COMMENTARY

Lessons Learned During COVID-19 Will Help Us Better Treat HCV

William F. Balistreri, MD

Disclosures

April 21, 2021

If the pandemic can be said to have any silver lining, it is that the rapid transition to telehepatology services allowed us to freshly address some of the key challenges that preceded it. Nowhere has this been more apparent than in our ability to simplify the care of patients with hepatitis C virus (HCV).

Typically, the care for such patients involves multiple steps and several providers. Anti-HCV screening is followed by the testing of positive patients for viremia, usually conducted by the primary care team. Patients are then referred to a specialist for HCV genotyping and staging of liver disease. If HCV treatment is prescribed, scheduled monitoring visits are conducted. This long road to a cure presents many opportunities for speed bumps that can delay or interrupt care.

Overcoming the Complexity of Care

Even before the pandemic, several programs aimed to reduce the complexity of the cascade of care. For example, Project ECHO programs combining various modalities of telemedicine mentored providers in rural and underserved communities on how to provide essential HCV care.

Using a different approach, we worked with the Kentucky Rural Health Association (KRHA) to overcome access barriers for patients in our outlying referral areas. Our southwest Ohio center borders Kentucky and includes portions of West Virginia, which are high-risk, low-resource rural areas with limited numbers of healthcare providers and specialists. Because of substantial issues with injection drug use, this Appalachian region has some of the highest rates of hepatitis C in the United States. Compounding these challenges is the fact that many residents lack resources for travel and specialist access.

The Kentucky Hepatitis Academic Mentorship Program was established in 2018 by the KRHA with the goal of building an expanded workforce of local providers, trained by experts, to screen, diagnose, and treat persons with HCV. This program allows patients to receive HCV care and treatment with their known local provider, thus overcoming many of the obstacles to healthcare access. In 2020, it was extended as the West Virginia Hepatitis Academic Mentorship Program.

Adapting Our Programs to Telemedicine

Our referral area additionally faces the dual epidemic of injection drug use and HCV infection among pregnant women. This results in a significant number of newborn infants who are HCV infected through perinatal transmission at delivery.

The revised US Preventive Services Task Force statement recommended HCV screening for all pregnant women during each pregnancy. With more attention to screening of infants born to women with documented drug use or HCV infection, or those at high risk, the number of newborns and toddlers referred to us substantially increased.

Before the pandemic, we based our clinical care pathway on a streamlined version of the structure used in our clinical trials of direct-acting antiviral (DAA) regimens for children and adolescents with chronic HCV infection. Since the US Food and Drug Administration's approval of these DAA therapeutic agents for children and adolescents, our approach was to schedule a baseline clinical visit, with follow-up clinic visits and laboratory monitoring at treatment weeks 4 and 12 and then at week 24 (12 weeks after treatment).

We pivoted our approach during the pandemic. Our telehealth service allowed us to further simplify the treatment of patients with HCV. We established a hybrid care model, combining video visits with minimal in-person visits and a reduced number of laboratory assessments, to serve the needs of our young patients.

A Potential Model for Simplifying HCV Care

Data presented at The Liver Meeting (and also at the recent Conference on Retroviruses and Opportunistic Infections) evaluated the success of a strategy to streamline HCV treatment delivery and the associated laboratory monitoring without compromising efficacy or safety. The authors reported an open-label trial that evaluated a minimal monitoring (MINMON) approach to HCV therapy. Adult participants received a single-tablet, fixed-dose DAA pangenotypic regimen; hence, no genotyping was required. All tablets were dispensed at entry, and no on-treatment visits or laboratory studies were required. Remote contact was established at week 4 for assessment of adherence and at week 22 to verify the response. The authors reported that the MINMON approach to HCV treatment delivery was safe and achieved sustained virologic response rates comparable to current standards.

The availability and real-world success of the pangenotypic DAAs will permit streamlining of treatment protocols. However, it must be cautioned that in view of the long-term risks in patients with fibrosis, it will be important to gauge the severity of liver disease before initiation of therapy.

The 2019 hepatitis C guidance update from the American Association for the Study of Liver Diseases-Infectious Diseases Society of America offers a simplified HCV treatment algorithm for persons aged 18 years or older who have not been previously treated for their infection and do not have evidence of cirrhosis. As stated in the updated recommendations from the European Association for the Study of the Liver, cirrhosis must be identified because it may require adjustment of treatment regimens. In addition, posttreatment surveillance for hepatocellular carcinoma is mandatory.

The pretreatment evaluation, which in my opinion could be conducted remotely, should include, in addition to an assessment for cirrhosis, a search for potential drug-drug interactions and screening for hepatitis B. The virtual visit can offer patient education regarding treatment administration and the importance of adherence.

As we continue to overcome access and care barriers, we may be able to adapt "COVID-safe" minimization approaches for our pediatric population. This must be linked to more universally applied HCV case-finding strategies.

Postpandemic life will be different; however, the somewhat sudden migration to the virtual world has equipped us all with new tools with which to successfully meet the challenges.

William F. Balistreri, MD, is the Dorothy M.M. Kersten Professor of Pediatrics; Director Emeritus, Pediatric Liver Care Center; Medical Director Emeritus, Liver Transplantation; and Professor, University of Cincinnati College of Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center. He has served as director of the Division of Gastroenterology, Hepatology and Nutrition at Cincinnati Children's for 25 years and frequently covers gastroenterology, liver, and nutrition-related topics for Medscape. Dr Balistreri is currently editor-in-chief of the Journal of Pediatrics, having previously served as editor-in-chief of several journals and textbooks. He also became the first pediatrician to act as president of the American Association for the Study of Liver Diseases. In his spare time, he coaches youth lacrosse.

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