Observational Multicenter Study in ex-People who INject Drugs (ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts (INTEGRATE)

Observational Multicenter Study in ex-People who INject Drugs (ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts (INTEGRATE)

This study will provide efficacy, safety, tolerability, and adherence data on telaprevir administered in combination with PegIFN alfa and RBV in ex-PWIDs with genotype 1 chronic hepatitis C in routine clinical practice.

Incivo

Nein

Rein exploratorische Untersuchung

Praxis/niedergelassener Bereich

Nein

Ja

The primary objective of this prospective study is to evaluate the efficacy, based on SVR as measured by HCV RNA <25 IU/mL, at 12 weeks (SVR12) after the last dose of anti-HCV treatment (telaprevir, PegIFN alfa, RBV), in ex-PWIDs with genotype 1 chronic hepatitis C under substitution therapy and/or followed in addiction centers.

- Adherence to telaprevir until Week 12 as measured by pill count and/or patient questionnaire (modified medication adherence self-report inventory [M-MASRI])
- Adherence to PegIFN alfa and RBV until end of treatment as measured by pill/vial count and/or patient questionnaire (M-MASRI)
- On-treatment virologic response (rapid virologic response [RVR], extended rapid virologic response [eRVR], Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL undetectable
- On-treatment virologic response (RVR*, eRVR*, Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL
- Tolerability and safety of telaprevir, in combination with PegIFN alfa and RBV
- Health-related quality of life based on patient-reported outcomes (PROs)
- Baseline and on-treatment predicting factors of SVR
- The virologic response rates in this study compared with historical data in ex-PWIDs treated with PegIFN alfa and RBV

Based on an expected response rate of 60% with the telaprevir-based regimen, a sample size of 80 evaluable patients will give a 2-sided 95% confidence interval that will extend 11% above and below the expected observed response rate of 60%. This calculation is based on exact binomial distribution and was derived using the Clopper-Pearson formula (8,12,31). To allow for up to 30% of patients to have nonevaluable data (ie, as-treated or observed analyses do not impute missing data) for the primary virologic endpoint, 115 patients will be enrolled.
Note that this is a non-comparative, nonrandomized study and therefore does not include a concurrent control group. Nevertheless, it is of interest to compare the viral load responses observed in this study to those of PegIFN alfa and RBV based on historical controls. Based on a review of similarly designed studies (1,40), the control response is estimated to be no larger than 40% (derived as the upper 95% confidence bound of the absolute response rate). Eighty evaluable patients provides approximately 93% power to detect a response rate of 60% versus this control rate of 40%; and the power is 80% when the expected delta is 16.5% (56.5% versus 40%), rather than 20% (60% versus 40%).

18

4

49

11

9

21 Monate

n.ap.

06.05.2013

60 Wochen

2 Jahre

VX-950HPC4017

Treptow-van Lishaut, Sylvia

Site Manager

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Deutschland

streptow@its.jnj.com

Telefon: +49 173 5131188

Janssen-Cilag GmbH

Johnson & Johnson Platz 1

41470 Neuss

Deutschland

31.08.2015

Studie bereits abgeschlossen

VX-950HPC4017_CSR_Synopsis.pdf