WASHINGTON — Replicor announced interim follow-up data from the REP 401 protocol, an ongoing evaluation of the company’s REP 2139 combined with tenofovir disoproxil fumarate with pegylated interferon alpha 2a as a treatment for patients with hepatitis B, according data presented at The Liver Meeting 2017.
REP 2139-based combination has for the first time achieved functional control or cure in a very high proportion of patients. Equally as important is the normalization of liver function in the absence of therapy, even in patients with significant liver enzyme elevation before treatment began. Andrew Vaillant, PhD, chief scientific officer at Replicor, told Healio Gastroenterology and Liver Disease. “Replicor believes this interim follow-up data from the REP 401 trial clearly demonstrates that REP 2139 will become the indispensable backbone of future combination therapies.”
Early data from the REP 401 protocol showed that eight of 10 patients with HBV achieved functional control of infection at the end of treatment with combined REP 2139, tenofovir disoproxil fumarate and pegylated interferon alpha 2a. Specifically, these eight patients had HBsAg below 1 IU/mL and HBV DNA below 10 IU/mL.
Therapeutic liver flares and anti-HBsAg antibody levels up to 223,055 mIU/mL accompanied functional control.
Functional control persisted after removal of all parts of therapy with data from 24 weeks in four patients and 12 weeks in four patients. The most recent data showed that four patients achieved HBsAg loss and HBV DNA below 1,000 copies per mL for 6 months after treatment ended.
“Replicor’s current REP 401 protocol will continue to track the functional control of patients for 48 weeks after removal of therapy,” Vaillant said. “After this follow-up, patients will be enrolled in a long term surveillance trial similar to the one currently underway following completion of our REP 301 trial in HBV/HDV coinfection.”