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

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

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

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: Sofosbuvir

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

• Study Type: Interventional
• Enrollment (Actual): 573
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Ojha, Duhs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; Sofosbuvir, 400 mg OD for 6 months	Drug: Sofosbuvir; 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 Names: Zoval

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd
• Investigators: Principal Investigator: Zahid Azam, FCPS, DUHS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: safety; HCV; efficacy; EVR; SVR
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: PE/ZOVAL/2016/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED