

10. Kalembelembe Pediatric Hospital, Kinshasa, Democratic Republic of the Congo

11. TREAT Asia, amfAR–The Foundation for AIDS Research, Bangkok, Thailandand

12. Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA

Abstract

Abstract Background Dolutegravir is being rolled out globally as part of preferred antiretroviral therapy (ART) regimens, including among treatment-experienced patients. The role of viral load (VL) testing before switching patients already on ART to a dolutegravir-containing regimen is less clear in real-world settings. Methods We included patients from the International epidemiology Databases to Evaluate AIDS consortium who switched from a nevirapine- or efavirenz-containing regimen to one with dolutegravir. We used multivariable cause-specific hazards regression to estimate the association of the most recent VL test in the 12 months before switching with subsequent outcomes. Results We included 36 393 patients at 37 sites in 5 countries (Democratic Republic of the Congo, Kenya, Rwanda, Tanzania, Uganda) who switched to dolutegravir from July 2017 through February 2020, with a median follow-up of approximately 11 months. Compared with those who switched with a VL <200 copies/mL, patients without a recent VL test or with a preswitch VL ≥1000 copies/mL had significantly increased hazards of an incident VL ≥1000 copies/mL (adjusted hazard ratio [aHR], 2.89; 95% confidence interval [CI], 1.99–4.19 and aHR, 6.60; 95% CI, 4.36–9.99, respectively) and pulmonary tuberculosis or a World Health Organization clinical stage 4 event (aHR, 4.78; 95% CI, 2.77–8.24 and aHR, 13.97; 95% CI, 6.62–29.50, respectively). Conclusions A VL test before switching to dolutegravir may help identify patients who need additional clinical monitoring and/or adherence support. Further surveillance of patients who switched to dolutegravir with an unknown or unsuppressed VL is needed.

Funder

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Cancer Institute

National Institute on Drug Abuse

National Heart, Lung, and Blood Institute

National Institute on Alcohol Abuse and Alcoholism

National Institute of Diabetes and Digestive and Kidney Diseases

Fogarty International Center

National Library of Medicine

Office of the Director

Harmonist project

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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