Globally, more than 37 million people were living with HIV in 2020, including 19 million women of childbearing age (UNAIDS). Each year, around 1.3 million of these women become pregnant, most of whom live in sub-Saharan Africa where rates of maternal and child mortality remain high.
Antiretroviral therapy is recommended for all pregnant women living with HIV, since this plays a crucial role in improving maternal health and reducing transmission of HIV from mother to child. However, to date there has been a critical lack of evidence on whether antiretroviral therapies increase the risk of adverse pregnancy outcomes such as preterm birth, low birth weight, stillbirth, and babies being small for their gestational age.*
In particular, there has been concern about a type of antiretroviral drug called protease inhibitors (including atazanavir, lopinavir, and darunavir). Current guidelines recommend that protease inhibitor-based therapies should be used in pregnancy only if ‘first-line’ treatments (such as integrase and reverse-transcriptase based treatments) are either unsuitable or unavailable. These guidelines also often advise against the use of a specific protease inhibitor, lopinavir/ritonavir (LPV/r), citing an increased risk of preterm birth. However, these recommendations are based on limited evidence, and can restrict treatment options for pregnant women with HIV.