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Frequency of Anxiety and Depression in Chronic Hepatitis C Patients Recieving Direct-Acting Antiviral Agents

Frequency of Anxiety and Depression in Chronic Hepatitis C Patients Recieving Direct-Acting Antiviral Agents.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03894696
Enrollment
200
Registered
2019-03-28
Start date
2019-08-01
Completion date
2020-05-01
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis c

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 .

Interventions

follow up chronic HCV patients recieving DAAs to detect anxiety and depression

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
frequency of anxiety and depression in chronic HCV patients recieving DAAs.6 months .to detect occurance of psychatric disorders specifically anxiety and depression in chronic HCV patients treated with DAAs ( sofosbuvir based regimens).

Contacts

Primary ContactDina khaled
dr.dina567@gmail.com00201096006362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026