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. 2022 Sep 10;75(4):630-637.
doi: 10.1093/cid/ciab1006.

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

Matthew L Romo  1 , Jessie K Edwards  2 , Aggrey S Semeere  3 , Beverly S Musick  4 , Mark Urassa  5 , Francesca Odhiambo  6 , Lameck Diero  7 , Charles Kasozi  8 , Gad Murenzi  9 , Patricia Lelo  10 , Katarzyna Wyka  1 , Elizabeth A Kelvin  1 , Annette H Sohn  11 , Kara K Wools-Kaloustian  12 , Denis Nash  1 ; International epidemiology Databases to Evaluate AIDS (IeDEA)
Affiliations

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

Matthew L Romo et al. Clin Infect Dis. .

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.

Keywords: HIV integrase inhibitors; antiretroviral agents; clinical decision-making; prognosis; viral load.

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Conflict of interest statement

Potential conflicts of interest. M. L. R. reports salary support with payments made directly to self from the CUNY Institute for Implementation Science in Population Health during the conduct of this study. J. K. E. reports support from the NIH NIAID during the conduct of this study, grants from NIH National Institute of General Medical Sciences outside the submitted work, and being on the executive committee of the Society for Epidemiologic Research. B. S. M. reports support from the NIH and Indiana University during the conduct of this study. F. O. and C. K. report support from the NIH during the conduct of this study. E. A. K. reports support from the NIH during the conduct of this study and grants from the NIH, New York City Economic Development Corporation, and CUNY Graduate School of Public Health and Health Policy outside the submitted work. A. H. S. reports grants from ViiV Healthcare outside the submitted work and an unpaid membership on the ViiV Healthcare Women’s Advisory Council. K. K. W.-K. reports support from the NIH during the conduct of this study and grants from Eli Lilly and Company and the Helmsley Charitable Foundation outside the submitted work. D. N. reports support from the NIH during the conduct of this study and support for attending meetings and/or travel from the NIH. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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