Evidence map›Paper›PMID 31893354›Full record

Observational studyInfection2020

Pregnancy and neonatal outcomes in women with HIV-1 exposed to integrase inhibitors, protease inhibitors and non-nucleoside reverse transcriptase inhibitors: an observational study.

Marco Floridia, Serena Dalzero, Vania Giacomet, Enrica Tamburrini, Giulia Masuelli, Valeria Savasi, Arsenio Spinillo, Beatrice Tassis, Laura Franceschetti, Anna Maria Degli Antoni and 6 more

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Infection, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

7 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Marco FloridiaNational Center for Global Health, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161, Rome, Italy. marco.floridia@iss.it.ORCID http://orcid.org/0000-0003-3971-0141
Serena DalzeroDepartment of Obstetrics and Gynaecology, DMSD San Paolo Hospital Medical School, University of Milan, Milan, Italy.
Vania GiacometDepartment of Pediatrics, Luigi Sacco Hospital and University of Milan, Milan, Italy.
Enrica TamburriniFondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Giulia MasuelliDepartment of Obstetrics and Neonatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.
Valeria SavasiDepartment of Obstetrics and Gynaecology, Luigi Sacco Hospital and University of Milan, Milan, Italy.
Arsenio SpinilloDepartment of Obstetrics and Gynaecology, IRCCS S. Matteo, Pavia, Italy.
Beatrice TassisObstetrics and Gynecology Unit, Fondazione IRCCS Ospedale Maggiore Policlinico di Milano, Milan, Italy.
Laura FranceschettiDepartment of Obstetrics and Gynecology, ASST Spedali Civili, Brescia, Italy.
Anna Maria Degli AntoniDepartment of Infectious Diseases and Hepatology, Azienda Ospedaliera di Parma, Parma, Italy.
Matilde SansoneDepartment of Neurosciences, Reproductive and Dentistry Science, University Federico II, Naples, Italy.
Giovanni GuaraldiDepartment of Medical Specialties, Infectious Diseases Clinic, University of Modena and Reggio Emilia, Modena, Italy.
Antonella VimercatiDepartment of Biomedical and Human Oncological Science (DIMO), 2nd Unit of Obstetrics and Gynaecology, University of Bari, Bari, Italy.
Alessandra MeloniDepartment of Surgical Sciences, Division of Gynaecology and Obstetrics, University of Cagliari, Cagliari, Italy.
Marina RavizzaDepartment of Obstetrics and Gynaecology, DMSD San Paolo Hospital Medical School, University of Milan, Milan, Italy.
Italian Group on Surveillance of Antiretroviral Treatment in Pregnancy

Funding

Agenzia Italiana del Farmaco, Ministero della Salute H85E08000200005
6 · The paper itself

Abstract

purposeRecommended regimens for pregnant women with HIV-1 are composed of two nucleoside reverse transcriptase inhibitors (NRTI) plus either a ritonavir-boosted protease inhibitor (PI) or an integrase strand transfer inhibitor (ISTI), with non-nucleoside reverse transcriptase inhibitors (NNRTI) representing an alternative drug class. The study's purpose was to compare these three options in terms of pregnancy outcomes.

methodsData from a national observational study of pregnant women with HIV-1 were used. The analysis included all pregnancies reported between 2008 and 2018, ending in live births and exposed within 32 weeks of gestation to three-drug regimens composed of a NRTI backbone plus a PI, a NNRTI or a ISTI, without class switching during pregnancy. Clinical and laboratory outcomes were evaluated in univariate and multivariable analyses.

resultsOverall, 794 exposed pregnancies were analyzed (PI 78.4%, NNRTI 15.4%, ISTI 6.2%). Almost all outcomes had similar rates in the three groups. Women who received PI in pregnancy were less likely to be virologically suppressed at third trimester. PI use was associated with higher bilirubin and triglyceride levels, and ISTI use with a lower rate of low birthweight. The differences in viral suppression at third trimester and in low birthweight were not maintained in multivariable analyses that were adjusted for confounders. DISCUSSION: We found no major differences in a wide range of outcomes relevant for pregnant women with HIV. Such results are reassuring, and this information may be helpful in a context of preconception counseling when therapeutic choices for pregnancy are discussed between women and care providers.

Indexed as

AdultAnti-HIV AgentsBirth WeightFemaleHIV-1HIV InfectionsHumansIntegrase InhibitorsMultivariate AnalysisPregnancyPregnancy OutcomeProtease InhibitorsReverse Transcriptase InhibitorsRNA, ViralAnti-HIV AgentsIntegrase InhibitorsProtease InhibitorsReverse Transcriptase InhibitorsRNA, ViralDelivery complicationsHIVHIV suppressionLow birthweightPregnancyPreterm delivery

Identifiers

What OpenQuestion holds

Textmetadata
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.