CDC Recommends Additional Malaria Treatment Option During Pregnancy
Artemether-lumefantrine was approved in 2009 by the Food and Drug Administration.
The Centers for Disease Control and Prevention (CDC) has issued updated recommendations on the treatment of malaria in pregnant patients in the United States.
The CDC now recommends the use of artemether-lumefantrine (Coartem; Novartis) as an additional treatment option for uncomplicated malaria in pregnant women during the second and third trimester of pregnancy at the same doses recommended for nonpregnant women. During the first trimester of pregnancy, mefloquine or quinine plus clindamycin should be used as treatment, however, when neither of these options is available, artemether-lumefantrine should be considered.
Artemether-lumefantrine was approved in 2009 by the Food and Drug Administration (FDA) to treat uncomplicated malaria, however, the combination treatment was not approved for use in pregnancy due to animal data indicating poor outcomes.
To assess the safety and efficacy of artemisinin-based combination therapies (ACTs) during pregnancy, researchers from the CDC conducted an analysis of the literature which included clinical trials, observational studies, meta-analyses and case reports conducted in Asia and Africa. In total, 21 articles were analyzed.
An analysis of 5 randomized, open-label, controlled trials conducted in Uganda and Thailand with women administered ACTs during their second and third trimester for uncomplicated P falciparum malaria found that the cure rates were ≥94.9%. Additionally, statistically similar treatment failure rates were noted in a meta-analysis of 6 trials involving women taking ACTs vs non-ACTs to treat uncomplicated malaria (RR 0.41; 95% CI, 0.16-1.06). The findings also indicated that doses recommended for nonpregnant women were efficacious during pregnancy.
Regarding safety, no differences in outcomes were found in 4 trials comparing ACTs with quinine-based regimens. Overall, the researchers found that fewer maternal adverse events occurred among women taking ACTs than in those taking non-ACTs. Three trials comparing artemether-lumefantrine with other ACTs found no difference in rates of serious adverse maternal effects.
The CDC's decision follows a similar one from the World Health Organization, which recently endorsed ACTs for treatment of uncomplicated malaria during the second and third trimester.
Ballard S, Salinger A, Arguin PM, Desai M, Tan KR. Updated CDC recommendations for using artemether-lumefantrine for the treatment of uncomplicated malaria in pregnant women in the United States. MMWR Morb Mortal Wkly Rep. 2018;67:424-431.