PegIFN alfa-2b Non-Inferior to PegIFN alfa-2a in CHB
SAN FRANCISCO, CA—Peginterferon alfa-2b (Pegberon) demonstrates non-inferior efficacy to peginterferon alfa-2a (PEG IFNα-2a) for the treatment of Chinese HBeAg-positive chronic hepatitis B (CHB) patients, reported Gui-Qiang Wang, MD, PhD, from Peking University First Hospital, Beijing, China, at The Liver Meeting® 2015.
“Pegberon treatment shows good tolerability and safety for CHB patients, which is similar as PEG IFNα-2a,” Dr. Wang reported.
A new global patent 40 kD, Y-shape pegylated interferon α-2b (Pegberon) was developed for Chinese patients with CHB because while PEG IFN is a recommended first-line treatment for HBeAg-positive CHB patients in international guidelines, very few patients in China opt for peginterferon therapy because of “economic burdon,” the research team explained.
Dr. Wang and his team set out to evaluate the efficacy and safety of Pegberon 180μg compared to PEG IFNα-2a 180μg in a head-to-head clinical trial. The clinical study was a randomized, multicenter, positive controlled, open label Phase 3 trial which randomly assigned 538 adult patients to the Pegberon group and 282 adult patients to the PEG IFNα-2a group, treated for 48 weeks, and followed-up for additional 24 weeks. Hepatitis B virus (HBV) DNA and HBV markers were tested in a central lab.
At 48 and 72 weeks, respectively, 18.96% and 28.62% of patients in the Pegberon group, and 17.02% and 24.47% of patients in the PEG IFNα-2a group had achieved HBeAg seroconversion.
At Week 48, the HBV DNA negative rate was 11.90% in the Pegberon group vs. 9.93% in the PEG IFNα-2a group, and at Week 72, 7.43% and 4.61%, respectively. In addition, the rate of combined HBV DNA<105 cp/mL and HBeAg seroconversion at Week 48 was 15.99% and 13.83%, respectively, and 21.38% and 18.09% at Week 72, Dr. Wang reported.
Both study treatment groups also showed similar HBeAg clearance rates.
Treatment with Pegberon or PEG IFNα-2a demonstrated similar efficacy, tolerability, and safety profile for Chinese CHB patients, the researchers concluded. Improving patients' HBeAb levels “may be an effective strategy to increase the HBeAg seroconversion rate in interferon-based therapies for CHB patients," the authors noted.