The obstacle is the way: Finding a path to hepatitis C elimination

This is the authors' abstract. We don't add key points for this paper.

Recently, the Biden-Harris administration proposed a 5-year program to eliminate HCV infection as a public health problem in the United States.1 This HCV Elimination Program, housed within the Office of the Assistant Secretary of Health and led by former US National Institutes of Health Director Francis Collins, aims to expand screening, treatment, prevention, and surveillance of HCV infection in the United States. It is rare to consider the elimination of any infectious disease, but the availability of highly effective HCV antivirals and the development of point-of-care HCV RNA tests make the national program's aims feasible.2 The American Association for the Study of Liver Diseases (AASLD)/Infectious Diseases Society of America (IDSA) HCV Guidance Panel, which was established in 2013 to formulate and disseminate evidence-based recommendations on HCV screening, treatment, and management,3 expresses its enthusiastic support for the HCV Elimination Program and is committed to furthering efforts toward elimination by helping to overcome barriers to HCV testing and treatment. Since its launch in January 2014, the HCV Guidance Panel's web-based platform (www.hcvguidelines.org) has been accessed worldwide by more than 2 million users from over 200 countries.4 The panel's expertise and wide-reaching website will be a valuable resource to advance HCV elimination.5 In anticipation of a national HCV Elimination Program and to meet the US 2030 HCV elimination goals, the HCV Guidance Panel will engage in 4 main efforts to reduce barriers to HCV care and support HCV elimination, including (1) design simplified, low-cost "test and treat" algorithms; (2) disseminate accessible resources to facilitate the treatment of HCV infection outside of specialty settings; (3) synthesize evidence on programs that decentralize HCV care and expand access to antiviral therapy; and (4) disseminate research that will aid HCV elimination strategies (Figure 1). In this Commentary, we consider the obstacles that have hindered progress toward HCV elimination in the United States, discuss potential solutions that have opened a path to elimination, and highlight how the resources proposed by the US HCV Elimination Program and efforts planned by the AASLD/IDSA HCV Guidance Panel will enable achievement of this goal in our country.FIGURE 1: American Association for the Study of Liver Diseases/Infectious Diseases Society of America Hepatitis C Virus (HCV) Guidance Panel's specific efforts to reduce barriers to HCV care and support HCV elimination in the United States by 2030. 1Point-of-care HBsAg assays will be valuable to rapidly exclude hepatitis B coinfection, which has overlapping risk factors with HCV infection. Persons who test positive for HBsAg require monitoring for hepatitis B reactivation during HCV therapy and may need hepatitis B treatment. ²Nontraditional settings for HCV treatment include primary care practices, correctional facilities, substance use treatment programs, mobile services, or telehealth programs.An estimated 2.4 million Americans have chronic HCV infection.6 The availability of all-oral, well-tolerated, direct-acting antiviral treatment regimens that cure chronic HCV infection in more than 95% of persons prompted the World Health Organization in 2016 to call for HCV elimination, defined as the cessation of HCV transmission and prevention of HCV-related liver complications, by 2030.7 In response to this call, the National Academies of Sciences, Engineering, and Medicine issued 2 seminal reports in 2016 and 2017 that highlighted the feasibility of HCV elimination in the United States and proposed evidence-based recommendations to achieve HCV elimination as a public health problem by 2030.8,9 The US Department of Health and Human Services subsequently established 2 key targets to achieve HCV elimination in the country by 2030: (1) a 90% reduction in the incidence of new HCV infections, and (2) a 65% reduction in HCV-related morbidity and mortality, both from a 2015 baseline.10 Since the establishment of these targets, significant threats to HCV elimination have emerged. The COVID-19 pandemic diverted attention and resources away from HCV elimination efforts. In addition, the opioid epidemic has driven significant increases in HCV transmission,11 with unsafe injection practices and limited access to harm-reduction services (eg, syringe exchange, substance use treatment) contributing to a rising incidence of HCV infection, particularly among persons aged 20–39 years.12–14 Notably, as of 2021, the estimated number of acute HCV infections exceeded the number of HCV cures, resulting in a lack of decline in prevalent viremic infections for the first time.14,15 These data underscore the importance of implementing strategies to achieve HCV elimination. To understand how HCV elimination could be achieved in the United States considering these threats, a modeling analysis estimated the number of people that would need to be newly diagnosed with HCV infection and newly initiated on antiviral treatment by 2030 to reduce HCV incidence and mortality to meet the national elimination targets.16 The results showed that these goals could be achieved in the United States by diagnosing 1.9 million new HCV infections and treating 2.7 million diagnosed persons by 2030.16 Furthermore, successfully achieving the 2030 HCV elimination goals could prevent more than 30,000 cases of HCC and over 29,000 HCV-related deaths.16 However, meeting the target number of persons diagnosed and treated for HCV infection requires overcoming obstacles to HCV diagnosis, linkage to care, and treatment. Approximately 40% of people with HCV infection in the United States remain unaware of their infection.17 Although HCV screening is recommended at least once in a lifetime for all persons ≥18 years of age,18,19 it has not fully penetrated into hard-to-reach populations, such as people who are underserved, uninsured, incarcerated, or formerly or currently inject drugs.20–22 Many persons identified as HCV antibody–positive are lost to follow-up before confirmatory HCV RNA testing or linkage to treatment.23 There also continue to be barriers to accessing HCV therapy.24 From 2019 to 2020, antiviral therapy was dispensed to only 23% of persons diagnosed with HCV infection covered by Medicaid, 28% covered by Medicare, and 