Evidence map›Paper›PMID 28291053›Full record

SynthesisJournal of acquired immune deficiency syndromes (1999)2017

Safety of Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis.

Jean B Nachega, Olalekan A Uthman, Lynne M Mofenson, Jean R Anderson, Steve Kanters, Francoise Renaud, Nathan Ford, Shaffiq Essajee, Meg C Doherty, Edward J Mills

Open access · hybridAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 4 pooled it
7.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 4 syntheses or guidelines pooled it, 88 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 6 countries.

Jean B Nachega*Departments of Epidemiology, Microbiology and Infectious Diseases, University of Pittsburgh, Pittsburgh, PA; †Department of Medicine, Centre for Infectious Diseases, Stellenbosch University, Cape Town, South Africa; ‡Departments of Epidemiology and International Health, Johns Hopkins University, Baltimore, MD; §Centre for Applied Health Research & Delivery, Warwick Medical School, The University of Warwick, Coventry, United Kingdom; ‖Department of Public Health (IHCAR), Karolinska Institute, Stockholm, Sweden; ¶Department of Global Health, Centre for Evidence-Based Health Care, Stellenbosch University, Tygerberg, South Africa; #Elizabeth Glazer Pediatric AIDS Foundation, Washington, DC; **Department of Obstetrics and Gynecology, Johns Hopkins School of Medicine, Baltimore, MD; ††Department of Statistics, University of British Columbia, Vancouver, Canada; ‡‡Global Evaluative Science, Vancouver, Canada; and §§Department of HIV, World Health Organization, Geneva, Switzerland.
Olalekan A Uthman
Lynne M Mofenson
Jean R Anderson
Steve Kanters
Francoise Renaud
Nathan Ford
Shaffiq Essajee
Meg C Doherty
Edward J Mills
World Health Organization · CHInstitute for Clinical Evaluative Sciences · CAJohns Hopkins University · USElizabeth Glaser Pediatric AIDS Foundation · USStellenbosch University · ZA

Funding

Stellenbosch University Clinical Trial Unit, Cape Town, South AfricaUM1AI069521 · NIAID · STELLENBOSCH UNIVERSITY · PI Shaun Barnabas, Anneke Catharina Hesseling · 2012 to 2026
$21.5M
Pittsburgh-Stellenbosch University AIDS-comorbidities Training Research Program (Pitt-SU AICoTRP)D43TW010340 · FIC · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI NACHEGA, JEAN BISIMWA · 2016 to 2016
$113k
CGH CDC HHS U2G GH001536FIC NIH HHS D43 TW010340NIAID NIH HHS UM1 AI069521PEPFARWorld Health Organization 001
6 · The paper itself

Abstract

backgroundThere are limited data on adverse effects of tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART) on pregnant women and their infants.

methodsWe conducted a systematic review of studies published between January 1980 and January 2017 that compared adverse outcomes in HIV-infected women receiving TDF- vs. non-TDF-based ART during pregnancy. The risk ratio (RR) for associations was pooled using a fixed-effects model.

resultsSeventeen studies met the study inclusion criteria. We found that the rate of preterm (<37 weeks gestation) delivery (RR = 0.90, 95% confidence interval [CI]: 0.81 to 0.99, I = 59%) and stillbirth (RR = 0.60, 95% CI: 0.43 to 0.84, I = 72.0%) were significantly lower in women exposed (vs. not) to TDF-based ART regimen. We found no increased risk in maternal severe (grade 3) or potentially life-threatening (grade 4) adverse events (RR = 0.62; 95% CI: 0.30 to 1.29), miscarriage (RR = 1.09; 95% CI: 0.80 to 1.48), very preterm (<34 weeks gestation) delivery (RR = 1.08, 95% CI: 0.72 to 1.62), small for gestational age (RR = 0.87, 95% CI: 0.67 to 1.13), low birth weight (RR = 0.91; 95% CI: 0.80 to 1.04), very low birth weight (RR = 3.18; 95% CI: 0.65 to 15.63), congenital anomalies (RR = 1.03; 95% CI: 0.83 to 1.28), infant adverse outcomes or infant mortality (age >14 days) (RR = 0.65; 95% CI: 0.23 to 1.85), but increased neonatal mortality (age <14 days) risk (RR = 5.64, 95% CI: 1.70 to 18.79) with TDR-based ART exposure. No differences were found for anthropomorphic parameters at birth; one study reported minor differences in z-scores for length and head circumference at age 1 year.

conclusionsTDF-based ART in pregnancy seems generally safe for women and their infants. However, data remain limited and further studies are needed, particularly to assess neonatal mortality and infant growth/bone effects.

Indexed as

Patient SafetyAnti-HIV AgentsBirth WeightCD4 Lymphocyte CountFemaleHIV InfectionsHumansInfant, Low Birth WeightInfant, NewbornInfectious Disease Transmission, VerticalPregnancyPregnancy Complications, InfectiousPregnancy OutcomeTenofovirAnti-HIV AgentsTenofovir

Identifiers

PMID28291053
PMCPMC5553236
OpenAlexW2599563006

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.