The Role of e-Health in Optimizing Task-Shifting in the Delivery of Antiviral Therapy for Chronic Hepatitis C

Introduction

Hepatitis C virus (HCV) infection is a major contributor to the global burden of infectious diseases. There are ∼180 million patients with chronic hepatitis C worldwide. ^{1 –3} In the United States, an estimated 2–3 million patients have treatment-naive chronic HCV infection; a significant proportion of these HCV-infected patients are diagnosed late, presenting with cirrhosis-related hepatic decompensation (liver failure) due to lack of effective screening protocols. ^4,5

On June 28, 2016, the FDA approved sofosbuvir/velpatasvir, a fixed-dose direct-acting antiviral (DAA) coformulation (single tablet) with pan-genotypic activity to treat all six major genotypes of HCV in adult patients with and without cirrhosis. ⁶ Thus today, every HCV-infected patient is a potential candidate for antiviral therapy. ⁷ However, access to HCV therapy in the United States continues to be limited by a provider shortage in the current specialist physician treatment model. The recent approval of second-generation DAA agents against HCV marks remarkable progress in terms of safety, tolerability, efficacy, and truncated duration of therapy and may shift the bottleneck in treatment access to the dearth of treating specialist physicians, particularly in remote areas.

Before the approval and availability of DAA agents, patients with HCV were treated with interferon-based regimens for 24 to 48 weeks. Unfortunately, interferon-based treatment of HCV-infected patients resulted in suboptimal response rates, high risk of adverse effects, poor tolerability to injectable regimen, and limited number of providers with expertise in treating chronic hepatitis C. Currently, available DAA agents have provided high cure rates, almost no adverse effects, truncated treatment course, and an opportunity to expand the pool of HCV treaters with downstream benefit of improving access to hepatology service in remote underserved areas.

Based on our experiences, a task-shifting treatment model is an effective alternative that facilitates easier treatment access—utilizing the relatively larger pool of nonspecialist healthcare providers such as nursing staff (medical assistants, vocational licensed nurses, registered nurses, etc.) and advanced practice providers (nurse practitioners and physician assistants). ^8,9 The task-shifting treatment model was recently introduced and implemented on a large scale by the World Health Organization with positive results in the fight against the human immunodeficiency virus, both in the United States and abroad. The ability to efficiently treat HCV-infected patients approved for DAA-based regimen can be optimized by using one of the above-mentioned nonphysician healthcare providers based on their scope of practice. ¹⁰

In this brief communication, we report the impact of integration and implementation of e-health-facilitated patient management on our task-shifting HCV treatment model—to monitor HCV-infected patients in the setting of a physician-backed safety net that utilizes the electronic medical record (EMR) system for secure and efficient communication between patients and key providers. The term e-health is a recent term for healthcare practice supported by electronic communication processes and the usage of the term varies. In our discussion, e-health refers to health informatics with a broad definition covering electronic/digital processes in health, healthcare practice using the Internet, and health applications/links on mobile phones—sometimes referred to as m-health or m-health. Up-to-date cybersecurity is the key to the success of widespread implementation of e-health. In the following account, we have attempted to present our experience since the approval of DAA agents at three remote outreach clinics, 180 to 230 miles away from our tertiary care center. We believe that the e-health platform has played a pivotal role in improving our capacity to treat a significantly higher number of HCV-infected patients in these remote outreach clinics.

Methods

Results

Between January 2015 and June 2016, we treated over 100 HCV-infected patients with DAA agents using our task-shifting treatment model. In our practice, we have not yet experienced DAA-related emergencies, and we have experienced only a few instances of symptoms deemed urgent by patients and a few critical laboratory results; however, none of these events warranted a referral to a local urgent care facility or emergency room. Three patients needed a visit to emergency room to address complications of end-stage liver disease and/or anemia related to ribavirin use. Symptom calls necessitating follow-up clinic visits by the hepatologist were noted in < 5% of patients and were found to be unrelated to DAA use, with the exception of anemia-related symptoms due to ribavirin use. Up to 20% of patients reported mild fatigue and self-limited headaches. Patients who were treated with DAA agents via task-shifting at our outreach clinics reached comparable results in regard to their sustained virological response rates at 12 weeks when compared with that of national studies with DAA. Integration of e-health to optimize task-shifting did not lead to significant differences in outcome. More importantly, it improved the access and capacity of our clinic.

Discussion

During the interferon era, we treated 20–30 HCV-infected patients annually, with 75–80% of the patients needing 48 weeks of treatment (based on HCV genotype) and the remainder needing 24 weeks of treatment. These patients on interferon regimens required laboratory tests on a monthly basis and follow-up visits with a hepatologist every 4–8 weeks during treatment. Since the availability of DAA agents in late 2013, our treatment capacity has more than doubled at these outreach clinics. As outlined in our study, all-oral DAA agents have provided truncated treatment duration with a significantly higher efficacy, safety, and tolerability compared with interferon-based regimens. HCV-infected patients treated with DAA agents are seen face-to-face at the time of decision to start treatment, and their next follow-up visit is 12 weeks after completion of 8–12 weeks of therapy (in 75% of patients), with the remaining patients being treated for 24 weeks. The favorable pharmacological profile of DAA agents and adaptation of task-shifting model have immensely improved the access to our outreach clinics; however, a third central component of our success is e-health. We have been able to securely communicate with our patients and staff in these remote outreach clinics, and the capacity, efficiency, and productivity of our outreach clinic have improved significantly. We believe e-health is the backbone to our DAA-based task-shifting HCV treatment protocol in remote and underserved outreach clinics.

With the limited number of specialist physicians and ease of use of DAA agents, it is logical to shift the task of addressing HCV treatment in the United States to nonspecialist healthcare providers and advanced practice providers according to their scope of practice with oversight from a specialist physician. While our task-shifting treatment protocol includes the use of telephones, pagers, EMR, and computers with access to high-speed Internet, we have recognized that throughout our experience with second-generation DAA agents, there was rarely a need for our hepatologist to intervene for medical adherence, tolerance, laboratory results, and medication-related side effects.

Conclusions

In conclusion, e-health and e-platforms have been the backbone to our implementation of DAAs in the setting of task-shifting at our outreach clinics. They brought efficiency to the setup and allowed for direct and secure communication among providers and patients; without e-health and e-portals, the increase in capacity, the remote management of HCV patients, and the implementation of task-shifting would not have been possible. The last two decades have heralded the rapid utilization of the Internet in conjunction with an ever-adapting software/hardware industry. This advancement in technology has helped the medical community start its nationwide transition to an EMR system. Moreover, these technological advancements have created secure ways for healthcare providers and patients to communicate almost instantaneously. While we have highlighted the importance of e-health in the management of HCV through the task-shifting treatment model, telemedicine is also a field with tremendous practical implications in this area. Others have already ventured into utilizing telemedicine with nonspecialist primary care physicians to diagnose and refer HCV-infected patients in rural areas. ¹¹ Telemedicine, in conjunction with task-shifting, may further efforts to battle HCV.