The Big Picture

Revising the Continuum of Care for Patients with Chronic Hepatitis C

We are all well aware of the progression and impact of HCV: (a) it has surpassed HIV as a cause of death in the United States; (b) it is the most common blood-borne infection in the U.S. and affects approximately 185 million people globally; (c) in the U.S., an estimated 2.7 million to 5.2 million people are living with HCV; (d) it increases the risk for fibrosis, cirrhosis and hepatocellular carcinoma and is a major indication for liver transplantation in the U.S.; and (e) it is associated with several extrahepatic manifestations such as renal disease, skin disorders and impaired quality of life. And despite the opportunity to cure greater than 90% of chronically infected individuals with the new direct-acting antiviral therapies administered once a day for between 8 and 24 weeks, 45% to 85% of chronically infected persons are estimated to be unaware of their infection. Thus, they leave their primary care appointment without being tested and are at continued risk for progressive disease.

Alexander Geboy

Dawn Fishbein

Ideally, once identified, all patients would continue through the HCoC to cure without setback. Yet while gaps clearly exist in all stages (ie, low rates of confirmatory testing, linkage to specialty care and treatment initiation), identification remains a critical gap. What is more problematic is we are running out of time to maximize the impact of life-saving medications. Last year, Denniston and colleagues reported prevalence of 2.7 million persons with chronic HCV between 2003 and 2010; this is lower than the 3.2 million reported between 1999 and 2002. They propose that the dip in prevalence is not a result of more patients receiving treatment, but attributable to an increase in HCV-related mortality, mostly within the “baby boom” generation, known simply as the Birth Cohort (BC).

Fortunately, the foundation has been established to identify the entirety of this population. In 2012, the CDC expanded BC and high-risk population HCV testing recommendations. They also released a Prevention and Public Health Fund (PPHF) funding opportunity to improve early identification of HCV in clinical and community settings and enhance linkage to care, treatment, and preventative services. In 2013, the United States Preventive Services Task Force (USPSTF) modified its stance and assigned a grade B recommendation to align with the CDC; and in 2014, the CMS issued a decision to reimburse screening for HCV when ordered within a primary care setting. This CMS guidance is very limited in its scope and will hopefully be revised as data is generated in alternative settings, such as EDs, revealing high rates of HCV.

Within the District of Columbia, from 2008 to 2012, there were 9,819 newly confirmed cases of HCV with 15,915 total cases documented during this timeframe, representing 2.5% of the D.C. population. It is estimated that HCV infection is approximately two times more prevalent than HIV infection. However, in D.C. the reported rate is equivalent. Thus, the D.C. HCV rate is likely a conservatively low estimate.

Constructing the Continuum

It was with PPHF funding in 2012 that we developed a primary care-based HCV testing and linkage program at MedStar Washington Hospital Center (MWHC) in Washington, D.C. The initial aim of our HepC Linkage to Care Navigation program was to identify a naive, previously untested population, provide either a free OraQuick HCV Rapid Antibody Test (OraSure Technologies) or have the PCP order an HCV antibody test (a reflex to HCV-RNA option was made available in mid-2013), and link HCV-positive people into appropriate HCV care services.

Testing focused exclusively on the BC, and patients were identified as eligible for testing via real-time chart review based on previous HCV testing and risk factors. Pop-up reminders with focused messages were manually inserted into each eligible electronic medical record (EMR) requesting HCV antibody testing based on CDC and USPSTF recommendations, or offering rapid tests (performed by the program coordinator) if no HCV antibody test was ordered. Advancement through the patient chart could not continue until the pop-up message was closed. It was the provider’s choice to offer the test to the patient or order the test as a part of the laboratory requisition.

If a provider elected a venipuncture test, they ordered an HCV antibody test. All results were automatically populated into the patient’s EMR and monitored by the HepC program team. If a patient was found to be HCV antibody positive, but did not have a confirmatory test, an electronic communication was sent to the provider to alert the patient of the result and order a HCV RNA test, or to provide the patient with an expedited referral to either Infectious Disease (ID) or Gastroenterology (GI) for further testing and counseling. For positive rapid HCV antibody tests, on-the-spot counseling was provided by the tester, an RNA test was ordered by the PCP, and an expedited referral to ID or GI was provided for an initial medical assessment. All appointments were made via clinic Medical Assistants (MAs).

In 2014, with funding from the Gilead FOCUS partnership, we expanded our program to identify and link patients who were previously tested HCV positive and who had fallen out of care back into appropriate HCV care. This was accomplished through an EMR search for patients who had a history of HCV infection (either antibody positive or HCV RNA positive), but who did not have an HCV specialty visit in more than 1 year. Once identified, we queried PCPs to either initiate or allow our team to initiate contact. Once linked, (ie, an appointment had been made with our team) we continued with follow-up contact until the patient was successfully engaged in HCV care (ie, seen at an office visit by an ID or GI physician).

