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Food insecurity is associated with poor virologic outcomes, but this has not been studied during pregnancy and breastfeeding. We assessed sustained viral suppression from 8 weeks on antiretroviral therapy to 48 weeks postpartum among 171 pregnant and breastfeeding Ugandan women; 74.9% experienced food insufficiency. In multivariable analysis, food insufficiency [adjusted odds ratio (aOR) 0.38, 95% confidence interval (CI): 0.16 to 0.91], higher pretreatment HIV-1 RNA (aOR 0.55 per 10-fold increase, 95% CI: 0.37 to 0.82), and lopinavir/ritonavir versus efavirenz (aOR 0.49, 95% CI: 0.24 to 0.96) were associated with lower odds of sustained viral suppression. Interventions to address food security may improve virologic outcomes among HIVinfected women.
We performed a secondary analysis of data from the PROMOTE-Pregnant Women and Infants study ({“type”:”clinical-trial”,”attrs”:{“text”:”NCT00993031″,”term_id”:”NCT00993031″}}NCT00993031), which was designed to test the hypothesis that lopinavir/ritonavir would reduce the prevalence of placental malaria. Study procedures31 and results20–22,24,31–35 are described elsewhere. Briefly, the study enrolled HIV-infected, ART-naive pregnant women between 12 and 28 weeks gestation in Tororo, Uganda from December 2009 to September 2012. Women initiated ART at enrollment and were randomized to receive lopinavir/ritonavir or efavirenz, in combination with lamivudine/zidovudine. Participants received multivitamins containing iron and folic acid, iron supplements, mebendazole, and trimethoprim/sulfamethoxazole prophylaxis. Women were seen at the study clinic every 4 weeks; participants continued ART and were followed for up to 1 year postpartum. Women were counseled to breastfeed their infants for 1 year, with exclusive breastfeeding for the first 6 months of life. One participant switched from lopinavir/ritonavir to efavirenz because of the need for tuberculosis treatment; all other participants remained on their assigned study drug. This analysis includes women who participated in assessments of food security, which were performed among all participants actively enrolled from September 11, 2011, to February 4, 2012. The study protocol was approved by the Makerere University School of Medicine Research and Ethics Committee, the Uganda National Council for Science and Technology, Cornell University Institutional Review Board, and the University of California, San Francisco Committee on Human Research. Participants provided written informed consent in their preferred language. HIV-1 RNA was measured at screening, 8 weeks after ART initiation, delivery, 8, 24, and 48 weeks postpartum, and at other intervals for clinical management. HIV-1 RNA polymerase chain reaction testing was performed using COBAS AMPLICOR version 1.5 (Roche Molecular Diagnostics, Pleasanton, CA) until September 2012, and thereafter with the m2000 RealTime HIV-1 assay (Abbott Laboratories, Abbott Park, IL). The primary outcome for this analysis was sustained viral suppression from 8 weeks after ART initiation to 48 weeks postpartum. Viral suppression was dichotomized as “sustained” if HIV-1 RNA ≤400 copies per milliliter (the lower limit of detection of the assays) at all measured time points and “not sustained” if HIV-1 RNA >400 copies per milliliter at any measured time point. Sixteen participants had missing HIV-1 RNA measurements at 8 weeks on ART (N = 8) or 48 weeks postpartum (N = 8). FI was operationalized using the Household Hunger Scale (HHS),36 a subset of 3 questions about insufficient food quantities from the 9-item Household Food Insecurity Access Scale,37 which has been previously been validated for cross-cultural use38 and measured among HIV-infected adults in rural Uganda.28,39 The HHS asks the frequency over the previous 4 weeks of (1) having no food to eat of any kind in one’s household, (2) going to sleep at night hungry, and (3) going a whole day and whole night without eating. A response of “never” received 0 points, “rarely or sometimes” received 1 point, and “often” received 2 points; points were summed as a score, with a maximum score of 6 points for a response of “often” to all 3 questions. For logistic regression analyses, FI was dichotomized as no household hunger (HH) versus any HH (any positive response, indicating the presence of FI). FI was assessed once, in the season when food is most abundant in Tororo, such that FI scores would be the most conservative and have the least seasonal variation. FI interviews were conducted among 197 women, at a median of 5.6 months postpartum (interquartile range 2.2–9.2); 18 participants were interviewed before delivery. A household wealth index was generated by performing a principal component analysis of questions regarding household possession of assets, including a radio, telephone, television, motorcycle, or bicycle, among all PROMOTE participants.22 The first principal component was used to create the index. Tertiles of the wealth index were used to categorize individual household wealth relative to the cohort. Participants in the middle and highest tertiles of wealth were grouped together for comparison with those in the lowest wealth tertile. Residence within the town of Tororo was defined as urban based on GPS coordinates; other residences in Tororo district were classified as rural. Gestational age at enrollment was determined based on last menstrual period and fetal ultrasound.21 For calculation of body mass index (BMI), maternal height was measured using a wall-mounted measuring tape (Seca 206; Seca, Hamburg, Germany); maternal weight was measured using a Seca 876 mechanical scale until September 2011 and thereafter using a Seca 874 digital scale. Participants were asked whether they were breastfeeding every 4 weeks postpartum. The end of breastfeeding was defined as the last period in which a participant reported any breastfeeding (exclusive or partial). ART adherence was assessed by self-reported recall of the number of pills taken of the expected number of pills over the 3 days before each study visit. Characteristics of enrolled participants with and without FI were compared using the χ2 test or Fisher’s exact test for categorical variables and the Wilcoxon rank-sum test for continuous variables. The proportion of participants with and without FI who achieved viral suppression at individual time points was evaluated using Fisher’s exact test because of the small number of participants who did not achieve viral suppression at each time point. A 4-week measurement window was used for virologic outcomes. Logistic regression models were used to evaluate the association between sustained viral suppression, FI, and covariates in our causal model (see Figure S1, Supplemental Digital Content, http://links.lww.com/QAI/A755). We postulated that the association between FI and sustained viral suppression is mediated through effects on adherence, absorption/pharmacokinetics/bioavailability, BMI, depression, poor nutrition, and reduced protein binding of drug. ART regimen and pretreatment HIV-1 RNA were included in the multivariable model as independent predictors of sustained viral suppression. Household wealth was included in the model as a confounder of the relationship between FI and viral suppression. Age was evaluated as a potential confounder. Using the causal model as a guide, we evaluated the effect of individual predictors and confounders, and assessed overall model fit to achieve the final model. Inclusion of age in the multivariable model did not alter the association between FI and viral suppression and did not improve overall model fit; thus, age was excluded from the final model. Statistical analyses were performed using SAS software version 9.3 (SAS Institute, Cary, NC).
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