Tenofovir disoproxil fumarate (tenofovir DF) is a nucleoside analog treatment used to treat chronic hepatitis B. Although the tenofovir DF is well-tolerated, the treatment is generally continued life-long, which may result in side effects. This study aims to investigate the efficacy and safety of long-term tenofovir DF treatment (at least 8 years) for chronic hepatitis B.
This is a prespecified analysis that included a total of 124 patients who were undergoing long-term tenofovir treatment therapy for chronic hepatitis B for more than 8 years. The participants who entered the 24-week treatment-free follow-up (TFFU) phase were followed up, and the primary outcomes were changes in serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) concentrations.
Out of 124 patients included in the study, 54 patients (44%) did not complete 24 weeks of follow-up. Out of the remaining patients, 32 (26%) reported an adverse event, and 5 patients (4%) reported a serious adverse event. The most common severe adverse event was T elevations that occurred in 36 patients.
The research concluded that within 24 weeks of stopping the long-term use of tenofovir DF in patients with chronic hepatitis B, almost one-third of the patients experienced laboratory abnormalities of grade-3 or higher.