Tenofovir/entecavir monotherapy after hepatitis B immunoglobulin withdrawal is safe and effective in the prevention of hepatitis B in liver transplant recipients

Fernández, Inmaculada; Loinaz, Carmelo; Hernández, Ó.; Abradelo, M.; Manrique, Alejandro; Pulido, Jorge Calvo; Manzano, María Luisa; García, Ana Isabel Morales; Cambra, F.; Castellano, Giancarlo; Jiménez, Carlos

doi:10.1111/tid.12434

Cited by 47 publications

(37 citation statements)

References 27 publications

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“…152 Conversely, lifelong combination therapy should be given to patients who are at a high risk for HBV recurrence, namely those who are HBV DNA positive at the time of liver transplantation, who are HBeAg-positive, have HCC, and HDV or HIV co-infection. [153][154][155] In the setting of liver transplantation, nephrotoxicity should always be considered and renal function should be carefully monitored because of the concomitant use of calcineurin inhibitors. When the immune system is therapeutically suppressed in the context of liver transplantation, there is potential for HBV reactivation in HBsAg-negative patients receiving donor organs with evidence of past HBV infection (anti-HBc positive).…”

Section: Recommendationsmentioning

confidence: 99%

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

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,032

3,081

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Section: Recommendationsmentioning

confidence: 99%

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

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,032

3,081

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“…A concern with TDF use has been nephrotoxicity. This has been rare in studies on chronic hepatitis B and postliver transplant, although it has been a significant issue in some patients treated with TDF for HIV . One patient in our cohort had overt features of Fanconi's syndrome, necessitating a change of therapy to entecavir, which underlines the potential for renal toxicity with TDF therapy in the posttransplant setting.…”

Section: Discussionmentioning

confidence: 84%

“…The finding that tenofovir disoproxil fumarate (TDF) is highly active against LAM‐resistant viruses suggests that the combination of this drug with LAM may at least be as effective as traditional HBIg/LAM combination therapy. However, the need for additional LAM is questionable because no cases of tenofovir resistance have been identified in either treatment‐naïve or nucleos(t)ide‐experienced patients …”

Section: Introductionmentioning

confidence: 99%

Long‐term safety and efficacy of tenofovir disoproxil fumarate substitution for hepatitis B immunoglobulin following liver transplantation

et al. 2018

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Background and AimsLimitations to the use of long‐term Hepatitis B Immunoglobulin (HBIg) following liver transplantation for hepatitis B (HBV) have led to the substitution of HBIg with oral nucleo(s)tide analogue prophylaxis. We prospectively assessed the long‐term safety and efficacy of switching to tenofovir disoproxil fumarate (TDF) from HBIg.MethodsAn open‐label, multicenter switch study was conducted to evaluate the substitution of TDF for HBIg whilst continuing lamivudine (LAM) therapy in preventing the recurrence of HBV in patients who had been maintained as hepatitis B surface antigen (HBsAg)‐negative posttransplantation for at least 12 months.ResultsEighteen patients were enrolled (median age 66 years, range 42–78 years); 84% were male, and 78% on calcineurin inhibitors. Median time after transplantation was 14 years (range 5–19), and median duration of HBIg/LAM prior to the switch was 10 years (range 1–14). Median follow‐up was 5 years (range 5–8). Of 18 patients, 16 (89%) remained HBsAg and HBV DNA negative at the end of follow‐up. Two patients had re‐emergence of HBsAg without a detectable HBV DNA and no clinical sequelae. Creatinine clearance significantly reduced (median 59 mL/min to 51 mL/min, P = 0.03), necessitating dose reduction of TDF in six (33%) participants, with two eventually ceasing TDF. One patient switched back to HBIg by choice. All patients who changed therapy maintained an undetectable HBsAg.ConclusionSubstitution of HBIg with TDF in patients on LAM is well tolerated and effective for the long‐term prevention of HBV recurrence posttransplantation. Renal dysfunction occurs frequently in the posttransplant setting and can require dose adjustment of TDF or change of therapy.

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“…Another 2 studies demonstrated a trend toward improved eGFR/CKD stage under sequential TAF treatment following TDF or HBIG+NAs 48,49 . The renal function remained at a stable level in other trials 35,36,40,41,52 .…”

Section: Renal Functionmentioning

confidence: 81%

“…≤6m vs >6m). In this regard, individualized decision should be made based on kinetics of anti-HBs 40,44,69 . We did not conduct strati cation by dosage because most of the studies applied low-dose of HBIG (≤ 1000 IU) one week/month post-LT.…”

Section: Discussionmentioning

confidence: 99%

The Strategy and Efficacy of Prophylaxis Against Hepatitis B Virus Recurrence After Liver Transplantation in the Era of High Potent Nucleos(t)ide Analogues: A Meta-Analysis

Li¹,

Hou²,

Yao³

et al. 2020

Preprint

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Background: High potent nucleos(t)ide analogues (HP NAs) with or without hepatitis B immunoglobulin (HBIG) is the standard prophylactic therapy for avoiding the HBV recurrence after liver transplantation (LT). While the clinical impact of HP NAs-based prophylaxis has not been well documented, the optimal treatment strategy is currently debated. This meta-analysis aims to evaluate clinical outcome of LT recipients under HP NAs-based regimens and investigate different prophylaxis schemes. Methods: We followed PRISMA statement to conduct this study. Two reviewers independently searched relevant literature via PubMed, EMBAES, MEDLINE, Web of Science, and Google Scholar. Studies were included if they observed HBV recurrence under HP NAs-based regimens in patients who received HBV-related LT. Primary and secondary outcome were HBV recurrence, HCC recurrence, all-cause and HBV-recurrence related mortality. Incidence with 95% confidence intervals was aggregated and assess by fixed effect model/random effect model. Subgroup analysis was applied to examine the impact of different treatment strategies. Results: 26 studies (n=2374) were included, with a pooled HBV recurrence rate of 0.92% (95% CI 0.47%-1.48%). Studies with and without HBV viremia or HDV superinfected patients demonstrated comparable HBV recurrence (p=0.25, p=0.69). Recurrence rate under indefinite combination of HP NAs and HBIG was lower than that under HP NAs monotherapy (p=0.0003), and similar to that under NAs plus finite course of HBIG (p=0.53). Pooled HCC recurrence rate was 5.34% (95% CI 0.78%-12.48%). HBV-recurrence related mortality and all-cause mortality were 0.17% (95% CI 0.00%-1.51%) and 7.29% (95% CI 4.42%–10.71%) respectively. Conclusion: Our study suggests HP NAs-based regimens provide satisfactory HBV antiviral prophylaxis and improved long-term outcome for LT recipients. Finite combination of HP NAs and HBIG is an alternative to lifelong dual therapy.

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Tenofovir/entecavir monotherapy after hepatitis B immunoglobulin withdrawal is safe and effective in the prevention of hepatitis B in liver transplant recipients

Abstract: Maintenance therapy with newer NAs, after discontinuation of HBIG prophylaxis, was safe and effective, with a low rate of serological recurrence and no evident clinical, biochemical, or virological consequences.

Cited by 47 publications

References 27 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

Long‐term safety and efficacy of tenofovir disoproxil fumarate substitution for hepatitis B immunoglobulin following liver transplantation

The Strategy and Efficacy of Prophylaxis Against Hepatitis B Virus Recurrence After Liver Transplantation in the Era of High Potent Nucleos(t)ide Analogues: A Meta-Analysis

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