DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral) (DARE-C II)
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|ClinicalTrials.gov Identifier: NCT02156570|
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : September 21, 2018
The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment.
The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Sofosbuvir and ribavirin||Phase 4|
To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection.
An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg <75 kg, 1200mg >/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Sofosbuvir and ribavirin
Sofosbuvir tablet 400 mg daily Ribavirin tablet weight based dosing (1000mg <75 kg, 1200mg >/= 75kg) daily
Treatment will be for 6 weeks in all participants.
Drug: Sofosbuvir and ribavirin
Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants.
- SVR 12 [ Time Frame: 12 weeks post treatment ]Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18)
- SVR 24 [ Time Frame: 24 weeks post treatment ]Proportion of patients with undetectable HCV RNA by TaqMan 24 weeks after therapy completion (SVR 24 - Week 30)
- End of treatment response [ Time Frame: End of treatment week 6 ]Proportion of patients with undetectable HCV RNA at end of therapy (ETR - week 6)
- SVR 4 [ Time Frame: 4 weeks post treatment ]Proportion of patients with undetectable HCV RNA by TaqMan 4 weeks after therapy completion (SVR 4 - Week 10)
- Follow up 1 year [ Time Frame: 1 year post treatment ]Proportion of patients with undetectable HCV RNA at end of study follow-up (FU1 - Week 58)
- Undetectable HCV RNA [ Time Frame: Week 1, 2, 3 and 4 of treatment ]Proportion of patients with undetectable HCV RNA at weeks 1, 2, 3 and 4
- Indicators of toxicity (ALT, HB, Neutrophils, Platelets) [ Time Frame: Baseline until week 4 of treatment ]To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during therapy
- Plasma ribavirin levels and haemoglobin [ Time Frame: Baseline to week 4 of treatment ]To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy
- Incidence of reinfection [ Time Frame: End of treatment until follow up 1 year ]Incidence of reinfection after documented SVR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156570
|Australia, New South Wales|
|St Vincent's Hospital|
|Sydney, New South Wales, Australia, 2010|
|Australia, South Australia|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Melbourne, Victoria, Australia, 3004|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Auckland City Hospital|
|Auckland, Grafton, New Zealand, 1023|
|Principal Investigator:||Gail Matthews, MbChB FRACP||Kirby Institute|