**New Perspective in HCV Clinical and Economical Management of the Current and Future Therapies**

P. Pierimarchi, G. Nicotera, G. Sferrazza, F. Andreola, A. Serafino and P.D. Siviero

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/61187

#### **Abstract**

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Hepatitis C virus (HCV) is a progressive disease that infects more than 185 million in‐ dividuals worldwide and is associated with persistence of viral replication and ongo‐ ing necroinflammation and fibrosis. To date 20% of patients chronically infected with HCV progress to cirrhosis. Epidemiological studies demonstrate that the incidence of HCV is not well known, because acute infection is generally asymptomatic. The glob‐ al prevalence is about 2.2% and there is a large degree of geographic variability. Be‐ fore the 2011, the gold standard of therapy for the treatment of chronic hepatitis C (CHC) was based on the combination of pegylated Interferon (peg-IFN) and Ribavirin (RBV). However, several aspects related to safety profile limited their use in clinical practice. In the recent years, thanks to basic research on HCV structure and replicative cycle, it has been possible to develop direct acting antiviral drugs that have dramati‐ cally increased the viral clearance rate. Specifically, the advent of the triple therapy employing direct acting antivirals has dramatically increased the viral clearance rate, from less than 10%, with the initial regimen of IFN monotherapy, to more than 95% with the current therapy. Even though new medications for hepatitis C are effective disease modifiers and have the potential, in a long term perspective, to eradicate the pathology, the cost of new treatments are unlikely to be sustainable for the NHSs. The evidence documenting the effectiveness and tolerability of the new therapies for HCV and several pharmacoeconomic analysis, shows that despite the cost, the new treat‐ ments can be considered cost-effective in the long period. However, the health care systems are unable to compensate the height financial resources immediately needed for treating patients with the long terms savings that will be obtained from the eradi‐ cation of HCV. Indeed, new pharmaceutical policy and a global commitment is re‐ quired to improve strategies of treatment and price negotiation with pharmaceutical companies to move from a theoretical cost-effectiveness approach to a practical costsustainable reality.

**Keywords:** HCV, Hepatitis, DAAs

© 2015 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

### **1. Introduction**

Hepatitis C virus (HCV) is a progressive disease that infects more than 185 million individuals worldwide and is associated with persistence of viral replication and ongoing necroinflam‐ mation and fibrosis. To date, 20% of patients chronically infected with HCV progress to cirrhosis.

Epidemiological studies demonstrate that the incidence of HCV is not well known since acute infection is generally asymptomatic. The global prevalence is about 2.2%, and there is a large degree of geographic variability. Before the 2011, the gold standard of therapy for the treatment of chronic hepatitis C (CHC) was based on the combination of pegylated interferon (peg-IFN) and ribavirin (RBV). However, several aspects related to safety profile limited their use in clinical practice. In the recent years, thanks to basic research on HCV structure and replicative cycle, it has been possible to develop direct acting antiviral drugs that have dramatically increased the viral clearance rate. This new therapeutic strategy contemplates the use of interferon-free treatment protocols that are shorter and well tolerated, and this might improve the management of patients. These new medications for hepatitis C are effective disease modifiers and could potentially eradicate the infection in a long-term perspective. However, their costs are even high and unlikely sustainable for the National Health Systems (NHSs), and new pharmaceutical policy and a global commitment are required for achieving the universal access to new treatment strategies.
