Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients
Publication Date
January 12, 2018
Authors
Heon Ju Lee, Sang Jin Kim, Young Oh Kweon, Soo Young Park, et al
Volume
13
Issue
1
Pages
e0190581
DOI
https://dx.plos.org/10.1371/journal.pone.0190581
Publisher URL
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0190581
Scopus
85040462732
Mendeley
http://www.mendeley.com/research/evaluating-efficacy-switching-lamivudine-plus-adefovir-tenofovir-disoproxil-fumarate-monotherapy-lam
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Mendeley | Further Information

{"title"=>"Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients", "type"=>"journal", "authors"=>[{"first_name"=>"Heon Ju", "last_name"=>"Lee", "scopus_author_id"=>"55085510500"}, {"first_name"=>"Sang Jin", "last_name"=>"Kim", "scopus_author_id"=>"57200243434"}, {"first_name"=>"Young Oh", "last_name"=>"Kweon", "scopus_author_id"=>"7004694832"}, {"first_name"=>"Soo Young", "last_name"=>"Park", "scopus_author_id"=>"57197525225"}, {"first_name"=>"Jeong", "last_name"=>"Heo", "scopus_author_id"=>"8422238800"}, {"first_name"=>"Hyun Young", "last_name"=>"Woo", "scopus_author_id"=>"12787138800"}, {"first_name"=>"Jae Seok", "last_name"=>"Hwang", "scopus_author_id"=>"7403897240"}, {"first_name"=>"Woo Jin", "last_name"=>"Chung", "scopus_author_id"=>"57198786970"}, {"first_name"=>"Chang Hyeong", "last_name"=>"Lee", "scopus_author_id"=>"57125061600"}, {"first_name"=>"Byung Seok", "last_name"=>"Kim", "scopus_author_id"=>"55974276800"}, {"first_name"=>"Jeong", "last_name"=>"Suh", "scopus_author_id"=>"7201515001"}, {"first_name"=>"Won Young", "last_name"=>"Tak", "scopus_author_id"=>"7004074582"}, {"first_name"=>"Byoung Kuk", "last_name"=>"Jang", "scopus_author_id"=>"8438708600"}], "year"=>2018, "source"=>"PLoS ONE", "identifiers"=>{"sgr"=>"85040462732", "doi"=>"10.1371/journal.pone.0190581", "pui"=>"620181543", "pmid"=>"29329305", "scopus"=>"2-s2.0-85040462732", "issn"=>"19326203", "isbn"=>"1111111111"}, "id"=>"3bfbdb3e-528f-3582-8dc1-65c5f175311b", "abstract"=>"BACKGROUND The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable switching) in patients with LAM-resistant chronic hepatitis B (CHB) and undetectable hepatitis B virus (HBV) DNA is not clear. METHODS In this non-inferiority trial, patients with LAM-resistant CHB and undetectable serum HBV DNA (<20 IU/mL) for >6 months after initiating LAM+ADV combination therapy were randomized (1:2) either to continue the combination therapy (LAM+ADV group, n = 58) or switched to TDF monotherapy (TDF group, n = 111). They were followed-up with serum biochemistry tests and HBV DNA measurement at 12-week intervals for 96 weeks. The primary endpoint of this study was the proportion of patients with viral reactivation at week 96. RESULTS Patients with CHB enrolled in this study (n = 169) included 74 patients with compensated liver cirrhosis. In total, 9 patients (4 in the LAM+ADV group and 5 in the TDF group) dropped-out from the study. After a mean follow-up period of 96 weeks, the proportion of HBV reactivation observed was 6.8% (4/58) in the LAM+ADV group and 4.5% (5/111) in the TDF group by using intention-to-treat analysis (difference, -2.3%; 95% CI, -9.84-5.24%). None of the subjects in either group experienced viral reactivation based on per protocol analysis. No serious adverse reactions were observed. In the subgroup analysis for estimated glomerular filtration rate (eGFR) before and after treatment, decreased eGFR was observed only in the TDF group with cirrhosis (85.22 vs. 79.83 mL/min/1.73 m2, p = 0.000). CONCLUSIONS Stable switching to TDF monotherapy yielded non-inferior results at 96 weeks compared to the results obtained with LAM+ADV combination therapy in patients with LAM-resistant CHB and undetectable HBV DNA. However, TDF monotherapy in patients with cirrhosis requires close attention with respect to renal function. TRIAL REGISTRATION ClinicalTrials.gov NCT01732367.", "link"=>"http://www.mendeley.com/research/evaluating-efficacy-switching-lamivudine-plus-adefovir-tenofovir-disoproxil-fumarate-monotherapy-lam", "reader_count"=>4, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Student > Postgraduate"=>1, "Student > Ph. D. Student"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Student > Postgraduate"=>1, "Student > Ph. D. Student"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>3, "Medicine and Dentistry"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>1}, "Unspecified"=>{"Unspecified"=>3}}, "group_count"=>0}

Scopus | Further Information

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Source
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Time
2019-04-25 17:13:49 UTC
Target URL
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