Long-term Virological and Adherence Outcomes to Antiviral Treatment in a 4-year Cohort Chronic HBV Study
Chronic hepatitis B (CHB) treatment adherence has been poorly studied worldwide. We evaluated long-term virological and adherence outcomes to antiviral treatment in CHB patients. A prospective 183 Brazilian CHB patient cohort treated with monotherapy or combination adefovir dipivoxil, entecavir, lam...
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| Published in | Antiviral therapy Vol. 24; no. 8; pp. 567 - 579 |
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| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
01.01.2019
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| Online Access | Get full text |
| ISSN | 1359-6535 2040-2058 2040-2058 |
| DOI | 10.3851/IMP3338 |
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| Abstract | Chronic hepatitis B (CHB) treatment adherence has been poorly studied worldwide. We evaluated long-term virological and adherence outcomes to antiviral treatment in CHB patients.
A prospective 183 Brazilian CHB patient cohort treated with monotherapy or combination adefovir dipivoxil, entecavir, lamivudine and/or tenofovir disoproxil fumarate was studied in a reference tertiary centre. Treatment adherence was evaluated by a validated questionnaire named 'Assessment of Adherence to Antiviral Therapy Questionnaire' (CEAT-HBV) within three yearly periods (2010/2011, 2013/2014 and 2014/2015).
CEAT-HBV identified 43% (79/183) patients with non-adherence to antiviral treatment and among them, 67% (53/79) were viral load positive. The main causes associated with non-response to antiviral treatment were drug resistance variants followed by non-adherence, insufficient treatment duration and other causes. Single-dose pharmacokinetics demonstrated 35% (23/65) antiviral non-adherence. 2 years after the first assessment, the CEAT-HBV indicated that 71% (101/143) of subjects adhered to treatment (per-protocol population). However, 21% (40/183) of the patients could not be evaluated and were excluded. The main reasons for exclusion were death (20/183), 11 out 20 deaths due to hepatocellular carcinoma. HBV booklet was used for medical education. The third CEAT-HBV assessment (2014/2015) showed that 83% (112/135) patients were compliant with treatment adherence (per-protocol population). Long-term evaluation showed that adherence rate based on CEAT-HBV continue to increase after 4-years (P<0.001).
The results highlight the importance of CHB therapy adherence assessment monitoring. Long-term adherence outcomes were dynamic and it is possible to increase the migration rate to adherence/HBV-DNA-negative group. |
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| AbstractList | Chronic hepatitis B (CHB) treatment adherence has been poorly studied worldwide. We evaluated long-term virological and adherence outcomes to antiviral treatment in CHB patients.
A prospective 183 Brazilian CHB patient cohort treated with monotherapy or combination adefovir dipivoxil, entecavir, lamivudine and/or tenofovir disoproxil fumarate was studied in a reference tertiary centre. Treatment adherence was evaluated by a validated questionnaire named 'Assessment of Adherence to Antiviral Therapy Questionnaire' (CEAT-HBV) within three yearly periods (2010/2011, 2013/2014 and 2014/2015).
CEAT-HBV identified 43% (79/183) patients with non-adherence to antiviral treatment and among them, 67% (53/79) were viral load positive. The main causes associated with non-response to antiviral treatment were drug resistance variants followed by non-adherence, insufficient treatment duration and other causes. Single-dose pharmacokinetics demonstrated 35% (23/65) antiviral non-adherence. 2 years after the first assessment, the CEAT-HBV indicated that 71% (101/143) of subjects adhered to treatment (per-protocol population). However, 21% (40/183) of the patients could not be evaluated and were excluded. The main reasons for exclusion were death (20/183), 11 out 20 deaths due to hepatocellular carcinoma. HBV booklet was used for medical education. The third CEAT-HBV assessment (2014/2015) showed that 83% (112/135) patients were compliant with treatment adherence (per-protocol population). Long-term evaluation showed that adherence rate based on CEAT-HBV continue to increase after 4-years (P<0.001).
