Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Infected Women Receiving Cotrimoxazole Prophylaxis: A Multicenter Randomized Placebo-Controlled Trial

González, Raquel; Desai, Meghna; Macete, Eusébio; Ouma, Peter; Kakolwa, Mwaka A.; Abdulla, Salim; Aponte, John J.; Bulo, Helder; Kabanywanyi, Abdunoor M.; Katana, Abraham; Maculuve, Sónia Amós; Mayor, Alfredo; Nhacolo, Arsénio; Otieno, Kephas; Pahlavan, Golbahar; Rosario, Maria; Sevene, Esperança; Slutsker, Laurence; Valá, Anifa; Williamsom, John; Menéndez, Clara

doi:10.1371/journal.pmed.1001735

Cited by 75 publications

(114 citation statements)

References 55 publications

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“…However, recent publications, which assessed MQ on LBW as primary end point and suggested a positive interaction between MQ-IPTp and MTCT in HIV-infected women, incited WHO working groups not to recommend MQ in this indication. 7,9,10 Generally, when a trial involves therapies for life-threatening conditions such as antimalarial drugs, which can potentially save newborns' lives, several outcomes should be systematically taken into account. Judging by a sole, albeit important, criterion may lead to permanently ruling out a potentially important drug, given its high efficacy and the heavy burden of the disease.…”

Section: Resultsmentioning

confidence: 99%

“…Although concerns have been raised about a possible increase in stillbirths in women treated with curative doses of MQ, 19 this finding was confirmed neither in larger datasets nor in two recent multicenter trials on MQ for IPTp conducted in around 6,000 pregnant women. 6,7,9,20,21 As guidelines, we would recommend not including overcoming AE criteria such as stillbirths, congenital malformations, or mother-to-child transmission (MTCT) of HIV-when relevant-in the multiple outcome analysis since these outcomes have to be evaluated separately, prior to other criteria. In such cases where the drug "under test" has been associated with a significant increased risk for one of these major outcomes, we consider that the multiple outcome approach is not appropriate because the drug should not be given in this indication.…”

Section: Discussionmentioning

confidence: 99%

“…6,7 It was also found to be more efficacious than SP-IPTp in preventing maternal anemia, symptomatic malaria, and placental, and peripheral malaria infections at delivery both in human immunodeficiency virus (HIV)-negative and HIV-positive women. [6][7][8][9] However, owing to its moderate tolerability, the Malaria Policy Advisory Committee to the WHO, which met in September 2013, proposed that MQ at the 15 mg/kg dose regimen should not be recommended for IPTp. 10 In the current debate regarding the relevance of MQ for IPTp, we reanalyzed data from the first Beninese trial with an original statistical approach already used to assess treatments in rheumatology, 6 which made it possible to perform a global comparison of SP and MQ for IPTp taking into account both the preventive and adverse effects of the treatments simultaneously.…”

Section: Introductionmentioning

confidence: 99%

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Mefloquine Versus Sulfadoxine–Pyrimethamine for Intermittent Preventive Treatment in Pregnancy: A Joint Analysis on Efficacy and Tolerability

Briand¹,

Escolano²,

Journot³

et al. 2015

The American Society of Tropical Medicine and Hygiene

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Abstract. Since there is no ideal candidate to replace sulfadoxine-pyrimethamine (SP) for intermittent preventive treatment (IPTp), alternatives need to be evaluated on basis of their benefit-risk ratio. We reanalyzed the first Beninese trial on mefloquine (MQ) versus SP for IPTp using a multiple outcome approach, which allowed the joint assessment of efficacy and tolerability. Overall superiority of MQ to SP was defined as superiority on at least one efficacy outcome (low birth weight [LBW], placental malaria, or maternal anemia), non-inferiority on all of them as well as on tolerability defined as cutaneous or neuropsychiatric adverse events (AEs) or low compliance with the treatment. The analysis included 1,601 women. MQ was found to be overall superior to SP (P = 0.004). Performing several sensitivity analyses to handle both missing data and stillbirths provided similar results. Using MQ for IPTp as an example, we show that a multiple outcome analysis is a pragmatic way to assess the benefits/disadvantages of one drug compared with another. In the current context of a lack of antimalarials that could be used for IPTp, such a statistical approach could be widely used by institutional policy makers for future recommendations regarding the prevention of malaria in pregnancy (MiP).