 

In an effort to provide a higher level of service, we assumed most clinic-related responsibilities, such as appointment scheduling and medication prior authorizations. In addition to two dedicated providers, we hired a patient navigator (formerly a MA in our clinic) and two social workers (formerly inpatient hospital social workers) to engage patients, assess and resolve barriers throughout the HCoC, coordinate the medication authorization process, and engage external organizations to create HCV-focused referral options and services.

Once a patient was linked, and prior to a first subspecialty appointment, our social workers contacted patients to conduct introductory assessments to identify and mitigate immediate barriers that could interrupt initial engagement, and pertinent medical and psychosocial history (ie, lack of transportation, current history of drug/alcohol abuse). Post-first visit, social workers completed a more in-depth biopsychosocial assessment to identify strengths and barriers to accessing future medical care. As patients moved through the HCoC, our patient navigator and social workers provided appointment reminders, followed up with missed, no-show or canceled appointments, and held biweekly support groups for patients at all stages of the HCoC. Testing days, supported by targeted media campaigns, were held at our hospital to increase HCV awareness, provide rapid tests and on-the-spot HCV counseling services.

HCoC Results

Our HCoC in the graph above combines data for 3 years, and includes data from our CDC and Gilead FOCUS funding sources. We focused on key milestones from diagnosis to linkage, subspecialty engagement and treatment. This figure does not include all patients screened, only those who were HCV antibody positive. We expanded our HCoC to include key diagnostic decision points such as liver staging (LS) and hepatocellular carcinoma screening that should be included as HCV standard of care, but are not referenced in most of the reported Continuum of Care data, as well as those cured. Regarding subspecialty engagement, once patients were in care, they were typically seen by our two ID providers and a full diagnostic workup was undertaken. This included alcohol and drug screening and harm reduction counseling, and LS (via Fibrosure [Biopredictive], Fibroscan [Echosens] and liver biopsies) and HCC screening (via abdominal ultrasound, CT and MRI) were ordered for all patients in need of assessment.

Concluding Remarks

Though not the focus of this article, from our CDC grant, 2,320 HCV tests were performed for an antibody prevalence of 7.6%. On July 1, 2015, we expanded testing to MedStar Health Primary Care Clinics through the EMR prompting system. This is still under development.

Clinic-based screening and linkage-to-care programs can be effective at retaining patients throughout the HCoC. We were able to overcome many of the commonly cited barriers to link 96% of those identified as chronically infected into care. Furthermore, our treatment rate of 27% of patients seen by a specialist (68% of patients who had a prescription written) represents progress considering the national average of patients making it this far through the HCoC is 7% to 11%. D.C. Medicaid did not start approving some of the newer DAAs until February 2015; thus, treatment results may be lagging. However, the bar needs to be set much higher than prior data on the Continuum of Care. Data using these new interferon-free DAAs needs to be published so that we can understand what the accepted treatment rate should be. Many of us would argue that we need to be approaching 100%, and quite soon, though barriers still remain in this continuum.

A low treatment rate does, however, identify a common and unique barrier for patients and providers. Unlike the other stages, treatment approval has little to do with the quality of care provided. Costs are high, and though newer DAA regimens are being covered by many insurance providers, there are coverage limitations aligned with disease severity, making it difficult for providers to treat all patients. However, it has been noted that treatment delays may reduce the benefit of achieving SVR.

We also observed a drop-off in completed HCC screening orders (72%). Though not terribly low and not a necessary procedure for treatment approval, it is still an area for improvement, as HCC screening is necessary for health maintenance, especially in patients with advanced fibrosis. However, HCC screening typically requires an additional visit and, therefore, an additional trip requiring some form of transportation. This can pose a financial burden for some patients who lack the necessary means to make multiple trips requiring transportation. Perhaps the simple solution would be to coordinate these screenings with other standard of care appointments to reduce the need for multiple visits.

Hospital-based testing and linkage programs can be successful and are a necessary component in the fight to eradicate HCV. However, not all adults use these facilities; though all adults in the BC should be screened for HCV. Provider- and system-level initiatives are needed, now perhaps more than ever, to expand the reach of testing, education and linkage to care initiatives into emergency rooms, nonmedical settings and other community-based facilities.

Eradicating HCV has been deemed a global “moral imperative” and is becoming a global health reality due to the recent emergence of curative and arguably cost-effective DAAs. We cannot get too excited, though, because we have placed the cart before the horse. We now need to place as much money, time, and effort that went into developing a cure into identifying those who need it and getting them into necessary care.

Disclosures: Fishbein reports various financial relationships with AbbVie, Boehringer Ingelheim and Gilead. Geboy reports no relevant financial relationships.

