A prognostic model that uses serum albumin-bilirubin (ALBI) and Fibrosis-4 (FIB-4) scores can identify patients with cirrhosis who are at high risk of liver decompensation, according to investigators.

During validation testing, the scoring system performed well among European and Middle Eastern patients, which supports prognostic value across diverse populations, reported lead author Neil Guha, MRCP, PhD, of the University of Nottingham (U.K.) and his colleagues, who suggested that the scoring system could fix an important practice gap.

“Identification of patients [with chronic liver disease] that need intensive monitoring and timely intervention is challenging,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Robust prognostic tools using simple laboratory variables, with potential for implementation in nonspecialist settings and across different health care systems, have significant appeal.”

Although existing scoring systems have been used for decades, they have clear limitations, the investigators noted, referring to predictive ability that may be too little, too late.

“[T]hese scoring systems provide value after synthetic liver function has become significantly deranged and provide only short-term prognostic value,” the investigators wrote. “Presently, there are no scores, performed in routine clinical practice, that provide robust prognostic stratification within early, compensated cirrhosis over the medium/long term.”

To fulfill this need, the investigators developed and validated a prognostic model that incorporates data from the ALBI and FIB-4 scoring systems because these tests measure both fibrosis and function. The development phase involved 145 patients with compensated cirrhosis from Nottingham. Almost half of the cohort had liver disease because of alcohol (44.8%), while about one out of three patients had nonalcoholic fatty liver disease (29.7%). After investigators collected baseline clinical features and scores, patients were followed for a median of 4.59 years, during which time decompensation events were recorded (ascites, variceal bleeding, and encephalopathy). Decompensation occurred in about one out of five patients (19.3%) in the U.K. group, with ascites being the most common (71.4%). Using these findings, the investigators created the prognostic model, which classified patients as having either low or high risk of decompensation. In the development cohort, patients with high risk scores had a hazard ratio for decompensation of 7.10.

In the second part of the study, the investigators validated their model with two clinically distinct groups in Dublin, Ireland (prospective; n = 141), and Menoufia, Egypt (retrospective; n = 93).

In the Dublin cohort, the most common etiologies were alcohol (39.7%) and hepatitis C (29.8%). Over a maximum observational period of 6.4 years, the decompensation rate was lower than the development group, at 12.1%. Types of decompensation also differed, with variceal bleeding being the most common (47.1%). Patients with high risk scores had a higher HR for decompensation than the U.K. cohort, at 12.54.

In the Egypt group, the most common causes of liver disease were nonalcoholic fatty liver disease (47.3%) and hepatitis C (34.4%). The maximum follow-up period was 10.6 years, during which time 38.7% of patients experienced decompensation, with ascites being the most common form (57.1%). The HR of 5.10 was the lowest of all cohorts.

The investigators noted that the cohorts represented unique patient populations with different etiological patterns. “This provides reassurance that the model has generalizability for stratifying liver disease at an international level,” the investigators wrote, suggesting that ALBI and FIB-4 can be used in low-resource and community settings.

“A frequently leveled criticism of algorithms such as ALBI-FIB-4 is that they are too complicated to be applied routinely in the clinical setting,” the investigators wrote. “To overcome this problem we developed a simple online calculator which can be accessed using the following link: https://jscalc.io/calc/gdEJj89Wz5PirkSL.”

“We have shown that routinely available laboratory variables, combined in a novel algorithm, ALBI-FIB-4, can stratify patients with cirrhosis for future risk of liver decompensation,” the investigators concluded. “The ability to do this in the context of early, compensated cirrhosis with preserved liver synthetic function whilst also predicting long-term clinical outcomes has clinical utility for international health care systems.”

The study was funded by National Institute for Health Research (NIHR) Nottingham Digestive Diseases Biomedical Research Centre based at Nottingham University Hospitals NHS Trust and the University of Nottingham. The investigators declared no conflicts of interest.

SOURCE: Guha N et al. CGH. 2019 Feb 1. doi: 10.1016/j.cgh.2019.01.042.