An expanding role for primary care providers in the treatment of hepatitis C virus infection in the community

Authors


  • Potential conflict of interest: G.J.D. has received research support, is on the speaker's bureau, and is a member of an advisory board for Roche Pharmaceuticals. G.J.D. is also a consultant/advisor for Merck, Tibotec, and Abbott. J.G. is a member of an advisory board for Merck.

  • The Kirby Institute for infection and immunity in society is funded by the Australian Government Department of Health and Ageing and is affiliated with the Faculty of Medicine, University of New South Wales. G.J.D. is supported by a National Health and Medical Research Council Practitioner Research Fellowship.

Arora S, Thornton K, Murata G, Deming P, Kalishman S, Dion D, et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med 2011;364:2199-2207. (Reprinted with permission.)

Abstract

The Extension for Community Healthcare Outcomes (ECHO) model was developed to improve access to care for underserved populations with complex health problems such as hepatitis C virus (HCV) infection. With the use of video-conferencing technology, the ECHO program trains primary care providers to treat complex diseases. We conducted a prospective cohort study comparing treatment for HCV infection at the University of New Mexico (UNM) HCV clinic with treatment by primary care clinicians at 21 ECHO sites in rural areas and prisons in New Mexico. A total of 407 patients with chronic HCV infection who had received no previous treatment for the infection were enrolled. The primary end point was a sustained virologic response. A total of 57.5% of the patients treated at the UNM HCV clinic (84 of 146 patients) and 58.2% of those treated at ECHO sites (152 of 261 patients) had a sustained viral response (difference in rates between sites, 0.7 percentage points; 95% confidence interval, −9.2 to 10.7; P = 0.89). Among patients with HCV genotype 1 infection, the rate of sustained viral response was 45.8% (38 of 83 patients) at the UNM HCV clinic and 49.7% (73 of 147 patients) at ECHO sites (P = 0.57). Serious adverse events occurred in 13.7% of the patients at the UNM HCV clinic and in 6.9% of the patients at ECHO sites. The results of this study show that the ECHO model is an effective way to treat HCV infection in underserved communities. Implementation of this model would allow other states and nations to treat a greater number of patients infected with HCV than they are currently able to treat.

Comment

Despite improvements in hepatitis C virus (HCV) treatment over the past decade, uptake remains low in many settings. Treatment uptake is high among some hospital-based liver clinics (16%-42%)1-3; however, there is considerable variation across centers.4 In a study of 29,695 HCV-infected patients who accessed care within 2 years of HCV diagnosis at 128 facilities in the Veterans Administration (VA) health care system,4 the overall rate of HCV treatment uptake by facility ranged from 1.5%-45% (median, 14.9%).4 In the community, the proportion having received treatment is even lower. Among 21 countries in the World Health Organization European region, only 1%-16% of the population estimated to be infected with HCV had received treatment.5 In Australia, ≈8% have received pegylated interferon (PEG-IFN)/ribavirin therapy since 2003,6 despite treatment being fully subsidized. In the United States, treatment rates are declining and if this trend continues, only 14.5% of estimated liver-related deaths caused by HCV between 2002-2030 will be prevented by therapy.7

Barriers to expanding HCV treatment in the community are multifactorial and include issues of access to therapy and barriers at the level of the patient, practitioner, and system.8 HCV-infected patients often have complex social, medical, and psychiatric comorbidities, complicating decisions around care. Factors associated with not receiving HCV treatment include older age,4 minority ethnicity,4 ongoing or former drug use,1-3, 8 ongoing alcohol use,2, 4 advanced liver disease,1 comorbid medical disease,3, 4 psychiatric disease,1, 4 and treatment for drug dependency.2, 8 The high prevalence of substance use, other medical diseases, and psychological comorbidity among patients with HCV makes increasing access to care particularly challenging.

Practitioners play an important role in facilitating HCV assessment and treatment. In one study in the VA system, the strongest independent predictor of HCV treatment was attending one visit with an HCV specialist.4 In a community-based study in Australia, HCV-infected patients who had seen a general practitioner about HCV in the last 6 months were four times more likely to be assessed for therapy by a specialist.8 Practitioner experience is also important. Patients evaluated by less experienced providers are less likely to receive treatment than those evaluated by more experienced providers.3 However, there is often a lack of consideration for HCV assessment or treatment in difficult-to-treat patients. In the VA, 68% of HCV-infected patients were considered not suitable candidates for HCV treatment, mainly because of issues related to substance abuse, psychiatric disease, and comorbid medical disease.1

At the systems level, there is limited infrastructure for the provision of HCV assessment and treatment delivery beyond well-established, hospital-based liver clinics. Patients report a limited knowledge of testing locations,9 limited accessibility of testing results and treatment,10 and long waiting lists for treatment11 as barriers to care.

