Clinical Drug Experience Knowledgebase

Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (Hepatitis Eradication Accuracy Trial of Sofosbuvir): An Observational Non-interventional Real Life Trial

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