Pharmacovigilance in low‐and middle‐income countries: a review with particular focus on Africa

R Kiguba, S Olsson, C Waitt - British journal of clinical …, 2023 - Wiley Online Library
Low‐and middle‐income countries (LMIC) face unique challenges with regard to the
establishment of robust pharmacovigilance systems capable of generating data to inform …

HIV and women in the USA: what we know and where to go from here

AA Adimora, C Ramirez, T Poteat, NM Archin, D Averitt… - The Lancet, 2021 - thelancet.com
New diagnoses of HIV infection have decreased among women in the USA overall, but
marked racial and geographical disparities persist. The federal government has announced …

Call to action: how can the US Ending the HIV Epidemic initiative succeed?

C Beyrer, AA Adimora, SL Hodder, E Hopkins, G Millett… - The Lancet, 2021 - thelancet.com
With more than 1· 2 million people living with HIV in the USA, a complex epidemic across the
large and diverse country, and a fragmented health-care system marked by widening health …

Ethical issues in therapeutic use and research in pregnant and breastfeeding women

ED Weld, TC Bailey, C Waitt - British journal of clinical …, 2022 - Wiley Online Library
Pregnant or potentially pregnant women have historically been excluded from clinical trials
of new medications. However, it is increasingly recognised that it is imperative to generate …

Dolutegravir in pregnant mice is associated with increased rates of fetal defects at therapeutic but not at supratherapeutic levels

H Mohan, MG Lenis, EY Laurette, O Tejada… - …, 2021 - thelancet.com
Background Dolutegravir (DTG) is a preferred regimen for all people with HIV including
pregnant women, but its effects on the fetus are not fully understood. Periconceptional …

Disparities in dolutegravir uptake affecting females of reproductive age with HIV in low-and middle-income countries after initial concerns about teratogenicity: an …

ML Romo, RC Patel, JK Edwards… - Annals of internal …, 2022 - acpjournals.org
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 …

Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

F Renaud, LM Mofenson, C Bakker… - Journal of the …, 2022 - Wiley Online Library
Abstract Introduction As new antiretrovirals (ARVs), including long‐acting ARVs for treatment
and prevention, are approved and introduced, surveillance during pregnancy must become …

Adverse pregnancy outcomes among HIV-positive women in the era of universal antiretroviral therapy remain elevated compared with HIV-negative women

VJ Tukei, HJ Hoffman, L Greenberg… - The Pediatric …, 2021 - journals.lww.com
Background: Without treatment, HIV infection in pregnant women is associated with adverse
pregnancy outcomes. We compared adverse pregnancy outcomes among HIV-positive …

Enhanced and timely investigation of ARVs for use in pregnant women

EJ Abrams, LM Mofenson, A Pozniak… - JAIDS Journal of …, 2021 - journals.lww.com
Background: Concerns have been voiced that the exclusion of pregnant women from clinical
trials results in a lack of safety and pharmacokinetic data for antiretroviral drugs (ARVs) in …

Registered clinical trials comprising pregnant women in China: A cross-sectional study

Y Zhao, G Du, X Luan, H Yang, Q Zhang… - Frontiers in …, 2022 - frontiersin.org
Background: In this study, an investigation was conducted on clinical drug trials comprising
pregnant women in China that provided data on the quantity, properties, source of funding …