Evidence map›Paper›PMID 36201354›Full record

Trial reportJournal of viral hepatitis2023

A randomized phase 1b trial of the active site polymerase inhibitor nucleotide ATI-2173 in patients with chronic hepatitis B virus infection.

Katherine E Squires, Lauren Ogilvie, Alina Jucov, Igor Anastasiy, Nelli Ghicavii, Jade Huguet, Rebeca Melara, Martin Constantineau, Abel De La Rosa, Douglas L Mayers

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Journal of viral hepatitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04248426 (A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% 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.

NCT04248426 phase1completednot on this map

A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection

TypeinterventionalSponsorAntios Therapeutics, IncRan2020 to 2021Enrolled88ConditionsHepatitis B, ChronicArmsATI-2173, ATI-2173 Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. 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

10 authors at 4 institutions in 4 countries.

Katherine E SquiresAntios Therapeutics, Doylestown, Pennsylvania, USA.ORCID 0000-0003-1925-2921
Lauren OgilvieAntios Therapeutics, Doylestown, Pennsylvania, USA.
Alina JucovARENSIA Exploratory Medicine, Republican Clinical Hospital, Chisinau, Moldova.
Igor AnastasiyDepartment of Infectious Diseases, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova.
Nelli GhicaviiARENSIA Exploratory Medicine, Republican Clinical Hospital, Chisinau, Moldova.
Jade HuguetAltasciences, Montreal, Quebec, Canada.
Rebeca MelaraAltasciences, Montreal, Quebec, Canada.
Martin ConstantineauAltasciences, Montreal, Quebec, Canada.
Abel De La RosaAntios Therapeutics, Doylestown, Pennsylvania, USA.
Douglas L MayersAntios Therapeutics, Doylestown, Pennsylvania, USA.
Doylestown Hospital · USAltasciences (Canada) · CAMoldova State University · MDNicolae Testemițanu State University of Medicine and Pharmacy · MD

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ATI-2173 is an active site polymerase inhibitor nucleotide in development as part of a potentially curative regimen for chronic hepatitis B virus (HBV) infection. This study evaluated the safety, tolerability, pharmacokinetics (PK) and antiviral activity of ATI-2173. This was a phase 1b, randomized, double-blind, placebo-controlled trial in treatment-naive adults with chronic HBV infection conducted in the Republic of Moldova and Ukraine (ClinicalTrials.gov: NCT04248426). Patients positive for hepatitis B surface antigen were randomized 6:2 to receive once-daily oral doses of ATI-2173 10, 25, or 50 mg (n = 6 per dose) or placebo (n = 7) for 28 days, with off-treatment monitoring for 24 weeks. Endpoints included PK parameters of ATI-2173 and its metabolite clevudine, maximum reduction from baseline in HBV DNA, and safety and tolerability. Treatment-emergent adverse events occurred in eight patients (47%) receiving ATI-2173 and five (71%) receiving placebo; headache was the most common (n = 4). ATI-2173 PK was generally dose proportional. Systemic clevudine exposure with ATI-2173 dosing was substantially reduced compared with historical values observed with clevudine administration. On Day 28, mean changes from baseline in HBV DNA were -2.72 to -2.78 log

Indexed as

Hepatitis B, ChronicAdultAntiviral AgentsCatalytic DomainDNA, ViralHepatitis B e AntigensHepatitis B virusHumansNucleotidesAntiviral AgentsDNA, ViralHepatitis B e AntigensNucleotidesactive site polymerase inhibitor nucleotidecccDNAclevudinehepatitis B virusnucleoside analogue

Identifiers

PMID36201354
PMCPMC10092119
OpenAlexW4302362273

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.