Expanding Capacity for Hepatitis C Treatment in the United States

Abstract

Hepatitis C treatment is rapidly evolving with significant improvements in patient outcomes. With an estimated prevalence of over 3 million persons living with chronic hepatitis C in the United States, it is anticipated that there will be an increase in the number of persons seeking care and treatment for chronic hepatitis C infection. Current systems of care may be overburdened with people seeking care for chronic hepatitis C virus (HCV). Interprofessional models of care have been shown to be feasible and effective in treating different populations affected by chronic HCV. Use of interprofessional teams, integrated models of care, and greater use of nonphysician providers offer a potential solution for expanding capacity to comprehensive HCV treatment and care in the United States.

Treatment and management of chronic hepatitis C virus (HCV) infection is rapidly changing. A proliferation of new therapies is expected to transform chronic HCV from a disease that had poor treatment success to one of vastly improved outcomes that will be available to most individuals. With an estimated prevalence in the United States of over 3 million, it is anticipated that many persons living with chronic HCV infection will soon become eligible for curative therapy. ¹ Historically, treatment for HCV was associated with numerous side effects, required lengthy treatment durations, and had relatively poor outcomes in terms of clearance of HCV. All of these factors posed barriers to treatment for persons living with chronic HCV infection. ^2,3

The challenges of earlier HCV treatment regimens resulted in only a small percentage of patients motivated enough to undertake the lengthy and intensive treatment regimens. With the availability of new directly acting antivirals (DAAs), HCV is now curable in the majority of individuals who are treated. Previous to the advent of DAAs, the need for clinicians skilled in HCV care was limited. Clinical management of patients undergoing HCV treatment was often deferred to specialists—such as hepatologists or infectious disease specialists. However, with advances in HCV treatment, including interferon-free agents and all-oral DAA regimens, it is anticipated that the demand for HCV treatment will soon exceed the capacity of specialty physicians. Expanding health system capacity to manage and deliver HCV care has been recognized as an integral component for successful HCV treatment. ⁴ The challenge remains how to effectively provide HCV therapy to the millions of people who are eligible for treatment. Just as the HCV treatment landscape is rapidly evolving, the need for newer models of care delivery will need to be developed to help address the issue of HCV treatment access.

The purpose of this review article is to provide a brief overview of innovative models of care that have expanded the availability of HCV treatment access in the United States. Specifically, this review highlights how hepatitis C treatment programs have utilized nonphysician providers, as well as technology, to increase capacity to provide HCV care. Models reviewed here are primarily those that have been described previously in the literature and have been shown to be feasible within various types of health systems in the United States.

Programs highlighted here were selected by conducting a search of peer-reviewed articles in PubMed using the key terms and phrases “hepatitis C treatment models,” “hepatitis C primary care,” and “HCV treatment interprofessional care.” Articles that described recently developed programs in the US health care system or programs that have integrated interprofessional teams were included for review.

The Hepatitis C Continuum of Care and the Need to Build Capacity

Chronic HCV infection has proven to be a silent epidemic, despite the fact that in the United States in 2007 it surpassed HIV in the number of deaths annually. ⁵ If left untreated, chronic HCV can result in fibrosis, decompensated cirrhosis, liver transplantation, hepatocellular carcinoma, or death. ⁶ In addition to the physical and emotional consequences of chronic HCV infection, the financial burden is impressive. The lifetime total cost for caring for a person with untreated chronic HCV infection may reach several hundred thousand dollars in health care costs and is further compounded by lost productivity. ⁷

The Centers for Disease Control and Prevention estimates that nearly 75% of those living with chronic HCV infection in the United States were born between 1945 and 1965. ¹ Other populations affected by chronic HCV include persons who inject drugs, recipients of blood products, chronic hemodialysis patients, persons with HIV infection, and children born to HCV-positive mothers. ¹ A disproportionate number of chronic HCV infection occurs in communities of color and among men who have sex with men. ¹ There is also a rise in new HCV infections occurring in young adults who inject drugs. ^1,4

