125 million pregnant women are at risk of malaria each year and up to 200,000 babies and 10,000 mothers die as a consequence.1.2 To protect them, WHO recommends intermittent preventive treatment in pregnancy (IPTp)3 with sulfadoxine-pyrimethamine (SP).4 Today, IPTp coverage is very low – only 24% of pregnant women in sub-Saharan Africa receive the minimum dosing.5 In addition, SP might one day lose its chemopreventive efficacy to drug resistance.
MMV and the London School of Hygiene & Tropical Medicine (LSHTM) will undertake a safety study in Tanzania testing dihydroartemisinin-piperaquine (DHA-PQP) as a possible alternative to SP for IPTp.
Matthew Chico from LSHTM talks about why DHA-PQP (specifically, Eurartesim®, developed by Sigma-Tau and MMV) was chosen for this study and when the results are expected.
1. Of all the ACTs, why was Eurartesim® selected for this study?
DHA-PQP is not only curative for malaria, but it also has a very long halflife. This means that it can clear malaria when administered and provide a long preventive window so that if a pregnant woman gets an infective bite a week after dosing, she will still be protected. PQP has been shown to be protective for up to 63 days after dosing; but it could be longer. In Africa, DHA-PQP has been shown to be superior to artemether-lumefantrine at preventing further parasitaemia, although both drugs have failure rates less than 5%.6
2. When will we have the answer the study seeks to find?
We should have the answer by June 2016. WHO is interested in the results. In July 2015, it will convene an Expert Review Group to discuss, among other topics, the safety of DHA-PQP in pregnancy. The Expert Review Group will make policy recommendations for consideration by WHO. But without the results of our study, it will be difficult to make an unequivocal endorsement of DHA-PQP for use in pregnancy. This is not ‘a-nice-to-know’ study; it’s a ‘need-to-know’ study.
1. Dellicour S et al. “Quantifying the number of pregnancies at risk of malaria in 2007: a demographic study.” PLoS Med. 7(1):e1000221 (2010).
3. IPTp: administration of a full course of an antimalarial treatment to pregnant women living at risk of malaria after their first trimester and at a minimum of 1-month intervals.
5. Chico M et al. “Global call to action: maximize the public health impact of intermittent preventive treatment of malaria in pregnancy in sub-Saharan Africa.” Malar J. 14(1):207(2015).
6. Zani B et al. “Dihydroartemisininpiperaquine for treating uncomplicated Plasmodium falciparum malaria.” Cochrane Database Syst Rev 1:CD010927 (2014).