A randomized, double-blind, phase 3, non-inferiority trial of pradefovir mesylate versus tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B.
Yanhang Gao, Xinrui Wang, Zhongfeng Wang et al.
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In 30 seconds
This ongoing, randomized, double-blind, phase 3 non-inferiority trial compared pradefovir with tenofovir disoproxil fumarate (TDF) in adults with chronic hepatitis B at 58 sites in China. Among 908 treated participants, week-48 viral suppression (HBV DNA <29 IU/mL) with pradefovir was non-inferior to TDF in both HBeAg-positive and HBeAg-negative groups, using a -12% margin. At week 96, pradefovir was associated with greater HBsAg decline in HBeAg-positive patients and a more favorable reported safety profile, including fewer drug-related adverse events.
Key findings
- At week 48, viral suppression was non-inferior to TDF in HBeAg-positive patients: difference -1.8% (95% CI: -9.7 to 6.1).
- At week 48, viral suppression was non-inferior to TDF in HBeAg-negative patients: difference 2.6% (95% CI: -5.1 to 10.3).
- At week 96, HBsAg decline ≥1 log 10 IU/mL in HBeAg-positive patients occurred in 39.3% with pradefovir versus 29.9% with TDF.
- At week 96, drug-related adverse events were reported in 58.6% with pradefovir versus 71.9% with TDF; bone and renal safety was also reported as more favorable.
Why it matters
The trial provides comparative evidence that pradefovir can achieve viral suppression similar to TDF in adults with chronic hepatitis B, while showing potentially relevant differences in antigen decline and safety outcomes. These findings help characterize an alternative antiviral option, although interpretation should account for the reported follow-up and the ongoing nature of the study.
What to keep in mind
The study is described as ongoing; the abstract reports efficacy at week 48 and selected safety outcomes at week 96, rather than complete long-term results.