NCT03894696

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
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Chronic Hepatitis c

Interventions

Type	Name	Description
DRUG	Direct Acting Antivirals	follow up chronic HCV patients recieving DAAs to detect anxiety and depression

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-04-01
• Completion: 2020-05-01
• First posted: 2019-03-28
• Last updated: 2019-07-08