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Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study.

ABSTRACT: BACKGROUND:The World Health Organization (WHO) recommendation of treating uncomplicated malaria during the second and third trimester of pregnancy with an artemisinin-based combination therapy (ACT) has already been implemented by all sub-Saharan African countries. However, there is limited knowledge on the effect of ACT on pregnancy outcomes, and on newborn and infant's health. METHODS:Pregnant women with malaria in four countries (Burkina Faso, Ghana, Malawi and Zambia) were treated with either artemether-lumefantrine (AL), amodiaquine-artesunate (ASAQ), mefloquine-artesunate (MQAS), or dihydroartemisinin-piperaquine (DHA-PQ); 3127 live new-borns (822 in the AL, 775 in the ASAQ, 765 in the MQAS and 765 in the DHAPQ arms) were followed-up until their first birthday. RESULTS:Prevalence of placental malaria and low birth weight were 28.0% (738/2646) and 16.0% (480/2999), respectively, with no significant differences between treatment arms. No differences in congenital malformations (p?=?0.35), perinatal mortality (p?=?0.77), neonatal mortality (p?=?0.21), and infant mortality (p?=?0.96) were found. CONCLUSIONS:Outcome of pregnancy and infant survival were similar between treatment arms indicating that any of the four artemisinin-based combinations could be safely used during the second and third trimester of pregnancy without any adverse effect on the baby. Nevertheless, smaller safety differences between artemisinin-based combinations cannot be excluded; country-wide post-marketing surveillance would be very helpful to confirm such findings. Trial registration ClinicalTrials.gov, NCT00852423, Registered on 27 February 2009, https://clinicaltrials.gov/ct2/show/NCT00852423.

SUBMITTER: Nambozi M

PROVIDER: S-EPMC6437904 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study.

Nambozi Michael M Tinto Halidou H Mwapasa Victor V Tagbor Harry H Kabuya Jean-Bertin Bukasa JB Hachizovu Sebastian S Traoré Maminata M Valea Innocent I Tahita Marc Christian MC Ampofo Gifty G Buyze Jozefien J Ravinetto Raffaella R Arango Diana D Thriemer Kamala K Mulenga Modest M van Geertruyden Jean-Pierre JP D'Alessandro Umberto U

Malaria journal 20190328 1

<h4>Background</h4>The World Health Organization (WHO) recommendation of treating uncomplicated malaria during the second and third trimester of pregnancy with an artemisinin-based combination therapy (ACT) has already been implemented by all sub-Saharan African countries. However, there is limited knowledge on the effect of ACT on pregnancy outcomes, and on newborn and infant's health.<h4>Methods</h4>Pregnant women with malaria in four countries (Burkina Faso, Ghana, Malawi and Zambia) were tre ...[more]

PMID: 30922317

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Project description:BackgroundActivation of hypnozoites of vivax malaria causes multiple clinical relapses, which contribute to the Plasmodium vivax burden and continuing transmission. Artemisinin-based combination therapy (ACT) is effective against blood-stage P. vivax but requires co-administration with primaquine to achieve radical cure. The therapeutic efficacy of primaquine depends on the generation of a therapeutically active metabolite via cytochrome P450 2D6 (CYP2D6). Impaired CYP2D6 metabolism has been associated with primaquine treatment failure. This study investigated the association between impaired CYP2D6 genotypes, drug-exposure to the long-acting ACT component (schizonticidal drugs) and tolerance and efficacy.MethodsAdult patients with acute vivax malaria were enrolled in a recently completed trial and treated with artesunate-mefloquine, chloroquine or artemether-lumefantrine. All received concomitant primaquine (0.5 mg/kg/day for 7-9 days). The association between efficacy and safety and drug exposure was explored using area-under-the-curve (AUC) and half-life (t1/2) estimates obtained by non-compartmental analysis of the long half-life drugs. Parasite recurrences by day 63 were categorized as related relapses or re-infections/unrelated hypnozoite activation by genotyping three microsatellite loci and two polymorphic loci of merozoite surface antigen-1. The CYP2D6 genotype was identified with Taqman assays by real-time PCR to 9 polymorphisms (8 SNPs and one deletion). Impaired CYP2D6 activity was inferred using the Activity Score System.ResultsMost recurrences in the ASMQ (67%), CQ (80%) and AL (85%) groups were considered related relapses. Eight of nine (88.9%) of the patients with impaired CYP2D6 activity relapsed with related parasite compared to 18/25 (72%) with normal activity (RR = 1.23, 0.88; 1.72, p = 0.40). There were no associations between the measured PK parameters and recurrence. Patients with longer chloroquine half-lives had more pruritus (RR = 1.09, 1.03; 1.14, p = 0.001). Higher CQ AUCs were associated with reduced falls in haemoglobin by day 14 (Coef - 0.02, - 0.005; - 0.03, p = 0.01). All regimens were well tolerated.ConclusionGenotyping of P. vivax showed that activation of related (homologous) hypnozoites was the most frequent cause of recurrence. The high proportion of the impaired CYP2D6 activity among patients with recurrent infections suggests that slow primaquine metabolism might influence related relapse rates in Brazil among patients receiving primaquine for radical cure, although confirmatory studies are needed. There was no association between drug exposure of the long-acting ACT component (schizonticidal drugs) and risk of related relapse. ACT was well tolerated. These results provide further re-assurance about the safety and efficacy of ACT when combined with short course primaquine to treat uncomplicated malaria vivax in Brazil. Trial registration RBR-79s56s ( http://www.ensaiosclinicos.gov.br/rg/RBR-79s56s/ ).