35% covered by private insurance.25 Some insurance providers still require attestation of abstinence from substances before HCV treatment or enrollment in a substance use program despite research demonstrating that abstinence from substances is not necessary for HCV treatment to be successful.26 Other insurers require that treatment be performed under specialist care.26 Such restrictions stigmatize persons living with HCV, discourage them from seeking HCV care, and delay or prevent HCV therapy.27,28 The proposed US HCV Elimination Program will help to achieve the targets of HCV elimination by focusing on 3 main priorities: (1) increasing HCV diagnosis, linkage to care, and treatment, (2) promoting the development and implementation of point-of-care HCV RNA tests, and (3) enhancing access to HCV treatment regimens.1 The program will be maintained within a central coordinating White House office, which provides logistical efficiency in advancing the efforts of these priority areas. If approved by the US Congress, the activities within this program will greatly accelerate our nation's progress toward HCV elimination. To meet the 2030 HCV elimination goal of diagnosing 1.9 million new HCV infections, the HCV Elimination Program seeks to increase HCV screening and treatment in high HCV prevalence settings and outside of traditional specialty practice venues. Expanding HCV care in primary care, correctional, and substance use treatment settings will mitigate drop-offs in linkage to care that occur with specialist referrals. To further promote HCV care in these settings, the HCV Guidance Panel created simplified HCV treatment algorithms that make administering and monitoring antiviral therapy feasible by nonspecialist providers.3 The panel is also collaborating with leaders of the HCV Elimination Program to develop even more simplified "test and treat" algorithms utilizing point-of-care HCV RNA and HBsAg assays, once available, which would enable safe initiation of HCV therapy when the diagnosis is made.29 The availability of point-of-care HBsAg assays will be valuable to rapidly exclude hepatitis B coinfection, which has overlapping risk factors with HCV infection. Persons who test positive for HBsAg require monitoring for hepatitis B reactivation during HCV therapy and may need hepatitis B treatment.30 To meet the goal of treating 2.7 million HCV-diagnosed persons by 2030, the HCV Elimination Program has proposed co-pay assistance to Medicare beneficiaries and a national subscription–based payment model to purchase HCV antivirals for underserved people with HCV infection, similar to an approach pioneered by the Louisiana Department of Health.31 However, while awaiting approval for this proposal, the HCV Guidance Panel is working to develop resources (eg, HCV telehealth algorithms, HCV management checklists) to facilitate HCV treatment by nonspecialist providers, including within populations that have had limited treatment uptake such as children, pregnant individuals, and people with HCC. The panel will also disseminate evidence on initiatives that reduce disparities in access to HCV treatment in vulnerable communities with the goal of increasing wider adoption of such practices. In addition, panel members will continue to advocate for the removal of barriers to HCV treatment by public (eg, requirement for sobriety, treatment by a specialist provider) and private insurers to make antiviral therapy available to all infected individuals. Because injection drug use is the predominant mode of HCV transmission in the United States, a comprehensive strategy to address the opioid epidemic will be crucial to reducing HCV incidence and achieving elimination.32 Stigma, discrimination, and structural racism continue to hinder HCV prevention, timely diagnosis, and treatment among historically marginalized groups vulnerable to HCV infection.33,34 Harm-reduction strategies, which include syringe service programs, safe injection sites, safe drug use education, and substance use treatment, are essential to HCV prevention,35 but their utilization remains low due to restrictive policies and barriers to implementation. Moreover, many settings that treat substance use disorders do not prescribe HCV treatment. Integrating services for opioid use disorder and infectious diseases, as recommended in a 2020 National Academies of Sciences, Engineering, and Medicine report,36 can facilitate the treatment and prevention of substance use disorder, HCV infection, and other infectious diseases. To aid efforts to reduce HCV transmission, the HCV Guidance Panel will synthesize and disseminate research that dismantles disparities in HCV prevention and treatment and centers the voices of people with lived experience. The panel will also create a repository of evidence on novel models of HCV prevention and care delivery that include telehealth, mobile, or community-based services. Microelimination, which refers to implementing HCV elimination strategies within key populations (eg, people with HIV or who inject drugs) or within a specific setting (eg, health system, prison, rural clinics in a geographic region), will be a valuable approach to reach the national elimination targets.37 Elimination efforts on a smaller scale could demonstrate what can occur if interventions are expanded and sustained at the larger population level. In 2024, the HCV Guidance Panel will launch a new section on its website devoted to strategies for HCV microelimination to support such efforts. The panel will synthesize and disseminate research, once available to clinicians and community partners, that could support microelimination efforts, such as long-acting injectable antivirals, HCV vaccines, and approaches to monitoring elimination metrics. Our country has a real opportunity for transformative work to turn the course of the HCV epidemic. The obstacles to HCV elimination in the United States provided opportunities for new collaborations, technical innovations, and novel approaches to care delivery that ultimately opened a viable path to achieving this goal. The actions that the United States takes over this decade to prevent new HCV infections, identify HCV-infected persons, and treat those diagnosed will determine the trajectory of the HCV epidemic in our country. The AASLD/IDSA HCV Guidance Panel, representing a partnership of both the hepatology and infectious diseases communities, is committed to helping make the nation's 2030 HCV elimination goals a reality.