In vivo efficacy of sulphadoxine-pyrimethamine for the treatment of asymptomatic parasitemia in pregnant women presenting for first antenatal care visit in Malawi. Público

Abstract

Background: In vivo assessments of anti-malarial treatments for pregnant women are important to ensure continued efficacy, especially in areas of increasing drug resistance.

Methods: Pregnant women with asymptomatic parasitemia who presented at the Machinga District Hospital, Malawi were treated with Sulphadoxine-pyrimethamine (SP) and followed for 42 days to determine the drug efficacy. Eligible participants were between 16 and 26 weeks gestation, eligible to take SP in the antenatal clinic on day of enrollment, had asymptomatic malaria defined as a parasitemia of 2,000-200,000/µl asexual forms and an axillary temperature below 37.5°C. Study endpoint was parasite-free status after the follow-up period. Survival analyses were performed to assess the effect of gravidity on the efficacy of SP treatment. The results of analyses were expressed as hazard ratios (HRs) accompanied by the corresponding 95% confidence intervals (CIs).

Results: Two hundred and forty five pregnant women were included in the analysis [245 = intention to treat (ITT); 150 = per-protocol (PP)]. The overall cure rate (adequate clinical and parasitologic response, ACPR) in the PP analysis was 42% (34.0-50.3) and the corresponding estimate in the ITT analysis was 25.7% (20.4-31.7). Multivariable analysis revealed statistically significant interaction between age and gravidity. Among women younger than 21 years, primigravid women were more likely to have parasitemia at study end when compared to multigravid women (Hazard Ratio (HR) =5.06; 95% CI, 1.76-14.57). By contrast, the corresponding analysis for older women demonstrated an no statistically significant association with a Hazard Ratio (HR) of 0.24 and a 95% CI between 0.04 and 1.34. Similarly, bed net use was associated with a statistically significant decrease in parasitemia among women over 20 years of age (HR=0.35; 95% CI, 0.14-0.86), but not in younger women (HR=1.05; 95% CI, 0.51-2.16).

Conclusion: SP efficacy may be waning in Malawi. The lower failure rate in multigravid women suggests that further SP efficacy studies should focus on the protection for primigravid women. Age-specific effect modification should be explored further.

Table of Contents

BACKGROUND .............................................................................................................................. 1
METHODS .................................................................................................................................... 3
Study design and study site ...................................................................................................... 3
Study population ...................................................................................................................... 3
Follow-up ................................................................................................................................ 4
Outcomes ................................................................................................................................ 4
Statistical analysis .................................................................................................................... 5
RESULTS ...................................................................................................................................... 7
Study population ...................................................................................................................... 7
Efficacy of IPTp-SP ................................................................................................................. 7
Gravidity and IPTp-SP ............................................................................................................. 8
DISCUSSION................................................................................................................................. 9
REFERENCES ............................................................................................................................... 12
TABLES AND FIGURES................................................................................................................. 14

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School	Rollins School of Public Health
Department	Epidemiology
Subfield / Discipline	Global Epidemiology - MPH & MSPH
Degree	MPH
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Biology, Parasitology Health Sciences, Epidemiology
Palavra-chave	IPTp-SP in vivo efficacy Malawi gravidity
Committee Chair / Thesis Advisor	Goodman, Michael, Emory University
Committee Members	Gutman, Julie, CDC/CGH/DPDM (Field Thesis Advisor) Jacek, Skarbinski, CDC/OID/NCHHSTP (Field Thesis Advisor)
Partnering Agencies	CDC

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