RETRACTION: Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients with Chronic HBV Infection

Seto, Wai‐Kay; Asahina, Yasuhiro; Brown, Todd T.; Peng, Cheng‐Yuan; Stanciu, C; Abdurakhmanov, Dzhamal; Tabak, Fehmı; Nguyen, Tuan; Chuang, Wan–Long; Inokuma, Tetsuro; Ikeda, Fusao; Santantonio, T.; Habersetzer, François; Ramji, Alnoor; Lau, Audrey H.; Suri, Vithika; Flaherty, John F.; Wang, Hongyuan; Gaggar, Anuj; Subramanian, G. Mani; Mukewar, Shrikant; Brunetto, M.R.; Fung, Scott; Chan, Henry Lik‐Yuen

doi:10.1016/j.cgh.2018.06.023

Cited by 42 publications

(45 citation statements)

References 34 publications

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“…5.1% of patients experienced renal impairment over the 10‐year period, which is within the range previously reported for NA therapies (2%‐7%) . The renal effects observed during TDF treatment have been attributed to the accumulation of tenofovir (TFV) within proximal tubular cells following oral administration . It is therefore recommended that patients treated with TDF undergo periodical renal monitoring.…”

Section: Discussionsupporting

confidence: 69%

Ten‐year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection

Marcellin

Wong

Sievert

et al. 2019

Liver International

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120

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Background & Aims: Tenofovir disoproxil fumarate (TDF) is a first-line treatment for chronic hepatitis B (CHB). We aimed to describe the efficacy and safety profiles of TDF treatment for up to 10 years in a well-described cohort of CHB patients. Methods: Hepatitis B e antigen (HBeAg)-negative and HBeAg-positive patients from two randomised, double-blind trials (ClinicalTrials.gov: NCT00117676 and NCT00116805) completed 48 weeks of randomised treatment with TDF or adefovir dipivoxil. A subset of these patients was then eligible to receive open-label TDF treatment for up to 10 years. At Year 10, patients were assessed for virological suppression, alanine aminotransferase (ALT) normalisation, serological response, safety and tolerability. Results: Of 641 randomised and treated patients, 585 (91%) entered the open-label extension phase with 203 (32%) patients completing Year 10 of the study. At Year 10, 118/118 (100%) of HBeAg-negative patients and 78/80 (98%) of HBeAg-positive | 1869 MARCELLIN Et AL.

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Section: Discussionsupporting

confidence: 69%

Ten‐year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection

Marcellin

Wong

Sievert

et al. 2019

Liver International

Self Cite

120

134

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“…The newer preparation of tenofovir, the tenofovir alafenamide, has been felt to have a lower detrimental effect on bone health. In a double‐blind randomized study by Seto et al, in which patients were assigned to either TDF or TAF treatment, patients receiving TDF were found to have greater decreases in hip and spine bone mineral density compared with patients receiving TAF following 2 years of treatment. While more studies are forthcoming to compare TDF to TAF, it is essential to investigate the impact of TDF on the development of osteopenia/osteoporosis given its long‐term use.…”

Section: Discussionmentioning

confidence: 99%

Antiviral therapy and the development of osteopenia/osteoporosis among Asians with chronic hepatitis B

Wei

Chang

et al. 2019

Journal of Medical Virology

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Background: Recent studies have suggested a potential increase in the incidence of osteoporosis for patients receiving tenofovir disoproxil fumarate (TDF), but this issue remains controversial. Methods:The retrospective cohort study of 1224 Asian chronic hepatitis B (CHB) patients greater than 18 years without baseline osteopenia/osteoporosis seen at four US centers from 2008 to 2016. Patients were categorized into three groupstreatment-naive patients who initiated therapy with TDF (1) or entecavir (ETV) (2), or untreated patients (3). Patients were followed until the development of osteopenia/ osteoporosis or end of the study.Results: Of the 1224 study patients, 276 were treated with TDF, 335 with ETV, and 613 were untreated. The prevalence of cirrhosis was lower for untreated patients (2.6% vs 16.3% for TDF and 17.6% for ETV; P < 0.001). The 8-year cumulative incidence rate of osteopenia/osteoporosis was 13.17% for TDF, 15.09% for ETV, and 10.17% for untreated patients, with no statistically significant difference among the three groups (P = 0.218). On multivariate Cox regression controlling for demographics, osteoporosis risk factors, albumin, and hepatitis B virus (HBV) DNA levels, neither TDF (adjusted hazard ratio [HR] = 0.74; 95% confidence interval [CI]: 0.34 and 1.59) nor ETV (adjusted HR = 0.98; 95% CI: 0.51 and 1.90) were associated with increased osteopenia/osteoporosis risk compared with untreated patients. Conclusions:Our retrospective study suggests that there is no significant increase in the incidence of osteopenia/osteoporosis for patients with CHB treated with TDF or ETV during a median follow-up of about 4 to 5 years. However, further study with longer follow-up is needed as an anti-HBV therapy, which is often lifelong or longterm and the development of osteopenia/osteoporosis can be a slow process. K E Y W O R D S entecavir, hepatitis B, osteoporosis, tenofovir, viral hepatitis J Med Virol. 2019;91:1288-1294. wileyonlinelibrary.com/journal/jmv 1288 |

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“…Few studies examine this, likely because of the logistical difficulty of studying osteopenia/osteoporosis, which requires regular bone densitometry scans. In Seto et al's 96‐week follow‐up study, in multivariate logistic regression, having baseline hip (OR 0.576 [95% CI: 0.406‐0.818] or spine (OR 0.663 [95% CI: 0.440‐0.999]) osteopenia/osteoporosis was found to be a significant factor for losing more than 3% hip and spine bone mineral density at week 96. When dividing up patients by hip fracture risk assessment tool (FRAX) score quartiles, at week 96, the proportion of patients who had bone mineral density greater than 3% increased with each FRAX score quartile for TDF, but for TAF this remained relatively similar.…”

Section: Adverse Effects Of Antiviral Therapymentioning

confidence: 96%

“…When dividing up patients by hip fracture risk assessment tool (FRAX) score quartiles, at week 96, the proportion of patients who had bone mineral density greater than 3% increased with each FRAX score quartile for TDF, but for TAF this remained relatively similar. Unfortunately, there is no direct comparison for patients with CHB who are not taking any antiviral therapy, making it difficult to determine whether the loss of bone mineral density is more rapid than natural progression …”

Section: Adverse Effects Of Antiviral Therapymentioning

confidence: 99%

“…Unfortunately, there is no direct comparison for patients with CHB who are not taking any antiviral therapy, making it difficult to determine whether the loss of bone mineral density is more rapid than natural progression. 47 At this point, current recommendations advise caution when prescribing the antiviral, especially for those with risk factors for development of or worsening of renal or bone disease. However, further study is needed to better understand the impact of antivirals on bone disease.…”

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confidence: 99%

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Nonliver Comorbidities in Patients With Chronic Hepatitis B

Wei

Henry

Nguyen

2019

Clinical Liver Disease

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RETRACTION: Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients with Chronic HBV Infection

Cited by 42 publications

References 34 publications

Ten‐year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection

Ten‐year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection

Antiviral therapy and the development of osteopenia/osteoporosis among Asians with chronic hepatitis B

Nonliver Comorbidities in Patients With Chronic Hepatitis B

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