Hepatitis C Clinical Trial
Official title:
Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs
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).
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).
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