Matthew L Romo1, Rena C Patel2, Jessie K Edwards3, John M Humphrey4, Beverly S Musick5, Caitlin Bernard6, Mercy W Maina7, Ellen Brazier1, Barbara Castelnuovo8, Jeremy Penner9, Katarzyna Wyka10, Sandra Wagner Cardoso11, Penh Sun Ly12, Cordelia Kunzekwenyika13, Claudia P Cortés14, Radoslaw Panczak15, Elizabeth A Kelvin1, Kara K Wools-Kaloustian4, Denis Nash1. 1. Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, and CUNY Institute for Implementation Science in Population Health, New York, New York (M.L.R., E.B., E.A.K., D.N.). 2. Department of Medicine and Department of Global Health, University of Washington, Seattle, Washington (R.C.P.). 3. Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (J.K.E.). 4. Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana (J.M.H., K.K.W.). 5. Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, Indiana (B.S.M.). 6. Department of Obstetrics & Gynecology, Indiana University School of Medicine, Indianapolis, Indiana (C.B.). 7. Department of Pharmacy, Moi Teaching and Referral Hospital, Eldoret, Kenya (M.W.M.). 8. Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda (B.C.). 9. Family AIDS Care & Education Services, Kisumu, Kenya, and Department of Family Practice, University of British Columbia, Vancouver, British Columbia, Canada (J.P.). 10. Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, New York, New York (K.W.). 11. Instituto Nacional de Infectologia, Laboratório de Pesquisa Clínica em HIV/AIDS, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil (S.W.C.). 12. National Center for HIV/AIDS, Dermatology and STDs, Ministry of Health, Phnom Penh, Cambodia (P.S.L.). 13. SolidarMed, Masvingo, Zimbabwe (C.K.). 14. Departamento de Medicina, Universidad de Chile & Fundación Arriarán, Santiago, Chile (C.P.C.). 15. Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (R.P.).
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. PRIMARY FUNDING SOURCE: National Institutes of Health.
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. PRIMARY FUNDING SOURCE: National Institutes of Health.
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