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Tenofovir Entecavir

Tenofovir Entecavir

Introduction

The goal of chronic hepatitis B (CHB) treatment is to achieve early and sustained suppression of hepatitis B virus (HBV) replication, which is demonstrated to prevent progression of liver disease to cirrhosis and development of hepatocellular carcinoma . The availability of nucleos(t)ide analogues such as tenofovir disoproxil fumarate (TDF) and entecavir (ETV), which are more potent than other antiviral drugs, has significantly improved treatment of CHB (3,–5). However, many patients were treated with less potent antiviral drugs (i.e., lamivudine [LAM], telbivudine [LdT], and adefovir [ADV]) as first-line therapy and then with sequential monotherapies, which contributed to the development of multidrug resistance (MDR) (6, 7). The emergence of drug-resistant viral strains results in increased viral loads, followed by increases in serum alanine aminotransferase (ALT) levels and subsequent progression of liver disease (8,–10). In the absence of treatment intervention with appropriate rescue therapy based on cross-resistance profiles, patients are at significant risk of hepatic decompensation . Previous antiviral treatment history may impair the antiviral efficacy of rescue therapy to induce viral suppression; therefore, the choice of optimal treatment in patients with MDR HBV strains is critical to avoid subsequent treatment failure.

Serum assay and methodology

Biochemistry was performed using standard laboratory procedures. Hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), HBeAg, and antibody to HBeAg (anti-HBe) were measured using microparticle enzyme immunoassay (Abbott Laboratories, North Chicago, IL, USA). Serum HBV DNA levels were measured using a COBAS TaqMan PCR assay (Roche, Branchburg, NJ, USA; lower limit of detection 20 IU/mL).

Statistical analyses

HBV DNA levels were logarithmically transformed for analysis. The Mann–Whitney U-test for continuous variables and chi-squared test for categorical variables were used in the analyses as appropriate. A repeated measures analysis was used to compare HBV DNA reduction according to the drug used. Cumulative VR and VBT rates were calculated using the Kaplan-Meier method, and the difference was determined by a log-rank test. The multivariate logistic regression model and Cox proportional hazards model were used to identify the independent risk factors significantly associated with short-term and long-term VR, respectively. Candidate variables with a P value of < 0.1 on univariate analysis were entered into the regression analysis. A P-value of less than 0.05 was considered significant. Statistical analyses were performed using SPSS, version 16 (SPSS, Inc, Chicago, IL).

Conclusion

The data reported in this study suggest that use of TDF and ETV could be associated with reductions in kidney function in patients with chronic HBV infection. The eGFRs of patients treated with TDF were reduced in a time-dependent manner, whereas the eGFRs of patients treated with ETV increased or decreased across various time points. TAF as the first drug of choice for the treatment of chronic HBV infection could be used in patients with decreased renal function or in those with risk factors for renal dysfunction, and TAF + LdT or LdT alone could also be considered for these patients. However, well-organized, prospective, large-scale, randomized clinical trials are necessary to determine the renal safety of TAF + LdT or LdT alone for the treatment of such patients. In addition, studies on management strategies for HBV-infected patients with various risk factors (eg, advanced age, pre-existing renal failure, comorbidities, history of transplant, and concomitant nephrotoxic drugs) associated with reduction in eGFR are warranted in the near future.

Efficacy measures

Efficacy was considered for patients 24 and 48 weeks post therapy by considering the following: HBV-DNA level (<400 copies/ml), ALT normalization rate (<40 IU/ml), HBeAg seroconversion rate (HBeAg loss and the appearance of HBe antibody), and drug safety (adverse events, laboratory abnormalities, deaths, tolerability, etc).

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