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

Phase 4

• Conditions: Hepatitis C virus infection; Schizophrenia; Schizoaffective disorder; Bipolar disorder; Cognitive dysfunction; Infection - Other infectious diseases; Mental Health - Schizophrenia; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001939280
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-29
• Study Completion: 2022-03-02
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified