Prospective Evaluation of HIV Patients Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis

In HIV-positive patients with or without chronic viral hepatitis co-infection, the primary aims of this project are: (i) to estimate the prevalence and incidence of liver injury (including progression of fibrosis, necro-inflammatory activity and steatosis) and to report the normal values of non-invasive methods in HIV population; (ii) to validate the diagnostic performance of non-invasive methods using a method without a gold standard (Latent Class Analysis); (iii) to validate the prognostic value of non-invasive markers to predict overall mortality and liver-related outcomes and (iv) to correlate liver injury with nutritional status. The secondary aim will be the constitution of a cohort of HIV patients, with or without chronic viral hepatitis co-infection for long-term follow-up of severe outcomes. This prospective cohort study has been approved by the Local Ethical Committee (CAAE: 32889514.4.0000.5262) and it has been enrolling patients from June 2015 at the Evandro Chagas National Institute of Infectious Diseases - Oswaldo Cruz Foundation (INI - FioCruz), Rio de Janeiro, Brazil. A total of 2,000 patients will be included in this study during the next 5 years. This project aims to report the prevalence and incidence of liver disease in a representative sample of HIV patients with and without chronic viral hepatitis co-infection. In addition, the risk factors associated to presence and progression of liver fibrosis and steatosis will be identified and an innovative non-invasive management for estimation of liver injury in HIV patients will be validated. Patients have been submitted at the same day to the following procedures: (i) clinical examination (anthropometric and demographic characteristics), (ii) blood sample collection (for blood analysis, calculation of biomarkers and stockage of samples), (iii) transient elastography (with M and XL probes by a single experienced operator (\>2,000 examinations) and (iv) nutritional status (bioelectrical impedance and 24h diet recall).