Evidence map›Paper›PMID 27672299›Full record

ArticleWorld journal of gastroenterology2016

Second-generation direct-acting-antiviral hepatitis C virus treatment: Efficacy, safety, and predictors of SVR12.

Christoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Robert Beck, Nisar P Malek, Ulrich M Lauer, Christoph P Berg

Abstract read
In one paragraph

Article in World journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–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

21 citing papers in PubMed.

  1. Article
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  7. Monitoring liver transplant rates in persons diagnosed with hepatitis C: a data linkage study, England 2008 to 2017.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2019
    Observational
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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

7 authors.

Christoph R WernerChristoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany.
Julia M SchwarzChristoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany.
Daniel P EgetemeyrChristoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany.
Robert BeckChristoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany.
Nisar P MalekChristoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany.
Ulrich M LauerChristoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany.
Christoph P BergChristoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo gather data on the antiviral efficacy and safety of second generation direct acting antiviral (DAA) treatment with respect to sustained virological response (SVR) 12 wk after conclusion of treatment, and to determine predictors of SVR12 in this setting.

methodsTwo hundred and sixty patients treated with SOF combination partners PR (n = 51), R (n = 10), SMV (n = 30), DCV (n = 81), LDV (n = 73), or 3D (n = 15). 144/260 were pre-treated, 89/260 had liver cirrhosis, 56/260 had portal hypertension with platelets < 100/nL, 25/260 had a MELD score ≥ 10 and 17/260 were post-liver transplantation patients. 194/260 had HCV GT1, 44/260 HCV GT3.

resultsTwo hundred and forty/256 (93.7%) patients achieved SVR12 (mITT); 4/260 were lost to follow-up. SVR12 rates for subgroups were: 92% for SOF/DCV, 93% for each SOF/SMV, SOF/PR, 94% for SOF/LDV, 100% for 3D, 94% for pretreated, 87% for liver cirrhosis, 82% for patients with platelets < 100/nL, 88% post-liver transplantation, 95% for GT1a, 93% for GT1b, 90% for GT3, 100% for GT2, 4, and 6. 12 patients suffered from relapse, 6 prematurely discontinued treatment, of which 4 died. Negative predictors of SVR12 were a platelet count < 100/nL, MELD score ≥ 10 (P < 0.0001), liver cirrhosis (P = 0.005) at baseline. In Interferon-free treatment GT3 had significantly lower SVR rates than GT1 (P = 0.016). Side effects were mild.

conclusionExcellent SVR12 rates and the favorable side-effect profile of DAA-combination therapy can be well translated into "real-world". Patients with advanced liver disease, signs of portal hypertension, especially with platelets < 100/nL and patients with GT3 are in special need for further research efforts to overcome comparatively higher rates of virological failure.

Indexed as

AdultAntiviral AgentsBenzimidazolesCarbamatesDrug Therapy, CombinationFemaleFluorenesHepacivirusHepatitis C, ChronicHumansHypertension, PortalImidazolesLiver CirrhosisLiver TransplantationMaleMiddle AgedAntiviral AgentsBenzimidazolesCarbamatesdaclatasvirFluorenesImidazolesledipasvirPyrrolidinesRibavirinSimeprevirSofosbuvirValineDaclatasvirHepatitis CLedipasvirLiver cirrhosisLiver transplantResistanceSide effectsSimeprevirSofosbuvirSustained virological response

Identifiers

PMID27672299
PMCPMC5028818

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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.