Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response
Background/Aims Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV. Methods T...
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| Format: | Article |
| Language: | English |
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Korean Association for the Study of the Liver
2020-07-01
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| Series: | Clinical and Molecular Hepatology |
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| Online Access: | http://e-cmh.org/upload/pdf/cmh-2019-0044n.pdf |
| _version_ | 1818506988552716288 |
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| author | Hyun Young Woo Jun Yong Park Si Hyun Bae Chang Wook Kim Jae Young Jang Won Young Tak Dong Joon Kim In Hee Kim Jeong Heo Sang Hoon Ahn |
| author_facet | Hyun Young Woo Jun Yong Park Si Hyun Bae Chang Wook Kim Jae Young Jang Won Young Tak Dong Joon Kim In Hee Kim Jeong Heo Sang Hoon Ahn |
| author_sort | Hyun Young Woo |
| collection | DOAJ |
| description | Background/Aims Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV. Methods This prospective randomized controlled trial examined 91 patients whose serum HBV DNA levels were greater than 60 IU/mL after at least 24 weeks of treatment with LAM/LdT+ADV for LAM-resistant HBV. Patients were randomized to receive a new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV, n=46) for 48 weeks. Patients with baseline ADV resistance were excluded. Results Compared to LAM/LdT+ADV group, ETV+TDF group had more patients with a virologic response (42/45 [93.33%] vs. 3/46 [6.52%], P<0.001) and had a greater mean reduction in serum HBV DNA level from baseline (-4.16 vs. -0.37 log10 IU/mL, P<0.001). Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response. At week 48, additional ADV- or ETV-associated mutations were cleared in ETV+TDF group, but such mutations were present in 4.3% of patients in LAM/LdT+ADV group (P=0.106). The two groups had similar rates of adverse events. Conclusions ETV+TDF combination treatment led to a significantly higher rate of virologic response compared to LAM/LdT+ADV combination treatment in patients with LAM-resistant HBV who had suboptimal responses to LAM/LdT+ADV regardless of HBV genotypic resistance profile (NCT01597934). |
| first_indexed | 2024-12-10T22:12:24Z |
| format | Article |
| id | doaj.art-064f57af020f4b918a6194c56d360f4f |
| institution | Directory Open Access Journal |
| issn | 2287-2728 2287-285X |
| language | English |
| last_indexed | 2024-12-10T22:12:24Z |
| publishDate | 2020-07-01 |
| publisher | Korean Association for the Study of the Liver |
| record_format | Article |
| series | Clinical and Molecular Hepatology |
| spelling | doaj.art-064f57af020f4b918a6194c56d360f4f2022-12-22T01:31:33ZengKorean Association for the Study of the LiverClinical and Molecular Hepatology2287-27282287-285X2020-07-0126335236310.3350/cmh.2019.0044n1507Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal responseHyun Young Woo0Jun Yong Park1Si Hyun Bae2Chang Wook Kim3Jae Young Jang4Won Young Tak5Dong Joon Kim6In Hee Kim7Jeong Heo8Sang Hoon Ahn9 Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, Korea Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University College of Medicine, Chonju, Korea Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea Department of Internal Medicine, Yonsei University College of Medicine, Seoul, KoreaBackground/Aims Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV. Methods This prospective randomized controlled trial examined 91 patients whose serum HBV DNA levels were greater than 60 IU/mL after at least 24 weeks of treatment with LAM/LdT+ADV for LAM-resistant HBV. Patients were randomized to receive a new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV, n=46) for 48 weeks. Patients with baseline ADV resistance were excluded. Results Compared to LAM/LdT+ADV group, ETV+TDF group had more patients with a virologic response (42/45 [93.33%] vs. 3/46 [6.52%], P<0.001) and had a greater mean reduction in serum HBV DNA level from baseline (-4.16 vs. -0.37 log10 IU/mL, P<0.001). Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response. At week 48, additional ADV- or ETV-associated mutations were cleared in ETV+TDF group, but such mutations were present in 4.3% of patients in LAM/LdT+ADV group (P=0.106). The two groups had similar rates of adverse events. Conclusions ETV+TDF combination treatment led to a significantly higher rate of virologic response compared to LAM/LdT+ADV combination treatment in patients with LAM-resistant HBV who had suboptimal responses to LAM/LdT+ADV regardless of HBV genotypic resistance profile (NCT01597934).http://e-cmh.org/upload/pdf/cmh-2019-0044n.pdfentecavirtenofovirlamivudineantiviral drug resistanceadefovir |
| spellingShingle | Hyun Young Woo Jun Yong Park Si Hyun Bae Chang Wook Kim Jae Young Jang Won Young Tak Dong Joon Kim In Hee Kim Jeong Heo Sang Hoon Ahn Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response Clinical and Molecular Hepatology entecavir tenofovir lamivudine antiviral drug resistance adefovir |
| title | Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response |
| title_full | Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response |
| title_fullStr | Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response |
| title_full_unstemmed | Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response |
| title_short | Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response |
| title_sort | entecavir tenofovir vs lamivudine telbivudine adefovir in chronic hepatitis b patients with prior suboptimal response |
| topic | entecavir tenofovir lamivudine antiviral drug resistance adefovir |
| url | http://e-cmh.org/upload/pdf/cmh-2019-0044n.pdf |
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