Gilead Science Korea said it has presented the data on the significance of the early achievement of normalizing alanine aminotransferase (ALT) levels in chronic hepatitis B treatment, at the Asian Pacific Digestive Week 2018.
Chaired by Professor Henry Chan from the Chinese University of Hong Kong, Professors Pietro Lampertico of the Università degli Studi di Milan and Lim Young-seok of University of Ulsan College of Medicine presented their findings.
According to Professor Chan, patients with chronic hepatitis B aged 50 years or older increased about twice as much between 2011 and 2015 compared to the 2000-2005period. Also, the percentage of chronic hepatitis B patients with chronic kidney disease, osteoporosis, and osteopenia increased by 16, 6, and 8 percent, respectively, in 2011-2015 compared to 2000-2005.
Professor Lampertico explained the changing dynamics of patient aging.
“The newly launched chronic hepatitis B treatment Vemlidy is attracting attention with its improved plasma stability, efficient drug delivery, and improved kidney and bone safety profiles,” he said. “Vemlidy has demonstrated inferior antiviral efficacy, improved renal and bone safety, and high resistance barriers compared to Viread at the end of 96 weeks of a large phase 3 clinical trial.”
Recent studies have also proved that Vemlidy also has higher ALT normalization reach rates than Viread, he added.
With such results, Professor Lampertico presented the latest findings that early normalization of ALT levels can lower the incidence of liver cancer.
The company conducted a cohort study in Hong Kong by treating 21,182 chronic hepatitis B patients treated with tenofovir disoproxil fumarate (TDF) and Entecavir (ETV) from 2005 to 2016, with a follow-up period of 12 months.
As a result, the incidence of hepatocellular carcinoma in patients that achieved ALT normalization values (male <30 U/L, female <19 U/L) was 2.7 percent, which was significantly lower than patients who did not achieve ALT normalization within the same period.
Patients with ALT levels above 2x upper limit of normal (ULN) at 12 months had an incidence of liver cancer of approximately 6 percent, while patients between 1 and 2x ULN had a frequency of roughly 4.6 percent, according to the Italian expert.
Professor Lim Young-seok also presented that TDF group among oral antiviral drugs had a lower incidence of liver cancer than ETV group.
“Both national cohort and hospital cohort studies showed that the TDF-treated group had a lower incidence of liver cancer than the ETV-treated group,” Professor Lim said.