[Edaily Reporter NA EUN-KYUNG ] “We need stronger clinical evidence that goes beyond a simple reduction in liver enzyme levels to demonstrate actual structural and pathological improvements in the liver.”

Kim Seung-eop, a professor in the Department of Gastroenterology at Yonsei University College of Medicine’s Severance Hospital, highlighted these future challenges for liver tonics in a recent interview with E-Daily. This is because the need to manage liver enzyme levels is growing as the number of patients with fatty liver disease increases in tandem with metabolic disorders such as obesity and diabetes. Professor Kim explained his prescribing experience and research findings regarding liver tonics such as Celltrion Pharm Inc.(068760)’s “Godex,” emphasizing that to enhance long-term therapeutic value, evidence demonstrating improvement in the disease itself—beyond just liver enzyme levels—is necessary.

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Fatty Liver Patients… Management Alongside Lifestyle Modifications

Godex is a liver medication manufactured by Celltrion Pharm Inc., and its approved indication is “liver disease with elevated transaminase (SGPT) levels.” SGPT is the former name for alanine aminotransferase (ALT), a liver function test marker, and is an enzyme primarily found within liver cells. When liver cells are damaged by conditions such as fatty liver disease, hepatitis, or alcohol consumption, the enzyme leaks into the bloodstream, causing levels to rise. Since Godex targets liver diseases characterized by elevated ALT rather than being limited to specific underlying conditions, it is prescribed to a diverse range of patient groups, including those with fatty liver disease, alcohol-related liver disease, and viral hepatitis.

Among these, the patient group whose proportion is growing in clinical practice is those with metabolic and fatty liver disease (MASLD). Based on his own prescribing experience, Professor Kim explained that approximately 50–60% of patients prescribed Godex have metabolic and fatty liver disease. Alcohol-related liver disease accounts for about 20–25%, while drug-induced liver injury and viral hepatitis combined account for about 15–20%.

He said, “In tandem with the rise in metabolic disorders such as obesity, diabetes, and hyperlipidemia, the number of patients showing elevated liver enzyme levels is increasing, and the age group of patients visiting the clinic after abnormal findings are detected during health screenings is gradually getting younger.”

Professor Kim explained that the role of liver-protective agents is to help improve liver enzyme levels while weight loss and dietary control take effect. The underlying principle is that, in addition to prescribing medication, the underlying conditions and lifestyle habits causing elevated liver enzyme levels must be managed.

When selecting prescription medications, both the patient’s liver damage profile and the drug’s mechanism of action are considered. Professor Kim elaborated that he considers ursodeoxycholic acid (UDCA) preparations in cases accompanied by cholestasis or biliary tract issues, and selects Godex for patients with markedly elevated ALT levels.

“We often start patients on Godex from the beginning if their ALT levels are more than two to three times the upper limit of normal during a health screening or blood test, or if early normalization is required,” he said. He explained that if improvement is insufficient even after administering other liver medications, the medication may be changed or supplemented.

Accumulated Prescribing Experience… The Next Challenge: Demonstrating Disease Improvement

Professor Kim cited the drug’s effectiveness in improving liver enzyme levels and accumulated clinical experience as the reasons behind the continued prescribing of Godex. Godex is a combination drug that includes carnitine; he explained that carnitine is involved in energy metabolism, such as by promoting the transport of fatty acids into mitochondria and their oxidation within liver cells.

He cited the “CORONA” and “GOAL” studies as relevant clinical evidence. According to Professor Kim, the CORONA study confirmed that administering Godex to patients with fatty liver disease and type 2 diabetes led to normalization of ALT levels and improvement in hepatic steatosis. In the GOAL study, patients with chronic hepatitis B and elevated ALT levels who received a combination of the antiviral drug entecavir and Godex showed a higher rate of ALT normalization compared to those treated with entecavir alone.

Professor Kim stated, “In some cases, Godex is used in combination with antiviral therapy when patients with chronic hepatitis B begin treatment to achieve slightly faster improvement in liver enzyme levels.”

The duration of treatment varies depending on the patient’s response and the underlying condition. Professor Kim explained that the initial treatment period is typically 3 to 6 months, and after about 3 months, blood tests are conducted to confirm whether ALT levels have normalized before deciding whether to continue the treatment. In cases where the underlying cause—such as MASLD—is difficult to resolve in the short term, or where patients must continue taking medication for other conditions, treatment may be prescribed long-term.

Professor Kim noted that for Godex to expand its prescription base in the future, it must accumulate clinical evidence demonstrating actual changes in liver condition, in addition to improvements in liver enzyme levels. He emphasized, “Clinical evidence must be strengthened to prove actual structural and pathological improvements in the liver, going beyond a simple reduction in ALT levels.”

In this regard, he introduced the ongoing “GOFLD” clinical trial. This study uses tools such as the FibroScan and magnetic resonance imaging proton density fat fraction (MRI-PDFF) to verify the efficacy of improving fatty liver disease. The FibroScan estimates the degree of fibrosis by measuring how quickly vibrations travel through the liver to determine how stiff it has become; it can also assess the level of fat accumulation based on the degree to which ultrasound signals weaken. MRI-PDFF distinguishes between water and fat signals emitted by the liver to quantify the fat fraction; it is used to compare the reduction in fat accumulation in the liver before and after treatment. The researchers also identified determining whether there are additional benefits when the drug is administered in combination with treatments for metabolic disorders, such as diabetes, as a future research goal.

He stated, “If clinical data is further substantiated to confirm that fatty liver disease is significantly improved through imaging markers and to demonstrate the efficacy of combination therapy with treatments for metabolic disorders, this approach will be able to solidify its role in the treatment of metabolic fatty liver disease.”