Clinical trial NCT02628691: Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia
Official title: Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia (HCV-Monitoring)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
HIV
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Sihanouk Hospital Center of HOPE
name: University Hospital, Antwerp
First posted: 2015-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult HIV-infected patients of the SHCH cohort who have chronic HCV infection (all genotypes) with no-to-moderate hepatic fibrosis and not considered in immediate need of HCV treatment.

Brief summary: Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.

Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.

The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.

All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.

Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study.

Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.

Detailed description: Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients.

Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.

The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment.

The study will be conducted in Sihanouk Hospital Center of Hope (SHCH) in Phnom Penh (Cambodia), more particularly within the ambulatory HIV clinic setting. SHCH is a non-governmental hospital providing comprehensive HIV care free of charge since March 2003, as part of the national antiretroviral (ARV) program. They dispose of an experienced HIV clinician, counselor and social worker team and several operational research studies were conducted within this setting.

All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate.

Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. No formal sample size is being calculated. The final sample will comprise all patients fulfilling the inclusion criteria.

The data collected from the HCV-Epi study will be considered as the baseline visit for the HCV-Monitoring study. Thereafter, visits are planned at 6, 12, 18 and 24 months follow-up. These patient visits will, beyond the habitual HIV follow-up, integrate a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.

Eligibility criteria: Inclusion Criteria:

* Male and females
* ≥18 years
* Documented HIV infection
* Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA
* Absence of advanced liver disease or clinical signs of extra-hepatic disease:

  * F0-F2 (\< 9,5 kPa) established by transient elastography, and
  * No clinical signs of extra-hepatic disease
* Not on HCV antiviral treatment

Exclusion Criteria:

* Currently on/or history of hepatitis C treatment
* Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography)
* Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in this study

Primary outcomes:
measure: Short-term progression to advanced liver fibrosis
timeFrame: 30 months
Secondary outcomes:
measure: Demographic characteristics
timeFrame: Baseline
measure: Clinical characteristics
timeFrame: Baseline
measure: Laboratory characteristics
timeFrame: Baseline
measure: Progression to cirrhosis
timeFrame: 30 months
measure: Liver stiffness measurement
timeFrame: 30 months
measure: Changes in fibrosis stage scores
timeFrame: 30 months
measure: Diagnostic accuracy of non-invasive serum bio-markers: APRI
timeFrame: 30 months
measure: Diagnostic accuracy of non-invasive serum bio-markers: FIB-4
timeFrame: 30 months
measure: Predictive factors for liver fibrosis progression
timeFrame: 30 months
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: