Health Information Technology Use Toward Eradicating Hepatitis C from an Underserved Community

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV) that affects roughly 4 million Americans. Hepatitis C kills more Americans than any other infectious disease that is reported to the CDC.(1) Because this virus often is undetectable due to its lack of noticeable clinical symptoms, it has been labeled a silent epidemic. The prevalence of hepatitis C infection in indigenous populations is thought to be higher than that in non-indigenous populations.(2) The primary purpose of our study was to assess the impact of HCV on the Blackfeet Native American people of North America.

Background

Browning, Montana, is the main town located on the Blackfeet Reservation where the majority of the Blackfeet Native Americans reside. On the surface, it resembles any other small rural town throughout the United States. Given the high incidence of hepatitis C in the Browning Community, a working group of professionals from the Indian Health Service along with Tribal Health Representation has established policy recommendations for coping with the epidemic. Globally, 170 million people are estimated to be infected with HCV.(3) The disease burden in North America is greatest in the American Indian and Native Alaskan populations. The most recent data reflecting the total Browning population (Tribal Council, 03/25/19) report 8556 residents on the reservation. The most recent data from the Blackfeet Community Hospital Indian Health Service database state that 236 persons were infected with the virus, based on individuals tested at the Indian Health Service in Browning. The hepatitis C working group believes that more than 500 individuals on the Blackfeet Reservation could be infected with the virus. The ratio of infected individuals relative to the entire Browning population is approximately 4%, but it is 10% when only the adult population is considered, indicating that 1 in 10 adults could be affected with HCV. The progression of hepatitis C is propelled by elevated rates of comorbid conditions including type 2 diabetes mellitus, liver disease related to alcohol use, and indiscriminate sexual intercourse accompanied with HIV coinfection. As of 2010, HCV infection had surpassed HIV infection as a cause for mortality in the United States.(3)

Hepatitis C is an indolent chronic disease. After 20 to 30 years of infection, 5% to 20% of individuals can be expected to develop cirrhosis of the liver, which can progress to hepatocellular carcinoma or fulminant hepatic decompensation.(4) This leads to lack of individual productivity, recurrent hospitalizations, family collapse, and patient deaths. One of the most daunting aspects of the epidemic on the Blackfeet Reservation is the cost barriers to treating infected individuals. Treatment with several antiviral technologies is curative; however, federal government cost pricing for these technologies tends to be in the area of $10,000 to $15,000 per treatment cycle. It is unrealistic to think that all infected individuals will be treated, but if that were to occur, the total cost could approach $4 million. This figure outstrips the annual budget for the Blackfeet Community Hospital pharmacy department. As a result, a protocol has been created for patient stratification that relies heavily on patient compliance, readiness, and the petition for Pharma compassionate use philanthropy. Unlike in the Department of Veterans Affairs, there is no line item budget for hepatitis C treatment in the Indian Health Service.

Objectives

The objective of this study was to investigate the hepatitis C epidemic on the Blackfeet Reservation and bring awareness to the problem. How can health IT aid in the detection and treatment of hepatitis C? Can conventional treatments make a difference?

Although HCV infection has reached epidemic proportions within the Native American community, studies conducted are limited to patients 18 years of age and older.(5) Analyses of the number of people infected with HCV on Native American reservations usually compare those numbers to the population as a whole,(6) which probably undervalues the percentage of people with HCV in relation to the population tested. In addition, not all Native American healthcare is provided through the Indian Health Service—some reservation healthcare is provided through tribal services. Consequently, it may not be possible to extrapolate the results from the implementation of a hepatitis C program at the Blackfeet Community Hospital to other reservations, due to variances in resources such as access to health IT.

Methodology

The retrospective data in our study were collected from November 2018 through June 2019. As of June 2019, there were 236 documented cases of active hepatitis C in the Blackfeet Community Hospital database. To establish a successful hepatitis C program, there must be a coherent workflow pattern including all parties involved. The following discussion details from start to finish how a patient is diagnosed and treated for hepatitis C:

• First, a patient goes through a preliminary screening at their regular office visit with community health nursing or clinic nursing.

• Nursing then administers an OraQuick HCV rapid antibody test. Positive results are documented in the EHR, and the patient is scheduled for an appointment with a provider.

• When a physician/physician extender makes a hepatitis C diagnosis, it is documented in the patient chart, and an electronic consult is placed to the hepatitis C pharmacist–driven clinic.

• The pharmacist reviews the patient’s chart notes and ensures that patients do not meet any of the exclusion criteria, such as poor maintenance medication compliance, recent drug or alcohol use, or invalid contact information. If none of the exclusion criteria are met, the pharmacist orders the HCV lab set.

• Community Health then reaches out to the patient to schedule the necessary blood draws for lab tests.

• Lab results are reported through Labcorp and imported into the lab section of the Indian Health Service EHR.

• Once results are available, the pharmacist performs a full chart review to ensure the patient meets the hepatitis C clinic criteria for readiness to treat and makes a pharmacologic decision for drug therapy.

• Before placing an order in the EHR for the selected medication, the pharmacist submits a completed electronic copy of the ECHO treatment analysis document to schedule a teleconference with Project ECHO—a team of infectious disease specialists and gastroenterologists/hepatologists including both MDs and PharmDs—out of New Mexico.(7) The pharmacist presents the treatment plan to the team via teleconference, and a final decision is made either to proceed with treatment or perform additional testing.

• The signed Project ECHO treatment analysis document is scanned into the patient’s chart in the EHR by the Health Information Management Department.

