Evidence map›Paper›PMID 22889114›Full record

SynthesisClinical drug investigation2012

Safety of telaprevir for chronic hepatitis C virus infection: a meta-analysis of randomized controlled trials.

Huimin Qin, Hongtao Li, Xiaolin Zhou, Fang Feng, Yanbing Shen, Hongku Tan, Feng Ye, Yingchun Xie

Abstract readMeta-AnalysisReview
PubMed Publisher
In one paragraph

Synthesis in Clinical drug investigation, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. 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.

Huimin QinDepartment of Infectious Diseases, The First College of Clinical Medical Science, China Three Gorges University, Yichang, Hubei Province, China.
Hongtao Li
Xiaolin Zhou
Fang Feng
Yanbing Shen
Hongku Tan
Feng Ye
Yingchun Xie

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies have reported telaprevir is effective for chronic hepatitis C virus infection, but the safety of a telaprevir-based regimen remains uncertain.

objectiveA meta-analysis was performed to assess the safety of the addition of telaprevir to a standard regimen of pegylated interferon (peginterferon) plus ribavirin (combination telaprevir with peginterferon plus ribavirin, the TPR group) compared with the standard regimen group (peginterferon plus ribavirin, the PR group). METHODS AND

resultsSeven randomized controlled trials involving a total of 2808 patients were included in the meta-analysis. The addition of telaprevir to the standard regimen was associated with a significantly increased risk of serious adverse events compared with the standard PR group (relative risk [RR] = 1.56; 95% confidence interval [CI] 1.21, 2.03; p = 0.0007; I2 = 0%). Telaprevir was also associated with increased risk of treatment discontinuation (RR = 2.10; 95% CI 1.56, 2.83; p < 0.0001; I2 = 42%). In addition, telaprevir was more likely to cause nausea (RR = 1.39; p < 0.0001), diarrhoea (RR = 1.32; p = 0.004), pruritus (RR = 1.56; p = 0.0006), rash (RR = 1.60; p < 0.0001) and anaemia (RR = 1.55; p = 0.007). There was no difference in the other kinds of adverse events between the two groups. Sensitivity analysis further validated the credibility of the above outcomes.

conclusionOur meta-analysis raises safety concerns about the potential for an increased risk of serious adverse events associated with the use of telaprevir among patients with chronic hepatitis C virus infection, and cautious use of telaprevir is warranted.

Indexed as

Antiviral AgentsConfidence IntervalsHepatitis C, ChronicHumansOdds RatioOligopeptidesPublication BiasRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeViral LoadAntiviral AgentsOligopeptidestelaprevir

Identifiers

PMID22889114

What OpenQuestion holds

Textmetadata
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.