Table 7.
Telaprevir
Ref. | n | Design | Treatment | Population | Outcome |
Hézode et al[73] | 334 | Phase 2 randomized clinical trial | Telaprevir PEGIFN/RBV | HCV genotype 1 - treatment naïve | Telaprevir groups had significantly higher rates of SVR than PEGIFN/RBV alone. Depression occurred in 20%-23% of patients and was not significantly different across groups |
McHutchison et al[68] | 115 | Randomized clinical trial | Telaprevir | HCV genotype 1 - previous non-responders to PEGINF/RBV | Re-treatment with telaprevir was more effective than PEGIFN-α/RBV alone. Depression occurred in 11%-17% of participants |
Zeuzem et al[69] | 663 | Phase III randomized clinical trial | Telaprevir, PEGIFN- α-2a/ RBV | HCV genotype 1 - previous non responders, partial responders and relapsers | Telaprevir in combination with PEGIFN/RBV significantly improved rates of SVR and, as compared with PEGIFN/RBV alone showed no increase in neuropsychiatric side effects |
Kumada et al[72] | 1126 | Multicenter randomized clinical trial | Telaprevir, PEGIFN-α-2b/RBV | HCV genotype 1 - treatment naive | Triple therapy with telaprevir-based regimen resulted in higher SVR with shorter duration. Depression was not listed as an adverse event |
Sherman et al[74] | 540 | Randomized clinical trial | Telaprevir PEGIFN-α-2a/RBV | HCV genotype 1 - treatment naïve | Combination therapy with telaprevir for 24 wk was non inferior to standard therapy for 48 wk. Fifty-three percent of patients experienced psychiatric symptoms |
PEGIFN: Pegylated interferon (peginterferon); RBV: Ribavirin; HCV: Hepatitis C virus; SVR: Sustained virologic response.