Project description:Background:In Nigeria, Artemisinin-based Combination Therapy (ACT) is the recommended first line antimalarial medicine for uncomplicated malaria. However, health care providers still continue the use of less efficacious medicines such as Sulphadoxine-pyrimethamine and chloroquine. We therefore determined preference for ACT (PFA) and factors associated with PFA among healthcare providers (HCP) in Lokoja, North-Central Nigeria as well as assessed healthcare providers' knowledge of malaria case management. Methods:We conducted a cross-sectional study among physicians, nurses, pharmacists, community health officers (CHOs), community health extension workers (CHEWs) and, patent and proprietary medicine vendors (PPMVs). Interviewer-administered questionnaires were administered to collect data on respondents' characteristics, previously received malaria case management training and knowledge of malaria treatment. Knowledge scores ≥3 were categorised as good, maximum obtainable being 5. Results:Of the 404 respondents, 214 (53.0%) were males. Overall, 219 (54.2%) respondents who received malaria case management training included PPMVs: 79 (65.8%), CHEWs: 25 (64.1%), CHOs: 5 (55.6%), nurses: 72 (48.7%), physicians: 35 (47.3%) and pharmacists: 3 (23.1%). Overall, 202 (50.0%) providers including physicians: 69 (93.2%), CHO: 8 (88.9%), CHEWs: 33 (84.6%), pharmacists: 8 (61.5%), nurses: 64 (43.2%) and PPMVs: 20 (16.5%), had good knowledge of malaria treatment guidelines. Overall, preference for ACT among healthcare providers was 39.6%. Physicians: 50 (67.6%), pharmacists: 7 (59.3%) CHOs: 5 (55.6%), CHEWS: 16 (41.0%), nurses: 56 (37.8%) and PPMV: 24 (19.8%) had PFA. Receiving malaria case management training (adjusted odds ratio [aOR]) = 2.3; CI = 1.4 - 3.7) and having good knowledge of malaria treatment (aOR = 4.0; CI = 2.4 - 6.7) were associated with PFA. Conclusions:Overall preference for ACT use was low among health care providers in this study. Preference for ACTs and proportion of health workers with good knowledge of malaria case management were even lower among PPMVs who had highest proportion of those who received malaria case management training. We recommend evaluation of current training quality, enhanced targeted training, follow-up supportive supervision of PPMVs and behavior change communication on ACT use.

Project description:BackgroundFollowing the development of resistance to anti-malarial mono-therapies, malaria endemic countries in Africa now use artemisinin-based combination therapy (ACT) as recommended first-line treatment for uncomplicated malaria. Patients' adherence to ACT is an important factor to ensure treatment efficacy, as well as to reduce the likelihood of parasite resistance to these drugs. This study reports adherence to a specific ACT, artemether-lumefantrine (AL), under conditions of routine clinical practice in Kenya.MethodThe study was undertaken in Garissa and Bunyala districts among outpatients of five government health facilities. Patients treated with AL were visited at home four days after having been prescribed the drug. Respondents (patients ≥ 15 years and caregivers of patients < 15 years) were interviewed using a standardized questionnaire, AL blister packs were physically inspected and the adherence status of patients was then recorded. Multivariate logistic regression modelling was used to determine predictors of adherence.ResultsOf the 918 patients included in the study, 588 (64.1%) were 'probably adherent', 291 (31.7%) were 'definitely non-adherent' and 39 (4.2%) were 'probably non-adherent'. Six factors were found to be significant predictors of adherence: patient knowledge of the ACT dosing regimen (odds ratio (OR) = 1.76; 95% CI = 1.32-2.35), patient age (OR = 1.65; 95% CI = 1.02-1.85), respondent age (OR = 1.37; 95% CI = 1.10-2.48), whether a respondent had seen AL before (OR = 1.46; 95% CI = 1.08-1.98), whether a patient had reported dislikes to AL (OR = 0.62 95% CI = 0.47-0.82) and whether a respondent had waited more than 24 hours to seek treatment (OR = 0.73; 95% CI = 0.54-0.99).ConclusionOverall, adherence to AL was found to be low in both Garissa and Bunyala districts, with patient knowledge of the AL dosing regimen found to be the strongest predictor of adherence. Interventions aimed at increasing community awareness of the AL dosing regimen, use of child friendly formulations and improving health workers' prescribing practices are likely to ensure higher adherence to AL and eventual treatment success.

