Evaluation of Liver Fibrosis in HIV-infected Patients With Metabolic Syndrome
Condition: Abdominal Obesity Metabolic Syndrome; HIV; Liver Fibrosis
MeSH terms: Liver Cirrhosis; Metabolic Syndrome; Obesity, Abdominal; Syndrome; Fibrosis
Study type: Observational

Summary: 
      This study aims to estimate the prevalence of bridging liver fibrosis and cirrhosis (METAVIR
      score ≥ F2) according to METAVIR score in HIV infected patients not chronically infected by
      viral hepatitis but exhibiting a metabolic syndrome according to the IDF definition
      (International Diabetes Foundation).
    

Detailed description: 
      HIV-associated morbidity and mortality has been considerably modified ever since the
      availability of potent antiretroviral treatment in 1996. Recent studies have shown the impact
      of treatment, with the decreased frequency of AIDS-related diseases coinciding with the
      preponderance of non-AIDS related pathologies.

      Consequently, diseases of hepatic origin have become a key problem in the therapeutic course
      of HIV-infected patients, representing a major source of significant morbidity and mortality.
      Liver-related diseases comprise of various etiologies, including co-infection with chronic
      viral hepatitis and excessive alcohol consumption. When excluding these particular diseases,
      fibrotic patients exhibit an elevated prevalence of metabolic syndrome, regardless of
      lipodystrophy. Directly linked to metabolic syndrome, non-alcoholic hepatic steatosis has the
      capacity to induce necro-inflammatory lesions with an increased risk of evolving into
      cirrhosis and its complications thereto (i.e. hepatocellular carcinoma, liver decompensation,
      and end-stage liver disease). In the context of HIV, very little data is available concerning
      the link between metabolic syndrome and hepatic fibrosis, despite the increasing risk of
      developing such disease during extended life-span, the long-term disruption of glycolipid
      metabolism induced by antiretroviral treatment, and the presence of various social
      risk-factors (i.e. increasing trends in weight gain and decreased physical activity).

      The principal objective of the present study is to then characterize the prevalence and
      determinants associated with hepatic fibrosis among HIV-infected patients, without
      co-infection with other hepatitis viruses, and who present symptoms of metabolic syndrome
      according to the AHA 2009 definition. In order to more appropriately answer this research
      question, we will conduct a nested, matched case-control study including 300 HIV-infected
      patients per group. We will also aim to identify risk-factors of liver fibrosis other than
      metabolic syndrome, to study agreement in 4 non-invasive scores of liver fibrosis and 3
      non-invasive score of steatosis, and to evaluate the performance of the Controlled
      Attenuation Parameter (CAP) method for use in diagnosing hepatic steatosis.

      All patients in this study will be recruited in a clinical center situated in the infectious
      disease unit at Saint-Antoine Hospital, where 3400 HIV-infected patients have regular
      consultations. Patients will be identified from an in-house informatics platform, serving as
      a surveillance tool for metabolic syndrome, among other diseases, with the intention of
      increasing better-adapted clinical and therapeutic care. Each patient presenting with
      metabolic syndrome will be matched with a control patient on the following characteristics:
      age (±5 years), duration of HIV-infection (±2 years), HIV-RNA viral load (in categories of
      <50-500, 501-1000, or >1000 copies/mL), and gender. Patients with abnormal transaminases will
      be excluded from this study.

      This study will bring about a clearer understanding of the frequency and importance of liver
      fibrosis risk in patients with metabolic syndrome, which will allow us to determine the more
      important elements of surveillance necessary in the prevention and development of hepatic
      lesions. Accordingly, this study will add more pertinent information regarding treatment
      guidelines specific to this patient population.
    

Intervention name(s): Noninvasive evaluation of liver fibrosis and steatosis
Intervention type(s): Procedure
Intervention description(s): Transient elastography (using the Fibroscan, CAP Fibroscan) and biomarker panels (FibroTest, Fibromètre, Hepascore, Steatotest, Nashtest)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients followed in the Infectious Diseases department of Saint-Antoine hospital.
      
Biospecimen description: 
      plasma, serum