Prospective Evaluation of a Fast-track Treatment Pathway for Patients With Chronic Hepatitis B Under Primary Care

This is a retrospective-prospective longitudinal cohort study, with analyses performed before and after introduction of the pathway, and comparisons made to unexposed controls. We will launch a protocol-driven management for CHB patients, and provide the appropriate assessment tools (transient elastography, HBV DNA assay) to general outpatient clinics (GOPC) in Hong Kong. Patients who fulfil treatment criteria will be referred to specialist outpatient clinics (SOPC) in a fast-track manner. We will also evaluate the linkage-to-care rate 3 years before the launch of this care pathway retrospectively.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hep B

Detailed Description

Chronic viral hepatitis is the seventh leading cause of mortality globally, responsible for 1.45 million deaths in 2013. The consequences of chronic hepatitis B and C infection - cirrhosis and liver cancer - account for 94% of deaths associated with hepatitis.1 Liver cancer is the second most common cause of cancer death in the Asia-Pacific region. Approximately 78% of liver cancer cases are a result of chronic viral hepatitis.1,2 In Hong Kong, the positive rate of hepatitis B surface antigen (HBsAg) remains high among adults of productive ages of 31-40 and 41-50 years (5.2% and 7.2% respectively) in 2015.3 World Health Organization (WHO) published the first global health sector strategy on viral hepatitis in June 2016, a strategy that contributes to the proposed targets for the reduction of chronic viral hepatitis incidence and mortality of 90% and 65% respectively by 2030.4 The Chief Executive's 2017 Policy Address in Hong Kong asked to set up the Steering Committee to formulate strategies to effectively prevent and control viral hepatitis.5 The Steering Committee is currently reviewing local and international trends and developments in the prevention and control of viral hepatitis; advising the Government on policies and cost-effective targeted strategies for prevention and control of viral hepatitis; and conducting and coordinating the surveillance and evaluation of viral hepatitis control and recommending appropriate response.5 One of the key gaps in CHB management is the suboptimal treatment in patients who fulfil treatment criteria but not started on antiviral treatment because of linkage-to-care issue, namely very long waiting time (up to 2.5 years) from primary care setting like general outpatient clinics (GOPC). There are limited resources for specialized assessments (e.g. HBV DNA assays, transient elastography for liver fibrosis assessment).

Therefore a novel fast-track treatment pathway for patients with chronic hepatitis B under primary care would fill this gap and provide pivotal data to the Government and the Steering Committee to guide the strategies for achieving the goals set by WHO.

• Study Type: Observational
• Enrollment (Estimated): 3300

Contacts and Locations

• Study Contact: Name: Angel Chim, MSc; Phone Number: +852 3505 4205; Email: angelchim@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Angel Chim; Email: angelchim@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

300 prospectively from FM/GOPC 3000 retrospectively from CDARS.

Description

Inclusion Criteria:

• Adult patients with positive hepatitis B surface antigen (HBsAg) for 6 months
• Under the care of GOPC

Exclusion Criteria:

• Age under 18
• Refusal to consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linkage-to-care	referral rate of patients from GOPC and SOPC who fulfil treatment criteria	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unnecessary referral	referral rate of patients from GOPC and SOPC who do not fulfil treatment criteria	3 years
GOPC care management rate	transient elastography uptake rate, fibrosis staging, clinical events, default rate	3 years
SOPC care management rate	antiviral uptake care, fibrosis staging, clinical events, default rate	3 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Grace LH Wong, Prof, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.

Helpful Links

• Hepatitis B
• Hepatitis C
• Surveillance of Viral Hepatitis in Hong Kong - 2016 Update Report
• Combating hepatitis B and C to reach elimination by 2030
• Building a Caring, Inclusive Society, Improving People's Livelihood

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Chronic Disease; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: HBV_GOPC study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No