Project description:BackgroundPre-pregnancy health and care are important for the health of the future generations. Smoking during pregnancy has been well-researched and there is clear evidence of harm. But there has been little research on the health impact of planning for pregnancy. This study aims to investigate the independent effects of pregnancy planning and smoking during pregnancy on neonatal outcome.MethodsThis analysis made use of data from the UK Millennium Cohort Study. The study sample consisted of 18,178 singleton babies born in UK between 2000 and 2001. The neonatal outcomes of interest were low birthweight (<2.5 Kg) and pre-term birth (<37 completed weeks gestation). Logistic regression was used to estimate the association between pregnancy planning and/or smoking and neonatal outcome. Adjusted odds ratios were used to calculate population attributable risk fractions (PAFs).Results43% of mothers did not plan their pregnancy and 34% were smoking just before and/or during pregnancy. Planners were half as likely to be smokers just before pregnancy, and more likely to give up or reduce the amount smoked if smokers. Unplanned pregnancies had 24% increased odds of low birth weight and prematurity compared to planned pregnancies (AORLBW1.24, 95% CI 1.04-1.48; AORPREM1.24, 95% CI 1.05-1.45), independent of smoking status. The odds of low birth weight for babies of mothers who were smoking just before pregnancy was 91% higher than that of mothers who were not (AORLBW1.91, 95% CI 1.56-2.34). Women who quit or reduced the amount smoked during pregnancy lowered the risk of a low birth weight baby by one third (AORLBW0.66, 95% CI 0.51-0.85) compared with women whose smoking level did not change. Smaller effects were found for prematurity. If all women planned their pregnancy and did not smoke before or during pregnancy, 30% of low birthweight and 14% of prematurity could, in theory, be avoided.ConclusionsPlanning a pregnancy and avoiding smoking during pregnancy has clear, independent, health benefits for babies. Quitting or reducing the amount smoked during pregnancy can reduce the risk of low birthweight.

Project description:BackgroundDengue is a mosquito-borne disease that is common in many tropical and subtropical areas. Dengue infections can occur at any age and time in the lifespan, including during pregnancy. Few large scale studies have been conducted to determine the risk of preterm birth (PTB) and low birthweight (LBW) for infants born to women who had symptomatic dengue infection during pregnancy.Methodology/principal findingsThis study is a retrospective cohort study using medical records from 1992-2010 from pregnant women who attended a public regional referral hospital in western French Guiana. Exposed pregnancies were those with laboratory confirmed cases of dengue fever during pregnancy. Each of the 86 exposed infants was matched to the three unexposed births that immediately followed them to form a stratum. Conditional logistic regression was used to analyze these matched strata. Three groups were examined: all infants regardless of gestational age, only infants> = 17 weeks of gestational age and their strata, and only infants> = 22 weeks of age and their strata. Odds ratios were adjusted (aOR) for maternal age, maternal ethnicity, maternal gravidity, interpregnancy interval and maternal anemia. There was an increased risk of PTB among women with symptomatic dengue; (aOR all infants: 3.34 (1.13, 9.89), aOR 17 weeks: 1.89 (0.61, 5.87), aOR 22 weeks: 1.41 (0.39, 5.20)) but this risk was only statistically significant when all infants were examined (p value = 0.03). Adjusted results for LBW were similar, with an increased risk in the exposed group (aOR All infants: 2.23 (1.01, 4.90), aOR 17 weeks: 1.67 (0.71, 3.93), aOR 22 weeks: 1.43 (0.56, 3.70)) which was only statistically significant when all infants were examined (p value = 0.05).Conclusions/significanceSymptomatic dengue infection during pregnancy may increase the risk of PTB and LBW for infants. More research is needed to confirm these results and to examine the role of dengue fever in miscarriage.

Dataset Information

Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study.

Publications

Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study.

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