One of the major barriers to care is that many individuals who have chronic HCV are unaware of their status. ⁴ Recent data suggest that as many as 50% of HCV-infected individuals remain unaware of their status. ⁸ In an effort to identify those who are HCV infected, but unaware, efforts have been made to incorporate HCV testing as part of routine preventive health screening, especially for those in the 1945 to 1965 birth cohort and other high-risk populations. ⁹ The US Preventive Services Task Force has given HCV screening a grade-level B recommendation, which is one of the highest levels or recommendation from this expert panel. ¹⁰ Additionally, the US Department of Health and Human Services recently revised and updated its national strategy for addressing viral hepatitis in the United States. As part of the new action plan, emphasis has been placed on screening, prevention, and treatment. ⁴

Although screening and identification of persons infected with HCV is the first step in the continuum of care, additional planning for expanded treatment capacity is also an important theme that needs to be addressed. Simply deferring treatment to hepatologists or infectious disease specialists will be insufficient in terms of meeting the potential demand for treatment. ⁴ To address this issue, there has been a movement to expand HCV treatment capacity by incorporating HCV treatment into existing systems of care—including general primary care. ^4,7

Primary care providers play a pivotal role in many aspects of HCV care—not only in screening and diagnosis. For patients who are undergoing HCV treatment, primary care providers can help with side effect management and posttreatment monitoring. Individuals who have other issues related to HCV infection, such as psychoactive substance use or mental health issues, may need ongoing care and monitoring to address these contributing factors for HCV infection, or possible reinfection. For individuals who have other comorbid conditions that can impact liver health, such as obesity and diabetes, primary care providers are invaluable partners in helping patients manage these other conditions. Individuals who may need to defer treatment may require periodic screening for hepatocellular carcinoma and rely on primary care providers to assist with surveillance of hepatocellular carcinoma or other signs of hepatic decompensation. One of the most significant roles of primary care providers is educating patients on prevention of HCV infection and risk reduction.

Educational efforts to train general primary care physicians on chronic HCV management have been increasing. However, it is important to recognize that other members of a health care team can, and should, be used as a means of expanding treatment capacity and access. In the United States there exists a shortage of primary care physicians. ¹¹ With the implementation of the Affordable Care Act, millions of formerly uninsured Americans now have access to basic health services. In order to address access to primary care, emphasis has been placed on the use of nonphysician providers to deliver primary care or components of primary care services, such as preventive health interventions and patient education. ¹² Nonphysician providers can include advanced practice nurses, physician assistants, pharmacists, registered nurses, social workers, or other members of the health care team. With the evolution of the HCV treatment paradigm, it is imperative that health care systems look at possibilities of utilizing and capitalizing on the contributions of nonphysician providers in the HCV treatment model. ¹³

Interprofessional Teams Can Improve Access to Care

The World Health Organization (WHO) has emphasized the importance of team-based, interprofessional collaboration as a means of improving patient outcomes. The WHO defines interprofessional collaboration as “multiple health workers from different professional backgrounds working together with patients, families, caregivers, and communities to deliver the highest quality of care.” ¹⁴ (p13) Delivering care for patients living with HCV is ideal for interprofessional team-based care. Given the diversity of the patient populations affected by HCV, and compounded by the shortage of primary care physicians, nonphysician providers can fill a potential gap in HCV care delivery. Especially in resource-limited or rural areas, expanding on the use of other members of the health care team to deliver and provide HCV care will be imperative. In addition, new treatment models may need to be developed to capitalize on the skills of HCV treatment experts.

Utilizing nonphysician providers to expand access to care is not a new concept. Other successful treatment paradigms have demonstrated the efficacy of nonphysician providers. Within the field of HIV, integrated models of care and use of nonphysician providers have shown that patient outcomes and access are similar. ^15,16 This has been shown not only in US-based health care models but also in the international setting where nonphysician providers, in particular nurses, played a pivotal role in expanding access to treatment with similar outcomes as care provided by physicians. ^15,16

Examples of Innovative HCV Treatment Models

One current model of expanding treatment capacity that has been successful in increasing primary care providers’ capacity to treat and manage patients with HCV infection is the Extension for Community Healthcare Outcomes (ECHO) model that was designed as a means to provide complex medical specialty care in rural regions where medical specialists are often not available. ¹⁷ Initially developed at the University of New Mexico, Project ECHO represents a pioneering educational intervention of team-based interprofessional care. It employs telehealth technology to train and support community health providers on a variety of diseases, such as HCV, HIV, and other medical conditions. It effectively maximizes the utilization of limited resources, such as hepatologists or other medical experts, thereby allowing patients in remote and underserved areas to receive high-quality care within their local communities. Project ECHO was first used for expanding HCV treatment but has subsequently been utilized successfully in a diverse range of complex diseases. Project ECHO has been expanded in different cities across the United States and replicated with similar success. ¹⁸

