Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year Prospective Field Practice Study in Germany

Petersen, Jörg; Heyne, R.; Mauss, Stefan; Schlaak, J. F.; Schiffelholz, W; Eisenbach, Christoph; Hartmann, Heinz; Wiese, Manfred; Boeker, Klaus; Loehr, H; John, C; Leuschner, M.; Trautwein, Christian; Felten, G; Trein, Andreas; Krause, W.; Ruppert, Susanne; Warger, Tobias; Hueppe, D.

doi:10.1007/s10620-015-3960-x

Cited by 47 publications

(43 citation statements)

References 21 publications

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“…69 During 3-4 years of TDF treatment in HBeAg-negative CHB patients in real practice, the virological response rates ranged from 92% to 100% without the emergence of TDF resistance, while 75% of patients had normalised ALT. [70][71][72][73] No HBeAg-negative CHB patient cleared HBsAg wihin the first year of ETV or TDF therapy and very few ($1%) achieved this endpoint during long-term (8 years) therapy.…”

Section: Hbsagmentioning

confidence: 99%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,207

3,081

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Section: Hbsagmentioning

confidence: 99%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,207

3,081

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“…The ideal ''real-world'' study would prospectively enroll consecutive patients and account for all patients at study end, provide intent-to-treat as well as perprotocol analyses, and include details of treatment failures, including reasons for treatment discontinuation. The ''realworld'' cohorts included in this issue of Digestive Diseases and Sciences-GEMINIS from Germany [5] and VIREAL from France [6]-partially meet these high standards. Regardless, some important practical messages can be gleaned from their analyses.…”

mentioning

confidence: 99%

“…The ''realworld'' cohorts included in this issue of Digestive Diseases and Sciences-GEMINIS from Germany [5] and VIREAL from France [6]-partially meet these high standards. Regardless, some important practical messages can be gleaned from their analyses.The VIREAL and GEMINIS cohorts enrolled [800 patients from diverse practice settings who were newly initiated on TDF therapy [5,6]. Treatment-naïve and experienced subjects were included, with a substantial proportion of the treatment-experienced patients transitioning from another nucleos(t)ide analog therapy to TDF and having low or undetectable HBV DNA levels at the time of TDF initiation.…”

mentioning

confidence: 99%

“…The VIREAL and GEMINIS cohorts enrolled [800 patients from diverse practice settings who were newly initiated on TDF therapy [5,6]. Treatment-naïve and experienced subjects were included, with a substantial proportion of the treatment-experienced patients transitioning from another nucleos(t)ide analog therapy to TDF and having low or undetectable HBV DNA levels at the time of TDF initiation.…”

mentioning

confidence: 99%

“…Treatment-naïve and experienced subjects were included, with a substantial proportion of the treatment-experienced patients transitioning from another nucleos(t)ide analog therapy to TDF and having low or undetectable HBV DNA levels at the time of TDF initiation. Hypertension, diabetes, renal disease, cardiovascular diseases, and other comorbidities were present in *40 % of patients [5] with up to 28 % having eGFR \90 ml/min [6]. Although the intent of the study was to follow patients for 3 years, both cohorts suffered from patient attrition, leading to incomplete reporting of virologic and safety data.…”

mentioning

confidence: 99%

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Real-World Experiences with Tenofovir Disoproxil Fumarate: Is this the “B-Ticket”?

