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Telaprevir for genotype 1 chronic hepatitis C: a systematic review and meta-analysis
Lian Gu1, Qing Chen, Juanjuan Xie
1Department of Internal Neurology, First Affiliated Hospital, Guangxi University of Chinese Medicine, Guangxi, China.
Insights
Telaprevir combined with peginterferon alfa and ribavirin improves viral response and reduces relapse in genotype 1 chronic hepatitis C patients. However, this treatment increases severe adverse events and discontinuation, requiring careful monitoring.
Area of Science:
- Hepatology and Virology
- Pharmacology and Drug Development
Background:
- Chronic hepatitis C (HCV) genotype 1 is a significant global health concern.
- Current treatment regimens aim to achieve sustained virologic response and prevent relapse.
Purpose of the Study:
- To evaluate the efficacy and safety of telaprevir in combination therapy for genotype 1 chronic hepatitis C.
- To assess viral response, relapse rates, and adverse events associated with telaprevir treatment.
Main Methods:
- A systematic review and meta-analysis of randomized clinical trials.
- Inclusion criteria: trials comparing telaprevir plus peginterferon alfa and ribavirin versus control in genotype 1 chronic hepatitis C patients.
- Primary outcomes: sustained virologic response and end-of-treatment virologic response; secondary outcomes: relapse, severe adverse events, and treatment discontinuation.
Main Results:
- Telaprevir combination therapy significantly improved sustained virologic response, end-of-treatment response, and reduced relapse rates in naive and previously treated patients, with some exceptions.
- The T12PR12 regimen showed no significant benefit in sustained virologic response or relapse rates for naive patients.
- A higher incidence of severe adverse events and treatment discontinuation due to adverse events was observed in previously treated patients, but not in naive patients.
Conclusions:
- Telaprevir in combination with peginterferon alfa and ribavirin is an effective option for genotype 1 chronic hepatitis C, improving viral response and reducing relapse.
- Careful monitoring is essential due to the potential for severe adverse events.
- Further randomized clinical trials are needed to confirm treatment effects and elucidate potential adverse events.
Objectives:
To assess the beneficial and harmful effects of telaprevir for patients with genotype 1 chronic hepatitis C.
Methods:
We searched Cochrane Central Register of Controlled Trials (Issue 4, 2012), MEDLINE, EMBASE, Chinese Biomedical Database (CBM), CNKI database and Chinese WanFang Database between 1980 and May 2012. Randomized clinical trials assessing telaprevir in combination with peginterferon alfa and ribavirin versus no intervention or placebo in combination with peginterferon alfa and ribavirin in patients with genotype 1 chronic hepatitis C were included. The primary outcome measure was viral response, including sustained virologic response and virologic response at the end of treatment. The secondary outcome measures were relapse rate, severe adverse events, treatment discontinuation and commonly reported adverse events.
Results:
Six trials with 2,775 participants were included. Telaprevir in combination with peginterferon alfa and ribavirin seemed to show a significant effect on sustained virologic response, virologic response at the end of treatment and relapse rate in naive patients and previously unsuccessfully treated patients, except T12PR12 which seemed without beneficial effect on sustained virologic response (Odds Ratio (OR) 1.41; 95% CI 0.83 to 2.40) and relapse rate (Odds Ratio (OR) 1.55; 95% CI 0.71 to 3.36) in naive patients. It also was associated with a significantly higher incidence of severe adverse events (Odds Ratio (OR) 2.15, 95% CI 1.29 to 3.58) and treatment discontinuation (Odds Ratio (OR) 4.79, 95% CI 1.72 to 13.37) because of adverse events in previously unsuccessfully treated patients, but not in naive patients.
Conclusions:
Telaprevir in combination with peginterferon alfa and ribavirin has been recommended as option for the treatment of genotype 1 chronic hepatitis C. It has been considered as effective to improve viral response and reduce relapse rate in patient who suffer genotype 1 chronic hepatitis C. However, the treatment should be monitored carefully as it may cause some severe adverse events. For further confirmation of its treatment effect and clarify its possible adverse events, more randomized clinical trials need to be carried out.
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