The 4 factors included baseline body mass index, fibrosis-4 index, albumin level at SVR, and alpha-foetoprotein level at SVR.
A new model that utilizes 4 predicative factors can help with surveillance of patients with hepatitis C virus (HCV) treated with direct-acting antivirals (DAA) who achieve sustained virologic response (SVR) for the risk of hepatocellular carcinoma (HCC).
A team, led by Yuki Tahata, developed and validated the usefulness of a new prediction model that forecasts hepatocellular carcinoma occurrence following direct-acting antiviral-mediated sustained virologic responses.
While there are many factors that lead to hepatocellular carcinoma following sustained virological response for patients with hepatitis C virus, there have been few validation studies performed since the advent of direct-acting antivirals.
“The development of direct-acting antivirals (DAAs) has led to a high rate of sustained virological response (SVR) in patients with chronic hepatitis C virus (HCV) infection,” the authors wrote. “The HCC incidence rate was lower in patients who achieved SVR by DAA treatment than in those who did not achieve SVR.”
The incidence of HCC occurrence in patients treated with direct-acting antivirals who achieved sustained virologic response was between 1.1-1.9% at year 1 and 1.9-4.1% at year 2.
The investigators analyzed 2209 patients who initiated direct-acting antiviral treatments at 24 hospitals in Japan. The patient population achieved sustained virologic responses but did not have a history of HCC.
The treatment regimen for patients with HCV genotype 1 were treated with 24 weeks of daclatasvir and asunaprevir, 12 weeks of ledipasvir and sofosbuvir, 12 weeks of ombitasvir, paritaprevir, and ritonavir, 12 weeks of elbasvir and grazoprevir or 8-12 weeks of glecaprevir and pibrentasvir.
The patients were divided into different cohorts—a training set (n = 1473) and a validation set (n = 736).
The investigators used multivariate Cox proportional hazard analysis in the training set to identify that baseline BMI (≥25.0 kg/m2, P = 0.024), baseline fibrosis-4 (FIB-4) index (≥3.25, P = 0.001), albumin level at SVR (<4.0 g/dL, P = 0.010) and alpha-foetoprotein level at SVR (≥5.0 ng/mL, P = 0.006) were all significantly linked to HCC occurrence.
The 4 factors (2 points were added for the FIB-4 index, and 1 point was added for each of the other 3 factors) were used in the prediction model.
Using a receiver operating characteristics curve analysis, the investigators identified a score of 2 as the optimal cut-off value for the prediction model (divided into 0-1 and 2-5). For the validation set, the sensitivity and negative predictive value for the occurrence of the disease were 87.5% and 99.7%, respectively at 2 years.
However, this dropped to 71.4% for sensitivity and 98.0% for negative predictive value at year 3.
“A prediction model combining these four factors contributes to an efficient surveillance strategy for HCC occurrence after DAA-mediated SVR,” the authors wrote.
The study, “Prediction model for hepatocellular carcinoma occurrence in patients with hepatitis C in the era of direct-acting antivirals,” was published online in Alimentary Pharmacology & Therapeutics.