A National Strategy for the Elimination of Hepatitis B and C Phase Two Report (2017) / Chapter Skim
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Appendix B: Modeling the Elimination of Hepatitis C in the United States
Appendix B: Modeling the Elimination of Hepatitis C in the United States
Pages 235-266
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Understanding future disease burden and potential strategies to mitigate burden is critical for the elimination of HCV in the United States (NASEM, 2016)
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The population in each age group, except for the ≥85 year cohort, was moved to the next age each year to simulate aging. Background population data for the United States were obtained from the United Nations' population database by age, gender, and one year age cohort (United Nations, 2015)
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. The age of prevalent cases was further validated by estimating the projected proportion of cases by birth cohort in 2010 and comparing that to published estimates, demonstrating that approximately three-quarters of infected persons in the United States were born during 1945-1965 (Smith et al., 2012)
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Diagnosed/Treated The number of diagnosed cases was calculated in the model in order to better understand potential constraints on treatment uptake. Analyses of NHANES data have demonstrated that 51 percent of infected cases were already aware of their infection (Denniston et al., 2014; Volk et al., 2009)
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In 2015, there were 7,127 liver transplants performed in the United States (HRSA, 2016) and 2010 (28 percent)
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2,500,000 4,700,000 Edlin et al., 2015 Annual treated 65,000 260,000 Drug unit sales, expert input (2017-2030) Mild to moderate 0.59 1.53 Harris et al., 2014 fibrosis – Transition probability multiplier Mod to cirrhosis – 0.57 1.9 Harris et al., 2014 Transition probability multiplier Transfusion SMR 1.3 17.6 Kamper-Jørgensen et al., 2008 Injection Drug Use 9.5 29.9 Bjornaas et al., 2008; Engstrom SMR et al., 1991; Frischer et al., 1997; Hickman et al., 2003; Oppenheimer et al., 1994; Perucci et al., 1991 Cirrhosis to HCC – 0.74 1.32 Harris et al., 2014 Transition probability multiplier Cirrhosis to 0.70 1.36 Harris et al., 2014 decompensated cirrhosis – Transition probability multiplier HCC to liver death 58.9% 74.2% Bernfort et al., 2006; Ries et al., (year 1)
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. Scenarios Four scenarios were developed to estimate the disease burden associated with varying levels of treatment efficacy, treatment and screening levels, and new infections.
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SOURCES: Altekruse et al., 2014; CDC, 2016; SEER Program, 2015; Yang et al., 2012.
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Finally, the cumulative number of incident decompensated cirrhosis, incident HCC, and liver-related deaths during 2015-2030 were calculated and compared against values for the 2015 Base scenario to estimate percentage reductions in disease burden as compared to the current
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244 TABLE B-2 Scenario Assumptions, United States, 2013-2030 Scenario Assumption Wave 1 Wave 2 Wave 3 Wave 4 Wave 5 Base 2013 Years 2013-2015 2016-2017 2018-2019 2020-2024 2025-2030 Annual Treated 32,000 32,000 32,000 32,000 32,000 Annual Newly Diagnosed 110,000 110,000 77,780 55,000 55,000 Fibrosis Stage ≥F0 ≥F0 ≥F0 ≥F0 ≥F0 Annual New Infections 29,690 30,270 30,100 29,980 29,800 Treated Age 15-64 15-64 15-64 15-64 15-64 SVR 58% 58% 58% 58% 58% Base 2015 Years 2013-2014 2015-2016 2017-2019 2020-2024 2025-2030 Annual Treated 32,000 260,000 183,800 130,000 130,000 Annual Newly Diagnosed 110,000 110,000 77,780 55,000 55,000 Fibrosis Stage ≥F0 ≥F2 ≥F2 ≥F2 ≥F2 Annual New Infections 29,690 30,340 30,160 29,980 29,830 Treated Age 15-64 15-64 15-74 15-74 15-74 SVR 58% 90% 95% 95% 95%
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Aggressive ≥F0 Years 2013-2014 2015-2016 2017-2019 2020-2024 2025-2030 Annual Treated 32,000 260,000 260,000 260,000 260,000 Annual Newly Diagnosed 110,000 110,000 110,000 88,790 71,660 Fibrosis Stage ≥F0 ≥F1 ≥F0 ≥F0 ≥F0 Annual New Infections 29,690 30,340 22,620 11,150 2,730 Treated Age 15-64 15-64 15-74 15-74 15-74 SVR 58% 90% 95% 95% 95% Aggressive ≥F2 Years 2013-2014 2015-2016 2017-2019 2020-2024 2025-2030 Annual Treated 32,000 260,000 260,000 260,000 260,000 Annual Newly Diagnosed 110,000 110,000 110,000 95,940 83,670 Fibrosis Stage ≥F0 ≥F2 ≥F2 ≥F2 ≥F2 Annual New Infections 29,690 30,330 30,150 29,960 29,800 Treated Age 15-64 15-64 15-74 15-74 15-74 SVR 58% 90% 95% 95% 95% NOTE: SVR = sustained virologic response.
