Treatment Outcome and Renal Safety of 3-Year Tenofovir Disoproxil Fumarate Therapy in Chronic Hepatitis B Patients with Preserved Glomerular Filtration Rate

Abstract

Background/AimsTo investigate the treatment efficacy and renal safety of long-term tenofovir disoproxil fumarate (TDF) therapy in chronic hepatitis B (CHB) patients with preserved renal function.MethodsThe medical records of 919 CHB patients who were treated with TDF therapy were reviewed. All patients had preserved renal function with an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m2.ResultsA total of 426 patients (184 treatment-naïve and 242 treatment-experienced) were included for analysis. A virologic response (VR) was defined as achieving an undetectable serum hepatitis B virus (HBV) DNA level, and the overall VR was 74.9%, 86.7%, and 89.4% at the 1, 2, and 3-year follow-ups, respectively. Achieving a VR was not influenced by previous treatment experience, TDF combination therapy, or antiviral resistance. In a multivariate analysis, being hepatitis B e antigen positive at baseline and having a serum HBV DNA level ≥2,000 IU/mL at 12 months were associated with lower VR rates during the long-term TDF therapy. The overall renal impairment was 2.9%, 1.8%, and 1.7% at the 1, 2, and 3-year follow-ups, respectively. With regard to renal safety, underlying diabetes mellitus (DM) and an initial eGFR of 60 to 89 mL/min/1.73 m2 were significant independent predictors of renal impairment.ConclusionsTDF therapy appears to be an effective treatment option for CHB patients with a preserved GFR. However, patients with underlying DM and initial mild renal dysfunction (eGFR, 60 to 89 mL/min/1.73 m2) have an increased risk of renal impairment.

Efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B virus infection

“…Nephrotoxicity has been reported during TDF treatment, especially in patients with lower baseline eGFR or prior ADV therapy. [11,12] Consistent with a previous study performed on Korean individuals, [12,21] data in the present study showed that Chinese patients with lower eGFR at baseline were also susceptible to have eGFR <90 mL/min/1.73 m 2 at the 96th week. Mechanisms of nephrotoxicity in the first 48 weeks may be various, including renal tubular injury, apoptosis, and mitochondrial toxicity.…”

Evidence of tenofovir resistance in chronic hepatitis B virus (HBV) infection: An observational case series of South African adults

“…The three patients presented reflect different phenotypes, with one case (ID 209, Figure 2 A Figure 2A) representing particularly strong evidence for HBV resistance to TDF. The other two cases illustrate the difficulties in discriminating between drug resistance and incomplete adherence, and may also reflect the long timelines sometimes associated with viraemic suppression on TDF [ 21 ]. These explanations are not mutually exclusive, and may all have a role in incomplete virologic suppression.…”

Clinical Outcomes and Renal Safety in HIV/AIDS Patients on Tenofovir-containing Regimens in Lesotho

“…Moreover, Arribas et al conducted a long-term follow-up of the study for over 144 weeks in which TDF/FTC-based regimen confirmed the superior ability over the AZT/FTCbased regimen to suppress viral load without causing the lipodystrophy (seen with AZT/3TC-containing regimens) and with less effect on lipids [17]. Therapy with TDF is a strongly effective treatment option for achieving virologic response irrespective of treatment experience, combination therapy containing TDF and resistance to antiretroviral drugs [18].…”