Evidence map›Paper›PMID 25322962›Full record

Trial reportHepatology (Baltimore, Md.)2015

Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis.

Eric Lawitz, Fred Poordad, Diana M Brainard, Robert H Hyland, Di An, Hadas Dvory-Sobol, William T Symonds, John G McHutchison, Fernando E Membreno

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

53 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2016
    Guideline
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Article
  10. The Bank Vole (Viruses · 2021
    Article
  11. Genotype 3-hepatitis C virus' last line of defense.World journal of gastroenterology · 2021
    Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Hepatitis C treatment: where are we now?International journal of general medicine · 2017
    Review
  20. 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

9 authors.

Eric LawitzTexas Liver Institute, San Antonio, TX; University of Texas Health Science Center, San Antonio, TX.
Fred Poordad
Diana M Brainard
Robert H Hyland
Di An
Hadas Dvory-Sobol
William T Symonds
John G McHutchison
Fernando E Membreno

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledSofosbuvir (SOF) in combination with ribavirin (RBV) for 12 or 24 weeks is the current standard of care for patients infected with hepatitis C virus (HCV) genotypes 2 and 3, respectively. However, in clinical trials treatment-experienced patients, particularly those with cirrhosis, had suboptimal sustained virological response (SVR) rates. We assessed the efficacy and safety of sofosbuvir plus peginterferon and ribavirin (SOF+Peg-IFN+RBV) administered for 12 weeks to treatment-experienced patients with HCV genotypes 2 and 3, with and without cirrhosis. We enrolled 47 patients in this open-label, nonrandomized, uncontrolled phase 2 study. The primary endpoint was the proportion of patients with SVR at 12 weeks after cessation of study treatment (SVR12). The overall rate of SVR12 was 89% (95% confidence interval [CI]: 77-97). Rates of SVR12 were higher in patients with genotype 2 than in those with genotype 3, 96% (95% CI: 78-100) and 83% (95% CI: 62-95), respectively. Rates of SVR12 were similar in patients with and without cirrhosis: for genotype 2, 93% of patients with cirrhosis and 100% of patients without cirrhosis achieved SVR12, and for genotype 3, the SVR12 rate was 83% in patients both with and without cirrhosis. One patient discontinued study treatment because of an adverse event and four patients experienced serious adverse events. The most common adverse events were influenza-like illness, fatigue, anemia, and neutropenia.

conclusionIn treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of SOF+Peg-IFN+RBV provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified.

Indexed as

AdultAgedAntiviral AgentsDrug Resistance, ViralDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansInterferon-alphaLiver CirrhosisMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinSofosbuvirUridine Monophosphate

Identifiers

PMID25322962
PMCPMC4365682

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.