Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study

Abstract

Introduction School-based preventive chemotherapy (Deworming) with praziquantel and albendazole to control and eliminate schistosomiasis and soil-transmitted helminths as public health problems is recommended by the World Health Organization (WHO). Safety monitoring during mass drug administration (MDA) is imperative but data from sub-Saharan Africa are scarce. Objective The aim of this active safety surveillance study was to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass administration of praziquantel and albendazole. Methods Overall, 8037 school children aged 5-15 years in Rwanda were enrolled. Baseline sociodemographic, medical history and any pre-existing clinical symptoms were recorded. Participants received a single dose of praziquantel and albendazole during MDA. AEs were actively monitored on days 1, 2, and 7 post MDA. Results Overall, 3196 AEs were reported by 1658 children; 91.3%, 8.4%, and 0.3% of the AEs were mild, moderate, and severe, respectively, and most resolved within 3 days. Headache (21%), dizziness or fainting (15.2 %), nausea (12.8%) and stomach pain (12.2%) were the most common AEs. The overall cumulative incidence of experiencing at least one type of AE was 20.6% (95% confidence interval [CI] 19.7-21.5%), being significantly higher (p < 0.001) in children with pre-MDA clinical events (27.5%, 95% CI 25.4-29.6%) than those without (18.7%, 95% CI 17.7-19.7%). Females, older age, having pre-MDA events, types of food taken before MDA and taking two or more praziquantel tablets were significant predictors of AEs. Conclusions Praziquantel and albendazole MDA is safe and well-tolerated; however, one in five children experience transient mild to moderate, and in few cases severe, AEs. The incidence of AEs varies significantly between sex and age groups. Pharmacovigilance in the MDA program is recommended for timely detection and management of AEs.

Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring

“…The incidence of AEs was significantly higher among female participants compared to male ones (15.4% versus 11.3%). Similar sex difference in the incidence of AEs was reported in the previous studies [ 35 , 38 , 39 ]. Recent studies conducted on the safety of a MDA for the control and elimination of lymphatic filariasis in east Africa also reported a difference in the incidence of AEs across the sexes [ 41 , 42 ].…”

“…Perhaps this can be explained by the higher dose of praziquantel taken by this age group, as the drug was given based on height. A higher dose of praziquantel is associated with an increased risk of AEs in the previously reported studies [ 35 ].…”

“…The participants’ sex, age group, enrolment site, and infection type were significant factors associated with the occurrence of AEs following the mass praziquantel and albendazole administration. Using a similar study design, a recent study from Rwanda reported that one in five child who received a praziquantel and albendazole MDA reported at least one type of MDA-associated AE [ 35 ]. The cumulative incidence of an MDA-associated AE (13.3%) in our study was slightly lower than the report from Rwanda, which could be due to variations in the prevalence of an STH or S. mansoni infection status of the study participants [ 32 , 36 ].…”

Effect of pharmacogenetic variations on praziquantel plasma concentration and safety outcomes among school children in Rwanda

“…Following MDA, study participants were actively monitored to record MDA-related adverse events (AEs) on days 1, 2, and 7 post MDA 13 . Collected data were entered into an electronic database using tablets and cleaned before statistical analysis.…”

“…In Rwanda, transmission of intestinal schistosomiasis is prevalent, and children aged 5-10 years are the most affected 8,12 . Although mass PZQ and albendazole co-administration is generally safe, approximately 20% of children in Rwanda experienced mild to severe adverse events post MDA 13 .…”