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treatment paradigm. The results for the 2013 Base scenario were included only for illustration purposes as this scenario was not considered a likely future option (treatment with the older therapies)
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Prevalent HCC decreased 40 percent between 2015 and 2030 to 13,600 cases in 2030. Cumulative incident decompensated cirrhosis and HCC were estimated at 188,000 and 188,800 cases, respectively.
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248 FIGURE B-6 Percentage change during 2015-2030 value by scenario, United States, 2015-2030. NOTE: HCC = hepatocellular carcinoma.
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, 53,300 TABLE B-3 Key Model Output Summary by Scenario, United States, 2015-2030 Scenario: Base 2015 Aggressive ≥F0 Aggressive ≥F2 Relative to: Base 2013 Base 2015 Base 2015 Reduction in viremic infections 910,000 1,105,100 515,500 Liver deaths averted 215,000 28,800 98,500 Total new HCC cases averted 123,000 19,000 57,700 (2015-2030) Total new decompensated 124,000 19,000 58,200 cirrhosis cases averted (2015-2030)
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250 FIGURE B-7 Distribution of viremic HCV cases by fibrosis stage and age group, United States, 2015, and distribution by fibrosis stage, United States, 2015-2030.
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Prevalent HCC also declines 70 percent to 6,600 cases in 2030, while annual liver deaths decline 65 percent to 7,100 deaths in 2030. As compared to the 2015 Base scenario, there were 75 percent fewer viremic cases in 2030, 50 percent fewer compensated cirrhosis, decompensated cirrhosis and HCC cases (see Figure B-10)
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252 A NATIONAL STRATEGY FOR THE ELIMINATION OF HEPATITIS B AND C FIGURE B-8 Distribution of viremic cases by subpopulation and insurance category. NOTE: NHANES = National Health and Nutrition Examination Survey.
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FIGURE B-9 Total cases by scenario, United States, 2015-2030. NOTE: HCC = hepatocellular carcinoma.
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254 FIGURE B-10 Percentage difference from 2015 Base scenario, United States, 2015-2030. NOTE: HCC = hepatocellular carcinoma.
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FIGURE B-11 Cumulative disease burden by scenario with percentage reduction from 2015 Base scenario in 2030, United States, 2015-2030. NOTE: HCC = hepatocellular carcinoma.
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NOTE: HCC = hepatocellular carcinoma; LRD = liver-related death; SMR = standardized mortality ratio.
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. For incident decompensated cirrhosis, HCC, and liver deaths in 2030, inputs for base prevalence, annual treated, and the mild to moderate fibrosis transition probability multiplier were found to have the largest impact on uncertainty, with these factors accounting for approximately 95 percent of uncertainty (see Figure B-12)
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The number of people diagnosed, treated, or progressing to advanced liver disease had a much smaller impact on total viremic infections in the United States. As a result, this analysis indicated that future HCV infection forecasts in the United States would benefit from important studies to develop more accurate estimates of current and future new infections in the United States and developing strategies to minimize new infections.
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The key drivers of uncertainty in the number of liver-related deaths in 2030 is the number of individuals already infected with HCV, the number of patients treated per year, and the progression probability from mild to moderate fibrosis (see Figure B-12)
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Although the number of treated patients in 2015 indicates that the healthcare system in the United States can already treat 260,000 patients per year, expansion of HCV treatment to general practitioners will be required to provide access to patients without access to major treatment centers and specialists.
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2014. Changing hepatocel lular carcinoma incidence and liver cancer mortality rates in the United States.
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2014. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey, 2003 to 2010.
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2016. Eliminating the public health problem of hepatitis B and C in the United States: Phase one report.
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2014. Emerging epidemic of hepatitis C virus infections among young non-urban per sons who inject drugs in the United States, 2006–2012.
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2009. Public health impact of antiviral therapy for hepatitis C in the United States.
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