The results highlight the importance of CHB therapy adherence assessment monitoring. Long-term adherence outcomes were dynamic and it is possible to increase the migration rate to adherence/HBV-DNA-negative group. Chronic hepatitis B (CHB) treatment adherence has been poorly studied worldwide. We evaluated long-term virological and adherence outcomes to antiviral treatment in CHB patients.BACKGROUNDChronic hepatitis B (CHB) treatment adherence has been poorly studied worldwide. We evaluated long-term virological and adherence outcomes to antiviral treatment in CHB patients.A prospective 183 Brazilian CHB patient cohort treated with monotherapy or combination adefovir dipivoxil, entecavir, lamivudine and/or tenofovir disoproxil fumarate was studied in a reference tertiary centre. Treatment adherence was evaluated by a validated questionnaire named 'Assessment of Adherence to Antiviral Therapy Questionnaire' (CEAT-HBV) within three yearly periods (2010/2011, 2013/2014 and 2014/2015).METHODSA prospective 183 Brazilian CHB patient cohort treated with monotherapy or combination adefovir dipivoxil, entecavir, lamivudine and/or tenofovir disoproxil fumarate was studied in a reference tertiary centre. Treatment adherence was evaluated by a validated questionnaire named 'Assessment of Adherence to Antiviral Therapy Questionnaire' (CEAT-HBV) within three yearly periods (2010/2011, 2013/2014 and 2014/2015).CEAT-HBV identified 43% (79/183) patients with non-adherence to antiviral treatment and among them, 67% (53/79) were viral load positive. The main causes associated with non-response to antiviral treatment were drug resistance variants followed by non-adherence, insufficient treatment duration and other causes. Single-dose pharmacokinetics demonstrated 35% (23/65) antiviral non-adherence. 2 years after the first assessment, the CEAT-HBV indicated that 71% (101/143) of subjects adhered to treatment (per-protocol population). However, 21% (40/183) of the patients could not be evaluated and were excluded. The main reasons for exclusion were death (20/183), 11 out 20 deaths due to hepatocellular carcinoma. HBV booklet was used for medical education. The third CEAT-HBV assessment (2014/2015) showed that 83% (112/135) patients were compliant with treatment adherence (per-protocol population). Long-term evaluation showed that adherence rate based on CEAT-HBV continue to increase after 4-years (P<0.001).RESULTSCEAT-HBV identified 43% (79/183) patients with non-adherence to antiviral treatment and among them, 67% (53/79) were viral load positive. The main causes associated with non-response to antiviral treatment were drug resistance variants followed by non-adherence, insufficient treatment duration and other causes. Single-dose pharmacokinetics demonstrated 35% (23/65) antiviral non-adherence. 2 years after the first assessment, the CEAT-HBV indicated that 71% (101/143) of subjects adhered to treatment (per-protocol population). However, 21% (40/183) of the patients could not be evaluated and were excluded. The main reasons for exclusion were death (20/183), 11 out 20 deaths due to hepatocellular carcinoma. HBV booklet was used for medical education. The third CEAT-HBV assessment (2014/2015) showed that 83% (112/135) patients were compliant with treatment adherence (per-protocol population). Long-term evaluation showed that adherence rate based on CEAT-HBV continue to increase after 4-years (P<0.001).The results highlight the importance of CHB therapy adherence assessment monitoring. Long-term adherence outcomes were dynamic and it is possible to increase the migration rate to adherence/HBV-DNA-negative group.CONCLUSIONSThe results highlight the importance of CHB therapy adherence assessment monitoring. Long-term adherence outcomes were dynamic and it is possible to increase the migration rate to adherence/HBV-DNA-negative group. |
| Author | Jiang, Yong Ono, Suzane K Carrilho, Flair J Ferreira, Aline S Abreu, Rodrigo M Hori, Patrícia CA Khudyakov, Yury Schinazi, Raymond F Ganova-Raeva, Lilia M Bassit, Leda C Tao, Sijia |
| AuthorAffiliation | 2 Divisão de Farmácia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, SP, Brazil 3 Laboratory of Biochemical Pharmacology, Center for AIDS Research, Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA 1 Divisão de Gastroenterologia e Hepatologia Clínica do Hospital das Clínicas HCFMUSP, Departamento de Gastroenterologia da Faculdade de Medicina, Universidade de Sao Paulo, SP, Brazil 4 Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA, USA |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31799942$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1111/jvh.12418 10.1016/S0140-6736(12)61425-1 10.4254/wjh.v4.i2.43 10.1053/j.gastro.2003.09.033 10.3892/etm.2016.3365 10.1086/380398 10.1002/hep.26301 10.3851/IMP1944 10.1056/NEJMoa051287 10.1056/NEJMoa020681 10.3748/wjg.v21.i32.9588 10.1002/hep.24318 10.1016/j.jiph.2016.06.012 10.1016/j.jhep.2010.06.016 10.1111/j.1365-2893.2011.01494.x 10.1038/nrgastro.2011.33 10.1002/hep.26180 10.1053/j.gastro.2010.06.053 10.1053/j.gastro.2008.10.026 10.1053/j.gastro.2007.08.025 10.1371/journal.pone.0109652 10.1016/S1665-2681(19)31000-2 10.1111/apt.13272 10.1007/s40121-015-0101-y 10.1002/hep.21189 10.1007/s12072-012-9365-4 10.1056/NEJMoa021812 10.1016/j.jhep.2015.01.002 10.1002/cncr.29537 10.1016/j.dld.2015.03.024 10.1016/j.jhep.2012.02.010 10.1002/hep.24199 10.1016/j.cld.2016.07.001 10.1111/jgh.13377 10.1056/NEJM199807093390201 10.1111/jgh.12416 10.1172/JCI11100 10.1002/hep.28156 10.1128/AAC.02213-16 10.1080/13548506.2012.722648 10.1016/j.jhep.2011.04.006 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 The principal investigators, RM Abreu and SK Ono, were responsible for the conception and design of the study, the acquisition, analysis and interpretation of the data, and the drafting of the manuscript. LC Bassit, S Tao, Y Jiang, AS Ferreira, PCA Hori, LM Ganova-Raeva, and Y Khudyakov helped with the design of the study, acquisition of the data, and critical revision of the manuscript regarding intellectual content. RF Schinazi, FJ Carrilho, and SK Ono guided the study and provided input on assays to be performed and helped write and review this paper. Author contributions |
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