We are all well aware of the progression and impact of HCV: (a) it has surpassed HIV as a cause of death in the United States; (b) it is the most common blood-borne infection in the U.S. and affects approximately 185 million people globally; (c) in the U.S., an estimated 2.7 million to 5.2 million people are living with HCV; (d) it increases the risk for fibrosis, cirrhosis and hepatocellular carcinoma and is a major indication for liver transplantation in the U.S.; and (e) it is associated with several extrahepatic manifestations such as renal disease, skin disorders and impaired quality of life. And despite the opportunity to cure greater than 90% of chronically infected individuals with the new direct-acting antiviral therapies administered once a day for between 8 and 24 weeks, 45% to 85% of chronically infected persons are estimated to be unaware of their infection. Thus, they leave their primary care appointment without being tested and are at continued risk for progressive disease.

Alexander Geboy

Dawn Fishbein

Ideally, once identified, all patients would continue through the HCoC to cure without setback. Yet while gaps clearly exist in all stages (ie, low rates of confirmatory testing, linkage to specialty care and treatment initiation), identification remains a critical gap. What is more problematic is we are running out of time to maximize the impact of life-saving medications. Last year, Denniston and colleagues reported prevalence of 2.7 million persons with chronic HCV between 2003 and 2010; this is lower than the 3.2 million reported between 1999 and 2002. They propose that the dip in prevalence is not a result of more patients receiving treatment, but attributable to an increase in HCV-related mortality, mostly within the “baby boom” generation, known simply as the Birth Cohort (BC).

Fortunately, the foundation has been established to identify the entirety of this population. In 2012, the CDC expanded BC and high-risk population HCV testing recommendations. They also released a Prevention and Public Health Fund (PPHF) funding opportunity to improve early identification of HCV in clinical and community settings and enhance linkage to care, treatment, and preventative services. In 2013, the United States Preventive Services Task Force (USPSTF) modified its stance and assigned a grade B recommendation to align with the CDC; and in 2014, the CMS issued a decision to reimburse screening for HCV when ordered within a primary care setting. This CMS guidance is very limited in its scope and will hopefully be revised as data is generated in alternative settings, such as EDs, revealing high rates of HCV.

Within the District of Columbia, from 2008 to 2012, there were 9,819 newly confirmed cases of HCV with 15,915 total cases documented during this timeframe, representing 2.5% of the D.C. population. It is estimated that HCV infection is approximately two times more prevalent than HIV infection. However, in D.C. the reported rate is equivalent. Thus, the D.C. HCV rate is likely a conservatively low estimate.

Constructing the Continuum

It was with PPHF funding in 2012 that we developed a primary care-based HCV testing and linkage program at MedStar Washington Hospital Center (MWHC) in Washington, D.C. The initial aim of our HepC Linkage to Care Navigation program was to identify a naive, previously untested population, provide either a free OraQuick HCV Rapid Antibody Test (OraSure Technologies) or have the PCP order an HCV antibody test (a reflex to HCV-RNA option was made available in mid-2013), and link HCV-positive people into appropriate HCV care services.

Testing focused exclusively on the BC, and patients were identified as eligible for testing via real-time chart review based on previous HCV testing and risk factors. Pop-up reminders with focused messages were manually inserted into each eligible electronic medical record (EMR) requesting HCV antibody testing based on CDC and USPSTF recommendations, or offering rapid tests (performed by the program coordinator) if no HCV antibody test was ordered. Advancement through the patient chart could not continue until the pop-up message was closed. It was the provider’s choice to offer the test to the patient or order the test as a part of the laboratory requisition.

PAGE BREAK

If a provider elected a venipuncture test, they ordered an HCV antibody test. All results were automatically populated into the patient’s EMR and monitored by the HepC program team. If a patient was found to be HCV antibody positive, but did not have a confirmatory test, an electronic communication was sent to the provider to alert the patient of the result and order a HCV RNA test, or to provide the patient with an expedited referral to either Infectious Disease (ID) or Gastroenterology (GI) for further testing and counseling. For positive rapid HCV antibody tests, on-the-spot counseling was provided by the tester, an RNA test was ordered by the PCP, and an expedited referral to ID or GI was provided for an initial medical assessment. All appointments were made via clinic Medical Assistants (MAs).

In 2014, with funding from the Gilead FOCUS partnership, we expanded our program to identify and link patients who were previously tested HCV positive and who had fallen out of care back into appropriate HCV care. This was accomplished through an EMR search for patients who had a history of HCV infection (either antibody positive or HCV RNA positive), but who did not have an HCV specialty visit in more than 1 year. Once identified, we queried PCPs to either initiate or allow our team to initiate contact. Once linked, (ie, an appointment had been made with our team) we continued with follow-up contact until the patient was successfully engaged in HCV care (ie, seen at an office visit by an ID or GI physician).

