TerminatedPhase 4ACTRN12618001939280

Sofosbuvir/Velpatasvir and Mental Health Impact in people with Lived Experience and Hepatitis C infection - SMILE-C Trial

Sponsor

The University of Adelaide

Enrollment

150 participants

Start Date

Apr 11, 2019

Study Type

Interventional

Conditions

Schizophrenia

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

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 Criteria8

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

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.