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HIV-1 disease progression in immune-competent HIV-1-infected and breastfeeding mothers participating in the ANRS 12174 clinical trial in Burkina Faso, South Africa, Uganda and Zambia: a cohort study.

ABSTRACT: OBJECTIVE:We have assessed HIV-1 disease progression among HIV-1-positive mothers in relation to duration of any or exclusive breast feeding in the context of ANRS 12174 trial. METHODS:The analysis was completed on 203, 212, 272 and 529 HIV-1-positive and lactating mothers with CD4 count >350 cells/µL from Burkina Faso, South Africa, Uganda and Zambia, respectively. The trial compared lamivudine and lopinavir/ritonavir as a peri-exposure prophylaxis during a 50-week follow-up time. A multiple logistic regression model was run with the mothers' weight, CD4 count and HIV-1 viral load as separate dependent variables, then combined into a dependent composite endpoint called HIV-1 disease progression where HIV-1 viral load was replaced by the HIV-1 clinical stage. Exclusive or predominant breast feeding (EPBF) and any breastfeeding duration were the key explanatory variables. RESULTS:In the adjusted model, the associations between EPBF duration and weight change, CD4 cell count and the HIV-1 viral load were consistently insignificant. The CD4 cell count was associated with a significantly higher mothers' body mass index (BMI; a mean increase of 4.9 (95% CI 2.1 to 7.7) CD4 cells/µL per each additional kilogram per square metre of BMI) and haemoglobin concentration (19.4 (95% CI 11.4 to 27.4) CD4 cells/µL per each additional gram per decilitre of haemoglobin concentration). There was no significant association between EPBF duration and HIV-1 disease progression. A higher education level was a factor associated with a slower HIV-1 disease progression. CONCLUSION:Breast feeding was not a risk factor for a faster progression of HIV-1 disease in mothers of this cohort with a baseline CD4 cell count >350 cells/µL. TRIAL REGISTRATION NUMBER:NCT0064026; Post-results.

SUBMITTER: Some EN

PROVIDER: S-EPMC5892762 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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HIV-1 disease progression in immune-competent HIV-1-infected and breastfeeding mothers participating in the ANRS 12174 clinical trial in Burkina Faso, South Africa, Uganda and Zambia: a cohort study.

Somé Eric Nagaonle EN Engebretsen Ingunn M S IMS Nagot Nicolas N Meda Nicolas Yelbomkan NY Vallo Roselyne R Kankasa Chipepo C Tumwine James K JK Singata-Madliki Mandisa M Harper Kim K Hofmeyr G Justus GJ Van de Perre Philippe P Tylleskär Thorkild T

BMJ open 20180405 4

<h4>Objective</h4>We have assessed HIV-1 disease progression among HIV-1-positive mothers in relation to duration of any or exclusive breast feeding in the context of ANRS 12174 trial.<h4>Methods</h4>The analysis was completed on 203, 212, 272 and 529 HIV-1-positive and lactating mothers with CD4 count >350 cells/µL from Burkina Faso, South Africa, Uganda and Zambia, respectively. The trial compared lamivudine and lopinavir/ritonavir as a peri-exposure prophylaxis during a 50-week follow-up time ...[more]

