Daewoong’s hepatitis B drug matches standard treatment in head-to-head trial

Daewoong Pharmaceutical’s Vemliver (tenofovir alafenamide, or TAF) held its ground against entecavir (ETV), a widely used hepatitis B antiviral, in a phase 4 head-to-head trial -- delivering full viral suppression at week 48 in stable patients who switched therapies, the company said Monday.

The randomized, multicenter study is the first in Korea to compare TAF and ETV under real-world conditions. Investigators enrolled 196 chronic hepatitis B patients who had maintained HBV DNA levels below 69 IU/mL on ETV for at least 24 weeks. 

According to data presented at Liver Week 2025, an international liver disease conference hosted in Korea, patients were randomized to either stay on Daewoong’s Baracross, the local brand of ETV (n=101), or switch to Vemliver (n=95), both taken once daily for 48 weeks.

At the final visit, 100 percent of patients in the Vemliver group maintained viral suppression below 29 IU/mL, a threshold considered effectively undetectable, compared to 99 percent in the ETV group.

The 1.03 percent difference, with a 97.5 percent confidence interval, met the trial’s 10 percent non-inferiority margin, showing Vemliver was not meaningfully less effective. No antiviral resistance was observed in either group.

“There’s been a lack of head-to-head evidence comparing TAF and ETV in our population,” said Kim Yoon-jun, coordinating investigator and professor of internal medicine at Seoul National University’s Liver Research Institute. “This trial closes that gap and confirms Vemliver’s viability as a switch option in long-term management.”

ALT normalization, a secondary endpoint that tracks the return of alanine aminotransferase levels to normal, showed no statistically significant difference between the two groups. By U.S.-based 2016 AASLD guidelines, 55 percent of patients on Vemliver and 38.7 percent on Baracross reached ALT normalization by week 48 (p=0.26). Under stricter Korean criteria, normalization was seen in 50 and 42.9 percent of patients, respectively (p=0.75).

HBsAg and HBeAg clearance and seroconversion, key markers of deeper immune response in hepatitis B, remained rare in both groups.

Renal safety remained stable throughout the study, addressing a key concern with nucleotide analogs like TAF. Mean change in estimated glomerular filtration rate (eGFR), a standard kidney function metric, was –0.64 percent in the Vemliver group versus –0.71 percent in the ETV group (p=0.08).

Lipid profiles, including LDL, HDL, total cholesterol, and triglycerides, also stayed flat, supporting a clean metabolic safety profile.

Treatment-emergent adverse events occurred in 32.6 percent of patients on Vemliver compared with 26.7 percent on Baracross. Serious adverse events were rare, occurring in 1.1 percent of Vemliver patients and 3.0 percent of Baracross patients. One patient in the ETV group discontinued due to dizziness.

“Even in a market historically dominated by the original brands, we showed that both generics, Vemliver and Baracross, offer strong efficacy and safety,” said Professor Kang Yeo-wool of the Department of Internal Medicine at Dong-A University Hospital who presented the data at Liver Week 2025.

While TAF is already established as a global first-line option for hepatitis B, most supporting data have focused on switches from tenofovir disoproxil fumarate (TDF), a more nephrotoxic predecessor. Data on switching from ETV have remained limited, especially in Asian populations, and have mostly come from retrospective analyses, according to Daewoong.

Vemliver can be taken with or without food and does not require dose adjustment in patients with mild to moderate renal impairment, which could improve adherence over the long term.