Combination HBV Therapy Shows Functional Control 24 Weeks After Cessation

Issue: August 2018

Replicor recently shared follow-up data from the ongoing REP 401 trial that showed high rates of persistent functional control of hepatitis B after cessation of therapy with REP 2139-Mg or REP 2165-Mg plus pegylated interferon alpha-2a and tenofovir disoproxil fumarate, according to a press release.

“REP 2139’s ability to rapidly reduce [HBV surface antigen] in 90% of patients is unique in the industry and is accompanied by immediate reductions of viremia in the blood and viral replication in the liver,” Andrew Vaillant, PhD, chief scientific officer at Replicor, said in the release. “In preclinical studies, this effect alone has led to complete control of and profound reduction of cccDNA in the liver.”

Among patients who completed 24 weeks of treatment-free follow-up, 87% had functional repression with 79% showing HBsAg levels less than 10 IU/mL, 70% had functional remission with 66% showing no detectable HBsAg, and 92% had normal liver function.

The researchers reported the combination therapy to be well-tolerated. PEG-IFN treatment resulted in mild side-effects but presented significant reactivation of HBV immune response and increased anti-HBs, the appearance of therapeutic transaminase flares and the establishment of functional control.

“The tolerability of PEG-IFN in the REP 401 trial was substantially better than when used with ribavirin in HCV infection,” Vaillant said in the release. “Although other immunotherapies will be assessed in future combination settings, the inclusion of PEG-IFN in REP 2139-Mg based combination therapy represents an option with clear clinical activity and benefit that can give patients access to the first effective finite therapy for HBV and HDV infection.”

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