Tenofovir showed better efficacy, safety than adefovir dipivoxil in Chinese patients with HBV
Hou JL. J Viral Hepat. 2015;22:83-91.
January 23, 2015
In a Chinese cohort of patients with hepatitis B virus infection, therapy with tenofovir disoproxil fumarate was safe and effective in treating the infection compared with adefovir dipivoxil, according to study data published in the Journal of Viral Hepatitis.
Researchers in China randomly assigned 509 patients (83.3% male; mean age, 36.3 years) with HBV to therapy with 300 mg tenofovir or 10 mg adefovir dipivoxil once per day for 48 weeks. The primary endpoint was for all patients to have HBV DNA levels less than 400 copies/mL at 48 weeks.
Overall, 498 patients completed 48 weeks of therapy; 245 in the adefovir dipivoxil group and 253 in the tenofovir group. Fourteen other patients withdrew prematurely, 1.2% withdrew consent, 1% deviated from protocol and 0.4% were lost to follow-up, according to the research. More patients in the tenofovir group reached primary endpoint compared with the adefovir dipivoxil group; 76.7% vs. 18.2% in those positive for hepatitis B e antigen and 96.8% vs. 71.2% in HBeAg-negative patients. In HBeAg-positive patients, those in the adefovir dipivoxil group experienced virologic breakthrough up to 48 weeks compared with 0% in the tenofovir group (P=.041). In HBeAg-negative patients, 0% of patients in the tenofovir group experienced virologic breakthrough compared with 1.3% in the adefovir dipivoxil group.
More patients in the adefovir dipivoxil group experienced adverse events compared with patients in the tenofovir group (4.8% vs. 3.9%).
“In Chinese patients with chronic hepatitis B, [tenofovir] demonstrated superiority over [adefovir dipivoxil] with respect to the primary endpoint of viral suppression in both HBeAg-positive and HBeAg-negative patients,” the researchers concluded. “[Tenofovir] was well-tolerated over the 48-week treatment period, and no HBV mutations associated with [tenofovir] resistance were identified. … [Tenofovir] is an efficacious and safe therapeutic option for the treatment of Chinese patients with chronic hepatitis B.”
Disclosure: The study was funded by GlaxoSmithKline. Hou has received consulting fees or grant/research support from Bristol-Myers Squibb, GlaxoSmithKline, Novartis and Roche. See the study for a full list of relevant financial disclosures of the other researchers.