HCV Treatment Initiation During Acute Psychiatric Admission

University Health Network, Toronto54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

SVR12 by intention to treat (ITT) in each arm

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).

Time frame: 24 months

Secondary Outcomes

SVR12 by modified intention to treat (mITT) in each arm

Time frame: 24 months

HCV relapse rate

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).

Time frame: 24 months

HCV seroprevalence rates

To determine HCV seroprevalence rates among acute vs addictions patients admitted to CAMH.

Time frame: 12 months

HCV RNA positivity rates

To determine HCV RNA positivity rates among acute vs addictions patients admitted to CAMH.

Time frame: 12 months

CAMH staff acceptability of POC antibody and RNA testing

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.

Time frame: 12 months

Concordance of POC HCV RNA with HCV RNA by phlebotomy

To determine concordance of POC HCV RNA (GeneXpert) with HCV RNA by phlebotomy (Abbott RealTime).

Time frame: 12 months

Minimum and mean times from diagnosis to treatment initiation

Evaluate the mean and minimum times to treatment initiation in both arms, and compare.

Time frame: 24 months

Adherence with out-patient follow-up visits

Evaluate and compare out-patient follow-up visit adherence in both arms.

Time frame: 24 months.

Adherence to HCV treatment, by HCV regimen

Evaluate and compare both arms for medication adherence (patient self-report and pill count), and variance by medication regimen.

Time frame: 24 months.

Adverse events while on HCV treatment

To determine and compare adverse events in both arms while patients are on treatment.

Time frame: 18 months.

HCV Reinfection

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

Time frame: 24 months.

HCV Treatment Initiation During Acute Psychiatric Admission

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts