None listed
Conditions
Brief summary
Hepatitis C virus (HCV) infection has itself been associated with impaired neuropsychological performance. Up to 50% of people diagnosed with HCV have reported neuropsychiatric disorders and neurocognitive dysfunction. People with schizophrenia, schizoaffective disorder and bipolar disorder suffer disproportionately high rates of HCV-infection. We hypothesis, that successful HCV treatment with DAA-based therapy is associated with improved neurocognitive function in people with severe mental illness. This may be particularly important for patients’ overall functioning and for quality of life in this marginalised and understudied population.
Interventions
This trial is a double blind placebo randomised control trial (RCT) using an immediate versus deferred direct-acting antiviral (DAA) treatment strategy (24 week delay). Participants are randomised to one of the two treatment groups:
Group 1 (immediate treatment): Immediate treatment with Sofosbuvir/Velpatasvir daily for 12 weeks, with follow-up 12 weeks thereafter (SVR12 check: week 24).
Group 2 (deferred treatment): Matched placebo daily for 12 weeks and follow-up 12 weeks thereafter (SVR12 c
This trial is a double blind placebo randomised control trial (RCT) using an immediate versus deferred direct-acting antiviral (DAA) treatment strategy (24 week delay). Participants are randomised to one of the two treatment groups: Group 1 (immediate treatment): Immediate treatment with Sofosbuvir/Velpatasvir daily for 12 weeks, with follow-up 12 weeks thereafter (SVR12 check: week 24). Group 2 (deferred treatment): Matched placebo daily for 12 weeks and follow-up 12 weeks thereafter (SVR12 check: week 48) with Sofosbuvir/Velpatasvir treatment. At week 24, following a second round of neuropsychological testing the trial will be unblinded and the participants in Group 2 will be informed that they had received the matched placebo. These Group 2 participants will then commence open-label Sofosbuvir/Velpatasvir for 12 weeks, with follow-up 12 weeks thereafter (SVR12; week 48). Our model of care follows recommendations such as prescribing Sofosbuvir/Velpatasvir on a monthly basis and contacting the participant at least once between visits. Participants will receive follow-up phone calls at weeks two, six, 10 and 12 to monitor adherence. Prior to receiving the the next month supply of the trial drug the participant will be asked to return the container and any remaining tablets from the previous month.
Sponsors
The University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 18 years of age or above • HCV RNA positive detected by PCR (PCR to be repeated if older than 12 months) • Established and stably treated schizophrenia, schizoaffective disorder or bipolar disorder, i.e. stably treated defined as no expected significant changes to the participant’s mental health treatment within six months after the baseline visit • HCV treatment naïve or experienced (defined as prior exposure to interferon-based therapy) • A comprehensive understanding of verbal and written English • Capacity to provide informed consent
Exclusion criteria
• Unstable mental health status at time of enrolment requiring acute intervention (e.g. psychosis, mania, suicidal depression) • Prior failure of a NS5A inhibitor containing antiviral regimen • Decompensated liver disease • Need for addition of ribavirin to the Sofosbuvir/Velpatasvir • eGFR<30 mL/min1.73m2 • Pregnant and breastfeeding women. Birth control whilst taking Sofosbuvir/Velpatasvir will be discussed • HIV coinfection • Taking any drug with known reported significant interactions with Sofosbuvir/Velpatasvir https://www.hep-druginteractions.org/checker
Outcome results
None listed