Treatment of Hepatitis C virus infection in Italy: A consensus report from an expert panel

Abstract

Hepatitis C virus (HCV) infection remains one of the main causes of chronic liver disease worldwide. The advent of direct-acting antivirals (DAAs) has significantly improved the course of patients with chronic HCV infection (CHC), due to the ability of these drugs to achieve high rates of sustained virological response (SVR). These exceedingly high rates of SVR and the excellent safety data have been confirmed in real life practice. Evolving guidelines have been issued by national and international scientific societies in accordance with the progression of clinical knowledge and the availability of new DAAs. These recommendations, however, may not be applied universally because of delays in drugs reimbursability in different countries and because some National Health Systems identify only patients with advanced disease as a treatment priority. Italy in this regard is a prototype about DAAs treatment of CHC patients. With the aim to assess the Italian treatment experience with DAAs and to respond to unmet needs in treatment optimization of antiviral therapy in specific settings of CHC patients, a group of Italian experts met in Stresa in February 2017. The summary of the considerations arising from this two-day meeting and some statements regarding a few open issues are reported in this position paper.

Increasing mortality associated with the more recent epidemic wave of hepatitis C virus infection in Northern Italy

“…Moreover, these new drugs provide the potential to reduce the burden of HCV infection at the population level; however, to reach such public health benefit, policies are needed in order to improve screening of HCV and access to care, particularly in high‐risk populations . In Italy, treatment with DAA was initially restricted to patients with advanced liver disease, and thereafter, the indication for treatment moved to the less severe stages . Early treatment of infected individuals is needed to reduce the risk of hepatocellular carcinoma occurrence .…”

“…9 In Italy, treatment with DAA was initially restricted to patients with advanced liver disease, and thereafter, the indication for treatment moved to the less severe stages. 10 Early treatment of infected individuals is needed to reduce the risk of hepatocellular carcinoma occurrence. 9 The results of the present study show that liver cancer currently represents the main cause of death among decedents with any mention of HCV infection.…”

Is global elimination of HCV realistic?

“…DAA-based therapies are effective and safe and result in an SVR of about 97%. [1][2][3][4][5][6][7][8][9][10][11][12] This means that 3% of treated patients do not achieve an SVR, mostly because of virological relapse, and frequently develop resistance-associated substitutions in the NS5a viral protein and resistance to available regimens. 37 Even if this proportion is small, this still represents a significant absolute number of patients who will fail HCV eradication, considering the large numbers of patients who are or will be treated.…”

“…The optimal safety profile and effectiveness of short regimens (8-24 weeks) of direct antiviral agents (DAA) has been confirmed in clinical trials and universally in real-life cohorts. [1][2][3][4][5][6][7][8][9][10][11][12] DAA-based therapies can be administered to patients with HCV infection and a wide spectrum of liver damage from mild disease to de- World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, with the final goal of eliminating viral hepatitis as a major public health threat by 2030. 13 Elimination of a disease involves the reduction in the prevalence of the disease in a regional population to zero, or the reduction in the global prevalence to a negligible amount.…”

Editoriale - Quando la terapia fallisce: limiti dei farmaci o errori nelle scelte

“…Anche al recente EASL i risultati presentati mostrano che qualsiasi schema terapeutico classico, anche includente farmaci di ultimissima generazione, mostra dei limiti nel garantire tassi di SVR12 paragonabili a quelli ottenuti nella terapia di prima linea (9). Sono pertanto da considerare terapie di seconda linea non convenzionali, basate su associazioni di farmaci guidate dal test di resistenza (10). Va segnalato che la rimborsabilità di combinazioni terapeutiche non convenzionali é a volte incompleta, legata ad una legislazione finora mirata in prevalenza all'impostazione terapeutica di prima linea.…”