There were concerns about the potential cardiovascular risks associated with the long-term use of tenofovir alafenamide fumarate (TAF) in patients with chronic hepatitis B.
However, a Korean study has confirmed this is not true.
Asan Medical Center (AMC) said Friday that a team led by Professor Choi Jong-gi and Dr. Hong Hye-yeon of the Department of Gastroenterology recently published their study results.
TAF is an antiviral drug that reduces the osteoporosis and renal deterioration side effects of tenofovir disoproxil fumarate (TDF) and has been mainly prescribed to patients with chronic hepatitis B because the former has the same therapeutic effect with a 10 percent dose of the latter.
However, TDF reduces all lipid markers, including total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol, while TAF does not, and that has raised concerns about TAF causing cardiovascular events.
Previous studies have demonstrated variations in lipid profile changes between TDF and TAF, but the precise impact of long-term use on cardiovascular diseases, such as unstable angina, ischemic stroke, myocardial infarction, and heart failure, remained unclear.
The researchers divided 4,124 patients treated for chronic hepatitis B from 2012 to 2022 into 3,186 TDF users and 938 TAF users and monitored the cumulative incidence of cardiovascular events in the two groups.
The results showed that during 15,527 person-years of observation (1 person-years of observation equals one year), there were 37 cardiovascular events in patients on TDF and five on TAF. The cumulative incidence rates were 0.4 percent, 0.8 percent, and 1.2 percent in the first, third, and fifth years of TDF use, and 0.2 percent, 0.7 percent, and 0.7 percent for TAF, with no statistically significant differences.
Notably, propensity score matching analysis, accounting for different comorbidities in the two groups, showed no significant difference. Additionally, there was no substantial difference in HDL cholesterol levels relative to total cholesterol, a known factor associated with cardiovascular disease risk.
"This study is significant as it showed no difference in the cumulative incidence of cardiovascular events between TDF and TAF use in a large cohort of patients with chronic hepatitis B," Professor Choi said. "In the future, it is expected that TAF can be used for long-term treatment of chronic hepatitis B without these concerns."
Their findings were recently published in the prestigious Clinical and Molecular Hepatology (with an impact factor 8.9).