Treatment of patients with chronic hepatitis B

Tenofovir disoproxil fumarate (TDF) has been demonstrated to have long-term efficacy and a high resistance threshold in a variety of chronic hepatitis B (CHB) populations outside of China. A recent study published in J Viral Hepat aimed to evaluate the efficacy and safety of TDF in a Chinese CHB population through 48 weeks of treatment and compare it to adefovir (ADV). Study Methods Researchers conducted a phase 3, multicenter, randomized, double-blind, controlled trial comparing the efficacy and safety of TDF and ADV in Chinese patients with CHB. The primary endpoint indicator was the proportion of patients with HBV DNA <400 copies/mL in each treatment group at 48 weeks, which was analyzed for superiority using the UNPOOLED Z-test. Secondary endpoints included viral suppression, serologic response, histologic improvement, normalization of alanine aminotransferase (ALT) levels, and emergence of resistance mutations. Findings A total of 509 patients were analyzed, of whom 202 were hepatitis B e antigen (HBeAg)-positive and 307 were HBeAg-negative, with HBV DNA ≥105 copies/mL, and were treated with either TDF 300 mg od or ADV 10 mg od, respectively. at 48 weeks, compared with the ADV group, the TDF group was HBeAg-positive (76.7 percent: 18.2 percent, P<0.0001< span="">) and HBeAg-negative (96.8 percent: 71.2 percent, P<0.0001< span="">) patients had superior viral suppression. ALT normalization was achieved in the majority of patients in both treatment groups (>85%). no resistance to TDF therapy was seen. Adverse event rates were comparable in both groups (TDF 3.9%: ADV 4.8%). Conclusions In this double-blind, randomized, clinical trial, TDF provided significantly better virologic suppression than ADV in Chinese patients with CHB through 48 weeks of treatment, without the development of drug resistance.