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Managed Care and Specialty Pharmacist Perspectives in Hepatitis C:
A 2016 Update - HCV Treatment Assessment: Opportunities for Individualized Care – Case 1

Introduction

Chronic hepatitis C virus (HCV) infection is the leading cause of cirrhosis, hepatocellular carcinoma (HCC), liver transplantation, and liver-related mortality in the United States. HCV is the most common blood-borne infection, and up to 85% of patients with acute HCV infections will experience a conversion to chronic infection.1 Given the particularly high burden of chronic HCV infection among older adults, national guidelines recommend one-time screening for all persons born between 1945 and 1965.1 Approximately 75% of all patients living with HCV infection are members of this birth cohort, and the majority of HCV-attributable deaths occur in this patient population.1

The goal of HCV treatment is a cure, which is expressed as a sustained virologic response (SVR).2 However, until recently, real-world treatment outcomes for patients with chronic HCV infection have been poor.3 Patients face major barriers at each stage of the diagnosis and treatment cascade, leading to very low cure rates. Between 2003 and 2013, an estimated 3.5 million persons had chronic HCV infection in the United States. 3 Of these:

  • 50% were diagnosed and aware of their infection
  • 43% had access to outpatient care
  • 27% had HCV RNA confirmed
  • 17% underwent liver fibrosis staging
  • 16% were prescribed treatment
  • 9% achieved an SVR

With several recent major advances in antiviral therapy, however, clinicians have new opportunities to improve treatment outcomes for patients with chronic HCV infection. Beginning in 2011, with the approval of the first direct-acting antiviral (DAA) agents (telaprevir and boceprevir), the HCV treatment paradigm underwent a major shift away from peginterferon (pegIFN) and ribavirin (RBV) as the cornerstones of therapy. With the approval of second-generation DAA agents in 2013 (simeprevir and sofosbuvir), the standard of care in HCV treatment shifted again in favor of all-oral, IFN-free regimens, and in many cases, RBV-free regimens. In 2014, 2 new all-oral regimens-ledipasvir/sofosbuvir and ombitasvir/paritaprevir/ritonavir plus dasabuvir (3D)-joined the HCV treatment armamentarium.4

Treatment options for patients with chronic HCV infection continue to evolve at a rapid pace with the recent approval of additional new agents (daclatasvir), and the expanded indications of available therapies across multiple HCV genotypes.5-7 In addition, numerous investigational regimens (grazoprevir/elbasvir; sofosbuvir/velpatasvir; sofosbuvir/velpatasvir/GS-9857; ABT-493/ABT-530) are under development and may be available in the near future.8-11

In the current era of HCV care, treatment regimens offer greater convenience for patients, shorter treatment durations, improved safety profiles, and cure rates that approach or even reach 100%. In clinical practice, the choice of therapy will be influenced by factors such as pill burden, potential drug-drug interactions, relevant comorbid conditions, treatment cost, insurance coverage, and patient and provider preferences. To develop an individualized HCV treatment plan, clinicians must begin with a comprehensive diagnostic workup often involving laboratory tests, noninvasive imaging, or liver biopsy. Patients should also undergo screening for substance abuse, mental health, and social/behavioral factors that may affect treatment eligibility. By matching each patient with the optimal antiviral regimen, pharmacists can enhance medication adherence, and improve clinical outcomes for patients with chronic HCV infection.

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