Evidence map›Paper›PMID 26035319›Full record

Trial reportAIDS (London, England)2015

Comparison of HBV-active HAART regimens in an HIV-HBV multinational cohort: outcomes through 144 weeks.

Chloe L Thio, Laura Smeaton, Kimberly Hollabaugh, Melissa Saulynas, Hyon Hwang, Shanmugam Saravanan, Smita Kulkarni, James Hakim, Mulinda Nyirenda, Hussain Syed Iqbal and 4 more

Open access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

13 citing papers in PubMed, 20 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

14 authors at 10 institutions in 5 countries.

Chloe L ThioaJohns Hopkins University, Baltimore, Maryland bHarvard School of Public Health, Boston, Massachusetts, USA cYRG Centre for AIDS Research and Education, Voluntary Health Services Hospital Campus, Taramani, Chennai dNational AIDS Research Institute-ICMR, Pune, India eUniversity of Zimbabwe Clinical Research Centre, College of Health Sciences, Harare, Zimbabwe fCollege of Medicine, Johns Hopkins Research Project, Department of Medicine, Blantyre, Malawi gNelson R Mandela School of Medicine, University of KwaZulu-Natal, Glenwood, South Africa hUniversity of Colorado School of Medicine, Aurora, Colorado iBrigham and Women's Hospital, Boston, Massachusetts jUCLA David Geffen School of Medicine, Los Angeles, California, USA.
Laura Smeaton
Kimberly Hollabaugh
Melissa Saulynas
Hyon Hwang
Shanmugam Saravanan
Smita Kulkarni
James Hakim
Mulinda Nyirenda
Hussain Syed Iqbal
Umesh G Lalloo
Thomas B Campbell
Shahin Lockman
Judith S Currier
Johns Hopkins University · USHarvard University · USVoluntary Health Services Hospital · INBrigham and Women's Hospital · USNational AIDS Research Institute · INUniversity of California, Los Angeles · USUniversity of Colorado Denver · USUniversity of KwaZulu-Natal · ZAUniversity of Malawi · MWUniversity of Zimbabwe · ZW

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024996 · NCRR · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2007 to 2011
$49.6M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
The Malawi Clinical Trials UnitU01AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 2007 to 2011
$46.7M
NCATS NIH HHS UL1 TR000457NCI NIH HHS R01 CA120206NCI NIH HHS R01CA120206NCI NIH HHS R01 CA136607NCI NIH HHS R01CA136607NCRR NIH HHS RR024996NCRR NIH HHS RR 025747NCRR NIH HHS UL1 RR 024160NCRR NIH HHS UL1 RR024160NCRR NIH HHS UL1 RR024996NCRR NIH HHS UL1 RR025747NIAID NIH HHS 1U01AI069399-01NIAID NIH HHS 1U01AI069401-01NIAID NIH HHS 1U01AI069417-01NIAID NIH HHS 1U01AI069421-01NIAID NIH HHS 1U01AI069424-01NIAID NIH HHS 1U01AI069426-01NIAID NIH HHS 1U01AI069432-01NIAID NIH HHS 1U01AI069436-01NIAID NIH HHS 1U01AI069456-01NIAID NIH HHS 1U01AI069463-01NIAID NIH HHS 1U01AI069470NIAID NIH HHS 1U01AI069471-01NIAID NIH HHS 1U01AI069476-01NIAID NIH HHS 1U01AI069495NIAID NIH HHS 1U01AI069518-01NIAID NIH HHS 5U01 AI069438NIAID NIH HHS 5U01AI069438NIAID NIH HHS AI050410NIAID NIH HHS AI068636NIAID NIH HHS AI069419NIAID NIH HHS AI069423NIAID NIH HHS AI069428NIAID NIH HHS AI069471NIAID NIH HHS AI069472-01NIAID NIH HHS AI069474NIAID NIH HHS AI069484-06NIAID NIH HHS AI-069513NIAID NIH HHS AI25868NIAID NIH HHS AI27661NIAID NIH HHS AI32782NIAID NIH HHS AI34853NIAID NIH HHS AI38858-09S1NIAID NIH HHS AI46370NIAID NIH HHS AI46381NIAID NIH HHS AI69450NIAID NIH HHS K24 AI056933NIAID NIH HHS K24 AI56933NIAID NIH HHS P30 AI045008NIAID NIH HHS P30-AI-045008-12NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI071820NIAID NIH HHS U01 AI025868NIAID NIH HHS U01 AI027661NIAID NIH HHS U01 AI032782NIAID NIH HHS U01 AI034853NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI046370NIAID NIH HHS U01 AI046376NIAID NIH HHS U01 AI046381NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069399NIAID NIH HHS U01 AI069401NIAID NIH HHS U01 AI069417NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069421NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069426NIAID NIH HHS U01 AI069428NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069436NIAID NIH HHS U01 AI069438NIAID NIH HHS U01 AI069439NIAID NIH HHS U01-AI069439NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069456NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069467NIAID NIH HHS U01 AI069470NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069476NIAID NIH HHS U01 AI069484NIAID NIH HHS U01 AI069495NIAID NIH HHS U01 AI069511NIAID NIH HHS U01AI069511-02NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069518NIAID NIH HHS U01-AI- AI69467-05NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069428NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069467NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069484NIAID NIH HHS UM1 AI069513NIAID NIH HHS UM1 AI069518NIAID NIH HHS Y1-AI-8374-01PHS HHS AL069532PHS HHS AL-27665PHS HHS U01-A1 069424
6 · The paper itself

