The FibroScan device pictured here assesses liver stiffness using Echosens patented VCTE technology.

Millions of Americans who are living with hepatitis C virus (HCV) will develop a chronic infection that, if left untreated, can cause serious health problems, including liver disease, cirrhosis, liver failure and liver cancer. More than one-third of HCV-infected individuals progress to advanced fibrosis and cirrhosis, and among those with cirrhosis, about 3–5% per year develop decompensated cirrhosis or hepatocellular carcinoma (HCC).

Nearly one-third of Americans have asymptomatic liver disease, also known as fatty liver disease (FLD). Approximately 85 million Americans have nonalcoholic fatty liver disease (NAFLD). In addition, a total of 20% have its more severe form, nonalcoholic steatohepatitis (NASH).

Liver disease often leads to developing other issues, such as advanced fibrosis, increased risk of cardiovascular events and, in extreme cases, liver cancer, liver transplantation and death.

One study on how NAFLD impacts patients treated and cured for HCV found that NAFLD identified in patients before treatment persisted after curing their HCV infection. Among those with NAFLD before treatment, 6.25% still had significant liver scarring after their HCV infection was cured.

Given these alarming statistics, clinicians are adopting VCTE technology, a noninvasive, painless and quick examination with a medical non-imaging modality that quantifies the stiffness of liver tissue. When it comes to identifying and monitoring liver disease earlier, this tool will also play a key role when medications for treating FLD reach the market.

FLD drugs in the pipeline

Novo Nordisk’s popular GLP-1 diabetes drug semaglutide — a weight-loss drug — has generated encouraging clinical results. Further studies are needed to see if semaglutide can reverse fibrotic-NASH. However, Novo states that its clinical results represent “the largest NASH resolution improvement so far,” confirming that the drug could be a potent anti-NASH agent.

In the phase 2 trial for semaglutide, a significantly higher percentage of patients on daily injections saw resolution of the effects of NASH — liver inflammation improved and liver cell ballooning eased — with no worsening in liver fibrosis than placebo patients experienced.

Another drug in the pipeline, obeticholic acid (OCA) from Intercept Pharmaceuticals, has shown it can improve liver fibrosis in 23.1% of patients, almost double the 11.9% rate investigators observed with placebo. Thus, OCA could be the first drug approved to treat fibrotic-NASH.

With the introduction of new treatment options, a targeted chronic care disease management (CCDM) program can help cost-effectively assess and manage the risk factors for NAFLD. Consistent scoring of liver stiffness and fat with vibration-controlled transient elastography (VCTE), such as FibroScan, a noninvasive point-of-care examination, supports the launch of these drugs in a way that could potentially improve outcomes and lower costs.

Prevention and treatment

Fortunately, NAFLD can be reversible if caught in the early stages. Research suggests that weight management is the best approach to controlling or reversing NAFLD. Even a loss of 3-5% can improve liver health. Also, exercise and diet therapy can reduce the fat accumulation in the liver and enhance hyperlipidemia, hypertension and insulin resistance.

The American Diabetes Association has recommended the evaluation of comorbidities that may impact NAFLD management. The identification of advanced fibrosis and cirrhosis is essential for risk factor reductions, medical management and improvement in daily activities and quality of life.

When it comes to addressing HCV and liver disease, clinicians should take a “whole person” approach to patient engagement and support behavioral changes that will lead to better outcomes and higher quality of life.

A closer look at VCTE technology

Current approaches for identifying fibrotic NASH tend to be complicated, expensive and potentially wasteful. In contrast, VCTE results and test scores are beneficial in providing additional information for clinicians, empowering them with data and information they can use in real-time to refer patients to a specialist or recommend changes to their overall care plans, if needed. Medicare, Medicaid and many insurance plans cover VCTE tools. A medical assistant can use such tools for immediate interpretation by a healthcare professional.

Clinicians can leverage VCTE quickly to provide a quantitative assessment of liver stiffness and liver fat at the point of care to make the detection of liver disease and long-term care for individuals with NAFLD and NASH more effective.

At the point of care, these tools can provide a simple, validated and reliable exam that creates savings for stakeholders. It does this by early identification of patients with FLD for proactive intervention and behavior change to slow disease progression. For those identified with liver fibrosis, these exams can also reduce the aggregate volume of some current diagnosis methods, such as liver biopsy.

Stephen Harrison

Dr. Stephen Harrison

The most effective noninvasive liver exam tools are highly mobile, can be operated by a medical assistant and interpreted by the healthcare professional. In addition, they produce numeric measurements rather than images for simplified interpretation and consistency of measurement. This capability enables clinicians to monitor changes in liver tissue over time. Eventually, it is likely that these noninvasive tools providing consistent liver measurements will become a routine part of care management. The tools are poised to play an increasingly important role in the detection and ongoing assessment of liver health to trigger FLD prescriptions at the appropriate time.

Dr. Stephen Harrison is a gastroenterologist and hepatologist. He is the medical director of Pinnacle Clinical Research and a visiting professor of hepatology at the University of Oxford.