Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon

Overview

Title Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin with or without Interferon among Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of Sofosbuvir (HEATS) Study Design Endpoint Classification: Safety/Efficacy Study Intervention Model: Treatment agents (non-interventional observational study): Real life clinical practice study Masking: Open Label Primary Purpose: Treatment Duration Around 12 Months Study Centre Multi centric Study

Indication Chronic Hepatitis C Virus (HCV) infection (serum HCV RNA level, \>10,000 IU per milliliter) with or without cirrhosis Primary Objective o Proportion of participants with sustained virologic response 12/24 weeks after discontinuation of therapy (SVR 12 or 24 weeks) \[ Time Frame: Post-treatment Week 12/24 \] \[ Designated as safety issue: No \] SVR 12/24 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 15 IU/mL) 12/24 weeks following the last dose of study medication. Secondary Objective o Proportion of participants experiencing viral breakthrough \[ Time Frame: Up to 12 or 24 weeks \] \[ Designated as safety issue: No \] Viral breakthrough is defined as HCV RNA ≥ lower limit of quantification (LLOQ) after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be post treatment), or last available on-treatment measurement with no subsequent follow-up values. * Proportion of participants experiencing viral relapse \[ Time Frame: Up to Post treatment Week 12 or 24 \] \[ Designated as safety issue: No \] Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post treatment measurement. * Proportion of participants with Early Virological Response 4 weeks after start of therapy (EVR4) \[ Time Frame: Treatment Week 4 \] \[ Designated as safety issue: No \] * SVR 12/24 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 15 IU/mL) 12/24 weeks following the last dose of study medication.Proportion of HCV RNA within 12 or 24 weeks change from baseline in HCV RNA (log10 IU/mL) \[ Time Frame: Up to 12 or 24 weeks \] \[ Designated as safety issue: No \] * Proportion of participants experiencing an adverse event (AE) leading to permanent discontinuation of study medication \[ Time Frame: Baseline to Week 12 or 24 \] \[ Designated as safety issue: No \] Number of Subjects 5000 patients Dosing - Sofosbuvir 400 mg tablet taken once daily orally * Ribavirin twice daily orally * 1000 mg in patients with body weights \<75 kg * 1200 mg in those with weights \>75 kg * Interferon for 12 or 24 weeks Drug duration Duration and combination depends upon the discretion of Principal investigator. Proposed Duration for Genotype: Inclusion criteria • Men and women, 18 years of age or older, * Treatment -Naïve and not responded with the previous therapy * HCV Relapse * Patient of HCV waiting for transplant, bridge to transplant * Cirrhosis * Not previously enrolled in any trial/study of Sofosbuvir Exclusion criteria o Not given informed consent o Pregnancy

Conditions

Interventions

Eligibility

Locations (1)

Outcomes