Five-Year Follow-Up of Cured HCV Patients under Real-World Interferon-Free Therapy

Abstract

(1) Background: Treatment of hepatitis C virus (HCV) infections with direct-acting antivirals (DAA) has demonstrated high efficacy and an excellent safety profile. The cured patients showed a sustained virological response and improved liver function, but also a continued risk of hepatocellular carcinoma (HCC) during the 2–3 years of follow-up after treatment; (2) Methods: A total of 192 patients out of 209 of the primary AMBER study were analyzed five years after treatment with ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with or without ribavirin. Results: We confirmed that HCV clearance after DAA treatment is stable regardless of baseline liver fibrosis. We found that sustained virologic response is associated with a gradual but significant reduction in liver stiffness over 5 years. Liver function improved during the first 2 years of follow-up and remained stable thereafter. The risk of death due to HCC as well as death due to HCV persists through 5 years of follow-up after successful DAA treatment. However, in non-cirrhotic patients, it appears to clear up 3 years after treatment; (3) Conclusions: Monitoring for more than 5 years after curing HCV infection is necessary to assess the long-term risk of possible development of HCC, especially in patients with cirrhosis of the liver.

Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long‐term follow‐up study

“…Other studies have also shown the potential for long-term durability of SVR and positive benefits on clinical outcomes for patients who maintain SVR. [26][27][28] Furthermore, in the current study, three of the four enroled participants who experienced virologic failure in a prior study achieved SVR12 after re-treatment; these data support other studies that have shown successful re-treatment of patients who did not achieve SVR after treatment with GLE/PIB. 29 Previous studies on the persistence of resistance-associated substitutions in NS3 have focused on substitutions emerging in DAA-naïve patients treated with NS3-inhibitor-containing regimens.…”

“…These results suggest high durability of SVR. Other studies have also shown the potential for long‐term durability of SVR and positive benefits on clinical outcomes for patients who maintain SVR 26‐28 . Furthermore, in the current study, three of the four enroled participants who experienced virologic failure in a prior study achieved SVR12 after re‐treatment; these data support other studies that have shown successful re‐treatment of patients who did not achieve SVR after treatment with GLE/PIB 29…”

“…There were five participants reported with progression of liver-related events, all of whom developed HCC; all participants who developed HCC had multiple comorbidities, with a varied range of days from the last dose of a GLE-and/or PIB-containing regimen to an HCC diagnosis visit, the shortest being 284 days. Other longterm studies have shown that the risk for HCC may persist even after successful DAA treatment amongst HCV patients regardless of cirrhosis status 26,28. Monitoring of patients cured of HCV infection is necessary to assess the long-term risk of possible development of HCC.…”

Are There Still Difficult-to-Treat Patients with Chronic Hepatitis C in the Era of Direct-Acting Antivirals?

“…Hepatitis C virus (HCV) infection, affecting, by the most recent estimations of the World Health Organization (WHO), approximately 71 million people globally, is one of the major public health issues [1,2]. Effective antiviral treatment is a first step to prevent the most serious complications of chronic hepatitis C (CHC), such as liver cirrhosis and hepatocellular carcinoma, resulting in nearly 400,000 deaths annually [1,3].…”

HCV Elimination in Central Europe with Particular Emphasis on Microelimination in Prisons

“…This has resulted in the commencement of research worldwide on the incidence of HCV infections and on the possibilities of its complete elimination as a public health problem [ 1 , 2 , 3 ]. Although new therapeutic regimens have eliminated the waiting lists for the treatment of diagnosed patients, a large group of patients with HCV remained undiagnosed and at risk of developing cirrhosis and/or hepatocellular carcinoma [ 3 , 4 ]. In 2016, the WHO announced a plan to eliminate viral hepatitis as a public health threat by 2030 [ 5 ].…”