 

In an effort to provide a higher level of service, we assumed most clinic-related responsibilities, such as appointment scheduling and medication prior authorizations. In addition to two dedicated providers, we hired a patient navigator (formerly a MA in our clinic) and two social workers (formerly inpatient hospital social workers) to engage patients, assess and resolve barriers throughout the HCoC, coordinate the medication authorization process, and engage external organizations to create HCV-focused referral options and services.

Once a patient was linked, and prior to a first subspecialty appointment, our social workers contacted patients to conduct introductory assessments to identify and mitigate immediate barriers that could interrupt initial engagement, and pertinent medical and psychosocial history (ie, lack of transportation, current history of drug/alcohol abuse). Post-first visit, social workers completed a more in-depth biopsychosocial assessment to identify strengths and barriers to accessing future medical care. As patients moved through the HCoC, our patient navigator and social workers provided appointment reminders, followed up with missed, no-show or canceled appointments, and held biweekly support groups for patients at all stages of the HCoC. Testing days, supported by targeted media campaigns, were held at our hospital to increase HCV awareness, provide rapid tests and on-the-spot HCV counseling services.

HCoC Results

Our HCoC in the graph above combines data for 3 years, and includes data from our CDC and Gilead FOCUS funding sources. We focused on key milestones from diagnosis to linkage, subspecialty engagement and treatment. This figure does not include all patients screened, only those who were HCV antibody positive. We expanded our HCoC to include key diagnostic decision points such as liver staging (LS) and hepatocellular carcinoma screening that should be included as HCV standard of care, but are not referenced in most of the reported Continuum of Care data, as well as those cured. Regarding subspecialty engagement, once patients were in care, they were typically seen by our two ID providers and a full diagnostic workup was undertaken. This included alcohol and drug screening and harm reduction counseling, and LS (via Fibrosure [Biopredictive], Fibroscan [Echosens] and liver biopsies) and HCC screening (via abdominal ultrasound, CT and MRI) were ordered for all patients in need of assessment.

PAGE BREAK

Concluding Remarks

Though not the focus of this article, from our CDC grant, 2,320 HCV tests were performed for an antibody prevalence of 7.6%. On July 1, 2015, we expanded testing to MedStar Health Primary Care Clinics through the EMR prompting system. This is still under development.

Clinic-based screening and linkage-to-care programs can be effective at retaining patients throughout the HCoC. We were able to overcome many of the commonly cited barriers to link 96% of those identified as chronically infected into care. Furthermore, our treatment rate of 27% of patients seen by a specialist (68% of patients who had a prescription written) represents progress considering the national average of patients making it this far through the HCoC is 7% to 11%. D.C. Medicaid did not start approving some of the newer DAAs until February 2015; thus, treatment results may be lagging. However, the bar needs to be set much higher than prior data on the Continuum of Care. Data using these new interferon-free DAAs needs to be published so that we can understand what the accepted treatment rate should be. Many of us would argue that we need to be approaching 100%, and quite soon, though barriers still remain in this continuum.

A low treatment rate does, however, identify a common and unique barrier for patients and providers. Unlike the other stages, treatment approval has little to do with the quality of care provided. Costs are high, and though newer DAA regimens are being covered by many insurance providers, there are coverage limitations aligned with disease severity, making it difficult for providers to treat all patients. However, it has been noted that treatment delays may reduce the benefit of achieving SVR.

We also observed a drop-off in completed HCC screening orders (72%). Though not terribly low and not a necessary procedure for treatment approval, it is still an area for improvement, as HCC screening is necessary for health maintenance, especially in patients with advanced fibrosis. However, HCC screening typically requires an additional visit and, therefore, an additional trip requiring some form of transportation. This can pose a financial burden for some patients who lack the necessary means to make multiple trips requiring transportation. Perhaps the simple solution would be to coordinate these screenings with other standard of care appointments to reduce the need for multiple visits.

Hospital-based testing and linkage programs can be successful and are a necessary component in the fight to eradicate HCV. However, not all adults use these facilities; though all adults in the BC should be screened for HCV. Provider- and system-level initiatives are needed, now perhaps more than ever, to expand the reach of testing, education and linkage to care initiatives into emergency rooms, nonmedical settings and other community-based facilities.

Eradicating HCV has been deemed a global “moral imperative” and is becoming a global health reality due to the recent emergence of curative and arguably cost-effective DAAs. We cannot get too excited, though, because we have placed the cart before the horse. We now need to place as much money, time, and effort that went into developing a cure into identifying those who need it and getting them into necessary care.

Disclosures: Fishbein reports various financial relationships with AbbVie, Boehringer Ingelheim and Gilead. Geboy reports no relevant financial relationships.