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

Chronic Hepatitis c Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03894696
• Other study ID #: DAAs and psychiatry
• Status: Not yet recruiting
• Start date: August 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Dina khaled
• Phone: 00201096006362
• Email: dr.dina567[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Depression
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Direct Acting Antivirals
follow up chronic HCV patients recieving DAAs to detect anxiety and depression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (17)

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Stanaway JD, Flaxman AD, Naghavi M, Fitzmaurice C, Vos T, Abubakar I, Abu-Raddad LJ, Assadi R, Bhala N, Cowie B, Forouzanfour MH, Groeger J, Hanafiah KM, Jacobsen KH, James SL, MacLachlan J, Malekzadeh R, Martin NK, Mokdad AA, Mokdad AH, Murray CJL, Plass D, Rana S, Rein DB, Richardus JH, Sanabria J, Saylan M, Shahraz S, So S, Vlassov VV, Weiderpass E, Wiersma ST, Younis M, Yu C, El Sayed Zaki M, Cooke GS. The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013. Lancet. 2016 Sep 10;388(10049):1081-1088. doi: 10.1016/S0140-6736(16)30579-7. Epub 2016 Jul 7. — View Citation

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Tully DC, Hjerrild S, Leutscher PD, Renvillard SG, Ogilvie CB, Bean DJ, Videbech P, Allen TM, McKeating JA, Fletcher NF. Deep sequencing of hepatitis C virus reveals genetic compartmentalization in cerebrospinal fluid from cognitively impaired patients. Liver Int. 2016 Oct;36(10):1418-24. doi: 10.1111/liv.13134. Epub 2016 Apr 26. — View Citation

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Wu JY, Shadbolt B, Teoh N, Blunn A, To C, Rodriguez-Morales I, Chitturi S, Kaye G, Rodrigo K, Farrell G. Influence of psychiatric diagnosis on treatment uptake and interferon side effects in patients with hepatitis C. J Gastroenterol Hepatol. 2014 Jun;29(6):1258-64. — View Citation

Younossi Z, Henry L. Systematic review: patient-reported outcomes in chronic hepatitis C--the impact of liver disease and new treatment regimens. Aliment Pharmacol Ther. 2015 Mar;41(6):497-520. doi: 10.1111/apt.13090. Epub 2015 Jan 23. Review. — View Citation

Younossi ZM, Stepanova M, Henry L, Nader F, Younossi Y, Hunt S. Adherence to treatment of chronic hepatitis C: from interferon containing regimens to interferon and ribavirin free regimens. Medicine (Baltimore). 2016 Jul;95(28):e4151. doi: 10.1097/MD.0000000000004151. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of anxiety and depression in chronic HCV patients recieving DAAs.	to detect occurance of psychatric disorders specifically anxiety and depression in chronic HCV patients treated with DAAs ( sofosbuvir based regimens).	6 months .