In July 2019, the World Health Organization (WHO) indicated dolutegravir for all adolescents and adults living with HIV. This recommendation came after a safety signal in May 2018 suggesting that exposure to dolutegravir at conception was associated with neural tube defects in the infant.
Although the WHO has reviewed additional evidence and weighed the risks and benefits before making its recommendation, absorption of dolutegravir remains low in women living with HIV.
Investigators conducted an observational cohort study of 87 sites that started using dolutegravir in 11 low- and middle-income countries. The sites included participated in the International Epidemiological Databases for AIDS Assessment (IeDEA) of the Asia-Pacific, Caribbean, Central and South America Network for HIV Epidemiology (CCASAnet) and the regions of Central, East and Africa. southern.
The study, published in Annals of Internal Medicine, included 134,672 patients aged 16-49 who received care from January 2017 to March 2020. Participants had just started or were on existing antiretroviral therapy.
At the end of the follow-up period, absorption of dolutegravir in women aged 16 to 49 was 29.4%, compared to 57.7% for men in this age group. This gap in dolutegravir use was larger in countries that implemented the drug before the safety signal and initially had restrictive policies, as opposed to countries that recommended dolutegravir after the WHO recommendation.
Professor CUNY Denis Nash, lead author of the study, discussed the implications of the findings: “The large disparities quantified by our study mean that the missed or delayed opportunities to improve HIV treatment outcomes could be substantial in the long term if they are not corrected quickly. We need faster and more robust pharmacovigilance surveillance both before and after safety signals, which is important to reliably detect, characterize and quantify adverse events, and to rigorously inform decisions. of implementation regarding the use of pharmaceuticals on a large scale.
Dolutegravir has the potential to help eradicate HIV as a global public health threat. It has a superior efficacy profile and reduces the transmission of HIV during sex, between needle-sharing partners and in utero.
The study concluded: “Although this disparity was anticipated due to country-level access restrictions, the results highlight its extent and initial persistence. “