Hepatitis C Disease Burden in the United States in the era of oral direct-acting antivirals

Abstract

Oral direct-acting antivirals (DAAs) represent a major advance in hepatitis C virus (HCV) treatment. Along with recent updates in HCV screening policy and expansions in insurance coverage, treatment demand in the United States is changing rapidly. Our objective was to project the characteristics and number of people needing antiviral treatment and HCV-associated disease burden in the era of oral DAAs. We used a previously developed and validated Hepatitis C Disease Burden Simulation model (HEP-SIM). HEP-SIM simulated the actual clinical management of HCV from 2001 onward, which included antiviral treatment with pegylated interferon (Peg-IFN)-based therapies as well as the recent oral DAAs, risk-based and birth-cohort HCV screening, and the impact of the Affordable Care Act. We also simulated two hypothetical scenarios-no treatment and treatment with Peg-IFN-based therapies only. We estimated that in 2010, 2.5 (95% confidence interval [CI], 1.9-3.1) million noninstitutionalized people were viremic, which dropped to 1.9 (95% CI, 1.4-2.6) million in 2015, and projected to drop below 1 million by 2020. A total of 1.8 million HCV patients will receive HCV treatment from the launch of oral DAAs in 2014 until 2030. Based on current HCV management practices, it will take 4-6 years to treat the majority of patients aware of their disease. However, 560,000 patients would still remain unaware by 2020. Even in the oral DAA era, 320,000 patients will die, 157,000 will develop hepatocellular carcinoma, and 203,000 will develop decompensated cirrhosis in the next 35 years.

Conclusions: HCV-associated disease burden will still remain substantial in the era of oral DAAs. Increasing HCV screening and treatment capacity is essential to further decreasing HCV burden in the United States. (Hepatology 2016;64:1442-1450).

Figure 1

Decreasing number of HCV-infected patients overall and by insurance status in the United States. The results provide a snapshot of number of viremic patients in the United States by taking into account the launch of oral DAAs, changes in HCV screening policies and implementation of the Affordable Care Act.

Figure 2

Number of hepatitis C-infected patients aware and unaware of their disease status, and those who achieved sustained virologic response (SVR) from 2010 to 2030.

Figure 3

Number of HCV patients who are aware of their disease status and have access to insurance using the annual treatment capacity of (A) 280,000 (base case), (B) 150,000 and (C) 400,000. Abbreviations: F0: no fibrosis; F1: portal fibrosis without septa, F2: portal fibrosis with few septa; F3: numerous septa without cirrhosis; F4: cirrhosis.

Figure 4A–D

Advanced disease outcomes associate with HCV in the DAA era (base case), pre-DAA era, and no treatment from 2015 onwards in the United States. Abbreviations: DAA: direct-acting antiviral

Figure 5

Reduction in disease burden associated with HCV because of increased treatment capacity from 150,000 in 2014 to 280,000 and 400,00 from 2015 onwards. The bars represent relative differences (and, not the absolute disease burden). The outcomes were avoided between the time periods 2015 and 2050. Abbreviations: DC, decompensated cirrhosis; HCC, hepatocellular carcinoma; LRD, liver-related deaths; LT, liver transplants.