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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Sofosbuvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, 18 years of age or older, Treatment -Naïve and not responded with the previous therapy Cirrhosis Not previously enrolled in any trial of Sofosbuvir Exclusion Criteria: Not given informed consent Pregnancy

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>Sofosbuvir, 400 mg OD for 6 months | Drug: Sofosbuvir<br>* Sofosbuvir (formerly known as GS-7977) is a direct-acting nucleotide polymerase inhibitor that is being developed as an oral drug for the treatment of chronic HCV infection<br>* Other names: Zoval;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Viralogical response (SVR) | HCV RNA LLQ < 10 IU/Ml | 12 or 24 weeks after discontinuation of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral break through and relapse after discontinuation | Viral break through and relapse after discontinuation [Time duration: Up to 12 or 24 weeks] | Time duration: Up to 12 or 24 weeks | 
| Level of (Hepatitis C Virus) HCV RNA | Level of HCV RNA within 12 or 24 weeks from baseline in HCV RNA (log10 IU/mL) [ Time Frame: Up to 12 or 24 weeks ] | within 12 or 24 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, safety, efficacy, EVR, SVR