• Next, the pharmacist enters the medication order into the Report Patient Management System for processing. The e-claim will be rejected for patients with third-party coverage, which is predominantly Medicaid.

• Now the pharmacist pursues procuring the medication directly from the manufacturer based on compassionate care or the patient assistance program. Patients are eligible for compassionate care if they do not have third-party coverage or their third-party coverage denies payment for the medication even after two appeals have been filed. Only then can the medication be procured and dispensed. This entire process can take up to one month.

• Once the medication is delivered to the pharmacy, the pharmacist notifies the patient and counsels them about the therapy. Two main medications are used in the treatment of HCV at the Blackfeet Community Hospital—Mavyret or Epclusa—but other therapies are considered when necessary. Complete eradication of the viremia can take anywhere from 8 weeks to 24 weeks, depending on clinical factors specific to each patient. After the therapy is completed, the patients are scheduled to return for final blood work to assess virus detection. If no virus is detected, the patient has reached sustained virologic response, meaning the patient has been cured of hepatitis C. These results are documented in the patient’s EHR and the hospital’s hepatitis C e-database.

Results

From late 2018 to mid-2019, 236 people with a diagnosis of hepatitis C were followed (Figure 1). Patients’ original diagnoses had been made as early as 2009 or as recently as 2019. Of those 236 patients, 34 patient (14.4%) met the readiness-to-treat criteria and were referred to the hepatitis C clinic. These 34 patients were started on hepatitis C pharmacologic therapy, which lasted for 8 to 24 weeks, depending on the severity and clinical manifestations of the infection. The average treatment time was 12 weeks. Thirty patients (12.7%) had a sustained virologic response after finishing treatment, meaning they were essentially cured of HCV. Four of the patients who started hepatits C treatment were lost to follow-up and never returned for a final blood draw to determine sustained virologic response. Therefore, these patients are viewed as a treatment failure. On the other hand, 30 of the 34 patients (88%) who began pharmacologic therapy were cured of hepatitis C. The other 200 patients met at least one of the exclusion criteria—recent drug or alcohol use, poor maintenance medication compliance, or lack of valid contact information. Two patients who were not a part of the referral group spontaneously cleared the virus without pharmacologic intervention. (This occurs in roughly <10% of HCV infections worldwide.)

Figure 1. Initial treatment group and sustained virologic responses.

Discussion and Recommendations

The treatment results show that the pharmacologic therapy options are efficacious. With treatment, in less than one year, 12% of the total patient population were clinically cured of hepatitis C. All of the health IT resources—telehealth, e-consults, and maintaining a complete EHR—factored into treatment success. These modalities enable patients to receive a higher level of care that mirrors healthcare outside the reservation. Although four patients were lost to follow-up, they can return to have final blood work at any time to determine sustained virologic response to assess their HCV status. Because there was no specific line item budget for hepatitis C treatment, most of the medication was procured through compassionate care. This forced the hepatitis C committee to vote on prioritizing patients who met the stringent readiness-to-treat criteria. Other programs that are better funded follow the motto of treating every patient despite current behaviors. In addition, the Medicaid system in some states, such as New Mexico, is willing to cover the cost of hepatitis C drugs, making it possible to treat more patients in an expedited manner.

Based on our results, there was significant improvement in persons on the Blackfeet Reservation with documented HCV infection. To optimize this program, it will be imperative to allocate funds specifically for hepatitis C drugs; work with state lawmakers to push Medicaid to expand coverage; take a proactive approach, such as mental health counseling; and fully develop a needle exchange program to reduce the infection rate in the future. Once all of these mechanisms are in place, hepatitis C will be eradicated.

Conclusion

The number of individuals infected with HCV in the Native American community is alarming. More research using public health informatics is needed within the Native American population to provide up-to-date information regarding infectious viruses and diseases in these populations, which often are located in geographically remote areas of the United States. To significantly decrease the transmission of HCV, extensive efforts in client education, needle exchange, data management, virus testing, and pharmacologic intervention must be undertaken. This will require extensive involvement of Federal and Tribal resources. Aggressive and robust intervention to decrease the spread of HCV on the Blackfeet Reservation, as well as additional resources to manage the data to achieve optimal clinical outcomes, are urgently needed.

Acknowledgment: We thank the staff of the Blackfeet Community Hospital in Browning, Montana.

References

1. Hepatitis C Information. Division of Viral Hepatitis. CDC. www.cdc.gov/hepatitis/hcv/index.htm . Accessed April 20, 2020.

2. Rempel JD, Uhanova J. Hepatitis C virus in American Indian/Alaskan Native and aboriginal peoples of North America. Viruses. 2012;4:3912-3931.

3. Reilley B, Leston J. Tale of two epidemics—HCV treatment among Native Americans and veterans. N Engl J Med. 2017;377:801-803.

4. Leston J, Finkbonner J. The need to expand access to hepatitis C virus drugs in the Indian Health Service. JAMA. 2016;316:817-818.

5. Dow A, Thibault G. Interprofessional education: a foundation for a new approach to health care. N Engl J Med. 2017;377:803-805.

6. Stephens D, Leston J, Terrault NA, et al. An evaluation of hepatitis C virus telehealth services serving tribal communities: patterns of usage, evolving needs, and barriers. J Public Health Manag Pract. 2019;25 Suppl 5:S97-S100.

7. The University of New Mexico. Project ECHO. Hepatitis C virus programs. https://hsc.unm.edu/echo/institute-programs/hcv-community/ . Accessed April 19, 2020.