Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia
Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia
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.
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.
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