GS 840 nucleotide analog data

GILD reported results of a Phase I/II trial of GS 840 in 20 patients with hepatitis B, showing reduced viral load that reverted toward baseline after the end of the four-week study. As reported at the Interscience Conference on Antimicrobial agents and Chemotherapy, 125 mg of the nucleotide analog as a single daily oral dose gave sustained reduction in viral DNA (p=0.001). The 15 patients receiving active drug had a 97 percent (1.8 log) reduction in viral load, compared to a 7 percent (0.02 log) increase in the 5 patients who received placebo.

The adverse event associated with the agent was elevation of liver transaminase enzyme, which was associated with HIV status - 3 of 6 HIV-negative but none of the 9 HIV-positive patients showed elevated enzyme levels. A more sustained decrease in viral DNA also was associated with the elevated transaminase. The findings point to the increase as an immunologic response to the drug, the company said. ...