Meta-analysis supported by MMV, WHO, WWARN with funding from BMGF contributes to the WHO recommendation of artemisinin-based combination therapy artemether-lumefantrine
In 2020, over 11 million pregnancies (the majority in sub-Saharan Africa) were at risk of health complications such as premature birth, severe anaemia and miscarriage due to malaria. Despite a clear need, there are few medicines available and recommended by the World Health Organization (WHO) to treat malaria in pregnancy. Until now, only one drug, quinine, was recommended to treat women in their first trimester. Although effective, quinine has some shortcomings: it must be taken three times a day for 7 days and is associated with side effects including hearing impairment and dizziness.
On 25 November, WHO updated its Guidelines for the Treatment of Malaria to include a ‘strong recommendation’ for artemisinin-based combination therapy (ACT) artemether-lumefantrine to treat malaria during the first trimester of pregnancy. The drug was previously only recommended for use in the second and third trimesters. WHO’s evaluation of the drug included evidence from a large meta-analysis coordinated by the Liverpool School of Tropical Medicine (LSTM), with funding from MMV, WHO and WWARN, funded by the Bill and Melinda Gates Foundation. That analysis examined 34,178 pregnancies, including 737 pregnancies exposed to artemisinin. Of these, 525 were treated with artemether-lumefantrine.
Despite the welcome news that an ACT can now be used to treat pregnant women in their first trimester, unmet needs for this at-risk group remain. Maud Majeres Lugand, co-lead of the Malaria in Mothers and Babies (MiMBa) initiative at MMV, said “This is excellent news which the malaria community has been awaiting for a long time. It marks a significant step towards improving treatment options for pregnant women. However, there is still work to be done to generate safety evidence on other ACTs to be able to extend their use for malaria treatment in all trimesters of pregnancy. We must also continue research to identify new chemoprevention options for pregnant and lactating women living with HIV who, to date, are not eligible to access the existing recommended preventative therapy with sulfadoxine-pyrimethamine.”
MMV and LSTM, in coordination with the Kenya Medical Research Institute, are currently supporting a long-term pregnancy registry programme – the goal of which is to capture vital new data about the safety and efficacy of other ACTs in addition to artemether-lumefantrine when given to women during any stage of their pregnancies. It is precisely this type of real-life safety data that should allow WHO and national authorities to determine what other malaria medicines can be safely administered during each trimester of pregnancy.
MMV’s MiMBa strategy aims to accelerate the discovery, development and delivery of antimalarial prevention and treatment options for women who are pregnant and lactating.