Evidence map›Paper›PMID 24458137›Full record

ArticleAntiviral therapy2014

Hepatic safety and tolerability of raltegravir among HIV patients coinfected with hepatitis B and/or C.

Christopher B Hurt, Sonia Napravnik, Richard D Moore, Joseph J Eron

Abstract read
In one paragraph

Article in Antiviral therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
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

4 authors.

Christopher B HurtInstitute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. churt@med.unc.edu.
Sonia Napravnik
Richard D Moore
Joseph J Eron

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
North American AIDS Cohorts on Collaboration and Design (NAACCORD)U01AI069918 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Keri Nicole Althoff, RICHARD Douglas MOORE · 2006 to 2026
$65.2M
Johns Hopkins HIV Clinical CohortU01DA036935 · NIDA · JOHNS HOPKINS UNIVERSITY · PI MOORE, RICHARD DOUGLAS · 2014 to 2024
$14.9M
HIV DISEASE OUTCOMES IN DRUG USERS IN CLINICAL PRACTICER01DA011602 · NIDA · JOHNS HOPKINS UNIVERSITY · PI MOORE, RICHARD DOUGLAS · 1998 to 2013
$10.8M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)KL2TR001109 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$5.7M
UNC Clinical Translation Science Award-K12 Scholars Program (KL2)KL2TR000084 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2012 to 2013
$2.3M
MID CAREER INVESTIGATOR AWARDK24DA000432 · NIDA · JOHNS HOPKINS UNIVERSITY · PI MOORE, RICHARD DOUGLAS · 2000 to 2009
$1.5M
Alcohol and HIV Treatment and Clinical ProgressionR01AA016893 · NIAAA · JOHNS HOPKINS UNIVERSITY · PI MOORE, RICHARD DOUGLAS · 2008 to 2011
$1.3M
NCATS NIH HHS 5KL2TR000084NCATS NIH HHS KL2 TR000084NCATS NIH HHS KL2 TR001109NIAAA NIH HHS 5R01AA016893NIAAA NIH HHS R01 AA016893NIAID NIH HHS 5P30AI50410NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI069918NIDA NIH HHS 5K24DA000432NIDA NIH HHS 5R01DA011602NIDA NIH HHS K24 DA000432NIDA NIH HHS R01 DA011602NIDA NIH HHS U01 DA036935
6 · The paper itself

Abstract

backgroundPotential liver toxicity is an important consideration for antiretroviral selection among patients coinfected with HIV and viral hepatitis (B and/or C). We sought to describe the hepatic safety profile of raltegravir in this population.

methodsUsing data from HIV clinical cohorts at Johns Hopkins University and the University of North Carolina at Chapel Hill, we evaluated factors associated with liver enzyme elevations (LEEs) and calculated adverse event incidence rates for patients initiated on raltegravir-containing regimens prior to 1 January 2010. LEEs were graded according to Division of AIDS definitions.

resultsDuring the study period, 456 patients received raltegravir - of whom 36% were hepatitis-coinfected (138 HCV, 17 HBV, 11 HBV+HCV). Coinfected patients were more likely to have baseline abnormal LEEs and developed severe (grade 3-4) LEEs at a rate 3.4× that of HIV-monoinfected patients (95% CI 1.28, 9.61). Among all participants, the incidence rate for first occurrence of severe LEEs was 5 per 100 person-years (95% CI 3, 7). In adjusted analyses, coinfected patients had a 2.7-fold increased hazard of severe LEEs (95% CI 1.03, 7.04). 60% of severe abnormalities occurred within 6 months after starting raltegravir; the drug was discontinued in 3 (1.3%) coinfected patients and 18 (6.2%) monoinfected patients.

conclusionsCompared with HIV-monoinfected patients, those with HIV-hepatitis coinfection are at increased hazard of developing LEEs on raltegravir, at a level similar to other antiretrovirals. Severe events were uncommon, rarely leading to raltegravir discontinuation. With appropriate monitoring, raltegravir-based therapy is safe in hepatitis-coinfected patients.

Indexed as

CoinfectionHepatitis BHepatitis CAdultAgedAnti-HIV AgentsCD4 Lymphocyte CountChemical and Drug Induced Liver InjuryFemaleHIV InfectionsHumansLiverMaleMiddle AgedPyrrolidinonesRaltegravir PotassiumAnti-HIV AgentsPyrrolidinonesRaltegravir Potassium

Identifiers

PMID24458137
PMCPMC4108567

What OpenQuestion holds

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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.