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Mefloquine Versus Sulfadoxine–Pyrimethamine for Intermittent Preventive Treatment in Pregnancy: A Joint Analysis on Efficacy and Tolerability

Briand¹,

Escolano²,

Journot³

et al. 2015

The American Society of Tropical Medicine and Hygiene

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“…15 Another study found that while SP should not be coadministered with CTX due to increased toxicity, women receiving CTX may still benefit from additional antimalarial prophylaxis. 26 Women receiving CTX should not be given SP; therefore, more research is needed to determine how CTX may factor into our findings and how other antimalarial drugs compare, particularly as CTX has also been associated with malaria and LBW.…”

Section: Discussionmentioning

confidence: 99%

Dosage of Sulfadoxine–Pyrimethamine and Risk of Low Birth Weight in a Cohort of Zambian Pregnant Women in a Low Malaria Prevalence Region

Stoner

Vwalika

Smid

et al. 2017

The American Society of Tropical Medicine and Hygiene

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Abstract. In Lusaka, Zambia, where malaria prevalence is low, national guidelines continue to recommend that all pregnant women receive sulfadoxine-pyrimethamine (SP) for malaria prophylaxis monthly at every scheduled antenatal care visit after 16 weeks of gestation. Human immunodeficiency virus (HIV)-positive women should receive co-trimoxazole prophylaxis for HIV and not SP, but many still receive SP. We sought to determine whether increased dosage of SP is still associated with a reduced risk of low birth weight (LBW) in an area where malaria transmission is low. Our secondary objective was to determine whether any association between SP and LBW is modified by receipt of antiretroviral therapy (ART). We analyzed data routinely collected from a cohort of HIV-positive pregnant women with singleton births in Lusaka, Zambia, between February 2006 and December 2012. We used a logPoisson model to estimate the risk of LBW by dosage of SP and to determine whether the association between SP and LBW varied by receipt of ART. Risk of LBW declined as the number of doses increased and appeared lowest among women who received three doses (adjusted risk ratio [ARR] = 0.78; 95% confidence interval [CI] = 0.64-0.95). In addition, women receiving combination ART had a higher risk of delivering an LBW infant compared with women receiving no treatment or prophylaxis (ARR = 1.18; 95% CI = 1.09-1.28), but this risk was attenuated among women who were receiving SP (risk ratio = 1.09; 95% CI = 0.99-1.21). SP was associated with a reduced risk of LBW in HIVpositive women, including those receiving ART, in a low malaria prevalence region.

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“…The contemporaneous HIV seroprevalence among pregnant women attending the ANC clinics was 30% [15]. A prevalence of 9% of MTCT at first month of age and of 25% at the end of the first year of life has also been reported in the area [19,20]. Before 2013, PMTCT relied on antiretroviral prophylaxis, which consisted in antepartum monotherapy with zidovudine (ZDV), a singledose nevirapine (NVP) at the onset of labor, and ZDV þ lamivudine (3TC) at delivery and for 7 days post partum.…”

Section: Study Area and Populationmentioning

confidence: 99%

Maternal HIV infection is an important health determinant in non-HIV-infected infants

Rosario

González

Maculuve

et al. 2017

Aids

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Objective: To assess morbidity and mortality in HIV-exposed uninfected (HEU) children to help guiding appropriate clinical care and effective preventive interventions.Design: This is a longitudinal study comparing two cohorts of children; one born to HIV-infected women and the other born to HIV-uninfected women. Methods:We have analyzed prospectively obtained information on nutritional status, morbidity and mortality from 966 HEU and 909 HIV-unexposed infants followed up until their first 18 months of life at a referral health facility in southern Mozambique. Determinants for adverse health outcomes in HEU children were also assessed using multivariate logistic regression.Results: Increased incidence of hospital admissions (P ¼ 0.0015), shorter survival in the first 18 months of life (P ¼ 0.0510) and moderate and severe malnutrition (P ¼ 0.0006 and 0.0014, respectively) were observed among HEU children compared with HIVunexposed children. Incidence of outpatient attendance in HEU children was associated with being men, older age and the mother being on antiretroviral treatment. Among HEU children, those who were never breastfed, or who were weaned or were partially breastfed, had an increased incidence of hospital admissions compared with children who were exclusively breastfed. Conclusion:Maternal HIV infection has important health consequences in non-HIVinfected children. As the prevalence of HIV-infected pregnant women is maintained and the proportion of HIV-infected children declines because of the scale-up of antiretroviral treatment during pregnancy and breastfeeding, more focus should be given to the health needs of HEU children to ensure that the post-2015 sustainable development goals are met.

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Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Infected Women Receiving Cotrimoxazole Prophylaxis: A Multicenter Randomized Placebo-Controlled Trial

Cited by 75 publications

References 55 publications

Mefloquine Versus Sulfadoxine–Pyrimethamine for Intermittent Preventive Treatment in Pregnancy: A Joint Analysis on Efficacy and Tolerability

Mefloquine Versus Sulfadoxine–Pyrimethamine for Intermittent Preventive Treatment in Pregnancy: A Joint Analysis on Efficacy and Tolerability

Dosage of Sulfadoxine–Pyrimethamine and Risk of Low Birth Weight in a Cohort of Zambian Pregnant Women in a Low Malaria Prevalence Region

Maternal HIV infection is an important health determinant in non-HIV-infected infants

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