Review article: long‐term safety of oral anti‐viral treatment for chronic hepatitis B

Wong, Grace Lai–Hung; Seto, Wai‐Kay; Wong, Vincent W. S.; Yuen, Man‐Fung; Chan, Henry Lik Yuen

doi:10.1111/apt.14497

Cited by 66 publications

(55 citation statements)

References 55 publications

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“…Both TDF and adefovir dipivoxil are nucleotide analogues and excreted via kidney by glomerular filtration. Mechanisms of nucleoside analogue induced renal toxicity include renal tubular injury and mitochondrial toxicity . However, the data concerning nephrotoxicity of TDF have been debatable in patients with CHB.…”

Section: Discussionmentioning

confidence: 99%

An observational study on long‐term renal outcome in patients with chronic hepatitis B treated with tenofovir disoproxil fumarate

Lim

Lee

Kim

et al. 2020

Journal of Viral Hepatitis

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In patients with chronic hepatitis B (CHB), long‐term effects of tenofovir disoproxil fumarate (TDF) on renal function have been controversial. This study aimed to analyse the real‐world long‐term effects of TDF on renal function in Korean patients with CHB. We analysed a cohort of 640 treatment‐naïve patients with CHB who were treated with TDF between May 2012 and December 2015 at Severance Hospital, Seoul, Republic of Korea. The mean age was 48.3 years old, and 59.5% were male. The proportions of hypertension and diabetes mellitus (DM) were 11.6% and 14.2%, respectively, and that of liver cirrhosis was 20.8%. During the 5‐year follow‐up, using a linear mixed model, serum creatinine increased from 0.77 ± 0.01 mg/dL to 0.85 ± 0.02 mg/dL (P < .001), and eGFR decreased from 102.6 ± 0.6 mL/min/1.73 m2 to 93.4 ± 1.4 mL/min/1.73 m2 (P < .001). In subgroup analysis, eGFR was statistically more decreased in patients with age > 60 than ≦60 years old (P = .027), and in patients with diuretic use than without diuretic use (P = .008). In multivariate analysis, the independent risk factors for eGFR decrease > 20% were baseline eGFR < 60mL/min/1.73 m2 (P = .034) and the use of diuretics (P < .001). CHB patients on TDF experienced greater reduction in renal function with age > 60 and with diuretic use compared to those without these characteristics. Baseline eGFR < 60 mL/min/1.73 m2 and use of diuretics were independent risk factors of eGFR decline of more than 20% on TDF therapy.

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Section: Discussionmentioning

confidence: 99%

An observational study on long‐term renal outcome in patients with chronic hepatitis B treated with tenofovir disoproxil fumarate

Lim

Lee

Kim

et al. 2020

Journal of Viral Hepatitis

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“…In addition, data on antiviral treatment in HBV/HCV+ mothers were unavailable, although usually, most parturients do not require therapy. Moreover, antiviral therapies used in HBV/HCV+ mothers during pregnancy are listed as category B or C under the FDA pregnancy categories, so it seems unlikely that maternal antiviral treatment accounts for our findings. We suggest that future studies will include data on antiviral treatments and investigate possible mechanisms of this study findings, as well.…”

Section: Discussionmentioning

confidence: 99%

Maternal hepatitis B or C status and the long‐term risk of gastrointestinal morbidity for offspring: A population‐based cohort study

Yoles

Abu‐Freha

Wainstock

2019

Liver International

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Background More than 360 million people have chronic hepatitis B or C (HBV/HCV) infection worldwide, many of which are women at childbearing age. While the risk of perinatal HBV/HCV has been well established, the long‐term implications on offspring health, have been less studied. We aimed to evaluate the association between maternal HBV/HCV carrier status and long‐term gastrointestinal (GI) morbidities in offspring. Aims & Methods A population‐based cohort analysis compared the risk for long‐term childhood GI morbidities in children born to HBV/HCV carrier mothers vs the risk in those who were born to noncarriers. Childhood GI morbidities were predefined based on ICD‐9 codes, as recorded in hospital medical files. Children with congenital malformations and multiple gestations were excluded from the analysis. A Kaplan‐Meier survival curve was constructed to compare the cumulative GI morbidities over time, and a Cox proportional hazards model was used to control for confounders. Results During the study period (1991‐2014), 242 342 newborns met the inclusion criteria: 771 (0.3%) were born to HBV/HCV mothers and 241 571 (99.7%) were not. The median follow‐up was 10.51 years (0‐18 years). Offspring to HBV/HCV mothers had a higher incidence of GI diseases (9.3% vs 5.4%, OR = 1.82; 95% CI 1.43‐2.32; Kaplan‐Meier log‐rank = 0.001). The increased risk remained significant in the Cox proportional hazards models, which adjusted for gestational age, mode of delivery and pregnancy complications (adjusted HR = 2.26, 95% CI: 1.79‐2.85; P < .001). Conclusion Maternal HBV or HCV carrier status is an independent risk factor for long‐term the GI morbidity of offspring.

