Vebicorvir associated with Increased viral suppression with in Hepatitis B infection
Vebicorvir was found to increase viral suppression by altering DNA and pregenomic (pg)RNA in Hepatitis B viral infection. It was also found to be safe and tolerable when taken with nucleos(t)ide reverse transcriptase inhibitors as per a study that was published in the Journal of Hepatology.
Total suppression of the hepatitis B virus replication is necessary for finite treatment regimens. Past data has shown persistent viremia during NrtI treatment despite HBV DNA being undetectable as HBV nucleos(t)ide reverse transcriptase inhibitors (NrtIs) do not completely suppress HBV replication. HBV core inhibitors may enhance viral suppression when combined with NrtIs. Vebicorvir (VBR) is a novel inhibitor of the HBV core protein which acts by interfering with two additional steps in HBV replication than NrtIs. Hence researchers conducted a study to evaluate the efficacy and safety of the investigational core inhibitor, vebicorvir (VBR), in virologically- suppressed patients on NrtIs.
Non-cirrhotic, NrtI-suppressed patients with chronic HBV were randomized to VBR 300 mg once daily or matching placebo (PBO) for 24 weeks. Treatment was stratified by hepatitis B e antigen (HBeAg) status. The primary endpoint was a change from the Baseline in serum HBeAg or hepatitis B surface antigen (HBsAg) after 24 weeks.
Results
- 73 patients were enrolled, 47 were HBeAg positive and 26 were HBeAg negative.
- In HBeAg-positive and -negative patients, there were no differences in the change from Baseline at Week 24 for HBsAg or HBeAg.
- A greater proportion of patients with detectable HBV DNA at the Baseline achieved undetectable HBV DNA at Week 24 in the VBR+NrtI vs. PBO+NrtI group.
- In HBeAg-positive patients, a greater change from the Baseline in HBV pregenomic (pg)RNA was observed at Week 24 with VBR+NrtI vs. PBO+NrtI.
- Treatment-emergent adverse events (TEAEs) in VBR+NrtI patients included upper respiratory tract infection, nausea, and pruritus.
- No serious adverse events, Grade 4 TEAEs, or deaths were reported.
Thus, the researchers concluded from their 24-week study that VBR+NrtI demonstrated a favorable safety and tolerability profile and also achieved enhanced viral suppression.
For full reading: https://doi.org/10.1016/j.jhep.2022.04.005
Yuen MF, Agarwal K, Ma X, et al. Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection. J Hepatol. 2022;77(3):642-652.