PMID: 29626043

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Project description:BackgroundHIV-1 transmission rates have been reduced over the last decade, an estimated 2 million new infections per year arise, including 220,000 paediatric cases. The main post-natal HIV exposure is through breastfeeding, where both its duration and modality (exclusive or not) are associated with postnatal transmission. The ANRS 12174 trial compared HIV-1 postnatal transmission of 2 prophylaxis drugs for infants during lactation (lamivudine and lopinavir-ritonavir). Our objective has been to examine the feeding practices and the determinants of exclusive/ predominant (EPBF) or any breastfeeding among the participants of this trial in Burkina Faso, South Africa, Uganda and Zambia.MethodsMothers infected with HIV-1 and their uninfected offspring were followed from day 7 after birth for 50 weeks, keeping monthly records of their feeding patterns. Feeding was classified into 3 categories: 1) exclusive breastfeeding during the first six months, only breast-milk being given to infant for 6 months, 2) predominant breastfeeding, breast-milk with liquid-based items being given, and 3) mixed feeding, other non-breast milk or solid food being given in addition to breast milk with or without liquid-based items. The categories were merged into 2 groups: EPBF applying to infants aged <6 months and mixed feeding applying to infants of any age. The feeding patterns have been given as Kaplan-Meier curves. A flexible parametric multiple regression model was used to identify the determinants of the mothers' feeding behaviour.ResultsA total of 1,225 mother-infant pairs provided feeding data from Burkina Faso (N = 204), South Africa (N = 213), Uganda (N = 274) and Zambia (N = 534) between November 2009 and March 2013. The mean maternal age was 27.4 years and the mean BMI was 24.5. 57.7 and 93.9% of mothers initiated breastfeeding within the first hour and first day, respectively. Overall, the median durations of any form of breastfeeding and EPBF were 40.6, and 20.9 weeks, respectively. Babies randomized to the lopinavir/ritonavir group in South Africa tended to do less EPBF than those in the lamivudine group. Overall the group of mothers aged between 25 and 30 years, those married, employed or multiparous tended to stop early EPBF. Mothers living in Uganda or Zambia, those aged between 25 -30 years, better educated (at least secondary school level), employed or having undergone C-section stopped any breastfeeding early.ConclusionsThere is a need to improve breastfeeding and complementary feeding practices of children, particularly those exposed to HIV and anti-retrovirals, taking into account context and socio-demographic factors.Trial registrationClinical trial registration: NCT00640263.

Project description:The rapid scale-up of human immunodeficiency virus (HIV) testing, counselling and treatment throughout sub-Saharan Africa has raised questions about how to protect patients' rights to consent, confidentiality, counselling and care in resource-constrained settings. The Multi-country African Testing and Counselling for HIV (MATCH) study investigated client and provider experiences with different modes of testing in sub-Saharan Africa. One component of that study was a survey of 275 HIV service providers in Burkina Faso, Kenya and Uganda that gathered quantifiable indicators and qualitative descriptions using a standardized instrument. This article presents provider perspectives on the challenges of obtaining consent, protecting confidentiality, providing counselling and helping clients manage disclosure. It also explores health workers' fear of infection within the workplace and their reports on discrimination against HIV clients within health facilities. HIV care providers in Burkina Faso, Kenya and Uganda experienced substantial rewards from their work, including satisfaction from saving lives and gaining professional skills. They also faced serious resource constraints, including staff shortages, high workloads, lack of supplies and inadequate infrastructure, and they expressed concerns about accidental exposure. Health workers described heavy emotional demands from observing clients suffer emotional, social and health consequences of being diagnosed with HIV, and also from difficult ethical dilemmas related to clients who do not disclose their HIV status to those around them, including partners. These findings suggest that providers of HIV testing and counselling need more resources and support, including better protections against HIV exposure in the workplace. The findings also suggest that health facilities could improve care by increasing attention to consent, privacy and confidentiality and that health policy makers and ethicists need to address some unresolved ethical dilemmas related to confidentiality and non-disclosure, and translate those discussions into better guidance for health workers.

Project description:The beneficial effects from exclusive breastfeeding (EBF) have been widely acknowledged. We assessed the effect of exclusive breastfeeding promotion by peer counsellors in Uganda and Burkina Faso, on cognitive abilities, social emotional development, school performance and linear growth among 5-8 years old children.Children in the PROMISE EBF trial (2006-2008) were re-enrolled in the follow-up PROMISE Saving Brains (SB) study (2013-2015). Caretaker interviews captured sociodemographic characteristics and social emotional development using the parent version of the Strengths and Difficulties Questionnaire (SDQ). Overall cognition and working memory were assessed using the Kaufman Assessment Battery for Children, second edition (KABC2), cognitive flexibility was measured with the Child Category Test (CCT), and attention with the Test of Variables of Attention (T.O.V.A), while school performance was measured by a standardized test on arithmetic and reading. Country-pooled, age adjusted z-scores from each of the above outcomes were entered into a linear regression model controlling for confounders.The number of children re-enrolled in the intervention and control arms were: 274/396 (69.2%) and 256/369 (69.4%) in Uganda and 265/392 (67.6%) and 288/402 (71.6%) in Burkina Faso. Assessment of cognitive ability showed small and no significant differences, of which general cognition (z-scores, 95% CI) showed the largest mean difference: -0.17 (-0.40; 0.05). Social emotional symptoms were similar across arms. There were no differences in school performance or linear growth for age detected.Peer promotion for exclusive breastfeeding in Burkina Faso and Uganda was not associated with differences at 5-8 years of age in a range of measures of child development: cognitive abilities, emotion-behaviour-social symptoms or linear growth. This study from sub Saharan Africa did not reconfirm findings elsewhere that have shown an association between exclusive breastfeeding and cognitive performance. This might be due to a number of methodological limitations inherent in the current study. For example since the majority of the children were breastfed, the benefits of the intervention could have been diluted. Other factors such as the mental and HIV status of the mothers (which were not assessed in the current study) could have affected our results. Hence regarding the effect of exclusive breastfeeding on measures of child neurocognitive development in sub Saharan Africa, the jury is still out.ClinicalTrials.gov NCT01882335.

