Matthew L Romo1, Jessie K Edwards2, Aggrey S Semeere3, Beverly S Musick4, Mark Urassa5, Francesca Odhiambo6, Lameck Diero7, Charles Kasozi8, Gad Murenzi9, Patricia Lelo10, Katarzyna Wyka1, Elizabeth A Kelvin1, Annette H Sohn11, Kara K Wools-Kaloustian12, Denis Nash1. 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
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.
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.
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