Projected Impact of HCV Treatment on Near-Term Progression of Advanced Liver Disease in HCV-Infected Patients in a High Prevalence Birth Cohort

Abstract

Purpose: Chronic hepatitis C virus (HCV) can lead to advanced liver disease (ALD), including decompensated cirrhosis (DC), and hepatocellular carcinoma (HCC). Many US patients born 1946-1970 are expected to develop ALD in the next decade. Currently approved direct acting antivirals (DAAs) are not indicated for use in DC or HCC. Objective: To quantify the epidemiologic impact of HCV treatment rates in patients (pts) with bridging fibrosis/cirrhosis (F3/F4) born 1946-1970. Methods: A Markov model of HCV natural history was used to model disease progression and outcomes. Health states include chronic HCV, DC, HCC, liver transplant (LT), and death. The target population was diagnosed, genotype 1 HCV-infected pts with F3/F4 born 1946-1970 and not previously treated with a DAA. We compared 3 scenarios: no treatment, 20% treated/yr over the next 2 yrs with telaprevir+peginterferon+ribavirin (T12PR), or 40% treated with T12PR/yr over the next 2 yrs. SVR rates used in the model were 59.1% for both F3 and F4, based on a weighted average of SVR rates in treatment-naïve and -experienced patients from telaprevir clinical trials and distribution of treatment experience from observational data. Epidemiologic inputs, including progression rates, were derived from published and publicly-available sources. We modeled pts over 3 yrs (2 treatment, 1 follow-up) and lifetime to assess ALD events and HCV-related deaths; we did not consider new pts diagnosed during the study period. While rash, including serious skin reactions, anemia and other adverse events have been reported with T12PR treatment, the model did not include treatment-related adverse events. Results: Among pts (N=105,000) estimated to have bridging fibrosis/cirrhosis in 2012, ALD cases increase in all treatment scenarios (Table). The model predicts 20-40% annual treatment rates over the next 2 yrs may reduce the burden of ALD in the next 3 yrs (Table). Over patient lifetimes: 8,562 and 3,761 fewer HCC events, 1,889 and 830 fewer LTs, 15,023 and 6,600 fewer HCV-related deaths were projected for 40% treatment compared to no treatment and 20% treatment, respectively.Table: Projected DC, HCC, LT events and HCV-related deaths over the 3-year period in patients with F3/F4 liver disease stageaConclusion: The model predicts that many HCV-infected patients with bridging fibrosis/cirrhosis will develop DC/HCC, require LT, or die from HCV-related events by 2015. Based on this analysis, treatment with T12PR may reduce the risk of progressing beyond treatment eligibility during the next 3 years. Disclosure: Jaime L Rubin is an employee and stock holder of Vertex Pharmaceuticals Incorporated. Lisa J McGarry and Hemangi Panchmatia are employees and stock holders of OptumInsight.