Quantification of Side Effects During Hepatitis C Therapy

Quantification of Side Effects During Dual or Triple Therapy for Chronic Hepatitis C

This study aims to assess the frequency and severity of adverse events during Hepatitis C therapy with or without first generation protease inhibitors.

Study Overview

• Status: Completed
• Conditions: Hepatitis C

Detailed Description

Hepatitis C Virus infection is one of the main causes of chronic liver disease worldwide with current estimates of approximately 130 - 210 million individuals (according to 3% of the world population) chronically infected with the hepatitis C virus. However, hepatitis C virus infections are among the most common causes leading to chronic hepatitis, liver cirrhosis and liver related death worldwide.

The current standard of care is a combination of pegylated Interferon and Ribavirin (dual-therapy). Since 2011, direct-acting antiviral drugs inhibiting viral protease are approved as an addition to the standard therapy (triple-therapy).

The occurrence of adverse events as well as their severity generally depends on the therapy regimen and is influenced by type and dosage of medications.

Most common adverse events (affects up to 95% of patients) are fever, fatigue, headache, nausea, arthralgia, depression, skin reactions, neutropenia, and anemia.

A more frequent occurrence of adverse events with triple-therapy compared to dual- therapy has become clear since it's introduction, particularly with regard to anemia, neutropenia, gastrointestinal discomfort, fatigue, dysgeusia, and skin reactions. How- ever, there is accumulating evidence for a more often appearance of infections and/or infestations in patients receiving triple-therapy.

The medical consequence from adverse events is a reduction of quality of life and consecutively the loss of antiviral therapy adherence. Thus, early recognition and immediate treatment of adverse events are crucial aspects in the success of antiviral treatment.

Aim of this study is to quantify reported adverse events with respect to therapy reg- imen (dual-therapy vs. triple-therapy) in patients who are treated at the Department of Internal Medicine, Division of Gastroenterology and Hepatology at the Medical University Graz. Furthermore, a detailed review of international treatment recommendations, as well as an analysis of possible predictor parameters for the appearance of adverse events and treatment success is done.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Department of Internal Medicine, Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with chronic hepatitis C undergoing therapy with pegylated interferon and ribavirin +/- a firstgeneration protease inhibitor

Description

Inclusion Criteria:

• chronic hepatitis C
• Indication for a hepatitis C therapy

Exclusion Criteria:

• none

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	reported adverse events	on average 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of adverse events	reported adverse events	on average 24 weeks

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Vanessa Stadlbauer, MD, Medical University of Graz

Publications and helpful links

General Publications

• Spindelboeck W, Horvath A, Tawdrous M, Schmerbock B, Zettel G, Posch A, Streit A, Jurse P, Lemesch S, Horn M, Wuensch G, Stiegler P, Stauber RE, Leber B, Stadlbauer V. Triple Therapy with First Generation Protease Inhibitors for Hepatitis C Markedly Impairs Function of Neutrophil Granulocytes. PLoS One. 2016 Mar 3;11(3):e0150299. doi: 10.1371/journal.pone.0150299. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• 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; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: HCV-side effects