Table 2.

Efficacy outcomes of the telaprevir phase II randomized-controlled trials in treatment-naïve patients with genotype 1 HCV. In each trial, patients were randomized to one of the featured treatment regimens: telaprevir for 12 weeks with pegylated interferon-α2a (pegIFN) and ribavirin for 12 weeks (T12PR12); 12 weeks of telaprevir with 24 weeks of pegIFN and ribavirin (T12PR24); 12 weeks of telaprevir with 48 weeks of pegIFN and ribavirin (T12PR48); 12 weeks of telaprevir with 12 weeks of pegIFN (T12P12); or 12 weeks of placebo with 48 weeks of pegIFN and ribavirin (the control group, PR48). Telaprevir was dosed at 750 mg 8-hourly after a 1250 mg loading dose. PegIFN and ribavirin were given at standard doses. Breakthrough refers to an increase of >1 log₁₀ unit from nadir or >100 IU/mL of previously undetectable HCV RNA during treatment; relapse refers to undetectable HCV RNA at the end of treatment but detectable during 24 weeks of follow up. SVR, sustained virological response.

Study	Number of participants	Duration of treatment	Treatment regimen (number of patients)	SVR	Relapse	Breakthrough
PROVE 1 [McHutchison et al. 2009]	250	12–48 weeks	T12PR12 (17) T12PR24 (79) T12PR48 (79) PR48 (75)	35% 61% 67% 41%	33% 2% 6% 23%	7% of all telaprevir-treated patients
PROVE 2 [Hezode et al. 2009]	334	12–48 weeks	T12PR12 (82) T12PR24 (81) T12P12 (78) PR48 (82)	60% 69% 36% 46%	30% 14% 48% 22%	1% 5% 24% 1%