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.

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 (2022). 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. Annals of internal medicine, 175(1), pp. 84-94. American College of Physicians 10.7326/M21-3037

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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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5 Citations in Web of Science ®
6 Citations in Scopus

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