Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients

Hospital Universitario de Valme446 enrolled

Overview

Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia, southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver disease. Patients are prospectively followed-up according to a uniform protocol of care. Epidemiological, clinical and laboratory variables are periodically recorded. The primary outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma), liver transplant or death. The predictors of these outcomes are analyzed.

Study Type

OBSERVATIONAL

Enrollment

446

Conditions

Liver Cirrhosis Hepatocellular Carcinoma HIV HCV Coinfection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV Infection * HCV chronic active infection (positive serum RNA HCV at inclusion) * New diagnosis of cirrhosis on the basis of a liver stiffness equal or greater than 14 kiloPascals. * No previous or concomitant decompensation of liver disease Exclusion Criteria: \-

Hospital de La Línea de la Concepción

La Línea de la Concepción, Cádiz, Spain

Hospital Universitario de Puerto Real

Puerto Real, Cádiz, Spain

Hospital Universitario Reina Sofía

Córdoba, Spain

Complejo Hospitalario de Huelva

Huelva, Spain

Complejo Hospitalario de Jaén

Jaén, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario de Valme

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Outcomes

Primary Outcomes

Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up

Episodes of liver decompensation will include those episodes of ascites, spontaneous bacterial peritonitis, portal hypertensive gastrointestinal bleeding, hepatorrenal syndrome, hepatic encephalopathy, hepatocellular carcinoma, non obstructive jaundice and acute on chronic liver failure. These episodes will be diagnosed according to standard definitions of clinical practice guidelines in the field (i.e. HCC diagnosis will be diagnosed according to AASLD criteria, spontaneous bacterial peritonitis and hepatorenal syndrome will be diagnosed following the EASL criteria, portal hypertensive gastrointestinal bleeding according Baveno VI consensus definition,…)

Time frame: 3 years

Secondary Outcomes

Liver-related mortality

Probability of liver-related death after enrollment

Time frame: 3 Years

All cause mortality

Probability of death of any cause