Clinical trial NCT03894696: Frequency of Anxiety and Depression in Chronic Hepatitis C Patients Recieving Direct-Acting Antiviral Agents
Official title: Frequency of Anxiety and Depression in Chronic Hepatitis C Patients Recieving Direct-Acting Antiviral Agents.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis c
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients fulfilling the inclusion criteria will attend the hepatitis outpatient clinic of Al-Rajhi Liver Hospital. Selected patients will be followed up for 6 months.

Brief summary: The primary objective of this study is to prospectively analyse psychiatric outcomes, specifically depression and anxiety in patients with hepatitis C virus infection who are initiated on DAA therapy (sofosbuvir based regimen).

Detailed description: Hepatitis C is a major cause of chronic liver disease worldwide with an estimated 71 million people infected in 2015 and approximately 1.75 million new infections each year .

Egypt had high burden of liver disease from viral hepatitis , and near to 15% of the adult population had HCV seropositivity and more than 4 million persons had also viraemia .

The discovery of direct-acting antiviral agents (DAAs) has dramatically changed HCV treatment by increasing the cure rate and decreasing the duration of therapy .The current generation of DAAs (e.g., daclatasvir \[DCV\], sofosbuvir \[SOF\], simeprevir \[SIM\] and ledipasvir \[LDV\]) is used without IFN .

The approval of direct - acting antiviral (DAA) agents revolutionized HCV treatment and allowed for non-IFN-a-based regimens. Psychiatric and psychosocial contraindications to treatment are reduced due to shorter duration of therapy and improved side effect profiles . Also, the favorable side effect profiles of DAA agents (less fatigue and blood dyscrasias) lead to high adherence rates of 96.2%, compared to 84.3% and 77.6% in IFN-free RBV-containing regimens and IFN- and RBV containing regimen respectively .

Sofosbuvir and daclatasvir are new direct acting antivirals (DAAs) which are tolerable and safe. Daclatasvir is a first-in-class HCV NS5A replication complex inhibitor with pangenotypic activity and can be used once-daily. Sofosbuvir is an orally administered HCV nucleotide polymerase NS5B inhibitor. It is given once daily with a good safety profile . The sofosbuvir and daclatasvir combination is associated with a high rate of SVR in difficult-to-treat patients infected with genotype 1 or 4. Addition of ribavirin increases the SVR rate in cirrhotic and treatment-experienced patients .

Mental illness are significantly higher in chronic HCV patients than in the general population, with depression, schizophrenia, and bipolar disorder occurring at 25%, 3.9%, and 2.6% respectively . HCV infection lead to psychiatric symptoms by inflammatory routes, direct brain neurotoxicity, metabolic and neurotransmitter pathway derangement and immune-mediated responses . Currently, the extent of psychiatric effects attributed to DAA agents is unclear; however, it is less than IFN-containing regimens . Though data suggests that DAAs confer a minimal risk of psychiatric adverse effects compared to IFN-based regimens; there is a paucity of data specifically adressing neuropsychiatric complications of these drugs. In addition, it is unclear whether DAA therapy may exacerbate mood symptoms in patients with prior psychiatric history .

Eligibility criteria: Inclusion Criteria:

18 years and older Chronic Hepatitis C infection Naive patients who will start a 12-week DAA therapy Acceptance to share in study

Exclusion Criteria:

Recieving antipsychotic . Previous failure of DAA agents. Significant life-threatening diseases HCV related liver cirrhosis. Non HCV related liver disease

Primary outcomes:
measure: frequency of anxiety and depression in chronic HCV patients recieving DAAs.
timeFrame: 6 months .
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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