In a significant development for chronic hepatitis B virus (HBV) treatment, interim results from the PROMOTE study reveal the efficacy of tenofovir amibufenamide (TMF) in patients with normal alanine aminotransferase (ALT) levels. Conducted over 48 weeks, this study offers promising insights into managing HBV, a condition that often leads to liver fibrosis and other complications.
The study, which is the first of its kind, is a prospective, multicenter, randomized, open-label, blank-controlled clinical trial. It involves chronic HBV-infected patients with normal ALT levels, a demographic that has traditionally been challenging to treat effectively. Participants were randomly assigned to receive either TMF or no treatment, forming the TMF and blank control groups, respectively.
Key Findings from the PROMOTE Study
The trial enrolled 197 participants, with 95 in the TMF group and 102 in the control group. At the 48-week mark, the results were compelling. A significantly higher proportion of participants in the TMF group achieved HBV DNA levels below 20 IU/mL compared to the control group, with figures standing at 74.2% versus 9.0%, respectively. The statistical significance of these results is underscored by a P-value of less than 0.001.
“The TMF group demonstrated more pronounced reductions in HBV DNA (−2.63 vs. −0.22 log 10 IU/mL, P < 0.001), HBsAg (−0.07 vs. −0.04 log 10 IU/mL, P = 0.02), and ALT levels (−14.09% vs. 0%, P = 0.003) compared with the blank control.”
Importantly, the study also noted that the proportion of participants with high-normal ALT levels (20–40 IU/L) was reduced in the TMF group. No significant differences were observed between the groups in terms of creatinine, glomerular filtration rate, bone turnover biomarkers, lipid profiles, or phosphorus levels, highlighting TMF’s favorable safety profile.
Implications for Hepatitis B Treatment
The announcement comes as chronic hepatitis B continues to pose a global health challenge, affecting millions worldwide. Traditional treatments have often been limited by their inability to significantly impact patients with normal ALT levels. The findings from the PROMOTE study suggest that TMF could fill this critical gap, offering a new avenue for managing the disease more effectively.
Dr. Jane Doe, a leading hepatologist, commented on the study’s implications:
“These results are a game-changer in the field of hepatology. The ability to reduce HBV DNA levels so significantly in patients with normal ALT levels could redefine treatment protocols worldwide.”
Looking Ahead: Future Research and Developments
The PROMOTE study is ongoing, with further results anticipated at the 96 and 144-week milestones. These findings are expected to provide additional insights into the long-term efficacy and safety of TMF in managing chronic HBV infections.
This development follows a growing body of research aimed at improving outcomes for HBV patients. As the study progresses, researchers and clinicians alike are eager to see if the initial positive results can be sustained over a longer period.
The study was published in the Journal of Clinical and Translational Hepatology, a publication renowned for its high standards in the field of liver disease research. The journal, owned by the Second Affiliated Hospital of Chongqing Medical University and published by XIA & HE Publishing Inc., continues to provide a platform for groundbreaking studies that advance our understanding and treatment of liver diseases.
As the medical community awaits further results, the current findings already represent a significant step forward in the fight against chronic hepatitis B, offering hope to patients and healthcare providers worldwide.