Abstract

objectivesTo explore factors associated with short and long-term hepatitis B virus (HBV) DNA suppression in a multinational cohort of HIV-HBV co-infected patients receiving HBV-active antiretrovirals.

methodsOne hundred and fifteen HIV-HBV co-infected patients participating in one of the two global randomized clinical trials conducted by the Adult AIDS Clinical Trials Group of different antiretroviral regimens received either HBV monotherapy with either lamivudine or emtricitabine (N = 56), or HBV dual therapy with tenofovir disoproxil fumarate (TDF) + lamivudine or emtricitabine (N = 59). Associations of pretreatment characteristics with the primary (HBV DNA <200 IU/ml at 24 weeks) and longitudinal outcomes through 144 weeks were explored using logistic regression. HBV drug-resistance mutations were determined by pol sequencing in those with viral rebound.

resultsThe proportion with HBV DNA below 200 IU/ml was 60% (95% confidence interval 50-69%) at 24 weeks and 79% (95% confidence interval 69-88%) at 144 weeks. Pretreatment factors associated with the primary outcome were HBV DNA, CD4 T-cell count, and aspartate aminotransferase, but only pretreatment HBV DNA remained associated with long-term suppression (P < 0.0001). HBV therapy group was not significantly associated with the primary outcome at 24 weeks; however, longitudinally, a greater proportion in the dual-therapy group achieved HBV DNA below 200 IU/ml (P = 0.007). A higher proportion of hepatitis B e antigen-negative patients (n = 57) achieved HBV DNA below 200 IU/ml at any point, regardless of the therapy group. All 12 patients with emergence of lamivudine-resistant mutants were in the monotherapy group.

conclusionsTDF-based dual HBV-active antiretroviral therapy is preferred to treat HIV-HBV co-infected patients. In resource-limited settings in which TDF may not be universally available, lamivudine or emtricitabine HBV monotherapy is a reasonable option in patients with low HBV replication.

Indexed as

AdultAntiretroviral Therapy, Highly ActiveAntiviral AgentsDrug Resistance, ViralFemaleHepatitis B, ChronicHepatitis B virusHIV InfectionsHumansLongitudinal StudiesMaleMutationTreatment OutcomeViral LoadAntiviral Agents

Identifiers

PMID26035319
PMCPMC4535336
OpenAlexW650409306

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Registered trials

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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.