The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end
Pegylated interferon plus ribavirin brings a good therapeutic response and curability. However, the adverse effects and sufferings are lots. Response-guided, personalized treatment is current principle. In patients of CHC, GT1 PR treatment for 24 weeks is established in rapid virologic responders (RVR) who have low viral load before treatment. As to patients with RVR but high viral load (HVL), the treatment duration is 48 weeks that is the same as patients with complete early virologic response (cEVR). Is a shorter duration of treatment feasible for those with a good virokinetic response? The ideal treatment duration for patients of chronic hepatitis C, GT-1, high viral load with RVR has had no enough data yet. Is it really necessary to double the treatment duration (48 weeks) for patients of chronic hepatitis C, GT-1, high viral load with RVR? Is 36-week adequate for them? A multicenter trial of INDIV-2 was presented at EASL 2010. They treated CHC patients of naïve GT1 HVL and RVR for 30 weeks and got similarly good SVR as those treated for 48 weeks (85% vs. 82%). Therefore, investigators design a randomized controlled study to investigate the SVR rates between treatment for 36 weeks and for 48 weeks in patients of CHC, GT1, HVL and RVR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
410
Peginterferon alfa-2a(pre-filled syringes 180 mcg/0.5 ml once a week) plus ribavirin(200 mg/Capsules, 1000\~1200 mg daily in split doses (morning/evening)) for 36 or 48 weeks
Show Chwan Memorial Hospital
Changhua, Taiwan
Changhua Christian Hospital
Changhua County, Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Sustained virological response
Sustained virological response (SVR) defined as percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 24 weeks post completion of the 36 or 48 week treatment periods.
Time frame: At 24 weeks after end of treatment
Virological Response Rate at week 2
Virological Response Rate at week 2 defined as the percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV at 2 weeks post treatment.
Time frame: At treatment week 2
Virological response at end of treatment
Virological response at end of treatment defined as the percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication(± 28 days).
Time frame: At end of treatment
Correlation of virological response and SVR rate
Correlation of virological response (HCV RNA \< 15 IU/ML) at week 2 and SVR rate in each group.
Time frame: At 24 weeks after end of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tungs' Taichung MetroHarbor Hospital
Taichung, Taiwan
Taipei Medical University - Shuang Ho Hospital
Taipei County, Taiwan
Linkou Medical Center, Chang Gung Memorial Hospital
Taoyuan County, Taiwan