A research team presented findings from a randomized controlled trial that evaluated the efficacy of a combination therapy comprising Baraclude (ingredient: entecavir), pegylated interferon alfa-2a, and a hepatitis B virus (HBV) vaccine.
The findings of the E+VIP study, which were presented at The Liver Week 2018 by Professors Kim Yoon-jun and Lee Jeong-hoon from Seoul National University College of Medicine, raised the possibility of a cure for the disease, Brisol-Myers Squibb said Wednesday.
"Since the functional cure of chronic hepatitis B has not been possible so far, the goal of treatment has been to prevent progression to severe liver disease and to improve survival by lowering the mortality rate,” Professor Kim said.
Currently, HBsAg-seroclearance is considered to be a functional cure for chronic hepatitis B patients although rarely achievable with oral nucleos(t)ide analogs (NAs) treatment alone.
“This E+VIP study administered Baraclude, pegylated interferon alfa-2a and then HBV vaccines to hepatitis B patients who achieved virological suppression after receiving Baraclude. Findings showed the rate of HBsAg-seroclearance, which can be regarded as a complete cure, was higher than any other studies and showed the possibility of a cure. This is very significant in the early stages of hepatitis B therapies,” Kim added.
The study aimed to evaluate the clinical efficacy of Baraclude, Peg-IFN and HBV vaccine as a combination therapy in 111 patients with chronic hepatitis B who were treated with Baraclude and had virological suppression.
Patients were randomly assigned to three groups: the treatment group, control group, and exploratory group. Study findings showed the probability of HBsAg-seroclearance was statistically higher in the combination therapy group that included Baraclude compared to the monotherapy group.
The treatment group (37 patients) taking Baraclude received weekly Peg-IFN injections for 48 weeks. Treatment was then followed by sequential administration of an HBV vaccine at 52, 56, 60, and 76 weeks. The control group (37 patients) received Baraclude as a monotherapy. The explorative group (37 patients) received Baraclude and Peg-IFN injection while simultaneously getting the HBV vaccine at 4, 8, 12, and 28 weeks.
There was no difference in baseline characteristics including qHBsAg, HBV DNA, HBeAg-positivity, and biochemical markers (e.g., ALT, AST, albumin) among three groups.
Intention-to-treat analysis showed chance of HBsAg-seroclearance at week 100 was statistically higher in the ETV + Peg-IFN + sequential vaccination treatment group at 16.2 percent than the comparison group with 0 percent. There was no statistically meaningful difference in the exploratory group of ETV + Peg-INF + simultaneous vaccination with 5.4 percent.
Changes in median qHBsAg titer from baseline to week 100 was –67.7% in the treatment group and –36.3% in the control group, respectively.
“The potential for cure of Baraclude and other vaccine combinations in this study is very promising for chronic hepatitis B patients and medical professionals,” BMS Korea CEO Park Hye-seon said.