Alternative prevention strategies, Kenya
Dr Meghna Desai (CDC, USA), Clara Menendez (IS Global, Spain)Co-investigators:
Dr Simon Kariuki (KEMRI, Kenya), Prof Feiko ter Kuile (LSTM, UK), Julie Gutman (CDC, USA)
The project aims were to compare intermittent screening and treatment (ISTp) or intermittent preventative treatment (IPTp) with Dihydroartemisinin-piperaquine (DP), versus IPTp with sulfadoxine-pyrimethamine (SP) in non-HIV positive pregnant women across four sites with high malaria transmission and SP resistance in Kenya.Study design
An open-label three-arm, randomised, superiority trial it was conducted in four sites with high malaria transmission and sulfadoxine-pyrimethamine resistance in Nyanza Province, western Kenya. The primary outcome was malaria infection at delivery, defined as a composite of peripheral or placental parasitaemia detected by placental histology, microscopy, or rapid diagnostic test. At total of 1546 women were recruited into the trial.Results and Conclusion
Compared with IPTp-SP, ISTp-DP was associated with a lower incidence of malaria infection during pregnancy and clinical malaria during pregnancy, whereas ISTp-DP was associated with a higher incidence of malaria infection and clinical malaria. Maternal and infant serious adverse events were least frequent in the ISTp-DP group
At the current levels of rapid diagnostic test (RDT) sensitivity, ISTp is not a suitable alternative to IPTp-SP, however DP is a promising alternative drug to replace SP for IPTp in areas of high SP resistance.Impact of the research
The World Health Organisation’s Malaria Policy Advisory Committee considered the evidence from the trial and acceptability studies of IPTp with DP in 2015 and recommended a larger, definitive trial to evaluate the impact of DP for IPTp in preventing low birth weight, safety of repeated dosed and adherence to the requires three-day regimen (WHO Malaria Policy Advisory Committee (2016). Malar J 15(1): 117).
LSTM together with the IMPROVE partners is leading two new clinical trials of intermittent preventive therapy with dihydroartemisin-piperaquine as an alternative to the currently recommended drug, sulphadoxine-pyrimethamine, for the prevention of malaria in pregnancy in HIV-infected and uninfected pregnant women are currently underway in Kenya, Tanzania and Malawi.
Desai M,. et al. (2015). "Intermittent screening and treatment (IST) or intermittent preventive treatment (IPT) with dihydroartemisinin-piperaquine versus IPT with sulphadoxine-pyrimethamine for the control of malaria in pregnancy in western Kenya: A randomized controlled superiority trial". Lancet
Hill, J., et al. (2016). "User and Provider Acceptability of Intermittent Screening and Treatment and Intermittent Preventive Treatment with Dihydroartemisinin-Piperaquine to Prevent Malaria in Pregnancy in Western Kenya." PLoS One 11(3): e0150259.
Gutman, J., et al. (2017). "Safety, tolerability, and efficacy of repeated doses of dihydroartemisinin-piperaquine for prevention and treatment of malaria: a systematic review and meta-analysis." Lancet Infect Dis 17(2): 184-193.
Desai, M., et al. (2018). "Prevention of malaria in pregnancy." Lancet Infect Dis 18(4): e119-e132