Hepatocellular Carcinoma in HIV-infected Individuals in Asian Population

NCT ID: NCT03702998

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2023-01-16

Brief Summary

This is a retrospective study, all HIV-infected individuals followed up at the three designated HIV clinics in Hong Kong with and without HBV and/or HCV co-infection will be included in the analysis. The incidence and mortality of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population will be determined.

Detailed Description

The incidence of hepatocellular carcinoma (HCC) is increasing over time among the HIV-infected population, and is an increasingly important cause of morbidity and mortality in HIV-infected individuals. Despite effective treatment for HBV and HCV infections, HCC is still reported in treated HIV-infected individuals with HBV/HCV co-infections. Currently, data on the risk and outcomes of HCC in HIV infected populations in Asia is lacking. This study aims to evaluate the incidence of HCC in HIV-infected individuals with and without HBV/HCV co-infection, and HBV/HCV mono-infected individuals in Hong Kong.

This is a retrospective study, all HIV-infected individuals followed up at the three designated HIV clinics in Hong Kong with and without HBV and/or HCV co-infection will be included in the analysis. The burden of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population will be determined by comparing their incidence and mortality.

Objectives:

1. To determine the burden of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population

2. To compare the incidence of HCC between HIV-infected individuals with HBV/HCV co-infection and HIV-uninfected individuals with HBV or HCV-monoinfection

3. To compare the mortality rate of HCC between HIV-infected individuals with HBV/HCV co- infection and HIV-uninfected individuals with HBV or HCV-monoinfection.

Study procedures

1. The electronic databases and medical records of all three HIV centres, and Clinical Data Analysis and Reporting System (CDARS) will be reviewed for data extraction for HIV-infected individuals.

2. The medical records and electronic database of Hospital Authority, Clinical Data Analysis and Reporting System (CDARS), will be reviewed for data extraction for HBV and HCV-infected individuals without HIV infection.

3. The following demographic and clinical data will be retrieved:

3.1 Date of birth, gender, ethnicity 3.2 Date of diagnosis of HIV infection 3.3 Route of transmission of HIV infection 3.4 Other concomitant chronic liver diseases (including alcoholic liver disease, fatty liver, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis etc) 3.5 Presence of cirrhosis and cirrhotic complications (including ascites, esophageal varices, encephalopathy, hepatorenal syndrome, hepatic coma) 3.6 Other comorbidities, including diabetes mellitus, drug-induced hepatitis, alcoholism 3.7 History of AIDS-defining illness 3.8 Nadir CD4 count, latest CD4 count 3.9 Latest HIV viral load 3.10 Bilirubin, ALT, ALP, total protein, albumin, platelet count, prothrombin time 3.11 HBeAg, anti-HBe, HBV DNA, HCV RNA 3.12 Antiviral therapy for HIV, HBV and HCV, including date of initiation and cessation, and name of drugs prescribed 3.13 Date of last follow-up 3.14 Date of diagnosis of liver cancer 3.15 Treatment of liver cancer (surgical, locoregional, chemotherapy, others) 3.16 Date and cause of death

Conditions

HIV Infections; Hepatitis B; Hepatitis C; Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HIV-infected individuals +/- HBV/ HCV

1 All HIV-infected individuals followed up in all public HIV clinics with and without HBV and/or HCV co-infection will be included in the analysis.

1.1 Inclusion criteria for HIV-infected individuals with and without HBV or HCV co-infection: 1.1.1 Positive HIV antibody 1.1.2 At least one visit in one of the HIV clinics 1.1.3 Subjects with positive HBsAg and/or anti-HBc will be regarded as having HBV co-infection 1.1.4 Subjects with positive HCV antibody will be regarded as having HCV co-infection

No interventions assigned to this group

HBV/HCV mono-infected individuals

2 All HBV and/or HCV-infected individuals followed up in public hospitals will be identified from the Hospital Authority electronic database.

2.1 Inclusion criteria for HBV/HCV mono-infected individuals 2.1.1 Documented diagnosis of hepatitis B or hepatitis C infection, or 2.1.2 Positive HBsAg and/or anti-HBc, or 2.1.3 Positive HCV antibody, and 2.1.4 Negative HIV antibody result, or no record of HIV diagnosis or anti-retroviral therapy prescription

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Positive HIV antibody
• At least one visit in one of the HIV clinics
• Subjects with positive HBsAg and/or anti-HBc will be regarded as having HBV co-infection
• Subjects with positive HCV antibody will be regarded as having HCV co-infection

• Documented diagnosis of hepatitis B or hepatitis C infection, or
• Positive HBsAg and/or anti-HBc, or
• Positive HCV antibody, and
• Negative HIV antibody result, or no record of HIV diagnosis or anti-retroviral therapy prescription

Exclusion Criteria

-nil

2. HBV/HCV mono-infected individuals:

• nil

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Grace Lui

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Lui

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

HCC_HIV protocol_V3_26042017

Identifier Type: -

Identifier Source: org_study_id