Researchers have seen promising early results in a trial of two nucleic acid polymers among people with e-antigen-negative hepatitis B virus who had not been treated for HBV before, Medscape reports. These results suggest that the treatments may lead to functional control of hep B.
Scientists conducted a randomized open-label trial of 40 people with HBV who were new to treatment for the virus. The participants did not have hepatitis C or D viruses (HCV/HDV) or HIV, had serum hep B surface antigen levels above 1,000, hep B viral loads above 7,500 and mild to moderate fibrosis of the liver; none had cirrhosis.
Preliminary safety and efficacy data were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
All participants were given Viread (tenofovir disoproxil fumarate, or TDF) daily for 26 weeks and then randomized to receive one of two regimens for an additional 48 weeks. One group received Viread and interferon plus weekly infusions of one of two nucleic acid polymers, REP 2139-Mg or REP 2165-Mg. Those in the control group received just Viread and interferon but were allowed to receive a polymer treatment if their surface antigen did not drop at least 1,000-fold by week 49.
The data presented concerned 29 people who had been on treatment for at least 12 weeks after the initial Viread lead-in treatment phase.
Many of those who received polymers had undetectable serum antigen levels. The researchers expect these individuals to become surface antigen-negative, a major step toward achieving functional control of hep B.
All nine of those who received REP 2179 and six of nine of those who received REP 2165 had a greater than 10-fold reduction in their surface antigen level.
The nucleic acid polymers proved safe and well tolerated, except for in one person who developed infusion reactions after receiving the 20th weekly dose of REP 2165.
One of three serious adverse health events among the participants was deemed related to treatment: an interferon-related case of transient profound weakness.
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