Cargando…

Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure

INTRODUCTION: HBV is major health problem globally due to complications, including ACLF, cirrhosis and hepa¬tocellular carcinoma. ACLF due to exacerbation of CHB is associate with 30%-70% mortality. Reduction of HBV-DNA is therefore a target of therapy in ACLF-B. METHODS: Patients with spontaneous r...

Descripción completa

Detalles Bibliográficos
Autores principales: Manik, Abul H, Malakar, Debraj, Noor-E-Alam, Sheikh M, Mahtab, Mamun A, Das, Dulal C, Mamun, Ayub A, Khan, Sakirul, Akbar, Mohammad Fazle, Rahman, Zakiur, Rahman, Salimur
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8284233/
https://www.ncbi.nlm.nih.gov/pubmed/34322441
http://dx.doi.org/10.4103/jfmpc.jfmpc_2300_20
_version_ 1783723358361223168
author Manik, Abul H
Malakar, Debraj
Noor-E-Alam, Sheikh M
Mahtab, Mamun A
Das, Dulal C
Mamun, Ayub A
Khan, Sakirul
Akbar, Mohammad Fazle
Rahman, Zakiur
Rahman, Salimur
author_facet Manik, Abul H
Malakar, Debraj
Noor-E-Alam, Sheikh M
Mahtab, Mamun A
Das, Dulal C
Mamun, Ayub A
Khan, Sakirul
Akbar, Mohammad Fazle
Rahman, Zakiur
Rahman, Salimur
author_sort Manik, Abul H
collection PubMed
description INTRODUCTION: HBV is major health problem globally due to complications, including ACLF, cirrhosis and hepa¬tocellular carcinoma. ACLF due to exacerbation of CHB is associate with 30%-70% mortality. Reduction of HBV-DNA is therefore a target of therapy in ACLF-B. METHODS: Patients with spontaneous reactivation of HBV [(ALT >5×ULN or >2× baseline) and HBV-DNA >20,000 IU/ml] were randomized to Tenofovir mono therapy (300 mg/day) or Tenofovir plus Telbivudine (600 mg/day) dual therapy with standard care. Clinical and biochemical parameters were evaluated at baseline, 1 week, 4 weeks and at 3 months. Virological evaluation was done at baseline and at 3 months. Primary end points were reduction of HBV-DNA and resolution of ascites, as applied. Secondary end point was reduction of liver related complications, therapy related adverse effects and survival at 3 months. RESULTS: 27 patients were enrolled. 15 received mono therapy with Tenofovir and 12 received dual therapy (Tenofovir plus Telbivudine). Baseline parameters in 2 groups had no significant difference. In both groups there was significant improvement of S. bilirubin, ALT, INR, CTP score and MELD score. Only MELD score showed significant improvement in patient with dual therapy at 3 months in comparison to mono therapy. 11 patients on Tenofovir mono therapy (n=15) showed undetected HBV-DNA (91.7%) at 3 months and one patient had detectable HBV-DNA (<2,000 IU/ml). 10 patients on dual therapy (n=12) had undetectable HBV-DNA (100%). Ascites resolved in 3 patients in both groups. Patients receiving dual therapy showed significant improvement in AKI on follow up compared to those on Tenofovir mono therapy. Among 5 deaths, 3 received mono therapy with Tenofovir and 2 dual therapy. Predictors of mortality had high S. bilirubin, HBV-DNA, MELD score and CTP score. CONCLUSION: In spontaneous reactivation of HBV presenting as ACLF, combination of Telbivudine plus Tenofovir is safer with less nephrotoxicity and better outcomes.
format Online
Article
Text
id pubmed-8284233
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Wolters Kluwer - Medknow
record_format MEDLINE/PubMed
spelling pubmed-82842332021-07-27 Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure Manik, Abul H Malakar, Debraj Noor-E-Alam, Sheikh M Mahtab, Mamun A Das, Dulal C Mamun, Ayub A Khan, Sakirul Akbar, Mohammad Fazle Rahman, Zakiur Rahman, Salimur J Family Med Prim Care Original Article INTRODUCTION: HBV is major health problem globally due to complications, including ACLF, cirrhosis and hepa¬tocellular carcinoma. ACLF due to exacerbation of CHB is associate with 30%-70% mortality. Reduction of HBV-DNA is therefore a target of therapy in ACLF-B. METHODS: Patients with spontaneous reactivation of HBV [(ALT >5×ULN or >2× baseline) and HBV-DNA >20,000 IU/ml] were randomized to Tenofovir mono therapy (300 mg/day) or Tenofovir plus Telbivudine (600 mg/day) dual therapy with standard care. Clinical and biochemical parameters were evaluated at baseline, 1 week, 4 weeks and at 3 months. Virological evaluation was done at baseline and at 3 months. Primary end points were reduction of HBV-DNA and resolution of ascites, as applied. Secondary end point was reduction of liver related complications, therapy related adverse effects and survival at 3 months. RESULTS: 27 patients were enrolled. 15 received mono therapy with Tenofovir and 12 received dual therapy (Tenofovir plus Telbivudine). Baseline parameters in 2 groups had no significant difference. In both groups there was significant improvement of S. bilirubin, ALT, INR, CTP score and MELD score. Only MELD score showed significant improvement in patient with dual therapy at 3 months in comparison to mono therapy. 11 patients on Tenofovir mono therapy (n=15) showed undetected HBV-DNA (91.7%) at 3 months and one patient had detectable HBV-DNA (<2,000 IU/ml). 10 patients on dual therapy (n=12) had undetectable HBV-DNA (100%). Ascites resolved in 3 patients in both groups. Patients receiving dual therapy showed significant improvement in AKI on follow up compared to those on Tenofovir mono therapy. Among 5 deaths, 3 received mono therapy with Tenofovir and 2 dual therapy. Predictors of mortality had high S. bilirubin, HBV-DNA, MELD score and CTP score. CONCLUSION: In spontaneous reactivation of HBV presenting as ACLF, combination of Telbivudine plus Tenofovir is safer with less nephrotoxicity and better outcomes. Wolters Kluwer - Medknow 2021-06 2021-07-02 /pmc/articles/PMC8284233/ /pubmed/34322441 http://dx.doi.org/10.4103/jfmpc.jfmpc_2300_20 Text en Copyright: © 2021 Journal of Family Medicine and Primary Care https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Original Article
Manik, Abul H
Malakar, Debraj
Noor-E-Alam, Sheikh M
Mahtab, Mamun A
Das, Dulal C
Mamun, Ayub A
Khan, Sakirul
Akbar, Mohammad Fazle
Rahman, Zakiur
Rahman, Salimur
Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure
title Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure
title_full Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure
title_fullStr Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure
title_full_unstemmed Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure
title_short Observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis B virus related acute on chronic liver failure
title_sort observational study on the response of tenofovir monotherapy versus tenofovir plus telbivudine dual therapy in patients with hepatitis b virus related acute on chronic liver failure
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8284233/
https://www.ncbi.nlm.nih.gov/pubmed/34322441
http://dx.doi.org/10.4103/jfmpc.jfmpc_2300_20
work_keys_str_mv AT manikabulh observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT malakardebraj observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT noorealamsheikhm observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT mahtabmamuna observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT dasdulalc observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT mamunayuba observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT khansakirul observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT akbarmohammadfazle observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT rahmanzakiur observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure
AT rahmansalimur observationalstudyontheresponseoftenofovirmonotherapyversustenofovirplustelbivudinedualtherapyinpatientswithhepatitisbvirusrelatedacuteonchronicliverfailure