This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.
Full Title of Study: “A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: November 30, 2017
- Drug: SOF
- SOF tablets administered orally once daily based on approved prescribing information
Arms, Groups and Cohorts
- SOF-based regimens
- Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information.
Clinical Trial Outcome Measures
- Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
- Time Frame: Up to Posttreatment Week 4
- Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)
- Time Frame: Posttreatment Week 12
- SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ) 12 weeks following the last dose of study drug, respectively.
Participating in This Clinical Trial
- HCV-infected patients living in India
- Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information.
- Patients who provide written and signed informed consent prior to initiation of treatment where required.
- Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
- Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country in a foreseeable future)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Gilead Sciences
- Provider of Information About this Clinical Study
- Overall Official(s)
- Gilead Study Director, Study Director, Gilead Sciences
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