Hepatitis B and C kill about 20,000 people every year in the United States, and more than 1 million worldwide (CDC, 2013; WHO, 2016). Hepatitis B virus (HBV) and hepatitis C virus (HCV) together account for most viral hepatitis, which kills more people every year than road traffic injuries, HIV and AIDS, and diabetes (WHO, 2016). While the deaths from other common killers (i.e., malaria, tuberculosis, and HIV) have decreased since the early 2000s, deaths attributable to viral hepatitis continue to rise (IHME, 2016).
These deaths can be averted. Three doses of HBV vaccine convey 95 percent immunity (WHO, 2015). Though HBV infection cannot be cured, proper treatment can reduce viral load to an undetectable level (EASL, 2012). While there is no vaccine for HCV, new curative treatments can eliminate the infection in over 95 percent of patients (Afdhal et al., 2014; Charlton et al., 2015; Feld et al., 2014). Improved prevention and expanded access to viral hepatitis treatments could greatly reduce the burden of these infections. The World Health Organization (WHO) estimates that reducing the incidence of chronic hepatitis B and C by 90 percent and reducing mortality by 65 percent would save 7.1 million lives by 2030 (WHO, 2016).
The United States has an opportunity and a responsibility to be part of the global action against hepatitis B and C. Already the Department of Health and Human Services’ viral hepatitis action plan lays out ambitious goals for improving prevention and care, and expanding hepatitis surveillance (HHS, 2014). In the near term, the committee finds control of both diseases to be imminently possible. This committee also believes that a more ambitious goal is within our reach: Elimination of HBV and HCV as
public health problems in the United States. Although an elimination goal is entirely feasible, it is not necessarily likely without considerable attention to the barriers discussed in this report. First of all, disease reductions programs require an accurate understanding of the true burden of disease in a population. There is wide uncertainty in all estimates of HBV and HCV incidence and prevalence. Limited surveillance contributes to the uncertainty, as does the often asymptomatic course of the infections. Wider screening could help identify more chronically infected people, but screening for both infections is complicated.
Expanding screening for chronic HBV and HCV infections would surely identify new cases, but some would be among people with no access to care. Diagnosis with a chronic disease requires follow-up in primary care. Diagnosis of chronic hepatitis B carries with it the opportunity for treatment and monitoring to reduce the long-term risk of liver cancer and cirrhosis. It also offers the opportunity to vaccinate the patient’s uninfected contacts. Such follow-up is not an option for people who are uninsured and ineligible for Medicaid.
Hepatitis B and C care require a health workforce knowledgeable about long-term management of viral hepatitis. Much of the burden falls on primary care providers, who are already overworked, and extends indefinitely. There is no cure for hepatitis B, and infected individuals require management for the rest of their lives. Hepatitis C, in contrast, can be cured in 8 to 12 weeks, thanks to new direct-acting antiviral drugs. These drugs are expensive in the United States. The first of these treatments to gain Food and Drug Administration approval cost $1,000 per pill in 2014 (Sanger-Katz, 2014). Competition from other products has brought the price down, but curing a chronically infected HCV patient in the United States still costs between $54,000 and $168,000 (Bickerstaff, 2015; Loria, 2016). Even at such prices, curing hepatitis C is cost-effective (Bickerstaff, 2015; Chhatwal et al., 2015; Najafzadeh et al., 2015; Younossi et al., 2015). The tension between the expense and cost-effectiveness of treating HCV puts Medicaid and insurance companies in a difficult position. They have responded by restricting access to treatment to only the sickest HCV patients. Even so, HCV treatments alone accounted for about a third of the sharp acceleration in drug spending between 2013 and 2014 (Martin et al., 2015). It is currently not financially possible to treat all the estimated 2.7 to 4.7 million people thought to have chronic HCV infection given the current prices (Edlin et al., 2015; Ward and Mermin, 2015).
The high price of treatment creates a tension in determining which patients’ treatment should be a priority. Those at most immediate risk of death are not necessarily those transmitting the virus, so the goals of ending HCV transmission and ending deaths from hepatitis C are somewhat at odds with each other.
There are creative strategies to mitigate this and other barriers to eliminating hepatitis B and C. Five years ago curing HCV infection with short-term, tolerable therapy seemed impossible. Similar breakthroughs in the treatment and management of hepatitis B are possible, as is the development of a prophylactic vaccine for HCV. This report has identified no shortage of research questions for basic scientists, pharmaceutical companies, and health services researchers. None of these questions is especially new, however. The challenge of directing more research interest to viral hepatitis remains.
It is also possible that limitations in disease surveillance, screening, treatment, vaccination, and research are all consequences of a more basic problem. Viral hepatitis is not a public priority in the United States. This too could change; attitudes toward disease can shift rapidly. Education and successful elimination of HBV among Alaskan Natives accompanied changes in local attitudes toward the disease. Liver disease often carries a stigma, perhaps because of its association with drug and alcohol use and sex; HBV and HCV can cause particular shame and distress in patients. Stigma, in turn, encourages silence and inaction among infected people, which is antithetical to any elimination program.
