Impact on QoL and Cognitive Functioning of New Antiviral Therapies in Subjects With Chronic Hepatitis HCV-related

Summary

Chronic hepatitis HCV-related is the most common cause of chronic liver disease in Italy. Patients with chronic hepatitis C present a prevalence of depressive disorders higher than that of the general population; moreover, it has been repeatedly demonstrated the presence of cognitive deficits and poor quality of life. Chronic hepatitis C therapy was based on the combined use of pegylated alpha-interferons (PEG-INF), and ribavirin. Recently, new therapeutic protocols have been introduced, and while some antiviral drugs, including the first-generation ones, were used only in combination with PEG-IFN and ribavirin, the second and third generation antiviral drugs protocols are interferon-free. However, because of the high cost, the access to interferon-free protocols is only for patients with advanced fibrous stages, or with concomitant extra-hepatic HCV-related diseases, or for transplanted patients. Many side effects, such as flu-like symptoms, and psychiatric symptoms (depression, anxiety, irritability, insomnia) are common during antiviral therapy with IFN. However, in patients with chronic hepatitis C, a high lifetime prevalence of major depressive disorder, panic disorder, and brief recurrent depression have been observed, irrespective of IFN treatment and the use of alcohol and narcotics; such associations between mood and anxiety disorders and chronic hepatitis C may reflect a high prevalence of bipolar spectrum disorders. The presence of severe psychopathological symptoms requires the reduction of posology and causes high rates of discontinuation of antiviral therapy.

This project represents an innovative psychiatric and neuropsychological screening program for patients with chronic hepatitis C, eligible for antiviral therapy.

1. Primary objectives:

1. to verify the medium-term impact of new antiviral therapies on quality of life, psychological well-being and cognitive function in subjects with chronic hepatitis C;
2. to verify the predictability of specific psychopathological components and specific determinants on compliance with new antiviral therapies.
2. Main secondary objectives:

1. to verify the evidence of association between various psychiatric disorders and cognitive deficits and chronic hepatitis C;
2. to evaluate the relative weight of psychopathological and/or cognitive disorders on the efficacy of antiviral therapy and on quality of life.

Conditions

• Psychiatric Disorders
• Cognitive Impairment
• Chronic Hepatitis c

Interventions

OTHER

Neuropsychiatric screening

Psychiatric diagnosis through: 1. clinical interview 2. the Advanced Neuropsychiatric Tools and Assessment Schedule (ANTAS), based on the SCID-I-NP (Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-Non Patient Version); 3. HAM-D (Hamilton Scale for Depression); 4. PHQ-9 (Patient's Health Questionnaire-9 items); 5. MDQ (Mood Disorders Questionnaire); 6. YMRS (Young Mania Rating Scale); 7. ASRM (Altman Self Rating Mania scale); 8. BRIAN (Biological Rhythms Interview of Assessment in Neuropsychiatry). Assessment of Quality of Life: 9. SF-12 (Short Form Health Survey-12 items). Neuropsychological screening: l) Addenbrooke's Cognitive Examination (ACE-R).

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria di Cagliari

  lead OTHER

Principal Investigators

• Gioia Mura, Dr · Azienda Ospedaliero Universitaria di Cagliari

• Mauro G Carta, Prof · Azienda Ospedaliero Universitaria di Cagliari

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-07-31

Completion

2018-09-30

Countries

• Italy

Study Locations