Clinical trial NCT03268317: Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs
Official title: Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hamilton anxiety scale (HAM-A) in patients with chronic hepatitis C treated by DAAs
timeFrame: 12 months
measure: Hamilton depression scale (HAM-D) in patients with chronic hepatitis C treated by DAAs
timeFrame: 12 months
Secondary outcomes:
measure: EEG in patients with chronic hepatitis C treated by DAAs
timeFrame: 12 months
measure: Visual evoked potential in patients with chronic hepatitis C treated by DAAs
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
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