Clinical trial NCT03158818: Chronic Hepatitis B Virus Infection in Zambia
Official title: Chronic Hepatitis B Virus Infection in Zambia: a Prospective Clinical Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HBV
Fibrosis, Liver
Cirrhosis, Liver
Alcoholic Hepatitis
Hepatocellular Carcinoma
Hepatitis, Delta
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Tropical Gastroenterology and Nutrition Group
name: Centre for Infectious Disease Research in Zambia
First posted: 2017-05-18
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 adults with chronic HBV infection

Brief summary: Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.

Detailed description: Viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as HIV/AIDS, tuberculosis, and malaria. Chronic viral hepatitis is caused by hepatitis C virus and hepatitis B virus and these infections are most common in low and middle-income countries, notably Asia and sub-Saharan Africa. In Zambia there are limited data, but from an HIV cohort, the investigators of this study described 10-12% prevalence of chronic HBV. To raise awareness of viral hepatitis in Zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic HBV infection and follow the cohort in an observational cohort study. In the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. The investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* HBV-infected, defined as any single positive HBsAg assay

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* HIV-positive

Primary outcomes:
measure: Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)
timeFrame: Baseline and after 1 year of treatment
Secondary outcomes:
measure: Proportion of chronic HBV-infected patients with an indication for antiviral treatment.
timeFrame: baseline, after 1 year of treatment, after 2 years of treatment
measure: HBV viral control among patients on antiviral treatment
timeFrame: baseline, after 1 year of treatment, after 2 years of treatment
measure: Serologic, virologic, and hepatic features of chronic HBV infection in Zambia
timeFrame: 0 to month 60
measure: Proportion with significant liver fibrosis
timeFrame: 0, 12, 24, 36, 48, and 60 months,
measure: Incidence and prevalence of hepatocellular carcinoma (HCC)
timeFrame: baseline and after month 60
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Tropical Gastroenterology and Nutrition Group
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael J Vinikoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franklin S, Mouliom A, Sinkala E, Kanunga A, Helova A, Dionne-Odom J, Turan JM, Vinikoor M. Hepatitis B virus contact disclosure and testing in Lusaka, Zambia: a mixed-methods study. BMJ Open. 2018 Sep 21;8(9):e022522. doi: 10.1136/bmjopen-2018-022522.