Project description:BACKGROUND:The 2016 World Health Organization guidelines recommend all children <3 years start antiretroviral therapy (ART) on protease inhibitor-based regimens. But lopinavir/ritonavir (LPV/r) syrup has many challenges in low-income countries, including limited availability, requires refrigeration, interactions with anti-tuberculous drugs, twice-daily dosing, poor palatability in young children, and higher cost than non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs. Successfully initiating LPV/r-based ART in HIV-infected children aged <2 years raises operational challenges that could be simplified by switching to a protease inhibitor-sparing therapy based on efavirenz (EFV), although, to date, EFV is not recommended in children <3 years. METHODS:The MONOD ANRS 12026 study is a phase 3 non-inferiority open-label randomised clinical trial conducted in Abidjan, Côte d'Ivoire, and Ouagadougou, Burkina Faso (ClinicalTrial.gov registry: NCT01127204). HIV-1-infected children who were tuberculosis-free and treated before the age of 2 years with 12-15 months of suppressive twice-daily LPV/r-based ART (HIV-1 RNA viral load (VL) <500 copies/mL, confirmed) were randomised to two arms: once-daily combination of abacavir (ABC)?+?lamivudine (3TC)?+?EFV (referred to as EFV) versus continuation of the twice-daily combination zidovudine (?ZDV) or? ABC?+?3TC?+?LPV/r (referred to as LPV). The primary endpoint was the difference in the proportion of children with virological suppression by 12 months post-randomisation between arms (14% non-inferiority bound, Chi-squared test). RESULTS:Between May 2011 and January 2013, 156 children (median age 13.7 months) were initiated on ART. After 12-15 months on ART, 106 (68%) were randomised to one of the two treatment arms (54 LPV, 52 EFV); 97 (91%) were aged <3 years. At 12 months post-randomisation, 46 children (85.2%) from LPV versus 43 (82.7%) from EFV showed virological suppression (defined as a VL <500 copies/mL; difference, 2.5%; 95% confidence interval (CI), -11.5 to 16.5), whereas seven (13%) in LPV and seven (13.5%) in EFV were classed as having virological failure (secondary outcome, defined as a VL ?1000 copies/mL; difference, 0.5%; 95% CI, -13.4 to 12.4). No significant differences in adverse events were observed, with two adverse events in LPV (3.7%) versus four (7.7%) in EFV (p?=?0.43). On genotyping, 13 out of 14 children with virological failure (six out of seven EFV, seven out of seven LPV) had a drug-resistance mutation: nine (five out of six EFV, four out of seven LPV) had one or more major NNRTI-resistance mutations whereas none had an LPV/r-resistance mutation. CONCLUSIONS:At the VL threshold of 500 copies/mL, we could not conclusively demonstrate the non-inferiority of EFV on viral suppression compared to LPV because of low statistical power. However, non-inferiority was confirmed for a VL threshold of <1000 copies/mL. Resistance analyses highlighted a high frequency of NNRTI-resistance mutations. A switch to an EFV-based regimen as a simplification strategy around the age of 3 years needs to be closely monitored. TRIAL REGISTRATION:ClinicalTrial.gov registry n° NCT01127204 , 19 May 2010.

Dataset Information

HIV-1 disease progression in immune-competent HIV-1-infected and breastfeeding mothers participating in the ANRS 12174 clinical trial in Burkina Faso, South Africa, Uganda and Zambia: a cohort study.

Publications

HIV-1 disease progression in immune-competent HIV-1-infected and breastfeeding mothers participating in the ANRS 12174 clinical trial in Burkina Faso, South Africa, Uganda and Zambia: a cohort study.

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