NCT03603327

Response Guided Treatment With Direct Acting Anti-Viral Medications for Chronic HCV Infection

Efficacy and Safety of Response Guided Treatment With Direct Acting Anti-Viral Medications for Chronic HCV Infection - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of direct acting anti-viral agents (DAA) therapy in chronically infected Hepatitis C Virus (HCV) patients using an individualized response guided therapy (RGT) model.

Detailed description

Treatment of HCV infection is directed at achieving sustained virological response (SVR), defined as the continued absence of detectable HCV RNA for 12 or more weeks after completion of therapy Given the limited resources available for the costly DAA treatment, implementation of a response-guided treatment (RGT) model to individualize length of DAA therapy in a prospective setting could result in substantial cost saving on HCV drug expenditure in addition to improving patients' compliance to treatment. Furthermore, if adopted at a larger scale, incorporation of such model into clinical practice may enable expansion of access to DAA therapy for patients who are currently not included in the various treatment programs, especially in resource-limited countries.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Direct acting anti-viral agents	Standard of care for Hepatitis C treatment

Timeline

• Start date: 2018-02-25
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-07-27
• Last updated: 2021-02-18

Locations

2 sites across 1 country: Israel