Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs

August 29, 2017 updated by: Mariana Tharwat, Assiut University
Neuropsychiatric adverse effects of direct acting antiviral drugs, especially Sofosbuvir and Daclatasvir combination therapy (with or without ribavirin) in patients with chronic hepatitis C , genotype four (the predominant genotype in Egypt).

Study Overview

Status

Unknown

Conditions

Detailed Description

Treatment of hepatitis C virus, a virus infecting over one hundred seventy million worldwide, has evolved over the last two decades and moved from interferon-alpha monotherapy to pegylated interferon-alpha in combination with ribavirin therapy. Despite enhanced sustained virological response rates, psychiatric illness remains a barrier to widespread hepatitis C virus treatment uptake due to the neuropsychiatric risks associated with interferon-alpha.The next generation of hepatitis C virus therapeutic agents is direct acting antivirals that still require the use of interferon-ribavirin combination therapy.

Poorly managed psychiatric illness can lead not only to treatment discontinuation,but also poor adherence to treatment and serious psychiatric sequels, such as suicide.

Data on neuropsychiatric adverse effects of direct acting antivirals is limited and predominantly derived from landmark clinical trials for boceprevir and telaprevir.These first generation direct acting antivirals are currently not in use due to their multiple side effects ,the need for concomitant interferon-alpha ,and there wide drug-drug interactions. Recently the treatment of hepatitis C virus has undergone a paradigm shift with the introduction of the second generation of direct acting antivirals. This interferon-free modality has brought about exceptional cure rates with sustained virological response exceeding ninety hundred percent, with better tolerability, minimized side effects and short duration of treatment . Of the current hepatitis C virus treatment regimens, the combinations of Sofosbuvir plus daclatasvir have shown a high efficacy rate in achieving sustained virological response in genotype one patients.

To the investigators' knowledge, the development of neuropsychiatric side effects with the use of these second generation direct acting antivirals in absence of interferon therapy, as well as the impact of the expected high sustained virological response to therapy on the psychiatric condition of patients with chronic hepatitis C (in absence of cirrhosis) have not been studied. Therefore, the purpose of this work is to evaluate the neuropsychiatric adverse effects of direct acting antivirals,especially Sofosbuvir and Daclatasvir combination therapy (with or without ribavirin) in patients with chronic hepatitis C, genotype four (the predominant genotype in Egypt).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be recruited from the Viral Hepatitis Clinic of Tropical Medicine Department, at Al-Rajhi Liver University Hospital Assiut, Egypt where these medications (DAAs) are available free for all insurance uncovered patients.

Description

Inclusion Criteria:

  • Patients with chronic hepatitis C only will be included.
  • Patients who are eligible for treatment by DAAs only.

Exclusion Criteria:

  • Cirrhotic patients will be excluded based on USS, APRI score index and FIB4 index.
  • Hepatitis B infected patients will also be excluded.
  • Patients with current or previous history of neuropsychiatric disorders will be excluded.
  • Failure to obtain consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with chronic hepatitis C treated by DAAs
All subjects will be given the same treatment regimen which includes Sofosbuvir 400 mg orally/24 hours (pre-breakfast) and Daclatasvir 60 mg orally/24 hours after lunch with or without ribavirin for a total period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton anxiety scale (HAM-A) in patients with chronic hepatitis C treated by DAAs
Time Frame: 12 months
12 months
Hamilton depression scale (HAM-D) in patients with chronic hepatitis C treated by DAAs
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
EEG in patients with chronic hepatitis C treated by DAAs
Time Frame: 12 months
12 months
Visual evoked potential in patients with chronic hepatitis C treated by DAAs
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAEIPWCHCTBDAAD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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