Evidence map›Paper›PMID 23924587›Full record

Trial reportHIV clinical trials

Baseline CD4+ T-cell counts predict HBV viral kinetics to adefovir treatment in lamivudine-resistant HBV-infected patients with or without HIV infection.

K J Cortez, M A Proschan, L Barrett, D G Brust, Barry Weatherley, E Formentini, R T Davey, H Masur, M A Polis, A U Neumann And and 1 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in HIV clinical trials. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Renal Impairment in Chronic Hepatitis B: A Review.Diseases (Basel, Switzerland) · 2018
    Review
  5. Article
  6. Article
  7. 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

11 authors at 4 institutions in 2 countries.

K J CortezDivision of Human Tissues, Office of Cell Therapy and Gene Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA.
M A Proschan
L Barrett
D G Brust
Barry Weatherley
E Formentini
R T Davey
H Masur
M A Polis
A U Neumann And
S Kottilil
National Institutes of Health · USBar-Ilan University · ILCenter for Biologics Evaluation and Research · USLee Memorial Health System · US

Funding

Immunologic And Virologic Approaches To HIV-1 TherapeuticsZIAAI000865 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DAVEY, RICHARD · 2009 to 2019
$8.8M
DC Partnership for HIV/AIDS Progress (DC PFAP)ZIACL009010 · CLC · CLINICAL CENTER · PI MASUR, HENRY · 2010 to 2025
$0k
Intramural NIH HHS Z99 AI999999
6 · The paper itself

Abstract

backgroundCoinfection with HIV and hepatitis B virus (HBV) substantially alters the course of HBV. Directly acting anti-HBV agents suppress HBV viral levels; however, the kinetics of HBV decline in mono- and coinfected persons have not been evaluated. We investigated the role of baseline CD4+ T-cell counts as a predictor of HBV response to adefovir (ADV) therapy in chronic HBV with and without HIV coinfection.

methodsWe conducted a double-blind, randomized, placebo-controlled study of HIV-infected (n = 12) and uninfected (n = 5) chronic HBV patients treated with ADV. Five HIV uninfected patients received ADV; the HIV+ patients received ADV or placebo for a total of 48 weeks. At the end of 48 weeks, all patients received open-label ADV for an additional 48 weeks. HBV, HIV viral loads, CD4+ T-cell counts, and safety labs were performed on days 0, 1, 3, 5, 7, 10, 14, and 28 and then every 4 weeks.

resultsLower HBV slopes were observed among coinfected compared to monoinfected patients (P = .027 at 4 weeks, P = .019 at 24 weeks, and P = .045 at 48 weeks). Using a mixed model analysis, we found a significant difference between the slopes of the 2 groups at 48 weeks (P = .045). Baseline CD4+ T-cell count was the only independent predictor of HBV decline in all patients.

conclusionHIV coinfection is associated with slower HBV response to ADV. Baseline CD4+ T-cell count and not IL28B genotype is an independent predictor of HBV decline in all patients, emphasizing the role of immune status on clearance of HBV.

Indexed as

CD4 Lymphocyte CountAdenineAdolescentAdultAgedAntiviral AgentsCoinfectionDouble-Blind MethodDrug Resistance, ViralFemaleHepatitis BHIV InfectionsHumansKineticsLamivudineMaleadefovirAdenineAntiviral AgentsLamivudineOrganophosphonates

Identifiers

PMID23924587
PMCPMC5573866
OpenAlexW2034266125

What OpenQuestion holds

Textmetadata
LicenceTDM
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.