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DISPARITIES IN DOLUTEGRAVIR UPTAKE AFFECTING FEMALES OF REPRODUCTIVE AGE WITH HIV IN LOW- AND MIDDLE-INCOME COUNTRIES AFTER INITIAL CONCERNS ABOUT TERATOGENICITY: AN OBSERVATIONAL STUDY
Dolutegravir
Antiretroviral therapy
Low- and middle-income countries (LMICs)
Reproductive age
Author
Romo, Matthew L.
Patel, Rena C.
Edwards, Jessie K.
Humphrey, John M.
Musick, Beverly S.
Bernard, Caitlin
Maina, Mercy W.
Brazier, Ellen
Castelnuovo, Barbara
Penner, Jeremy
Wyka, Katarzyna
Cardoso, Sandra Wagner
Ly, Penh Sun
Kunzekwenyika, Cordelia
Cortés, Claudia P.
Panczak, Radoslaw
Kelvin, Elizabeth A.
Wools-Kaloustian, Kara K.
Nash, Denis
Patel, Rena C.
Edwards, Jessie K.
Humphrey, John M.
Musick, Beverly S.
Bernard, Caitlin
Maina, Mercy W.
Brazier, Ellen
Castelnuovo, Barbara
Penner, Jeremy
Wyka, Katarzyna
Cardoso, Sandra Wagner
Ly, Penh Sun
Kunzekwenyika, Cordelia
Cortés, Claudia P.
Panczak, Radoslaw
Kelvin, Elizabeth A.
Wools-Kaloustian, Kara K.
Nash, Denis
Affilliation
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA / CUNY Institute for Implementation Science in Population Health. New York, NY, USA.
University of Washington. Department of Medicine and Department of Global Health. Seattle, Washington, USA.
University of North Carolina at Chapel Hill. Department of Epidemiology. Chapel Hill, North Carolina, USA.
Indiana University School of Medicine. Department of Medicine. Indianapolis, Indiana, USA.
Indiana University School of Medicine. Department of Biostatistics and Health Data Science. Indianapolis, Indiana, USA.
Indiana University School of Medicine. Department of Obstetrics & Gynecology. Indianapolis, Indiana, USA.
Moi Teaching and Referral Hospital. Department of Pharmacy. Eldoret, Kenya.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA / CUNY Institute for Implementation Science in Population Health. New York, NY, USA.
Makerere University College of Health Sciences. Infectious Diseases Institute. Kampala, Uganda.
Family AIDS Care & Education Services. Kisumu, Kenya / University of British Columbia. Department of Family Practice. Vancouver, British Columbia, Canada.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Ministry of Health. Dermatology and STDs. National Center for HIV/AIDS. Phnom Penh, Cambodia.
SolidarMed. Masvingo, Zimbabwe.
Universidad de Chile & Fundación Arriarán. Departamento de Medicina. Santiago, Chile.
University of Bern. Institute of Social and Preventive Medicine. Bern, Switzerland.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA / CUNY Institute for Implementation Science in Population Health. New York, NY, USA.
Indiana University School of Medicine. Department of Medicine. Indianapolis, Indiana, USA.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA / CUNY Institute for Implementation Science in Population Health. New York, NY, USA.
University of Washington. Department of Medicine and Department of Global Health. Seattle, Washington, USA.
University of North Carolina at Chapel Hill. Department of Epidemiology. Chapel Hill, North Carolina, USA.
Indiana University School of Medicine. Department of Medicine. Indianapolis, Indiana, USA.
Indiana University School of Medicine. Department of Biostatistics and Health Data Science. Indianapolis, Indiana, USA.
Indiana University School of Medicine. Department of Obstetrics & Gynecology. Indianapolis, Indiana, USA.
Moi Teaching and Referral Hospital. Department of Pharmacy. Eldoret, Kenya.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA / CUNY Institute for Implementation Science in Population Health. New York, NY, USA.
Makerere University College of Health Sciences. Infectious Diseases Institute. Kampala, Uganda.
Family AIDS Care & Education Services. Kisumu, Kenya / University of British Columbia. Department of Family Practice. Vancouver, British Columbia, Canada.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Ministry of Health. Dermatology and STDs. National Center for HIV/AIDS. Phnom Penh, Cambodia.
SolidarMed. Masvingo, Zimbabwe.
Universidad de Chile & Fundación Arriarán. Departamento de Medicina. Santiago, Chile.
University of Bern. Institute of Social and Preventive Medicine. Bern, Switzerland.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA / CUNY Institute for Implementation Science in Population Health. New York, NY, USA.
Indiana University School of Medicine. Department of Medicine. Indianapolis, Indiana, USA.
City University of New York. CUNY Graduate School of Public Health and Health Policy. Department of Epidemiology and Biostatistics. New York, NY, USA / CUNY Institute for Implementation Science in Population Health. New York, NY, USA.
Abstract
Background: The transition to dolutegravir-containing antiretroviral therapy (ART) in low- and middle-income countries (LMICs) was complicated by an initial safety signal in May 2018 suggesting that exposure to dolutegravir at conception was possibly associated with infant neural tube defects. On the basis of additional evidence, in July 2019, the World Health Organization recommended dolutegravir for all adults and adolescents living with HIV. Objective: To describe dolutegravir uptake and disparities by sex and age group in LMICs. Design: Observational cohort study. Setting: 87 sites that began using dolutegravir in 11 LMICs in the Asia-Pacific; Caribbean, Central and South America network for HIV epidemiology (CCASAnet); and sub-Saharan African regions of the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. Patients: 134 672 patients aged 16 years or older who received HIV care from January 2017 through March 2020. Measurements: Sex, age group, and dolutegravir uptake (that is, newly initiating ART with dolutegravir or switching to dolutegravir from another regimen). Results: Differences in dolutegravir uptake among females of reproductive age (16 to 49 years) emerged after the safety signal. By the end of follow-up, the cumulative incidence of dolutegravir uptake among females 16 to 49 years old was 29.4% (95% CI, 29.0% to 29.7%) compared with 57.7% (CI, 57.2% to 58.3%) among males 16 to 49 years old. This disparity was greater in countries that began implementing dolutegravir before the safety signal and initially had highly restrictive policies versus countries with a later rollout. Dolutegravir uptake was similar among females and males aged 50 years or older. Limitation: Follow-up was limited to 6 to 8 months after international guidelines recommended expanding access to dolutegravir. Conclusion: Substantial disparities in dolutegravir uptake affecting females of reproductive age through early 2020 are documented. Although this disparity was anticipated because of country-level restrictions on access, the results highlight its extent and initial persistence.
Keywords
HIVDolutegravir
Antiretroviral therapy
Low- and middle-income countries (LMICs)
Reproductive age
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