Abstract
BackgroundAn unexpected increased HCC recurrence and occurrence rate among HCV patients treated with direct acting antivirals combination has been reported. Aim of the study was the evaluation of early HCC occurrence rate and its risk factors in a HCV infected population, treated with direct-acting-antivirals.MethodsAccording to the Italian ministerial guidelines for direct-acting-antivirals treatment, 1022 consecutive HCV patients treated with direct-acting-antivirals were enrolled. Patients either with active HCC at imaging or history of previous treated HCC, HBV or HIV co-infection, or liver transplant recipients were excluded. The SVR, defined as the persistent absence of detectable serum HCV-RNA 12 weeks after the end of treatment (SVR12), was assessed for all enrolled patients. Abdominal ultrasound was performed before starting antiviral therapy, and repeated every 6 months. HCC was diagnosed according to the international guidelines. Patients showing either nodular patterns suggestive of HCC or with uncertain dynamic vascular behaviour were excluded from a further follow-up.ResultsNine hundred and eighty-five patients completed the 48 weeks follow-up after the end of treatment. A Sofosbuvir-based regimen was administered in the 74.9% of patients, among whom, the 71.6% underwent a simultaneous Ribavirin administration. A sustained virological response at 12 weeks off treatment was documented in 966 patients (98.2%). During the post treatment follow-up HCC was detected in 35 patients, with a cumulative incidence rate of the 3.55%. At multivariate analysis, four variables resulted independently associated with HCC development, both in a cirrhosis based and a class B Child based model, respectively: cirrhosis/class B Child, therapeutic schedule including Sofosbuvir without Ribavirin, liver stiffness values, male gender and presence of diabetes. A multivariate analysis performed on Child A cirrhotic patients, showed that Sofosbuvir based therapeutic treatment without Ribavirin had a HCC occurrence 5.7 higher than Ribavirin-based schedules with or without Sofosbuvir (p < 0.0001, OR: 5.686, 95% CI 2.455–13.169).ConclusionsOur data suggest that early HCC occurrence appears more frequently related to Sofosbuvir-based therapy without Ribavirin which, indeed, seems to play a protective role on HCC onset. Therefore, a careful follow-up should be mandatory, especially in those regimens including Sofosbuvir without Ribavirin.
Highlights
An unexpected increased Hepatocellular carcinoma (HCC) recurrence and occurrence rate among hepatitis C virus (HCV) patients treated with direct acting antivirals combination has been reported
During the post treatment follow-up, HCC onset was reported in 35 patients, with a cumulative incidence rate of the 3.55%, which raised till the 4.65% considering only the cirrhotic subset of patients
The first model, built based on the presence of cirrhosis, showed four variables resulted independently associated with HCC development: the use of a SOF-based regimen without RBV (p = 0.000, O.R.: 15.363, 95% C.I. 6.668–35.396), liver stiffness values (p = 0.001, O.R.: 1.048, 95% C.I. 1.020–1.077), male gender (p = 0.022, O.R.: 2.852, 95% C.I. 1.162–6.999) and presence of diabetes as comorbidity (p = 0.047, O.R.: 0.392, 95% C.I. 0.155–0.988), whilst presence of cirrhosis just showed a trend at multivariate analysis, without reaching the statistical significance (p = 0.079; O.R.: 0.153; 95% C.I. 0.019–1.239) (Table 3)
Summary
An unexpected increased HCC recurrence and occurrence rate among HCV patients treated with direct acting antivirals combination has been reported. Aim of the study was the evaluation of early HCC occurrence rate and its risk factors in a HCV infected population, treated with direct-acting-antivirals. Direct acting antiviral (DAA) based treatment dramatically changed the natural history of hepatitis C virus (HCV) chronic infection. The viral clearance embodies a fundamental turning point in the chronic HCV infection, as it may prevent the most part of severe complications and disease evolution of persistent infection, since these are related to immune system imbalance because of viral replication [2, 3]. According to all these evidences, HCV eradication and its necro-inflammation activity may be crucial in HCC prevention
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