Safety of telaprevir for chronic hepatitis C virus infection: a meta-analysis of randomized controlled trials.
BACKGROUND
Previous studies have reported telaprevir is effective for chronic hepatitis C virus infection, but the safety of a telaprevir-based regimen remains uncertain.


OBJECTIVE
A 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).


RESULTS
Seven 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.


CONCLUSIONS
Our 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.
Department of Infectious Diseases, The First College of Clinical Medical Science, China Three Gorges University, Yichang, Hubei Province, China.
Huimin
H
Qin
Hongtao
H
Li
Xiaolin
X
Zhou
Fang
F
Feng
Yanbing
Y
Shen
Hongku
H
Tan
Feng
F
Ye
Yingchun
Y
Xie
D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016001:Confidence Intervals; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016017:Odds Ratio; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D017594:Publication Bias; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D009842:Oligopeptides; C486464:telaprevir