Evidence map›Paper›PMID 27749900›Full record

Trial reportPloS one2016

A Randomized Study of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a in Combination with Ribavirin and Telaprevir in Patients with Genotype-1 Chronic Hepatitis C.

Robert Flisiak, Mitchell Shiffman, Juan Arenas, Hugo Cheinquer, Igor Nikitin, Yuping Dong, Khurram Rana, Subasree Srinivasan

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

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 30% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Interferon Lambda: The Next Frontier in Antiviral Therapy?Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  2. Article
  3. Structure-function of type I and III interferons.Current opinion in immunology · 2024
    Review
  4. Review
  5. Review
  6. Review
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

8 authors at 6 institutions in 5 countries.

Robert FlisiakDepartment of Infectious Diseases and Hepatology, Medical University of Bialystock, Bialystock, Poland.
Mitchell ShiffmanBon Secours Liver Institute of Virginia, Richmond, Virginia, United States of America.
Juan ArenasDepartment of Gastroenterology and Hepatology, University Hospital Donostia, San Sebastián, Spain.
Hugo CheinquerDepartment of Internal Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Igor NikitinDepartment of Higher Level General Medicine, Russian State Medical University, Moscow, Russia.
Yuping DongResearch and Development, Bristol-Myers Squibb, Inc., Wallingford, Connecticut, United States of America.
Khurram RanaResearch and Development, Bristol-Myers Squibb, Inc., Wallingford, Connecticut, United States of America.
Subasree SrinivasanResearch and Development, Bristol-Myers Squibb, Inc., Wallingford, Connecticut, United States of America.
Bristol-Myers Squibb (United States) · USBiogipuzkoa Health Research Institute · ESBon Secours Liver Institute of Richmond · USMedical University of Białystok · PLPirogov Russian National Research Medical University · RUUniversidade Federal do Rio Grande do Sul · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection.

methodsPatients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks. The primary endpoint was the proportion of patients who achieved a sustained virologic response at post treatment week 12 (SVR12), which was tested for noninferiority of Lambda/RBV/TVR.

resultsA total of 838 patients were enrolled, and 617 were treated; 411 and 206 patients received Lambda/RBV/TVR and Alfa/RBV/TVR, respectively. The majority of patients were treatment-naïve, with HCV GT-1b and a high baseline viral load (≥800,000 IU/mL). Less than 10% of patients had cirrhosis (Lambda, 7.5%; Alfa, 6.8%). Lambda/RBV/TVR did not meet the criterion for noninferiority (lower bound of the treatment difference interval was -12.3%); the SVR12 in all patients (modified intent-to-treat) was 76.2% in the Lambda arm and 82.0% in the Alfa arm. Overall, the frequency of adverse events in each arm was comparable (Lambda, 91.7%; Alfa, 97.1%). As expected based on the safety profile of the 2 interferons, there were more hepatobiliary events observed in the Lambda arm and more hematologic events in the Alfa arm.

conclusionsIn this comparison of Lambda/RBV/TVR and Alfa/RBV/TVR in patients who were treatment-naïve or had relapsed on prior Alfa/RBV treatment, Lambda failed to demonstrate noninferiority based on SVR12 results. Treatment with Lambda/RBV/TVR was associated with a higher incidence of relapse. More patients discontinued Lambda/RBV/TVR treatment during the first 4 weeks of study treatment, mainly due to hepatobiliary-related events, and more Lambda patients were lost to follow-up.

Indexed as

AdultAgedAntiviral AgentsDouble-Blind MethodDrug Therapy, CombinationFemaleGenotypeHematologic DiseasesHepacivirusHepatitis C, ChronicHumansInterferon-alphaInterferon LambdaInterferonsInterleukinsMaleAntiviral AgentsInterferon-alphaInterferon Lambdainterferon-lambda, humanInterferonsInterleukinsOligopeptidespeginterferon alfa-2apeginterferon lambda-1aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, Viraltelaprevir

Identifiers

PMID27749900
PMCPMC5066958
OpenAlexW2535513668

What OpenQuestion holds

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LicenceCC BY
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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.