In making its conclusion regarding the feasibility of hepatitis B and C elimination, the committee acknowledges that considerable barriers must be overcome to meet these goals. For example, as elimination policies gain traction, the risk of infection should fall. Some people may respond by reducing efforts to protect themselves from infection. Public health campaigns highlighting the importance of elimination and the need to prevent individual infection might mitigate such behavior. A discussion of this and other solutions to the problems discussed in this report is not within the scope of the project. A second report, to be released in 2017, will outline a national strategy to eliminate hepatitis B and C. This report will discuss ways to address the critical factors and reduce the barriers to elimination set out in this document. The second phase of this project will also explore specific national targets for the elimination effort.
Afdhal, N., S. Zeuzem, P. Kwo, M. Chojkier, N. Gitlin, M. Puoti, M. Romero-Gomez, J. P. Zarski, K. Agarwal, P. Buggisch, G. R. Foster, N. Brau, M. Buti, I. M. Jacobson, G. M. Subramanian, X. Ding, H. Mo, J. C. Yang, P. S. Pang, W. T. Symonds, J. G. McHutchison, A. J. Muir, A. Mangia, P. Marcellin, and I. O. N. Investigators. 2014. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. New England Journal of Medicine 370(20):1889-1898.
Bickerstaff, C. 2015. The cost-effectiveness of novel direct acting antiviral agent therapies for the treatment of chronic hepatitis C. Expert Review of Pharmacoeconomics & Outcomes Research 15(5):787-800.
CDC (Centers for Disease Control and Prevention). 2013. Viral hepatitis surveillance: United States, 2013. Atlanta, GA: Centers for Disease Control and Prevention.
Charlton, M., G. T. Everson, S. L. Flamm, P. Kumar, C. Landis, R. S. Brown, Jr., M. W. Fried, N. A. Terrault, J. G. O’Leary, H. E. Vargas, A. Kuo, E. Schiff, M. S. Sulkowski, R. Gilroy, K. D. Watt, K. Brown, P. Kwo, S. Pungpapong, K. M. Korenblat, A. J. Muir, L. Teperman, R. J. Fontana, J. Denning, S. Arterburn, H. Dvory-Sobol, T. Brandt-Sarif, P. S. Pang, J. G. McHutchison, K. R. Reddy, and N. Afdhal. 2015. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease. Gastroenterology 149(3):649-659.
Chhatwal, J., F. Kanwal, M. S. Roberts, and M. A. Dunn. 2015. Cost-effectiveness and budget impact of hepatitis V virus treatment with sofosbuvir and ledipasvir in the United States. Annals of Internal Medicine 162(6):397-406.
EASL (Eurpoean Association for the Study of the Liver). 2012. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. Journal of Hepatology 57(1): 167-185.
Edlin, B. R., B. J. Eckhardt, M. A. Shu, S. D. Holmberg, and T. Swan. 2015. Toward a more accurate estimate of the prevalence of hepatitis C in the United States. Hepatology 62(5):1353-1363.
Feld, J. J., K. V. Kowdley, E. Coakley, S. Sigal, D. R. Nelson, D. Crawford, O. Weiland, H. Aguilar, J. Xiong, and T. Pilot-Matias. 2014. Treatment of HCV with abt-450/r-ombitasvir and dasabuvir with ribavirin. New England Journal of Medicine 370(17):1594-1603.
HHS (Department of Health and Human Services). 2014. Action plan for the prevention, care, & treatment of viral hepatitis. Washington, DC: Department of Health and Human Services.
IHME (Institute for Health Metrics and Evaluation). 2016. Global burden of disease study 2013 (gbd 2013) data downloads—full results. http://ghdx.healthdata.org/global-burden-disease-study-2013-gbd-2013-data-downloads-full-results (accessed March 14, 2016).
Loria, P. 2016. This week in pharma: Questions for experts on Merck’s zepatier, Portola’s betrixaban. http://seekingalpha.com/article/3869636-week-pharma-questions-experts-mercks-zepatier-portolas-betrixaban (accessed March 14, 2016).
Martin, A. B., M. Hartman, J. Benson, and A. Catlin. 2015. National health spending in 2014: Faster growth driven by coverage expansion and prescription drug spending. Health Affairs (Millwood) 35(1):150-160.
Najafzadeh, M., K. Andersson, W. H. Shrank, A. A. Krumme, O. S. Matlin, T. Brennan, J. Avorn, and N. K. Choudhry. 2015. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Annals of Internal Medicine 162(6):407-419.
Sanger-Katz, M. 2014. Boon for hepatitis C patients, disaster for prison budgets. The New York Times, August 7.
Ward, J. W., and J. H. Mermin. 2015. Simple, effective, but out of reach? Public health implications of HCV drugs. New England Journal of Medicine 373(27):2678-2680.
WHO (World Health Organization). 2015. Hepatitis B. http://www.who.int/mediacentre/factsheets/fs204/en (accessed January 15, 2016).
WHO. 2016 (unpublished). The case for investing in the elimination of hepatitis B and C as public health problems by 2030.
Younossi, Z. M., H. Park, S. Saab, A. Ahmed, D. Dieterich, and S. C. Gordon. 2015. Cost-effectiveness of all-oral ledipasvir/sofosbuvir regimens in patients with chronic hepatitis C virus genotype 1 infection. Alimentary Pharmacology and Therapeutics 41(6):544-563.