Tenofovir Disoproxil Fumarate Is Superior to Entecavir in Reducing Hepatitis B Surface Antigen for Chronic Hepatitis B in China: 2-Year Comprehensive Comparative Result of a Matched Comparative Study

Abstract

Aim: Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are equally recommended as the first-line antiviral treatments for chronic hepatitis B (CHB) at present. We aimed to compare the long-term efficacy and safety between ETV and TDF therapy in CHB patients who had not received nucleoside analog treatment.Method: In this single-center retrospective study, 414 patients who received ETV (290 patients) or TDF (124 patients) therapy at our center from January 2017 to May 2019 were included. To reduce the imbalance of baseline variables, propensity score matching (PSM) was employed to yield 124 pairs of patients at a ratio of 1:1 based on the treatment regimen.Result: After PSM, the cumulative rate of patients who achieved complete virological response (CVR) was not different by drug therapy at each inspection time (1, 3, 6, 12, 18, and 24 months). Subgroup analysis on HBeAg status and level of HBV DNA demonstrated that evolution of proportion of achieving CVR was not significantly different between groups. Despite the insignificant incidence of HBsAg seroclearance in either group, patients in TDF group achieved higher on-treatment HBsAg decline at each inspection time (1, 3, 6, 9, 12, 18, and 24 months), 0.39, 0.51, 0.61, 0.64, 0.68, 0.76, and 0.91 log IU/mL, respectively; while the corresponding reduction were 0.27, 0.37, 0.40, 0.45, 0.48, 0.55, and 0.66 log IU/mL in ETV group (p < 0.05). In subgroup analysis, we found that the significant difference still existed in patients with high baseline HBsAg level (>3 log IU/mL). Additionally, the proportion of patients who achieved on-treatment HBsAg decline >1 log IU/mL in TDF and ETV group was 33.3 and 17.1% (p < 0.01) at the 12th month, 44.4 and 29.5% (p = 0.03) at the 24th month, respectively. Mean increase in serum creatinine from baseline was 0.10 and 0.08 mg/dL in TDF and ETV group (p = 0.11), with no patient experienced acute kidney injury.Conclusions: TDF has higher potency in reducing HBsAg than ETV in this study. Considering the effect still existed in patients with high HBsAg level (>3 log IU/mL), TDF might be a superior therapeutic regimen combining with its relatively safety.

The Effects of the National Centralized Drug Purchasing Pilot Program on Nucleos(t)ide Analogs in Shenzhen City: An Interrupted Time Series Analysis

“…The NA represents the treatment option for the majority of patients with CHB ( 48 ), such as Entecavir, Tenofovir Fumarate, Lamivudine, Adefovir dipivoxil, and Telbivudine. Entecavir and Tenofovir Fumarate are guanine NAs for the treatment of HIV infection, which were equally recommended by the Guidelines as the first-line antiviral treatments for CHB at present ( 51 ). In the first round of the “4+7” pilot program, a total of 25 drugs won the bidding.…”

A quasi-experimental study of the volume-based procurement (VBP) effect on antiviral medications of hepatitis B virus in China

“…The NAs represent the treatment option for most patients with Chronic Hepatitis B (CHB) ( Siakavellas et al, 2021 ). Entecavir and Tenofovir Fumarate are guanine nucleoside analogs for treating hepatitis B virus infection, which the Guidelines recommend as the first-line antiviral treatments for CHB at present ( Yang et al, 2021 ). This study focused on NAs medication, including Entecavir, Tenofovir Fumarate, Lamivudine, Adefovir dipivoxil, and Telbivudine.…”

“…The NAs medications are including Entecavir, Tenofovir Fumarate, Lamivudine, Adefovir dipivoxil and Telbivudine ( Siakavellas et al, 2021 ). Entecavir and Tenofovir Fumarate were recommended by the Diagnosis and Treatment Guideline as the first-line antiviral therapy for patients with chronic hepatitis B ( Yang et al, 2021 ). A lower price of NAs medication will make more patients receive antiviral treatment timely and adequately and light their economic burdens.…”

Hepatitis B Infections in Neonates

“…The preferred oral nucleoside analogues which have been licensed for use in United States are tenofovir, disoproxil fumarate and entecavir, in children above the age of 2 years. 71…”