Hepatitis C, Chronic
Conditions
Brief summary
Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of people with chronic hepatitis C (CHC) infection knowing their status. The major challenges are that awareness is lacking, reliable diagnostics and testing services are not sufficiently available, and laboratory capacity is weak. In the context of major tertiary hospitals, the well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the identification of inpatients who are unaware of HCV infection. However, given the preliminary data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly low. A recent study from a major hospital in Jilin province of China showed that 3.36% of inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further performed in this study. From the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during 2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the infectious department in Chinese hospitals are relative independent from non-ID departments, meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians. Therefore, an appropriate clinical pathway for integration and linkage of non-ID department and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The investigator aim to establish a feasible clinical pathway and consensus guideline to enhance HCV testing surveillance with linkage to care in non-ID departments. Moreover, the participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which the intervention and clinical outcome of hepatitis will be longitudinally monitored in the future study.
Interventions
DIAGNOSTIC_TESTHCV screening
HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment
Sponsors
Gilead Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Retrospective cohort: 1. ≥ 18 years of age. 2. Inpatients from non-infectious department. 3. Documentation of laboratory test indicating positive HCV antibody. Prospective cohort: 1. ≥ 18 years of age. 2. Inpatients from non-infectious departments. 3. Patients who meet the requirement of HCV antibody screening: 1. patients with high risk possibility of HCV infection. 2. patients who will have special or invasive medical operation. 3. patients with unexplained abnormal liver biochemical laboratory results.
Exclusion criteria
Retrospective cohort: Duplicated subjects. Prospective cohort：Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test. | 1 years |
| The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening. | 1 years |
| The percentage of HCV-RNA positivity linkage to care consensus guideline shaped. | 1 years |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of CHC patients linked to care in non-infectious departments. | 1 years |
| The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment. | 1 years |
| The referral rate of identified HCV infected patients. | 1 years |
Countries
China
Contacts
Primary ContactChao Wu, M.D, Ph.D.
Backup ContactYuxin Chen, Ph.D.
Outcome results
None listed