Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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
    

Intervention name(s): Sofosbuvir
Intervention type(s): Drug
Intervention description(s): 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
Other intervention name(s): Zoval
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; safety; efficacy; EVR; SVR