Clinical trial NCT02804386: Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: HCV
safety
efficacy
EVR
SVR
Lead sponsor: PharmEvo Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 573
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Viralogical response (SVR)
timeFrame: 12 or 24 weeks after discontinuation of therapy
Secondary outcomes:
measure: Viral break through and relapse after discontinuation
timeFrame: Time duration: Up to 12 or 24 weeks
measure: Level of (Hepatitis C Virus) HCV RNA
timeFrame: within 12 or 24 weeks from baseline
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ojha, Duhs
state: Sindh
Study officials:
affiliation: DUHS
name: Zahid Azam, FCPS
role: PRINCIPAL_INVESTIGATOR
References: