Acute hepatitis C infection is on the rise among kidney disease patients who are on dialysis. In fact, between 2014 and 2015, the Centers for Disease Control and Prevention (CDC) received reports of about 36 cases of acute hepatitis C infection in 19 different hemodialysis clinics in eight states. “Lapses in infection control (eg, injection safety, environmental disinfection, and hand hygiene) were commonly identified at these facilities,” CDC stated.
Hepatitis C disproportionately affects patients with advanced kidney disease on dialysis, with increased rates of morbidity and mortality the longer they are on dialysis.
In an effort to reverse these trends, Fresenius Medical Care (FMC), headquartered in Waltham, MA, has launched a major initiative to diagnose, treat, and prevent hepatitis C in its clinics through a comprehensive and integrated approach that provides coordinated, personalized care. FMC aims to achieve this “through its network of social workers who are trained to provide individualized care for each patient’s unique needs, extending additional emotional support and building strong relationships with each patient to help ease the challenges of living with kidney disease,” according to the company.
In this interview, Dr. Franklin Maddux, a nephrologist and FMC’s Chief Medical Officer, discusses the need for improved care for patients with chronic kidney disease, particularly those with hepatitis C, and he explains how this integrated care strategy can improve health outcomes for these patients.
MDLinx: Can you describe the scope of the problem for dialysis patients, particularly in relation to hepatitis C?
Dr. Maddux: Hepatitis C is more prevalent in patients with end-stage renal disease (ESRD) than the general population. Patients with hepatitis C are at higher risk for many other disorders including cardiac events, infectious events, and progressive liver injury leading to premature morbidity and mortality. Historically, the treatment with interferon and ribavirin was poorly tolerated with many side effects and had only a partially beneficial response. Since the introduction of the direct-acting antiviral medications—and specifically those that can be safely given to patients with advanced renal disease—the opportunity to cure hepatitis C in this group of patients is remarkably improved. The results of trials on patients with kidney failure show a response and cure rate as measured by a sustained viral response at 12 weeks post-treatment in excess of 95%. This is a very gratifying result for a new class of medications that are easy to take and have relatively few side effects.
MDLinx: What is your integrated care model, and how will it help these patients?
Dr. Maddux: Our approach has been to organize around the identification of people with active hepatitis C and characterization of the exact type of virus they are infected with. This includes organization of a case management process to help them assess any systemic disease from their infection and to consider treatment with observation and support throughout the process of gaining treatment authorization, management, and clinical observation during treatment and testing and review for response following a course of therapy. This end-to-end support has provided a chance to help patients and physicians navigate the difficult environment of identifying disease and accessing a potentially curative therapy.
MDLinx: How do social workers play a major role in this integrated approach?
Dr. Maddux: Social workers have a key relationship with patients and the social determinants of their health needs and outcomes. I think the social worker can act as a strong advocate that patients with hepatitis C have good options now to treat and cure their disorder. As those who facilitate the interaction patients have in navigating the health care system, social workers offer the chance to make sure that patients don’t fall through the cracks in the system when a beneficial treatment is available and support systems are needed to affect the therapy.
MDLinx: Do you have any outcomes data yet on this integrated approach?
Dr. Maddux: We continue to collect and monitor the outcomes, as this is a complex and long course of testing and therapy to achieve the confidence that a cure is achieved. We are seeing as many as 5% of our population of patients with the genotype for hepatitis C that is directly treatable. The mechanics of getting approved for therapy, initiating therapy, and completing the course takes about several months today. As such, we have clearly cured a group of people who were previously unable to tolerate or respond to treatment and are very pleased that for many patients this is a highly beneficial therapy that they and their medical teams have undertaken.
MDLinx: You're also a major supporter of The Chronic Kidney Disease Improvement in Research and Treatment Act. What's the latest on that bill?
Dr. Maddux: This Act is part of the bill introduced by House members Tom Marino (R-PA), John Lewis (D-GA), and Peter Roskam (R-IL). We are very interested in seeing the bill move forward or that other legislative vehicles in Congress take these provisions and move them forward. It is a complex legislative climate today. Some of the key attributes of the bill will help to highlight the need for more research that includes and incorporates patients with advanced kidney disease; stabilization of the ESRD prospective payment system; advancing innovative care models that benefit patients as options for their care delivery; rationalization and harmonization of quality programs and measures that make sense to patient and physicians; and support for telehealth to expand and provide greater access to caregivers for patients desiring home dialysis or transplantation as a mode of treatment for their kidney failure.
About Dr. Maddux: Franklin W. Maddux, MD, FACP, is the Chief Medical Officer and Executive Vice President for Clinical and Scientific Affairs at Fresenius Medical Care North America. He is also Chair of Kidney Care Partners, an advocacy group whose goal is to improve the quality of care for individuals with chronic kidney disease.