Pharmacovigilance in low‐and middle‐income countries: a review with particular focus on Africa
Low‐and middle‐income countries (LMIC) face unique challenges with regard to the
establishment of robust pharmacovigilance systems capable of generating data to inform …
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 …
marked racial and geographical disparities persist. The federal government has announced …
Call to action: how can the US Ending the HIV Epidemic initiative succeed?
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 …
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
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 …
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 …
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 …
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 …
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 …
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 …
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 …
pregnant women in China that provided data on the quantity, properties, source of funding …