Evidence map›Paper›PMID 33984038›Full record

Trial reportPloS one2021

Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV.

Calvin Q Pan, Ting-Tsung Chang, Si Hyun Bae, Maurizia Brunetto, Wai-Kay Seto, Carla S Coffin, Susanna K Tan, Shuyuan Mo, John F Flaherty, Anuj Gaggar and 4 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.5field-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, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Review
  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

14 authors at 11 institutions in 10 countries.

Calvin Q PanCenter for Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-3723-6688
Ting-Tsung ChangNational Cheng Kung University Hospital, Tainan, Taiwan.
Si Hyun BaeCollege of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Maurizia BrunettoUniversity of Pisa, Pisa, Italy.
Wai-Kay SetoDepartment of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
Carla S CoffinCumming School of Medicine, University of Calgary, Alberta, Canada.
Susanna K TanGilead Sciences, Inc., Foster City, California, United States of America.
Shuyuan MoGilead Sciences, Inc., Foster City, California, United States of America.
John F FlahertyGilead Sciences, Inc., Foster City, California, United States of America.
Anuj GaggarGilead Sciences, Inc., Foster City, California, United States of America.
Mindie H NguyenStanford University, Palo Alto, California, United States of America.
Mustafa Kemal ÇelenDicle University School of Medicine, Diyarbakir, Turkey.
Alexander ThompsonSt. Vincent's Hospital Melbourne and The University of Melbourne, Melbourne, Australia.
Edward J GaneNew Zealand Liver Transplant Unit, Auckland Clinical Studies, Auckland, New Zealand.
Gilead Sciences (United States) · USCapital Medical University · CNCatholic University of Korea · KRChinese University of Hong Kong · HKClinical Trials New Zealand · NZDicle University · TRNational Cheng Kung University Hospital · TWPalo Alto University · USThe University of Melbourne · AUUniversity of Calgary · CAUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background/purposeUse of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression with TAF and TDF were evaluated in women of childbearing potential (WOCBP) participating in 2 randomized, double-blind, Phase 3 studies in chronic HBV.

methodsIn a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA <200,000 IU/mL at weeks 12 and 24 were assessed. Multivariate logistic regression was used to identify factors predictive of failure to suppress HBV DNA to the target level.

resultsIn 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA <200,000 IU/mL at weeks 12 and 24, respectively. Results for TAF (n = 194) vs TDF (n = 81) treatment were similar at weeks 12 and 24 (94% vs. 90% and 97% vs. 93%), respectively. High baseline HBV DNA level, genotype D infection, and prior interferon (week 24 only) were predictive of failure to achieve the target level. Both treatments were well tolerated with TAF showing less impact on renal and bone parameters.

conclusionsIn WOCBP with high VL, no differences were found between TAF and TDF in reducing HBV DNA to levels associated with lower transmission risk. These data support ongoing studies of TAF for pMTCT.

Indexed as

AdolescentAdultAlanineAntiviral AgentsDouble-Blind MethodFemaleHepatitis B, ChronicHepatitis B virusHumansInfectious Disease Transmission, VerticalMiddle AgedProspective StudiesTenofovirTreatment OutcomeViral LoadYoung AdultAlanineAntiviral AgentsTenofovirtenofovir alafenamide

Identifiers

PMID33984038
PMCPMC8118264
OpenAlexW3163583149

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.