1Assistance Publique Hôpitaux de Paris (AP-HP), University Pierre Marie Curie (UPMC), INSERM, UMR_S 938, Liver Center, Paris, France. Electronic address: firstname.lastname@example.org.
2University of Bordeaux, Bordeaux, France; Service de Biochimie Métabolique, Groupe Hospitalier Pitié-Salpêtrière (GHPS), AP-HP, Paris, France.
3BioPredictive, Paris, France.
4University of Milano, 1st Division of Gastroenterology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
5Infectious Disease Unit, GHPS, AP-HP, Paris, France.
6University of Miami Center for Liver Diseases, University of Miami School of Medicine, Miami, FL, USA.
7Former employees Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA.
8Assistance Publique Hôpitaux de Paris (AP-HP), University Pierre Marie Curie (UPMC), INSERM, UMR_S 938, Liver Center, Paris, France.
BACKGROUND & AIMS:
FibroTest™ (FT) and Transient Elastography (TE) have been validated as non-invasive markers of METAVIR fibrosis stages from F0 to F4 using biopsy, and as prognostic markers of liver related mortality in patients with chronic hepatitis C. The aim was to extend the validation of FT and TE as markers of critical steps defined by occurrence of cirrhosis without complications (F4.1), esophageal varices (F4.2), and severe complications (F4.3): primary liver cancer, variceal bleeding, or decompensation (ascites, encephalopathy, or jaundice).
The updated individual data of 3927 patients (1046 cirrhotics) without complications at baseline were pooled from three prospective cohorts called "EPIC", "Paris", and "Bordeaux" cohorts.
At 5years, among 501 patients without varices at baseline (F4.1) varices occurred in 19 patients [F4.2 incidence of 4.0% (95% CI 2.2-5.8)]. The predictive performance (AUROC) of FT was 0.77 (0.66-0.84; p<0.001). At 10years severe complications occurred in 203 patients, [F4.3 incidence of 13.4% (9.6-17.1)], including primary liver cancer in 84 patients [6.4% (3.5-9.3)]. FT was predictive (Cox adjusted on treatment) of severe complications [AUROC 0.79 (76-82); p<0.0001], including primary liver cancer [AUROC 0.84 (80-87); p<0.0001]. Similarly TE was predictive of severe complications [AUROC 0.77 (72-81); p<0.0001], including primary liver cancer [AUROC 0.86 (81-90); p<0.0001].
FibroTest™ and TE increase were associated with the occurrence of all severe complications including hepatocellular carcinoma, hepatic insufficiency, and variceal bleeding. FibroTest™ increase was also associated with the occurrence of esophageal varices.