Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while demonstrating higher rates of alanine aminotransferase (ALT) normalization and improved bone and renal safety profiles. This study presented the long-term efficacy and safety of TMF in a phase IV study.
Participants from the Phase III registrational trial of TMF were enrolled and followed for another seven years, starting at week 144 in the Phase III study as the baseline. Once-daily oral dose of 25 mg TMF were maintained in all participants. Clinical assessments were conducted every 24 weeks. The primary efficacy endpoint was the percentage of patients with serum HBV DNA levels below the quantification limit at week (144+) 96.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
640
Once-daily oral dose of 25 mg TMF were maintained in all participants
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory
The primary efficacy endpoint was the proportion of patients with HBV DNA lower than in the central laboratory at week (144+)96.
Time frame: week (144+)96
The proportion of subjects with HBV DNA with lower than in the central laboratory
The proportion of patients with HBV DNA lower than in the central laboratory at week(144+)240、week(144+)336
Time frame: week(144+)240、week(144+)336
Proportion of subjects with ALT normalization rate
The proportion of patients with normal ALT
Time frame: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBsAg loss,HBsAg conversion
The denominator of HBsAg loss was the number of HBsAg- positive patients at 144 weeks. The denominator of HBsAg seroconversion was the number of HBsAg positive and anti-HBs negative persons at 144 weeks.
Time frame: week (144+)96、week (144+)240、week (144+)336
Incidence of resistance mutation
Resistance detection when a virological breakthrough occurs
Time frame: week (144+)96、week (144+)240、week (144+)336
Progression of liver disease associated with HBV infection
The proportion of patients with new HCC, Decompensated liver cirrhosis, death related to Hepatitis B
Time frame: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBeAg loss,HBeAg conversion ratio
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The denominator of HBeAg loss was the number of HBeAg- positive patients at 144 weeks. The proportion of HBeAg seroconversion was the number of HBeAg positive and anti-HBs negative persons at 144 weeks.
Time frame: week (144+)96、week (144+)240、week (144+)336
Percent Change from Baseline in Hip and spine Bone Mineral Density (BMD)
measured by dual energy x-ray absorptiometry(DXA)
Time frame: week (144+)96、week (144+)240、week (144+)336
Change from Baseline in Serum Creatinine
Time frame: week (144+)96、week (144+)240、week (144+)336
Change in HBV DNA from baseline
Time frame: week (144+)96、week (144+)240、week (144+)336