Efficacy and safety of long-term entecavir therapy in a European population

Collo, Alessandro; Belci, Paola; Fagoonee, Sharmila; Loreti, Lucia; Gariglio, Valeria; Parise, R.; Mapelli, Paola; Durazzo, Marilena

doi:10.23736/s1121-421x.18.02470-4

Cited by 11 publications

(6 citation statements)

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“…Therapeutic strategies for CHB include finite treatment with pegylated-interferon (PEG-IFN) and indefinite treatment with nucleos(t)ide analogues (NAs) [ 9 ]; the latter allows an effective suppression of viral replication, normalization of alanine aminotransferase (ALT) and thus the prevention of liver disease progression [ 10 ]. Despite the low cumulative rate of hepatitis B surface antigen (HBsAg) loss (i.e., functional cure), international guidelines recommend long-term administration of NAs with a high genetic barrier to resistance regardless of liver disease severity [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Usefulness of a Hepatitis B Surface Antigen-Based Model for the Prediction of Functional Cure in Patients with Chronic Hepatitis B Virus Infection Treated with Nucleos(t)ide Analogues: A Real-World Study

Caviglia

Troshina

Garro

et al. 2021

JCM

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In patients with chronic hepatitis B (CHB) under long-term treatment with nucleso(t)ide analogues (NAs), the loss of hepatitis B surface antigen (HBsAg) is a rare event. A growing body of evidence supports the use of quantitative HBsAg for the prediction of functional cure, although these results are mainly derived from studies performed on Asian patients with hepatitis B e antigen (HBeAg)-positive CHB. Here, we investigated the clinical role of quantitative HBsAg in a real-life cohort of CHB patients under treatment with NAs in a tertiary care center from North-West Italy. A total of 101 CHB patients (HBeAg-negative, n = 86) undergoing NAs treatment were retrospectively enrolled. HBsAg was measured at baseline (T0), 6 months (T1), 12 months (T2) and at the last follow-up (FU). Median FU was 5.5 (3.2–8.3) years; at the end of FU, 11 patients lost the HBsAg (annual incidence rate = 1.8%). Baseline HBsAg levels were significantly different between patients with no HBsAg loss and those achieving a functional cure (3.46, 2.91–3.97 vs. 1.11, 0.45–1.98 Log IU/mL, p < 0.001). Similarly, the HBsAg decline (Δ) from T0 to T2 was significantly different between the two groups of patients (0.05, −0.04–0.13, vs. 0.38, 0.11–0.80 Log IU/mL, p = 0.002). By stratified cross-validation analysis, the combination of baseline HBsAg and ΔHBsAg T0–T2 showed an excellent accuracy for the prediction of HBsAg loss (C statistic = 0.966). These results corroborate the usefulness of quantitative HBsAg in Caucasian CHB patients treated with antivirals for the prediction of HBsAg seroclearance.

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Section: Introductionmentioning

confidence: 99%

Usefulness of a Hepatitis B Surface Antigen-Based Model for the Prediction of Functional Cure in Patients with Chronic Hepatitis B Virus Infection Treated with Nucleos(t)ide Analogues: A Real-World Study

Caviglia

Troshina

Garro

et al. 2021

JCM

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“…The improvement in eGFR with switch-over from TDF to TAF was observed for up to 24 weeks, regardless of the duration of prior TDF therapy. A significant decline was also noted in the urinary b2MG/ Cre ratio, a marker of renal tubular disorder, at 12 and 24 weeks of switch-over from TDF to TAF, thus indicating significant improvement in renal function with TDF to TAF switch-over [62].…”

Section: Switch-over From Tdf To Tafmentioning

confidence: 89%

“…The reviewed literature clearly highlights the benefits of TAF therapy in terms of both efficacy and safety, along with minimal resistance issues. Improving the access to medication can help further optimize the use of TAF therapy in chronic HBV patients in Asia [ 22 , 24 ].…”

Section: Indications For the Use Of Taf In Asia: Expert Consensus Recmentioning

confidence: 99%

“…This difference, however, did not persist in the long term and in patients with HBV-related cirrhosis [22]. Both ETV and TDF have been clinically proven to be effective in the long term for the treatment of patients with chronic HBV infection, including those who relapsed after PegIFNa therapy [23][24][25][26]. Further, ETV has also been found to be effective in patients with chronic kidney disease, including those on hemodialysis, without affecting the renal function [27].…”