Some states, such as New York, have funded demonstration projects to examine ways of integrating both primary care and HCV care together in various settings, including drug treatment centers. ^19,20 These demonstration projects have shown that integrated care is feasible and can work in a variety of settings. The use of team-based systems with physicians, nurse practitioners, physician assistants, substance abuse counselors, social workers, psychologists, and other mental health providers have all been effective in delivering HCV care to patient populations with a variety of co-occurring social, medical, and mental health issues. ^19,20

There are other reports as well, which demonstrate the success of expanding and providing HCV care with nonphysician providers. The Veterans Administration (VA) has been a leader in the utilization of nurse practitioners and team-based care in the HCV treatment model. A 2014 retrospective observational cohort analysis examined the effect of provider type on HCV treatment outcomes among 820 patients at 94 VA practices. ²¹ This study demonstrated that there was no difference in sustained virologic response between physicians and nonphysician providers. The study also found that there is a scarcity of similar studies that compare treatment outcomes achieved by nonphysician providers who provide HCV therapy, despite the fact that many already work in this capacity. This study is unique both in its exploration of nonphysician provider treatment outcomes and in the fact that its providers are using the newer directly acting antiviral regimens. Although this analysis did not purport to study team-based care, it ultimately observed that physicians may not be as involved in routine follow-up of patients being treated, although they often are the ones to initiate treatment. The involvement of nonphysician providers in a team-oriented environment may improve treatment outcomes.

Similarly, Smith and colleagues investigated the outcomes from a pharmacist-led HCV treatment program within a VA medical center and found similar treatment outcomes compared to patients managed in traditional care with physicians. ²² Pharmacists can play a key role in terms of expanding an organization’s capacity to provide care for HCV patients undergoing therapy and can work to augment and enhance care delivered by physicians, nurse practitioners, nurses, and physician assistants.

Olson and Jacobson explored the key role that nurse practitioners play in screening, side effect management, and education during the HCV treatment. ²³ Although this article focused on the support role of the nurse practitioner, it is inevitable that as therapies become less complicated and more patients enter the treatment pool, nurse practitioners will need to transition from the support role to the main provider and initiator of treatment as has already occurred in the VA system.

In a report from Kaiser Permanente, a large health maintenance organization, patients who underwent HCV treatment received care from either a team comprised of a nurse paired with a clinical pharmacist or a physician. ²⁴ Evaluation of patient satisfaction found that patients who were treated by the nurse and clinical pharmacist teams reported higher satisfaction of care when compared to persons who received care provided by physicians alone. Patients appreciated the support they received from nurses and the impact that nurses had on quality of life during HCV treatment. ²⁴

The role of mental health professionals is also critical for a comprehensive HCV treatment program. Although many of the depressive and psychiatric symptoms of interferon-based HCV therapy may be less in the future, there will still be a portion of the HCV-infected population who will need ongoing mental health or psychiatric management. Successful HCV treatment programs that specialize in working with individuals having co-occurring psychiatric illness and psychoactive substance use have been implemented. ^{25 –28} The role of mental health providers in HCV treatment, especially within these settings, has been invaluable. By combining the skills and expertise of mental health professionals into HCV treatment programs, organizations can ensure that patients can succeed with HCV treatment.

Conclusion

In summary, HCV treatment is one of the most rapidly evolving fields. Efforts to improve screening, diagnosis, treatment, and prevention of HCV infection has now become a priority focus. Advances in HCV therapeutics have made eradication of HCV a viable possibility. However, issues of access and capacity must be addressed in order to meet future demands. Within the US health care system, several innovative models have demonstrated the feasibility of expanding access through the use of nonphysician providers. Organizations and systems of care should look at creating innovative team-based approaches, and capitalizing on the skills of nonphysician providers working collaboratively with other health professionals, to meet the potential of serving those seeking care for chronic HCV infection.