Ther Clin Risk Manag. 2017 Sep 26;13:1273-1285. doi: 10.2147/TCRM.S143286. eCollection 2017.
Renal safety of tenofovir and/or entecavir in patients with chronic HBV monoinfection.Yang YM1, Choi EJ1. Author information 1Department of Pharmacy, College of Pharmacy, Chosun University, Gwangju, South Korea.
AbstractBACKGROUND: Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are recommended as the first-line therapy for chronic hepatitis B (CHB) due to their genetic barrier to resistance and effectiveness of virological suppression. TDF and ETV may cause renal toxicity through various mechanisms such as renal tubular injury, apoptosis, and mitochondrial toxicity. The aims of the current review were to assess the potential renal toxicity associated with the use of TDF and ETV in patients infected with chronic hepatitis B virus (HBV) and to provide clinical perspectives on these two agents in the treatment of CHB.
METHODS: A literature search of clinical studies published in PubMed and posted on ClinicalTrials.gov website was implemented to find studies evaluating the potential renal toxicity of TDF and ETV.
RESULTS: Twenty-one studies were examined in this review. The TDF dose used in the studies was 245 or 300 mg/day and that of ETV was 0.5 or 1 mg/day. Based on the markers of renal function, patients treated with TDF were not more likely to show changes in renal function than those treated with ETV; however, the estimated glomerular filtration rates (eGFRs) of patients receiving TDF tended to be more clearly reduced than those of patients receiving ETV. The eGFRs of patients treated with TDF decreased in a time-dependent manner, whereas those of patients treated with ETV increased or decreased across various time points.
CONCLUSION: The data shown in this study suggest that use of TDF and ETV could be at least associated with reductions in renal function in patients with chronic HBV infection. However, various risk factors, such as pre-existing renal failure and comorbidities, are also associated with decreased renal function during the treatment of TDF and ETV. Thus, studies of management strategies for HBV-infected patients with these risk factors are necessary in the near future.
This observation from the above study should be noted:
"This study had some limitations that should be addressed. Two electronic databases (ie, PubMed and ClinicalTrials.gov website) were utilized to search relevant clinical trials, although various databases are available. This limited data-base utilization also likely limited our opportunities to search additional valuable and relevant clinical trials. Almost all of the selected clinical trials mentioned that TDF and ETV were not likely to have significantly negative effects on renal functions. However, consistent results were not shown partially owing to the different characteristics of study subjects and various markers used to measure renal functions, which made the conducting of further meta-analysis difficult."