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“…13 Beberapa mekanisme telah ditemukan untuk menjelaskan bagaimana penurunan fungsi ginjal ini terjadi pada (2) penurunan volume arterial efektif pada penyakit hati kronik tahap akhir dan sirosis, yang menimbulkan hipoperfusi ginjal dan penurunan fungsi ginjal 15 ; dan (3) efek nefrotoksisitas jangka panjang dari analog nukleos(t) ida. 16 Observasi pada kelompok tenofovir di minggu ke-48 menunjukkan rerata kreatinin serum meningkat secara signifikan dari 0,88 (SB 0,17) mg/dL pada awal terapi menjadi 0,94 (SB 0,26) mg/dL (p = 0,008) pada minggu ke-48 dan rerata eLFG juga menurun secara signifikan, yaitu dari 93,69 (SB 16,56) mL/menit/1,73 m 2 menjadi 90,67 (SB 20,89) mL/menit/1,73 m 2 dalam 48 minggu (p = 0,029) pada pasien infeksi hepatitis B kronik dengan eLFG ≥60 mL/menit/1,73 m 2 .…”

Section: Diskusiunclassified

“…Mekanisme tenofovir yang berhubungan dengan nefrotoksisitas yaitu akumulasi intraseluler dari tenofovir menyebabkan saturasi MRP-4 sehingga menimbulkan kerusakan tubulus ginjal. 16 Sebuah penelitian di Taiwan membandingkan keamanan ginjal pada pemberian telbivudin dan tenovofir terhadap pasien infeksi hepatitis B kronik tanpa gangguan ginjal sebelumnya (eLFG ≥60 mL/menit/1,73 m 2 ). Estimasi LFG menurun secara signifikan pada kelompok tenovofir dalam 2 tahun pertama yang dibandingkan dengan awal.…”

Section: Diskusiunclassified

Perbandingan Profil Keamanan Tenofovir dan Telbivudin terhadap Fungsi Ginjal pada Pasien Hepatitis B di Indonesia

Gani¹

2018

JPDI

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ABSTRAKPendahuluan. Tenofovir disoproksil fumarat (tenofovir) dan telbivudin merupakan dua analog nukleos(t)ida yang tersedia untuk terapi pasien hepatitis B. Tenofovir telah diketahui sebagai agen nefrotoksik pada pasien HIV, namun masih menjadi kontroversi pada pasien hepatitis B kronik. Di lain sisi, telbivudin memiliki efek proteksi terhadap fungsi ginjal dan bahkan meningkatkan estimasi laju filtrasi glomerulus (eLFG). Penelitian ini bertujuan untuk mengetahui profil keamanan terhadap fungsi ginjal dari tenofovir dan telbivudin pada pasien hepatitis B kronik di Indonesia.Metode. Penelitian ini menggunakan desain studi kohort retrospektif pada pasien hepatitis B kronik yang mendapat terapi tenofovir atau telbivudin dalam rentang waktu Januari 2013-Desember 2016. Pasien yang mempunyai eLFG awal <60 mL/ menit/1,73 m 2 sebelum mulai terapi, mengalami perubahan regimen, lost to follow up, atau meninggal dalam 1 tahun tidak diikutsertakan dalam penelitian ini. Data kreatinin serum yang dinilai adalah data pada minggu ke-24 dan 48 setelah pemberian tenofovir atau telbivudin.Hasil. Sebanyak 68 pasien dalam terapi tenofovir dan 62 pasien dalam terapi telbivudin dimasukkan penelitian ini. Kadar kreatinin serum meningkat pada kelompok tenofovir dari 0,88 (simpang baku [SB] 0,17) mg/dL pada awal studi menjadi 0,93 (SB 0,22) mg/dL setelah 24 minggu (p = 0,02) dan cenderung plateau setelah penggunaan selama 48 minggu. Namun, pada kelompok telbivudin, kadar kreatinin serum menurun dari 0,85 (SB 0,21) mg/dL pada awal menjadi 0,80 (SB 0,18) mg/ dL pada minggu ke-48 (p = 0,003) Simpulan. Tenofovir berhubungan dengan peningkatan kadar kreatinin serum dan penurunan eLFG pada pasien hepatitis B kronik dengan eLFG ≥60 mL/menit/1,73 m 2 . ABSTRACTIntroduction. Tenofovir disoproxil fumarate (tenofovir) and telbivudine are two available nucleos(t)ide analogue (NA) for the treatment of chronic hepatitis B (CHB) patients. Tenofovir has been known as a nephrotoxic agent in HIV patients, but still controversy in CHB patients. On the other hand, telbivudine had a renal protective effect and increased estimated glomerular filtration rate (eGFR). This studi aimed to address the renal safety of tenofovir and telbivudine in Indonesian patients. Method.A retrospective cohort study design was conducted in CHB patients who prescribed with tenofovir or telbivudine from January 2013 to December 2016. Patients who hade baseline eGFR <60 mL/min/1.73 m 2 , change the regimen, lost to follow up, or died within a year were excluded in this study. Creatinine serum data evaluated were creatinine serum in week-24 and week-48 after the administration of tenofovir or telbivudine.Results. Among CHB patients, 68 and 62 patients that prescribed with tenofovir or telbivudine, respectively, were enrolled in this study. Serum creatinine level was increased in tenofovir group from 0.88 (SD 0.17) mg/dL at baseline to 0.93 (SD 0.22) mg/dL after 24 weeks (p = 0.02), but creatinine trend to reach plateau after 48 weeks. However, in telbivudine group, serum creatini...

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Review article: long‐term safety of oral anti‐viral treatment for chronic hepatitis B

Cited by 66 publications

References 55 publications

An observational study on long‐term renal outcome in patients with chronic hepatitis B treated with tenofovir disoproxil fumarate

An observational study on long‐term renal outcome in patients with chronic hepatitis B treated with tenofovir disoproxil fumarate

Maternal hepatitis B or C status and the long‐term risk of gastrointestinal morbidity for offspring: A population‐based cohort study

Perbandingan Profil Keamanan Tenofovir dan Telbivudin terhadap Fungsi Ginjal pada Pasien Hepatitis B di Indonesia

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