Comparison of the long-term efficacy of tenofovir and entecavir in nucleos(t)ide analogue-naïve HBeAg-positive patients with chronic hepatitis B: A large, multicentre, randomized controlled trials.

Abstract

OBJECTIVE:

We conducted this study to compare the efficacy and safety of entecavir and tenofovir in the treatment of treatment-naïve HBV e antigen (HBeAg)-positive patients with chronic hepatitis B (CHB) for 144 weeks.

METHODS:

A total of 320 treatment-naïve HBeAg-positive CHB patients who received randomly a single regimen of either entecavir capsule (ETV) (n = 160) or tenofovir disoproxil fumarate capsule (TDF) (n = 160) for 144 weeks were consecutively enrolled from 14 tertiary hospitals or university hospitals in China between January 2012 and December 2014.

RESULTS:

Two groups showed no difference in baseline characteristics. After 144 weeks of treatment, HBV DNA levels were similarly suppressed in both groups (ETV vs TDF; -6.6485 vs -6.692 log10IU/mL, P = .807). At the same time, both groups showed no difference in terms of the serologic and biochemical response. Of all patients, 2 dropped out due to adverse events and 5 experienced serious adverse reactions.

CONCLUSION:

Both capsules (ETV or TDF) were equally effective in nucleos(t)ide-naive CHB patients with a comparable side-effect profile even in a long-term of 144 weeks.

• Authors: Dachuan Cai, Chen Pan, Weihua Yu, Shuangsuo Dang, Jia Li, Shanming Wu, Nan Jiang, Maorong Wang, Zhaohua Zhang, Feng Lin, Shaojie Xin, Yongfeng Yang, Baoshen Shen, Hong Ren
• Journal: Medicine (Medicine (Baltimore)) Vol. 98 Issue 1 Pg. e13983 (Jan 2019) ISSN: 1536-5964 [Electronic] United States
• PMID: 30608440 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• entecavir
• Guanine
• Tenofovir

Topics

• Adult
• Antiviral Agents (adverse effects, therapeutic use)
• China (epidemiology)
• DNA, Viral (drug effects)
• Female
• Guanine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Hepatitis B e Antigens (blood, drug effects)
• Hepatitis B virus (genetics)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Male
• Tenofovir (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome