Direct Acting Anti-Viral's In Chronic HCV Patients

New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients

The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon To calculate the percentage of patients with severity of medical event as per Karch and Lasagna classification To determine the percentage of patient having serious adverse event as per ICH Classification

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Drug: Sofosbuvir

Detailed Description

The cross sectional survey data will be collected on a pre-defined questionnaire from Gastroenterologist and Hepatologist. The questionnaire will provide us information on demographics, relevant patient history, concomitant medication, ongoing treatment plan recommended for chronic HCV and adverse event details.

The questions related to Pharmacovigilance and safety assessment includes the International Nonproprietary Names (INN) unless it is prescribed brand of Getz Pharma. All adverse events associated with the prescribed treatment will be recorded. Data on outcome assessment will be based on action taken due to AE and other reported details. Seriousness of adverse event will also be recorded as per the ICH classification and severity of medical event will be assessed as per Karch and Lasagna classification.

All the information will be recorded by the healthcare professionals on the questionnaire during direct interaction with the patients.

Patients' written authorization to use and/or disclose the patient's personal and/or health data will be obtained. However, patient data secrecy will follow ICH GCP requirements.

• Study Type: Observational
• Enrollment (Actual): 511

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan
      • Liver Center Faisalabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic hepatitis C on DAAs therapy were included. The primary inclusion criteria was both gender with age >18years and written informed consent.

Description

Inclusion Criteria:

1. Written informed consent
2. Male or Female patient
3. Age of patient ≥18 years
4. Patients already diagnosed with HCV and on DAAs therapy.

Exclusion Criteria:

1. Written informed consent
2. Male or Female patient
3. Age of patient ≥18 years
4. Patients already diagnosed with HCV and on DAAs therapy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon	Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients reported severity of medical event as per Karch and Lasagna classification	Percentage of patients reported severity of medical event as per Karch and Lasagna classification	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patient having serious adverse event as per ICH Classification	Percentage of patient having serious adverse event as per ICH Classification	12 months

Collaborators and Investigators

• Sponsor: Getz Pharma

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: adverse events; chronic hepatitis; direct acting antivirals
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Sofosbuvir; Velpatasvir; Ribavirin
• Other Study ID Numbers: GTZ-NLRF-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No