Research Article, J Virol Antivir Res Vol: 3 Issue: 4
Twice Daily Dosing of Telaprevir for Treatment-Naive and Treatment-Experienced Patients with Hepatitis C Infection
|David M You1, Douglas Hunt2, Michael W Fried3, David R Nelson4, Andrea Scherschel2, Bryan Still2 and Paul J Pockros2,5*|
|1Department of Gastroenterology, Naval Medical Center San Diego, USA|
|2Division of Gastroenterology/Hepatology, Scripps Clinic, La Jolla, CA, USA|
|3Division of Gastroenterology, University of North Carolina, USA|
|4Division of Gastroenterology/Hepatology, University of Florida, USA|
|5Scripps Translational Science Institute, La Jolla, CA, USA|
|Corresponding author : Paul J Pockros
Scripps Clinic, 10666 North Torrey Pines Road, La Jolla, CA 92037, USA
Tel: 1 (858) 554-8879; Fax: 1 (858) 541-1200
|Received: June 16, 2014 Accepted: December 10, 2014 Published: December 17, 2014|
|Citation: You DM, Hunt D, Fried MW, Nelson DR, Scherschel A, et al. (2014) Twice Daily Dosing of Telaprevir for Treatment-Naive and Treatment-Experienced Patients with Hepatitis C Infection. J Virol Antivir Res 3:4. doi:10.4172/2324-8955.1000133|
Background & Aims: Twice daily dosing of telaprevir in combination with peg interferon/ribavirin has not been extensively studied in treatment-naïve and treatment-experienced genotype 1 HCV patients, including a “real-world” setting. The purpose of this study was to assess the effectiveness and safety of telaprevir dosed at 1125 mg Q12 hr in treatment-naïve and treatment-experienced patients with genotype 1 chronic HCV infection in both a clinical study and “real-world” setting. Methods: A total of 163 subjects were evaluated in this study, including 103 treatment-naïve and treatment-experienced HCV genotype 1 patients who were treated prospectively with telaprevir 1125 mg Q12 hr along with peg interferon/ribavirin. In addition, we reviewed “real-world” data from a large multicenter longitudinal database (HCV-TARGET) of 60 treatment-naïve and treatment-experienced patients who received telaprevir dosed twice daily with peg interferon/ribavirin. Results: In a clinical study setting, the SVR 12 was 73% in treatment-naïve/relapsers and 41% in prior treatment-failures while in a “real-world” setting, the SVR 12 was 64% and 33%, respectively. Overall, treatment discontinuation due to adverse events occurred in 21% of treatment-naïve/relapsers and 53% of prior treatment-failures.
Conclusions: In our study, response rates to telaprevir taken twice daily appear to be similar to published sustained virologic rates for telaprevir taken every 8 hours for treatment of genotype 1 HCV infection for both treatment-naïve and treatment-experienced patients, although a lower SVR12 was seen in a “real-world” setting.