Evidence map›Paper›PMID 27375283›Full record

Trial reportAlimentary pharmacology & therapeutics2016

Long-term lamivudine therapy in chronic hepatitis B.

S Lingala, D T-Y Lau, C Koh, S Auh, M G Ghany, J H Hoofnagle

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Application of Nanotechnology in the COVID-19 Pandemic.International journal of nanomedicine · 2021
    Review
  6. Durability of Spontaneous and Treatment-Related Loss of Hepatitis B s Antigen.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
    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

6 authors at 3 institutions in 1 country.

S LingalaLiver Diseases Branch, Intramural Division, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD, USA.
D T-Y LauBeth Israel-Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
C KohLiver Diseases Branch, Intramural Division, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD, USA.
S AuhNIDDK, NIH, Bethesda, MD, USA.
M G GhanyLiver Diseases Branch, Intramural Division, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD, USA.
J H HoofnagleLiver Diseases Branch, Intramural Division, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD, USA.
National Institutes of Health · USNational Institute of Diabetes and Digestive and Kidney Diseases · USBeth Israel Deaconess Medical Center · US

Funding

Natural History, Therapy and Pathogenesis of Chronic Viral Hepatitis BZIADK054517 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI GHANY, MARC · 2009 to 2025
$9.6M
Natural History, Therapy and Pathogenesis of Chronic Viral Hepatitis BZ01DK054517 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI GHANY, MARC · 2008 to 2008
$567k
Intramural NIH HHS Z01 DK054517Intramural NIH HHS Z99 DK999999
6 · The paper itself

Abstract

backgroundOne to 5 years of therapy of chronic hepatitis B with oral nucleoside analogues result in significant clinical improvements, but effects of more prolonged therapy are not well defined.

aimTo describe outcomes of chronic hepatitis B with long-term lamivudine therapy.

methodsForty-two patients with chronic hepatitis B treated with lamivudine were followed for 3.2-19.5 (median = 16.1) years. Therapy was switched to other agents (n = 16) if patients developed lamivudine resistance and relapse of disease.

resultsAmong 22 HBeAg-positive patients, 17 (77%) became HBeAg negative, of whom 5 (23%) subsequently cleared HBsAg. Among 20 HBeAg-negative patients, 10 (50%) cleared HBsAg. The time to HBsAg clearance ranged from 0.9 to 16.8 (median = 9.3) years. Lamivudine resistance arose in 24 patients (57%) of whom 6 (25%) lost HBsAg. HBsAg clearance was not always accompanied by seroconversion; anti-HBs appearing concurrently in only five patients (33%). Nevertheless, HBsAg loss allowed for stopping therapy in all patients, none re-developing HBsAg or suffering relapse; all having normal alanine aminotransferase levels and no (n = 13) or unquantifiable HBV DNA levels (n = 2) when last seen. In contrast, seven of 27 patients (26%) who remained HBsAg-positive died of liver disease or liver cancer or underwent liver transplantation, all of whom had cirrhosis.

conclusionsLong-term viral suppression with nucleoside analogues leads to HBsAg loss in a substantial proportion of patients, particularly if HBeAg-negative. Serious outcomes during the first 10-20 years of treatment occur largely among patients with pre-existing cirrhosis who do not clear HBsAg with therapy.

Indexed as

AdolescentAdultAgedAntiviral AgentsFemaleHepatitis B, ChronicHepatitis B Surface AntigensHumansLamivudineLiver CirrhosisLiver NeoplasmsLiver TransplantationMaleMiddle AgedTreatment OutcomeYoung AdultAntiviral AgentsHepatitis B Surface AntigensLamivudine

Identifiers

PMID27375283
PMCPMC4969625
OpenAlexW2464391186

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.