Clinical trial NCT02361541: Determination of HCV Prevalence in a HIV Patient Cohort in Phnom Penh, Cambodia
Official title: Determination of Hepatitis C Prevalence, Genetic Diversity and Treatment Eligibility in an HIV Patient Cohort in Phnom Penh, Cambodia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
HIV
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia
name: Universiteit Antwerpen
First posted: 2015-02-11
Enrollment: 3045
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients in a cohort of HIV-positive patients in Cambodia

Brief summary: Hepatitis C (HCV) is an important global public health problem, disproportionately affecting HIV positive populations. Asia and Africa account for most of the co-infection burden, but access to HCV screening and treatment is still very limited. It is expected though, with the recent therapeutic advances and increasing global advocacy efforts, that HCV treatment should become a feasible option in the near future.

Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest HIV cohorts of the country, followed in an ambulatory settings. In this cohort, the prevalence of HCV co-infection will be determined, as well as HCV genotype diversity and the severity of liver disease. The researcher will also explore the performance of simple blood tests/panels as predictors of significant fibrosis and/or cirrhosis.

Patients will attend two study-visits. All adult patients of the HIV patient cohort of SHCH will be proposed HCV testing during their next HIV follow-up consultation, following the latest algorithm of the Centre for Disease Control (CDC) (May 2013). Anamnesis and clinical examination will focus, additionally to routine practice, on presence of general and HCV liver-disease related features. Laboratory analyses will include basic HIV tests (CD4), and tests for liver function such as Hepatitis B surface antigen (HbsAg) .

During the following routine HIV follow-up consultation, the results of HCV testing will be explained to the patient. If the patient is HCV negative, his/her study participation ends here. If currently infected with HCV, the clinician will repeat the HCV liver-disease (extra-hepatic \& hepatic) related anamnesis and clinical examination, and prescribe additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests, liver and kidney function. Patients will moreover be asked to undergo a liver ultrasound and liver stiffness measurements.

Detailed description: Hepatitis C (HCV) is an important global public health problem, disproportionally affecting HIV positive populations. Asia and Africa account for most of the co-infection burden, but access to HCV screening and treatment is still very limited. The high cost and complexity of current diagnostic and treatment algorithms are major bottlenecks and the linked lack of accurate HCV prevalence estimates and treatment-need data do not allow for robust treatment advocacy and program planning. Cambodia is not an exception.

It is expected though, with the recent therapeutic advances and increasing global advocacy efforts, that HCV treatment should become a feasible option in the near future. Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest HIV cohorts of the country, and it is planning to engage in HCV treatment from 2014 2015 onwards, with a double objective of direct patient benefit and catalyst role at national level, as in the past when starting its antiretroviral (ARV) program.

Within this specific setting, the researchers plan to determine the prevalence of HCV co-infection, HCV genotype diversity and severity of liver disease in this HIV patient cohort, followed in an ambulatory setting. The researchers will also explore the performance of simple blood tests/panels as predictors of significant fibrosis and/or cirrhosis .

The current HCV diagnostic procedures (and tools), as applied in this study, are too expensive and resource-demanding to allow for scalability in resource limited settings. Thus, the researchers plan to set up during this study a biobank with samples of a clinically well described HIV patient population. These samples should allow constituting a well-balanced panel for evaluation of future 'more scalable' HCV diagnostic tools.

Patients will attend two study-visits. All adult patients of the HIV cohort will be proposed HCV testing during their next regular HIV follow-up consultation. HCV testing will follow the latest algorithm of the Centre for Disease Control (CDC) (May 2013). During this same consultation, anamnesis and clinical examination will focus, additionally to routine practice ,on presence of general and HCV liver-disease related features. Laboratory analyses will also include basic HIV (CD4), and tests for liver function such as Hepatitis B surface antigen (HbsAg).

During the following routine HIV follow-up consultation (2-3 months later), the results of HCV testing will be explained to the patient. If the patient is HCV negative, his/her study participation ends here. If currently infected with Hepatitis C, the clinician will repeat the HCV liver-disease (extra-hepatic \& hepatic) related anamnesis and clinical examination and prescribe additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests, liver and kidney function. Patients will moreover be asked to undergo a liver ultrasound and liver stiffness measurements.

The biobank will be set up with left over biological samples (whole blood plasma and serum) and comprehensive clinical information of all patients who give additional consent for this scope. Both biological samples and clinical information will be coded, to ensure confidentiality.

Eligibility criteria: Inclusion Criteria:

* Adult (\> or = 18 years old)
* Documented HIV positive
* In regular HIV care follow-up (min. 2 consultations in the last six months prior to the study)
* Willing and able to provide written informed consent

Exclusion Criteria:

• HIV patients with currently taking Hepatitis C treatment or with a history of prior hepatitis C treatment

Primary outcomes:
measure: Seroprevalence of HCV infection
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of current HCV infection
timeFrame: Baseline
measure: Proportion of HCV false-positives
timeFrame: Baseline
measure: HCV genotypes
timeFrame: Baseline
measure: Severity of liver disease in HCV patients
timeFrame: Baseline
measure: HCV diagnostic accuracy
timeFrame: Baseline
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Sihanouk Hospital Center of HOPE (SHCH), Cambodia
Study officials:
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Anja De Weggheleire, MD
role: STUDY_DIRECTOR
affiliation: Sihanouk Hospital Center of HOPE (SHCH), Cambodia
name: An Sokkab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Weggheleire A, De Baetselier I, An S, Goletti S, Suin V, Thai S, Francque S, Crucitti T, Lynen L, Van Gucht S, Kabamba BM. Challenges to Differentiate Hepatitis C Genotype 1 and 6: Results from A Field-Study in Cambodia. Infect Dis Ther. 2020 Sep;9(3):657-667. doi: 10.1007/s40121-020-00304-7. Epub 2020 May 30.