An efficacy study of combined oral doses of glecaprevir/pibrentasvir and sofosbuvir for 16 weeks in hepatitis C patients with documented NS5A resistance who did not respond to previous treatment
Phase 4
- Conditions
- Hepatitis CInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12620000794909
- Lead Sponsor
- Auckland District Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Confirmed prior treatment with VIEKIRA PAK or MAVIRET or ZEPATIER
- Confirmed failure of VIEKIRA PAK or MAVIRET or ZEPATIER as demonstrated by positive viral load at greater than or equal to (=) 12 weeks after end of treatment (SVR12) and no history of continued injecting drug use to suggest reinfection
- Confirmed NS5A resistance demonstrated
Exclusion Criteria
- Severe hepatic impairment classed as Child-Pugh C decompensated cirrhosis. Patients with moderate hepatic impairment classed as Child-Pugh B decompensated cirrhosis will be considered on a case-by-case basis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who commence retreatment with Maviret and sofosbuvir (intention-to-treat [ITT] and per-protocol [PP] population) who achieve sustained virological response. This is defined as HCV RNA below the lower limit of quantitation (target not detected or target detected, not quantifiable). Presence of HCV RNA in blood sample will be assessed by running Polymerase Chain Reaction using primers that are specifically designed to bind to the HCV. [Sample for HCV RNA detection will be collected at a single time point that is greater than or equal to (=) 12 weeks following last dose of treatment. When the result is HCV RNA negative then the patient will have achieved sustained virologic response (SVR12) and clinically judged as cured from HCV.]
- Secondary Outcome Measures
Name Time Method