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.
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.
Authors: Helena H Borba; Astrid Wiens; Laiza M Steimbach; Cassio M Perlin; Fernanda S Tonin; Maria L A Pedroso; Fernando Fernandez-Llimos; Roberto Pontarolo Journal: Eur J Clin Pharmacol Date: 2016-10-19 Impact factor: 3.064