Nonalcoholic fatty liver disease (NAFLD) – the hepatic manifestation of the metabolic syndrome – is the most common cause of chronic liver disease in the industrialized world. With insulin resistance being the underlying pathophysiological defect, the global prevalence of NAFLD is 25.24%, giving rise to significant healthcare expenditures. The most common causes of death in NAFLD are liver-related complications and cardiovascular disease.
Within the diagnostic spectrum of NAFLD, simple fatty liver disease (steatosis) is a benign entity, reversible by weight loss. In contrast, inflammatory cell infiltration leading to nonalcoholic steatohepatitis (NASH) is a more aggressive condition that may result in varying degrees of fibrosis and cirrhosis.
Currently, no therapies have been approved for the improvement of NAFLD/NASH and there is a huge unmet medical need to get an FDA/EMA approved treatment for these conditions. Genfit and Intercept Pharmaceuticals Inc., two clinical-stage biopharmaceutical companies, are currently focusing on the development of innovative therapies for metabolic liver disorders, including NAFLD/NASH. Ongoing clinical trials may expand our current understanding of the disease and provide hope for finding safer and more effective agents in the future.
Non-invasive diagnostic tools in NAFLD/NASH
Liver fibrosis is the most important predictor of overall and disease-specific mortality in NAFLD/NASH, with the risk of liver-related mortality raising exponentially with increase in fibrosis stage. As a consequence, the accurate non-invasive staging of liver fibrosis is of paramount importance to determine the state of disease progression, therapy responses, and to optimize treatment strategies.
Currently, the place of liver biopsy as the standard of reference for assessing liver fibrosis has been challenged by the increasing awareness of a number of drawbacks related to its use (invasiveness, sampling error, inter-/intraobserver variability).
In parallel with this, non-invasive assessment of liver fibrosis has experienced explosive growth in recent years and a wide spectrum of non-invasive diagnostic methods have been developed. Some are validated methods, such as transient elastography, and are gaining a growing role in routine clinical practice.
How competitive is FibroTouch?
MR elastography is effective for detecting fibrosis but is a costly procedure mainly used for research purposes. Transient elastography FibroScan® (Echosens, Paris, France) is a globally used noninvasive method for the detection and quantification of liver fibrosis and hepatic steatosis using the liver stiffness measurement (LSM) and the controlled attenuation parameter (CAP), respectively.
FibroTouch, a new generation of transient elastography that integrates a two-dimensional image-guided system for precise positioning, possesses independent intellectual property rights. LSM and the fat attenuation parameter (FAP) can be synchronously measured by FibroTouch for the quantitative assessment of liver fibrosis and hepatic steatosis, using a dynamic broadband ultrasound probe that can overcome errors encountered in obesity, automatically adjusting the thickness of subcutaneous fat in all body shapes, including those of children, adults, and obese patients.
FibroTouch has shown good diagnostic performance compared to liver biopsy and FibroScan. Benefiting from the creative probe, FibroTouch has a higher rate of successful detection than FibroScan (100% vs. 97%, respectively)
Capture the opportunity
In spite of many great strides in understanding the pathophysiology of NAFLD/NASH, the lack of effective interventions along with the rapid expansion of the population with the metabolic syndrome pose an ever-increasing threat to healthcare systems worldwide.
To date, however, there is an overwhelming optimism in the field with respects to the prospects of developing disease-modifying intervention to delay the onset of liver fibrosis, and eventually to prevent it.
The shift towards non-invasive assessment of hepatic fibrosis with FibroTouch has brought prevention and treatment trials of NAFLD/NASH much closer to each other than before.