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Status unknownNCT03268317Updated Aug 31, 2017

Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs

An observational study in Hepatitis C, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2017-08-31.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study summary

Neuropsychiatric adverse effects of direct acting antiviral drugs, especially Sofosbuvir and Daclatasvir combination therapy (with or without ribavirin) in patients with chronic hepatitis C , genotype four (the predominant genotype in Egypt).

Read the detailed description

Treatment of hepatitis C virus, a virus infecting over one hundred seventy million worldwide, has evolved over the last two decades and moved from interferon-alpha monotherapy to pegylated interferon-alpha in combination with ribavirin therapy. Despite enhanced sustained virological response rates, psychiatric illness remains a barrier to widespread hepatitis C virus treatment uptake due to the neuropsychiatric risks associated with interferon-alpha.The next generation of hepatitis C virus therapeutic agents is direct acting antivirals that still require the use of interferon-ribavirin combination therapy.

Poorly managed psychiatric illness can lead not only to treatment discontinuation,but also poor adherence to treatment and serious psychiatric sequels, such as suicide.

Data on neuropsychiatric adverse effects of direct acting antivirals is limited and predominantly derived from landmark clinical trials for boceprevir and telaprevir.These first generation direct acting antivirals are currently not in use due to their multiple side effects ,the need for concomitant interferon-alpha ,and there wide drug-drug interactions. Recently the treatment of hepatitis C virus has undergone a paradigm shift with the introduction of the second generation of direct acting antivirals. This interferon-free modality has brought about exceptional cure rates with sustained virological response exceeding ninety hundred percent, with better tolerability, minimized side effects and short duration of treatment . Of the current hepatitis C virus treatment regimens, the combinations of Sofosbuvir plus daclatasvir have shown a high efficacy rate in achieving sustained virological response in genotype one patients.

To the investigators' knowledge, the development of neuropsychiatric side effects with the use of these second generation direct acting antivirals in absence of interferon therapy, as well as the impact of the expected high sustained virological response to therapy on the psychiatric condition of patients with chronic hepatitis C (in absence of cirrhosis) have not been studied. Therefore, the purpose of this work is to evaluate the neuropsychiatric adverse effects of direct acting antivirals,especially Sofosbuvir and Daclatasvir combination therapy (with or without ribavirin) in patients with chronic hepatitis C, genotype four (the predominant genotype in Egypt).

02

Conditions studied

  • Hepatitis C
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients will be recruited from the Viral Hepatitis Clinic of Tropical Medicine Department, at Al-Rajhi Liver University Hospital Assiut, Egypt where these medications (DAAs) are available free for all insurance uncovered patients.

Inclusion criteria

  • Patients with chronic hepatitis C only will be included.
  • Patients who are eligible for treatment by DAAs only.

Exclusion criteria

Exclusion Criteria:

  • Cirrhotic patients will be excluded based on USS, APRI score index and FIB4 index.
  • Hepatitis B infected patients will also be excluded.
  • Patients with current or previous history of neuropsychiatric disorders will be excluded.
  • Failure to obtain consent.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with chronic hepatitis C treated by DAAs

    All subjects will be given the same treatment regimen which includes Sofosbuvir 400 mg orally/24 hours (pre-breakfast) and Daclatasvir 60 mg orally/24 hours after lunch with or without ribavirin for a total period of 12 weeks.

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What researchers measure

Primary outcomes

  1. Hamilton anxiety scale (HAM-A) in patients with chronic hepatitis C treated by DAAs

    Time frame: 12 months

  2. Hamilton depression scale (HAM-D) in patients with chronic hepatitis C treated by DAAs

    Time frame: 12 months

Secondary outcomes

  1. EEG in patients with chronic hepatitis C treated by DAAs

    Time frame: 12 months

  2. Visual evoked potential in patients with chronic hepatitis C treated by DAAs

    Time frame: 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Wasley A, Alter MJ. Epidemiology of hepatitis C: geographic differences and temporal trends. Semin Liver Dis. 2000;20(1):1-16. doi: 10.1055/s-2000-9506. PubMed 10895428 ↗
  • Dieperink E, Ho SB, Tetrick L, Thuras P, Dua K, Willenbring ML. Suicidal ideation during interferon-alpha2b and ribavirin treatment of patients with chronic hepatitis C. Gen Hosp Psychiatry. 2004 May-Jun;26(3):237-40. doi: 10.1016/j.genhosppsych.2004.01.003. PubMed 15121353 ↗
  • Ademmer K, Beutel M, Bretzel R, Jaeger C, Reimer C. Suicidal ideation with IFN-alpha and ribavirin in a patient with hepatitis C. Psychosomatics. 2001 Jul-Aug;42(4):365-7. doi: 10.1176/appi.psy.42.4.365. No abstract available. Erratum In: Psychosomatics 2002 Jan-Feb;43(1):88. Clemens J [corrected to Jaeger C]. PubMed 11496031 ↗
  • Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912. PubMed 21696307 ↗
  • Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494. PubMed 21449783 ↗
  • Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, Fried MW, Adler M, Reesink HW, Martin M, Sankoh AJ, Adda N, Kauffman RS, George S, Wright CI, Poordad F; ILLUMINATE Study Team. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011 Sep 15;365(11):1014-24. doi: 10.1056/NEJMoa1014463. Erratum In: N Engl J Med. 2011 Oct 20;365(16):1551. PubMed 21916639 ↗
  • Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17. doi: 10.1056/NEJMoa1009482. PubMed 21449784 ↗
  • Gutierrez JA, Lawitz EJ, Poordad F. Interferon-free, direct-acting antiviral therapy for chronic hepatitis C. J Viral Hepat. 2015 Nov;22(11):861-70. doi: 10.1111/jvh.12422. Epub 2015 Jun 17. PubMed 26083155 ↗
  • Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218. Erratum In: N Engl J Med. 2014 Apr 10;370(15):1469. PubMed 24428467 ↗
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Registry details

Key details

Study ID
NCT03268317
Lead sponsor
Assiut University
Responsible party
Mariana Tharwat (Principle investigator, Assiut University) — Principal investigator
First posted
Aug 31, 2017
Start date
Jan 2018 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
Jan 2020 (estimated)
Last update
Aug 31, 2017

Study contacts

Esam Darwish
Contact
darwishe@aun.edu.eg
01224785281

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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