WEDNESDAY, Dec. 3 (HealthDay News) -- Tenofovir disoproxil fumarate (DF) is superior to adefovir dipivoxil for the treatment of chronic hepatitis B virus (HBV) infection regardless of prior lamivudine exposure, according to data published in the Dec. 4 issue of the New England Journal of Medicine.
Patrick Marcellin, M.D., from the Hopital Beaujon in Clichy, France, and colleagues reported the results of two randomized phase 3 studies that compared tenofovir DF to adefovir dipivoxil therapy in either HBeAg-positive or HBeAg-negative HBV patients. Both treatments were administered over 48 weeks. The primary study outcomes were viral suppression (HBV DNA level less than 400 copies/mL) and histologic improvement (decreased Knodell necroinflammation score).
In both HBeAg-positive and HBeAg-negative patients, tenofovir DF produced significantly superior efficacy in all endpoints tested, the investigators found. More patients treated with tenofovir DF than adefovir dipivoxil achieved both primary study outcomes, viral suppression and histologic improvement (71 percent versus 49 percent in HBeAg-negative patients, 67 percent versus 12 percent in HBeAg-positive patients). Patient response to tenofovir DF was not affected by previous lamivudine exposure, they note. The researchers also found a similar safety profile between the two drugs.
"Tenofovir DF was shown to be a potent therapy for the treatment of HBeAg-negative and HBeAg-positive chronic HBV infection," the authors write, adding that in light of its favorable safety profile, it "should be considered for the treatment of chronic HBV infection."
The study was supported by Gilead Sciences. Authors of the study and editorial report financial relationships with the pharmaceutical industry.
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