Chronic Hepatitis c Clinical Trial
Official title:
Frequency of Anxiety and Depression in Chronic Hepatitis C Patients Recieving Direct-Acting Antiviral Agents.
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).
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 .
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