Dataset Information

Pregnancy outcome among HIV-infected women on different antiretroviral therapies in Ethiopia: a cohort study.

ABSTRACT:

Objective

The objective of the study was to compare pregnancy outcomes according to maternal antiretroviral treatment (ART) regimens.

Design

A retrospective cohort study.

Participants and settings

Clinical data was extracted from ART exposed pregnancies of HIV-infected Ethiopian women attending antenatal care follow-up in public health facilities in Addis Ababa between February 2010 and October 2016.

Outcomes

The primary outcomes evaluated were preterm birth, low birth weight and small-for-gestational-age.

Results

A total 1663 of pregnancies exposed to ART were included in the analyses. Of these pregnancies, 17% resulted in a preterm birth, 19% in low birth weight and 32% in a small-for-gestational-age baby. Compared with highly active antiretroviral therapy (HAART) initiated during pregnancy, zidovudine monotherapy was less likely to result in preterm birth (adjusted OR 0.35, 95%?CI 0.19 to 0.64) and low birth weight (adjusted OR 0.48, 95%?CI 0.24 to 0.94). We observed no differential risk of preterm birth, low birth weight and small-for-gestational-age, when comparing women who initiated HAART during pregnancy to women who initiated HAART before conception. The risk for preterm birth was higher in pregnancies exposed to nevirapine-based HAART (adjusted OR 1.44, 95%?CI 1.06 to 1.96) compared with pregnancies exposed to efavirenz-based HAART. Comparing nevirapine-based HAART with efavirenz-based HAART indicated no strong evidence of increased risk of low birth weight or small-for-gestational-age.

Conclusions

We observed a higher risk of preterm birth among women who initiated HAART during pregnancy compared with zidovudine monotherapy. Pregnancies exposed to nevirapine-based HAART also had a greater risk of preterm births compared with efavirenz-based HAART.

SUBMITTER: Ejigu Y

PROVIDER: S-EPMC6687026 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pregnancy outcome among HIV-infected women on different antiretroviral therapies in Ethiopia: a cohort study.

Ejigu Yohannes Y Magnus Jeanette H JH Sundby Johanne J Magnus Maria C MC

BMJ open 20190805 8

<h4>Objective</h4>The objective of the study was to compare pregnancy outcomes according to maternal antiretroviral treatment (ART) regimens.<h4>Design</h4>A retrospective cohort study.<h4>Participants and settings</h4>Clinical data was extracted from ART exposed pregnancies of HIV-infected Ethiopian women attending antenatal care follow-up in public health facilities in Addis Ababa between February 2010 and October 2016.<h4>Outcomes</h4>The primary outcomes evaluated were preterm birth, low bir ...[more]

PMID: 31383698

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Project description:BackgroundNearly all newly infected children acquire Human Immunodeficiency virus (HIV) via mother-to-child transmission (MTCT) during pregnancy, labour or breastfeeding from untreated HIV-positive mothers. Antiretroviral therapy (ART) is the standard care for pregnant women with HIV. However, evidence of ART effectiveness and harms in infants and children of HIV-positive pregnant women exposed to ART has been largely inconclusive. The aim of our systematic review and network meta-analysis (NMA) was to evaluate the comparative safety and effectiveness of ART drugs in children exposed to maternal HIV and ART (or no ART/placebo) across different study designs.MethodsWe searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (inception until December 7, 2015). Primary outcomes were any congenital malformations (CMs; safety), including overall major and minor CMs, and mother-to-child transmission (MTCT; effectiveness). Random-effects Bayesian pairwise meta-analyses and NMAs were conducted. After screening 6,468 citations and 1,373 full-text articles, 90 studies of various study designs and 90,563 patients were included.ResultsThe NMA on CMs (20 studies, 7,503 children, 16 drugs) found that none of the ART drugs examined here were associated with a significant increase in CMs. However, zidovudine administered with lamivudine and indinavir was associated with increased risk of preterm births, zidovudine administered with nevirapine was associated with increased risk of stillbirths, and lamivudine administered with stavudine and efavirenz was associated with increased risk of low birth weight. A NMA on MTCT (11 studies, 10,786 patients, 6 drugs) found that zidovudine administered once (odds ratio [OR] = 0.39, 95% credible interval [CrI]: 0.19-0.83) or twice (OR = 0.43, 95% CrI: 0.21-0.68) was associated with significantly reduced risk of MTCT.ConclusionsOur findings suggest that ART drugs are not associated with an increased risk of CMs, yet some may increase adverse birth events. Some ART drugs (e.g., zidovudine) effectively reduce MTCT.