Section: Treatment Of Chronic Hbv Infection: Current Guideline Recommendationsmentioning

confidence: 99%

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An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia

Charlton

Alam²,

Shukla

et al. 2020

J Gastroenterol

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Asia has intermediate-to-high prevalence and high morbidity of hepatitis B virus (HBV) infection. The use of guideline-recommended nucleos(t)ide analogs with high barrier to resistance, such as entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), is one of the key interventions for curbing HBV infection and associated morbidity in Asia. However, there are some challenges to the use of ETV and TDF; while ETV is associated with high resistance in lamivudine (LAM)-exposed (especially LAM-refractory) patients; bone and renal safety issues are a major concern with TDF. Hence, a panel of twenty-eight expert hepatologists from Asia convened, reviewed the literature, and developed the current expert opinion-based review article for the use of TAF in the resource-constrained settings in Asia. This article provides a comprehensive review of two large, phase 3, double-blind, randomized controlled trials of TAF versus TDF in HBeAg-negative (study 0108) and HBeAg-positive (study 0110) chronic HBV patients (> 70% Asians). These studies revealed as follows: (1) non-inferiority for the proportion of patients who had HBV DNA < 29 IU/mL; (2) significantly high rate of normalization of alanine aminotransferase levels; (3) no incidence of resistance; and (4) significantly better bone and renal safety, with TAF vs. TDF up to 144 weeks. Considering the benefits of TAF, the expert panel proposed recommendations for optimizing the use of TAF in Asia, along with guidance on specific patient groups at risk of renal or bone disease suitable for TAF therapy. The guidance provided in this article may help clinicians optimize the use of TAF in Asia.

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“…However, complications such as small for size syndrome or those of the biliary and vascular pathways, especially in recipients with high Model for End-Stage Liver Disease (MELD) scores, may ensue. Despite the fact that, in case of liver diseases caused by viral infections, new antiviral treatments have permitted significant advances, the risk of recidivisms that require a re-transplantation for other severe liver diseases remains a major obstacle [12][13][14]. Moreover, inflammatory responses and acute or chronic immune-mediated organ rejection, life-long requirement of immunosuppressive drugs, and incidence of postoperative infections following LT are still unresolved issues.…”

Section: Introductionmentioning

confidence: 99%

Evolving Cell-Based and Cell-Free Clinical Strategies for Treating Severe Human Liver Diseases

Cernigliaro

Peluso

Zedda

et al. 2020

Cells

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Liver diseases represent a major global health issue, and currently, liver transplantation is the only viable alternative to reduce mortality rates in patients with end-stage liver diseases. However, scarcity of donor organs and risk of recidivism requiring a re-transplantation remain major obstacles. Hence, much hope has turned towards cell-based therapy. Hepatocyte-like cells obtained from embryonic stem cells or adult stem cells bearing multipotent or pluripotent characteristics, as well as cell-based systems, such as organoids, bio-artificial liver devices, bioscaffolds and organ printing are indeed promising. New approaches based on extracellular vesicles are also being investigated as cell substitutes. Extracellular vesicles, through the transfer of bioactive molecules, can modulate liver regeneration and restore hepatic function. This review provides an update on the current state-of-art cell-based and cell-free strategies as alternatives to liver transplantation for patients with end-stage liver diseases.

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Efficacy and safety of long-term entecavir therapy in a European population

Cited by 11 publications

References 0 publications

Usefulness of a Hepatitis B Surface Antigen-Based Model for the Prediction of Functional Cure in Patients with Chronic Hepatitis B Virus Infection Treated with Nucleos(t)ide Analogues: A Real-World Study

Usefulness of a Hepatitis B Surface Antigen-Based Model for the Prediction of Functional Cure in Patients with Chronic Hepatitis B Virus Infection Treated with Nucleos(t)ide Analogues: A Real-World Study

An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia

Evolving Cell-Based and Cell-Free Clinical Strategies for Treating Severe Human Liver Diseases

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