Clinical trial NCT03702998: Hepatocellular Carcinoma in HIV-infected Individuals in Asian Population
Official title: Incidence and Mortality of Hepatocellular Carcinoma in HIV-infected Individuals in an Asian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Hepatitis B
Hepatitis C
Hepatocellular Carcinoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 3900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected individuals with and without HBV/HCV co-infection, and HBV/HCV mono-infected individuals in Hong Kong

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

Eligibility criteria: 1. HIV-infected individuals with and without HBV or HCV co-infection:

   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

   Exclusion criteria:

   -nil
2. HBV/HCV mono-infected individuals:

Inclusion criteria:

* 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

Primary outcomes:
measure: Incidence of HCC
timeFrame: From the time of diagnosis up to 20 years of follow up.
Secondary outcomes:
measure: Mortality due to HCC or liver-related conditions
timeFrame: From the time of diagnosis up to 20 years of follow up.
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Grace Lui
role: PRINCIPAL_INVESTIGATOR
References: