These are challenging times in the public health front, as a new disease epidemic, each with its own challenges to overcome, keeps cropping up every few years. Recent outbreaks have been mostly viral in origin, including those caused by the Ebola, Zika, and pandemic flu viruses. However, the next global threat could be metabolic, and in the form of a liver disease that most people are not even aware of—non-alcoholic steatohepatitis (NASH).

This “silent” liver disease originates with the accumulation of fat in the liver and does not show any recognizable symptoms at an early stage. It therefore remains mostly undetected until the accompanying inflammation worsens, leading to scar tissue formation and eventual liver failure. In fact, NASH is projected to become the number one cause for liver transplantation in the US within the next decade, surpassing hepatitis C.

Affecting more than 60 million people worldwide, NASH is tightly linked to obesity, which – decades after it was called an epidemic – is still itself an unsolved public health threat. Given the association between these diseases, it is not surprising that physicians recommend diet and exercise as the first line of therapy for most NASH patients. However, the majority of people are unable to follow through these lifestyle modifications and end up seeking medical treatment as the disease progresses. At this juncture, physicians are stuck, as there are no drugs approved specifically for the treatment of NASH, and the few treatments used off-label are riddled with sub-optimal efficacy and safety issues.

There is hope on the horizon, however. A number of drugs are in late-stage development, including Intercept’s Ocaliva, Genfit’s elafibranor, Gilead’s selonsertib, Galmed’s aramchol, Tobira’s cenicriviroc, Conatus’ emricasan, and Novo Nordisk’s semaglutide. In spite of this, it remains to be seen which of these therapies will ultimately be commercialized, since there are a myriad of challenges to be faced on the way. The most important of these are: poorly understood etiology and pathophysiology of the disease, heterogeneous patient populations, a dearth of biomarkers for patient staging, and the need for consensus clinical endpoints. That being said, a concerted effort by major stakeholders can go a long way in mitigating these issues.

All in all, a multi-pronged approach including pharmacotherapy and lifestyle changes, in addition to greater involvement by healthcare agencies and policy makers, would be essential to curb and possibly avoid the looming NASH epidemic.

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