What is the efficacy of tenofovir for the treatment of chronic hepatitis B (HBV) (Hep B)?

Updated: Aug 01, 2018
  • Author: Nikolaos T Pyrsopoulos, MD, PhD, MBA, FACP, AGAF; Chief Editor: BS Anand, MD  more...
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Answer

In 2 double-blind, phase III studies in which patients with HBeAg-negative or HBeAg-positive chronic hepatitis B were randomized to receive tenofovir (300 mg) or adefovir (10 mg) (ratio, 2:1) once daily for 48 weeks, Marcellin et al concluded that among patients with chronic hepatitis B, tenofovir at a daily dose of 300 mg had superior antiviral efficacy and a similar safety profile to adefovir at a daily dose of 10 mg through week 48. [93]

At week 48 in both studies, a significantly higher proportion of patients receiving tenofovir than those receiving adefovir had reached the primary end point (plasma HBV DNA level < 400 copies/mL [69 IU/mL]), and viral suppression occurred in more HBeAg-negative patients in the tenofovir group (93%) than in the adefovir group (63%), as well as in more HBeAg-positive patients receiving tenofovir (76%) than in those receiving adefovir (13%). [93]

Furthermore, significantly more HBeAg-positive patients in the tenofovir group (68%) not only had normalized ALT levels relative to those in the adefovir group (54%), but these individuals also had loss of HBsAg (3% tenofovir group vs 0% adefovir group). [93]

At the end of 48 weeks, none the patients had developed the amino acid substitutions within HBV DNA polymerase that are associated with phenotypic resistance to tenofovir or other drugs used to treat hepatitis B. Tenofovir produced a similar HBV DNA response in patients who had previously received lamivudine and in those who had not. The 2 treatments in both studies had similar safety profiles. [93]


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