HCV Treatment Initiation During Acute Psychiatric Admission

Phase 4

• Conditions: Hepatitis C
• Interventions: Other: HCV care provided by hospitalist during acute psychiatric admission

• Registration Number: NCT04625322
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Hepatitis C virus (HCV) disproportionally affects certain populations, including those facing substance use and mental health challenges. In the past, many individuals with mental illness were not treated due to the psychiatric side-effects of interferon. However, the development of highly effective, direct-acting antivirals (DAA) has revolutionized HCV treatment such that cure rates are \>95% with 8-12 weeks of simple, safe, and well-tolerated therapy.

A recent systematic review reported that across 13 North American studies, HCV prevalence among people admitted to psychiatric hospitals was a staggering 17.4% (13.2-22.6%). Despite these concerning figures, mental health facilities have not been a focus of HCV elimination efforts to date. The Centre for Addiction and Mental Health (CAMH) in Toronto is the largest mental health facility in Canada, with a psychiatric emergency department seeing \~35 patients per day with many admitted to the acute psychiatric units for safety and stabilization. Currently, psychiatric patients screened for HCV at CAMH have a 75% 'no show' rate at the Toronto Centre for Liver Disease (TCLD), which is located less than 5km away, suggesting that referral upon discharge is ineffective.

This study will be the first trial to evaluate whether it would be feasible and beneficial to initiate treatment during an acute psychiatric admission rather than referring to specialty upon discharge. The combination of broad HCV screening with rapid linkage to treatment has led to successful elimination of HCV within defined populations, so-called micro-elimination. The investigators hypothesize that HCV treatment can be effectively delivered by providers in psychiatric care facilities, which will improve treatment uptake over traditional referral models.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Status Verified: 2021-12
• Study Start: 2022-04-19
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-05
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Chronic HCV infection, positive HCV RNA
2. Aged 18 to 80
3. Willingness and capacity to provide informed consent, or consent is provided by a substitute decision maker

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Exclusion Criteria

1. Presence of or history of decompensated cirrhosis (evidence of decompensation with history of either ascites, variceal hemorrhage, or hepatic encephalopathy)
2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin >34 μmol/L, INR >1.5
3. History of current or past hepatocellular carcinoma.
4. HBV (HBsAg +ve) co-infection or untreated HIV co-infection
5. Prior HCV antiviral therapy with DAA with or without peginterferon/ribavirin
6. Chronic liver disease other than mild nonalcoholic or alcoholic fatty liver disease from a cause other than HCV
7. Pregnancy/breastfeeding/inability to use contraception
8. Use of concomitant contraindicated medications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receive HCV care during inpatient admission by a hospitalist	HCV care provided by hospitalist during acute psychiatric admission	CAMH hospitalists covering the inpatient units will undergo a training designed for non-specialist providers, used in the ASCEND trial, which has already occurred. An algorithm-based work-up which has been used for non-specialist treaters in ECHO Liver, a Ministry-of-Health supported tele-mentoring program, will then be completed for all who test HCV RNA positive. Labs will be drawn by the hospital phlebotomist following a positive HCV RNA result from the Gene Xpert Viral Load Assay. At this time, a sample will also be obtained to send to for conventional HCV RNA quantification and genotyping.

Primary Outcome Measures

Name	Time	Method
SVR12 by intention to treat (ITT) in each arm	24 months	To determine whether screening for HCV using rapid diagnostics during an acute psychiatric admission with inpatient initiation of HCV treatment is superior to standard post-discharge referral and treatment by intention to treat (ITT).

Secondary Outcome Measures

Name	Time	Method
HCV RNA positivity rates	12 months	To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.
HCV relapse rate	24 months	To compare the HCV viral relapse rate in both arms (re-appearance of HCV RNA in those undetectable at end of treatment; relapse distinguished from reinfection by sequencing of the recurrent HCV RNA and comparing to baseline).
Concordance of POC HCV RNA with HCV RNA by phlebotomy	12 months	To determine concordance of POC HCV RNA (GeneXpert) with HCV RNA by phlebotomy (Abbott RealTime).
Adherence with out-patient follow-up visits	24 months.	Evaluate and compare out-patient follow-up visit adherence in both arms.
Adverse events while on HCV treatment	18 months.	To determine and compare adverse events in both arms while patients are on treatment.
HCV Reinfection	24 months.	Reinfection rates by the end of the defined as HCV RNA detectability after prior SVR with demonstration of distinct viral sequence from baseline sample to distinguish
SVR12 by modified intention to treat (mITT) in each arm	24 months	To determine whether screening for HCV using rapid diagnostics during an acute psychiatric admission with inpatient initiation of HCV treatment is superior to standard post-discharge referral and treatment by modified intention to treat (mITT).
CAMH staff acceptability of POC antibody and RNA testing	12 months	CAMH staff involved in the trial will be asked to particiapte in an acceptibility survey regarding rapid POC antibody and RNA testing on the acute units.
Minimum and mean times from diagnosis to treatment initiation	24 months	Evaluate the mean and minimum times to treatment initiation in both arms, and compare.
Adherence to HCV treatment, by HCV regimen	24 months.	Evaluate and compare both arms for medication adherence (patient self-report and pill count), and variance by medication regimen.
HCV seroprevalence rates	12 months	To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada