Table 1.
Summary of virological outcomes in the telaprevir phase I randomized-controlled trials. Where not otherwise stated, telaprevir was dosed at 750 mg 8-hourly after a 1250 mg loading dose. Pegylated interferon-α2a (PegIFN) and ribavirin were given at standard doses. SVR, sustained virological response; q8h, every 8 hours; q12h, every 12 hours.
| Study | Patients | Duration of treatment | Dosing regimen (number of patients) | Median HCV reduction from baseline to end of treatment (log10 IU/mL) | Viral rebound/breakthrough (% (number/total number of patients in group)) |
|---|---|---|---|---|---|
| Reesink et al. [2006] and Sarrazin et al. [2007] | 34 genotype 1 (7 treatment naïve) | 14 days | Telaprevir 450 mg q8h (10) Telaprevir 750 mg q8h (8) Telaprevir 1125 mg q12h (10) Placebo (6) |
−2.37 −4.41 −2.21 −0.21 |
60% (6/10) 13% (1/8) 40% (4/10) |
| Forestier et al. [2007] and Kieffer et al. [2007] | 16 genotype 1; all treatment naive | 14 days | Telaprevir (8) PegIFN/telaprevir (8) PegIFN/placebo (4) |
−3.99 −5.49 −1.09 |
50% (4/8) 0% (0/8) |
| Lawitz et al. [2008] | 12 genotype 1; all treatment naïve | 28 days/ 44 weeks | PegIFN/ribavirin/ telaprevir for 28 days (12) Then pegIFN/ribavirin for 44 weeks |
Undetectable HCV RNA at 28 days in 100% (12/12) SVR in 67% (8/12) |
0% (0/12) 17% (2/12) |