A Comprehensive HBsAg-positive Patients Centered Screening Strategy

NCT03794791 | Completed

• 1 other identifier: LS2018037
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

HBV(hepatitis B virus) /HCV(hepatitis C virus) co-infection may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported HCV co-infection harmfully affects liver fibrosis in HBV patients, while decompensated cirrhosis is increased in co-infected patients compared with HBV- or HCV- mono-infected patients. One meta-analysis having pooled 39 studies performed in China reported that around 5% of HCC was associated with HCV infection alone and 6% with co-infection of HBV + HCV. However, the exact prevalence of HCV infection in HBsAg(Hepatitis B virus surface antigen)(+) cohort is actually unknown. It is estimated to be between 0.7% and 16%, a percentage that varies over a wide range among several studies from literature, mainly depending on different geographical distribution and study population. However, in regions where HBV is endemic, such as China with a HBsAg positive rate of 7.18%, the probability of co-infection increases due to a similar transmission route, especially in patients with high risk of HCV infection, like dialysis, HIV infection, organ transplantation, sex workers, drug abuser, tattoo, piercing, blood donation, history of scaling or dental filling, HCV family history and so on. As for China, the awareness of HCV infection is much lower than HBV because the occult of HCV infection, also because governments as well as medical authorities didn't input enough resources to disease education. Up to now, the national HCV elimination in China is daunting because of barriers in HCV awareness/link to care, and lack of well-established strategies. On the contrary, HBV infection has been widely known and educated to general population. As an add-on benefit, it might be relatively easier to conduct HCV screening test among those HBsAg-positive population. HCV elimination in high-risk subgroups from the basis in HBV population can be achieved with greater possibility and such model could be further shared to health care societies.

Conditions

Hepatitis B and Hepatitis C (Disorder)

Keywords

HBV; HCV; Co-infection

Outcome Measures

Primary Outcomes (1)

• Evaluate value of HCV education

  This patients will receive education about HCV infection as well as HBV/HCV co-infection and then be asked whether they are willing to do anti-HCV test or not. Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.

  1 Year

Secondary Outcomes (2)

• Prevalence of HCV co-infection

  1 Year

• Awareness of HCV infection

  1 Year

Study Arms (2)

education

Education will be used to see whether or not improve the HCV screening and diagnosis in HBsAg(+) patients. Blood test ,HCV-RNA quantification test and HCV genotyping will be employed to evaluate the prevalence of HBV-HCV co-infection. Awareness of HCV infection in HBV/HCV cohort and analysis of risk factors will also be assessed.

Behavioral: education

no education

There is no education at all.Screening and diagnosis of HCV infection in HBsAg(+) patients are based on voluntary. Blood test ,HCV-RNA quantification test and HCV genotyping will still be employed to evaluate the prevalence of HBV-HCV co-infection. Awareness of HCV infection in HBV/HCV cohort and analysis of risk factors will also be assessed.

Behavioral: no education

Interventions

education BEHAVIORAL

Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.

Also known as: HCV RNA quantification test/HCV genotyping

education

no education BEHAVIORAL

Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.

Also known as: HCV RNA quantification test/HCV genotyping

no education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HBsAg(+) patients

You may qualify if:

• HBsAg(+) patients

You may not qualify if:

• none

Sponsors & Collaborators

• Hong Ren: lead
• Gilead Sciences: collaborator

Study Sites (1)

The 2nd affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (6)

• Pol S, Haour G, Fontaine H, Dorival C, Petrov-Sanchez V, Bourliere M, Capeau J, Carrieri P, Larrey D, Larsen C, Marcellin P, Pawlostky JM, Nahon P, Zoulim F, Cacoub P, de Ledinghen V, Mathurin P, Negro F, Pageaux GP, Yazdanpanah Y, Wittkop L, Zarski JP, Carrat F; French Anrs Co22 Hepather Cohort. The negative impact of HBV/HCV coinfection on cirrhosis and its consequences. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1054-1060. doi: 10.1111/apt.14352. Epub 2017 Oct 9.

  PMID: 28994127 BACKGROUND

• Wang M, Wang Y, Feng X, Wang R, Wang Y, Zeng H, Qi J, Zhao H, Li N, Cai J, Qu C. Contribution of hepatitis B virus and hepatitis C virus to liver cancer in China north areas: Experience of the Chinese National Cancer Center. Int J Infect Dis. 2017 Dec;65:15-21. doi: 10.1016/j.ijid.2017.09.003. Epub 2017 Sep 19.

  PMID: 28935244 BACKGROUND

• Papadopoulos N, Papavdi M, Pavlidou A, Konstantinou D, Kranidioti H, Kontos G, Koskinas J, Papatheodoridis GV, Manolakopoulos S, Deutsch M. Hepatitis B and C coinfection in a real-life setting: viral interactions and treatment issues. Ann Gastroenterol. 2018 May-Jun;31(3):365-370. doi: 10.20524/aog.2018.0255. Epub 2018 Mar 28.

  PMID: 29720863 BACKGROUND

• Wang H, Swann R, Thomas E, Innes HA, Valerio H, Hayes PC, Allen S, Barclay ST, Wilks D, Fox R, Bhattacharyya D, Kennedy N, Morris J, Fraser A, Stanley AJ, Gunson R, Mclntyre PG, Hunt A, Hutchinson SJ, Mills PR, Dillon JF. Impact of previous hepatitis B infection on the clinical outcomes from chronic hepatitis C? A population-level analysis. J Viral Hepat. 2018 Aug;25(8):930-938. doi: 10.1111/jvh.12897. Epub 2018 Apr 15.

  PMID: 29577515 BACKGROUND

• Lazarus JV, Wiktor S, Colombo M, Thursz M; EASL International Liver Foundation. Micro-elimination - A path to global elimination of hepatitis C. J Hepatol. 2017 Oct;67(4):665-666. doi: 10.1016/j.jhep.2017.06.033. Epub 2017 Jul 29. No abstract available.

  PMID: 28760329 BACKGROUND

• Cai D, Zhang D, Hu P, Ren H. A Comprehensive Hepatitis B Surface Antigen-Positive Patient-Centered Screening and Linkage to Care Strategies Targeting Microelimination of Hepatitis C Virus Infection in Chongqing, China. Can J Gastroenterol Hepatol. 2022 Dec 27;2022:9644576. doi: 10.1155/2022/9644576. eCollection 2022.

  PMID: 36606100 DERIVED

MeSH Terms

Conditions

Hepatitis B; Hepatitis C; Coinfection

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• HONG REN, Prof.

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 7, 2019
• Study Start: February 20, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)