Project description:AimTo evaluate the prevalence and associated factors of abnormal renal function among Ethiopian HIV-infected patients at baseline prior to initiation of antiretroviral therapy (ART) and during follow-up.MethodsWe conducted a retrospective observational cohort study of HIV infected patients who initiated ART at the outpatient ART clinic of Mehal Meda Hospital of North Shewa, Ethiopia from January 2012 to August 2018. Demographic and clinical data were abstracted from the medical records of patients. Renal function was assessed by estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation. Univariate and multivariate analysis were conducted to determine the factors associated with abnormal renal function at baseline and during follow-up.ResultsAmong 353 patients, 70 (19.8%) had baseline eGFR <60 ml/min/1.73m2 and 102 (28.9%) had eGFR = 60-89.9 ml/min/1.73m2. Factors associated with baseline renal impairment (eGFR <60 ml/min/1.73m2) included female sex (AOR = 3.52, CI 1.75-7.09), CD4 count < 200 cells/mm3 (AOR = 2.75, CI 1.40-5.42), BMI < 25 Kg/m2 (AOR = 3.04, CI 1.15-8.92), low hemoglobin (AOR = 2.19, CI 1.16-4.09) and high total cholesterol (AOR = 3.15, CI 1.68-5.92). After a median of 3.0 years of ART, the mean eGFR declined from 112.9 ± 81.2 ml/min/1.73m2 at baseline to 93.9 ± 60.6 ml/min/1.73m2 (P < 0.001). The prevalence of renal impairment increased from 19.8% at baseline to 22.1% during follow-up. Of 181 patients with baseline normal renal function, 49.7% experienced some degree of renal impairment. Older age (AOR = 3.85, 95% CI 2.03-7.31), female sex (AOR = 4.18, 95% CI 2.08-8.40), low baseline CD4 (AOR = 2.41, 95% CI 1.24-4.69), low current CD4 count (AOR = 2.32, 95% CI 1.15-4.68), high BMI (AOR = 2.91, 95% CI 1.49-5.71), and low hemoglobin (AOR = 3.38, 95% CI 2.00-7.46) were the factors associated with renal impairment during follow-up.ConclusionImpaired renal function was common in HIV-infected patients initiating ART in an outpatient setting in Ethiopia, and there appears to be a high prevalence of renal impairment after a median ART follow-up of 3 years. There is a need for assessment of renal function at baseline before ART initiation and regular monitoring of renal function for patients with HIV during follow-up.

Project description:BackgroundSelection of an appropriate patient-reported outcome (PRO) instrument for a clinical trial requires knowledge of the instrument's responsiveness to detecting treatment effects. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D).MethodsA systematic review identified clinical trials using the MOS-HIV or EQ-5D to assess outcomes for HIV-infected adults. Data abstracted from each study included study type, treatment regimen(s), PRO results, and effect size (either reported or calculated). Effect size was calculated as the difference between baseline and follow-up mean scores divided by the baseline standard deviation. Magnitude was categorized as small (d=0.20), medium (d=0.50), and large (d=0.80).ResultsBetween 2005 and 2010, the MOS-HIV was administered in 12 trials. Significant differences were observed between groups and over time in physical health summary (PHS) and mental health summary (MHS) scores (P<0.05) in subjects switching therapy after experiencing Grade-2 adverse events. Effect sizes were medium (0.55 and 0.49 for PHS and MHS, respectively) among treatment-naïve adults beginning therapy (two studies), but negligible among treatment-experienced adults (0.04 and 0.13 for PHS and MHS, respectively; three studies). The EQ-5D was used in five trials between 2001 and 2010. It was responsive to occurrences of adverse events and opportunistic infections, with small-to-medium effect sizes (range 0.30-0.50) in each of its five dimensions.ConclusionsA systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and/or over time in treatment-naïve HIV-infected patients. These instruments may be used either individually or together in clinical trials to measure changes in HRQL.

Dataset Information

Pregnancy outcome among HIV-infected women on different antiretroviral therapies in Ethiopia: a cohort study.

Objective

Design

Participants and settings

Outcomes

Results

Conclusions

Publications

Pregnancy outcome among HIV-infected women on different antiretroviral therapies in Ethiopia: a cohort study.

Similar Datasets

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