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.
|Number of pages||11|
|Journal||Annals of Internal Medicine|
|Publication status||Published - 2022 Jan 1|
Bibliographical noteFunding Information:
Financial Support: Research reported in this article was supported by the National Institutes of Health's National Institute of Allergy and Infectious Diseases; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Cancer Institute; the National Institute on Drug Abuse; the National Heart, Lung, and Blood Institute; the National Institute on Alcohol Abuse and Alcoholism; the National Institute of Diabetes and Digestive and Kidney Diseases; the Fogarty International Center; the National Library of Medicine; and the Office of the Director under award numbers U01AI069907 (Asia-Pacific), U01AI069923 (CCASAnet), U01AI096299 (Central Africa), U01AI069911 (East Africa), and U01AI069924 (Southern Africa). Informatics resources are supported by the Harmonist project (R24AI124872). Dr. Patel's effort was supported by the National Institute of Allergy and Infectious Diseases (K23AI120855). Dr. Humphrey's effort was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (K23HD105495).
© 2021 American College of Physicians.
All Science Journal Classification (ASJC) codes
- Internal Medicine