In the study by Arora et al., the authors compared HCV treatment outcomes among patients treated by primary care providers (as part of a model consisting of 21 sites in rural areas and prisons) to patients treated by specialists at an urban hospital-based liver clinic (University of New Mexico [UNM]) in the United States.12 Using state-of-the-art telehealth technology, the Extension for Community Healthcare Outcomes (ECHO) model offers primary care providers training, advice, and support in delivering best-practice care to improve access to care for marginalized populations with HCV. In this prospective cohort study of participants initiating PEG-IFN and ribavirin between 2004 and 2008, sustained virological response (SVR) was compared among patients at the ECHO (n = 261) and UNM HCV clinic sites (n = 146).

The authors demonstrated that SVR following treatment of HCV by primary care providers at ECHO sites was comparable to that observed in the UNM HCV clinic (overall patients, 58% versus 58%; patients infected with HCV genotype 1, 50% versus 46%). This SVR is higher than that reported in the WIN-R study (41% overall, 29% in genotype 1), a large community-based trial of 5027 patients treated with PEG-IFN/ribavirin in the United States.13 The results from Arora et al. are impressive, given the higher proportion of men and Hispanics enrolled at ECHO study sites, which are both factors associated with reduced response to HCV therapy.14

This important study by Arora and colleagues demonstrates the successful implementation of a novel and highly effective model of care for the treatment of HCV by primary care providers. As the authors propose, ECHO represents a needed change from the conventional approaches in which specialized care and expertise are concentrated in academic medical centers in urban areas.

The ECHO model is effective because it addresses a number of patient, practitioner, and systems-related barriers to HCV treatment. First, it provides a model for addressing patient-related HCV treatment barriers. Primary care providers have broad expertise across medical disciplines, often having experience in managing care in marginalized populations such as minorities or individuals who use alcohol and drugs. Incorporating active HCV screening and assessment in the primary care setting ensures that a system is established for identifying those with HCV and in need of treatment who may never have accessed care through urban hospital–based clinics. The ECHO model includes education and training of primary care providers as an essential component. Weekly HCV case discussion clinics and seminars are conducted where primary care providers (physicians, nurses, physician assistants, and so forth) can interact with specialists from the fields of hepatology, infectious diseases, psychiatry, and pharmacology through the use of telehealth techonology. However, it should be noted that the community-based groups described in the study do not include isolated medical or nursing practitioners. The groups consisted of at least three persons at the practitioner, nurse practitioner, and medical assistant level. Also, the groups were based in prison settings in 25% of cases.

Community-based HCV treatment models are being implemented in other countries. In Canada, a model similar to ECHO has been established that is based on a public health nurse and physician partnership in four rural and small urban centers.15 Between 2001 and 2005, among 1795 patients assessed for HCV, 26% were eligible for therapy. PEG-IFN/ribarivin was initiated in 363 individuals, and the SVR was 61% (48% in patients infected with HCV genotype 1). Nurses played a central role and were often the first point of contact, coordinating referrals and client intake, completing initial assessments, and scheduling physician visits.

In Australia, the Enhanced Treatment for Hepatitis C in Opioid Substitution Settings (ETHOS) project is evaluating a model of HCV treatment delivery to marginalized populations (92% unemployed, 77% receiving opiate substitution treatment) within a network of opiate substitution and community-based clinics. Among the first 237 participants enrolled (of a planned 500 total participants), 44% attended a specialist appointment and 19% were commenced on HCV treatment, providing encouraging early data that support the feasibility of such a model.

In conclusion, the results from this study highlight that with careful planning and excellent implementation, equal SVRs in the setting of antiviral therapy for HCV can be achieved in the community as well as in the hospital setting. Thus, further steps must be made to supplement existing models for HCV treatment which move beyond urban hospital–based liver clinics. Models incorporating primary care providers (nurses, physicians, and other allied health staff) and drug and alcohol practitioners will enhance HCV assessment and treatment in the community and reduce the future burden of HCV-related liver disease.

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