Terrault

2016

Dig Dis Sci

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The preferred options for treatment of chronic hepatitis B viral (HBV) infection in countries without resource constraints are peginterferon, entecavir, or tenofovir disoproxil fumarate (TDF) [1,2]. For most clinicians, peginterferon is infrequently considered due to the greater complexity of monitoring, higher frequency of adverse effects and patient preference, which narrows the treatment options to TDF or entecavir. In the registration trials of treatment-naïve patients with chronic hepatitis B, both TDF and entecavir demonstrated high rates of on-treatment HBV DNA suppression and low rates of viral resistance coupled with excellent safety [3,4]. Given that TDF and entecavir have been approved therapies for HBV for more than a decade, data derived from ''real-world'' cohort studies have helped fill knowledge gaps regarding the use of these drugs in clinical practice. In the case of TDF, the issues of particular interest include: (1) the efficacy of TDF across a wider spectrum of patients including those less adherent than patients in clinical trials, and (2) the risks associated with longer-term use of TDF, especially the frequency of viral resistance and the risk of renal and bone toxicity.Patients participating in clinical trials are a select group-typically healthier than many patients in the clinic, with fewer comorbidities and higher rates of adherence. The registration trials for TDF required a estimated glomerular filtration rate (eGFR) [70 ml/min, absence of anemia, neutropenia, and liver decompensation or presence of unstable comorbidities [3]. In practice, patient complexity can be greater, comorbidities not always optimized, and adherence less assured. Understanding how antivirals perform under these less than ideal circumstances is important. The ideal ''real-world'' study would prospectively enroll consecutive patients and account for all patients at study end, provide intent-to-treat as well as perprotocol analyses, and include details of treatment failures, including reasons for treatment discontinuation. The ''realworld'' cohorts included in this issue of Digestive Diseases and Sciences-GEMINIS from Germany [5] and VIREAL from France [6]-partially meet these high standards. Regardless, some important practical messages can be gleaned from their analyses.The VIREAL and GEMINIS cohorts enrolled [800 patients from diverse practice settings who were newly initiated on TDF therapy [5,6]. Treatment-naïve and experienced subjects were included, with a substantial proportion of the treatment-experienced patients transitioning from another nucleos(t)ide analog therapy to TDF and having low or undetectable HBV DNA levels at the time of TDF initiation. Hypertension, diabetes, renal disease, cardiovascular diseases, and other comorbidities were present in *40 % of patients [5] with up to 28 % having eGFR \90 ml/min [6]. Although the intent of the study was to follow patients for 3 years, both cohorts suffered from patient attrition, leading to incomplete reporting of virologic and safety data. The primary...

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First‐line therapies for hepatitis B in the United States: A 3‐year prospective and multicenter real‐world study after approval of tenofovir alefenamide

et al. 2022

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Real‐world data are limited on tenofovir alafenamide (TAF). We aimed to study TAF real‐world outcomes with other first‐line regimens for chronic hepatitis B (CHB). We enrolled patients with CHB from 10 centers retrospectively and followed them for 36 months prospectively. We analyzed switching patterns of antiviral therapy and treatment outcomes of TAF, tenofovir disoproxil fumarate (TDF), and entecavir therapy. For efficacy and safety, we analyzed a subset of patients with complete data at 24 months after switching to TAF or remaining on TDF or entecavir. Among 1037 enrollees, 889 patients were analyzed. The mean age was 52%, and 72% were hepatitis B e antigen–negative. After enrollment, shifts in therapies were mostly in reduced use of TDF from 63% to 30% due to switching to TAF. Clinical parameters were compared at enrollment or initiation to measures at 24 months for patients remaining on TAF (187), TDF (229), or entecavir (181). At 24 months, a significantly higher portion of patients on TAF achieved hepatitis B virus (HBV) DNA ≤ 20 IU/ml (93% vs. 86%; p = 0.012) and normalized alanine aminotransferase (ALT) (66% vs. 56%; p = 0.031) with stable estimated glomerular filtration rates (eGFRs). However, a higher percentage of the patient with eGFR < 60 ml/mi/1.7 m2 was observed in the TDF‐treated group (9% vs. 4%; p = 0.010). In patients who remained on entecavir or TDF for 24 months, ALT and HBV‐DNA results did not differ significantly from baseline. Treatment of CHB in the United States has significantly shifted from TDF to TAF. Our data suggest that switching from TDF or entecavir to TAF may result in increased frequency of ALT normalization and potential clearance of viremia at the 24‐month time point.

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Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year Prospective Field Practice Study in Germany

Cited by 47 publications

References 21 publications

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Real-World Experiences with Tenofovir Disoproxil Fumarate: Is this the “B-Ticket”?

First‐line therapies for hepatitis B in the United States: A 3‐year prospective and multicenter real‐world study after approval of tenofovir alefenamide

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