NAFLD and NASH in HIV-patients, prevalence and risk factors.

Non-alcoholic fatty liver disease (NAFLD) refers to hepatic steatosis in
individuals with little or no alcohol use. A subgroup of NAFLD patients
develops non-alcoholic steatohepatitis (NASH), defined by the presence of
inflammation in addition to steatosis, with a risk of developing liver
cirrhosis or hepatocellular carcinoma. Some recent studies that investigated
the causes of transaminitis among HIV-infected patients showed NAFLD to be the
most common cause (up to 60%)7-9. Recognition and staging of NAFLD should be
part of the metabolic monitoring of all patients with HIV. Life style
intervention (diet and exercise) remains the most important strategy to lower
prevalence of NASH and NALFD and should be cornerstone of NAFLD treatment
30,31.

Primary objectives:
1. . To study prevalence of NASH in unselected HIV-monoinfected patients
assessed by Fibro scan.

Secondary objectives:
2. To identify risk factors for NASH in HIV infected patients compared to
HIV-positive patients without NASH.
3. To study prevalence of NALFD in unselected HIV-monoinfected patients
assessed by Fatty Liver Score and CAP.
4. To identify risk factors for NALFD in HIV-positive patients compared to
HIV-positive patients without NAFLD.

Observational cross sectional study in HIV-infected patients to access the rate
of and risk factors for NAFLD and NASH. Sample size: n=740 patients. Duration:
1 year.

All out clinic patients with HIV of the department of infectious diseases are
offered a fibro scan with CAP-measurement and an short questionnaire regarding
to risk factors for fatty liver disease. See page 9 for criteria and page 14
for study procedures.

Fibroscan + CAP measurement.

The fibroscan non-invasively measures the elasticity of the liver, allowing the
degree of fibrosis to be determined. With the same device a CAP measurement is
performed, also called Controlled Attenuation Parameter: a non-invasive
measurement for liver steatosis

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
A study-related fibroscan could be a burden to patients, not because of the
non-invasive, fast and painless procedure, but because of the possible outcome
(steatosis, fibrosis or other pathology which otherwise would have stayed
unknown). And because of these possible outcome, referral to a hepatologist
could be needed to support clinical management.

However earlier diagnosis of NAFLD and especially NASH could lead successful
implementation of life style interventions and secondary prevention of further
progression of disease to cirrhosis and HCC. That is why we think the benefits
of participating in this study outweighs the burden and risks.