Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B
Background/Aims Little is known about the effect of early flares on response during first-line tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB). The aim of this study was to investigate the incidence and outcome of early alanine aminotransferase (ALT) flare in treatment-na...
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| Format: | Article |
| Language: | English |
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Korean Association for the Study of the Liver
2017-06-01
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| Series: | Clinical and Molecular Hepatology |
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| Online Access: | http://e-cmh.org/upload/pdf/cmh-2016-0067.pdf |
| _version_ | 1819047901117022208 |
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| author | Hee Yeon Seo Han Ah Lee Soon Young Ko Joon Ho Wang Jeong Han Kim Won Hyeok Choe So Young Kwon |
| author_facet | Hee Yeon Seo Han Ah Lee Soon Young Ko Joon Ho Wang Jeong Han Kim Won Hyeok Choe So Young Kwon |
| author_sort | Hee Yeon Seo |
| collection | DOAJ |
| description | Background/Aims Little is known about the effect of early flares on response during first-line tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB). The aim of this study was to investigate the incidence and outcome of early alanine aminotransferase (ALT) flare in treatment-naive patients with CHB during long-term TDF monotherapy. Methods One hundred eighty-one treatment-naive CHB patients were treated with a 300-mg once-daily dose of TDF for more than 12 weeks. Virological markers of hepatitis B virus (HBV) and biochemical data were measured at baseline and every 4-12 weeks during the therapy. The proportion of patients with undetectable HBV DNA level (< 100 copies/mL) was noted. Results The median age was 48.3 years and 122 patients (67.4%) were men. Hepatitis B envelope antigen (HBeAg) was positive in 101 patients (55.8%). No patient had cirrhosis. The median follow-up duration was 45 weeks (12-155 weeks). ALT flare (>5 × upper limit of the normal range) occurred in seven patients (3%) without viral breakthrough within the first 8 weeks after the start of TDF monotherapy. Among them, six patients were HBeAg-positive and one patient was HBeAg-negative. All cases of early ALT flares resolved within 4 weeks and virologic response was observed in all patients without interruption or discontinuation of treatment. Conclusions Continuous TDF monotherapy was effective and safe in treatment-naive patients with CHB who experienced early ALT flares followed by a decrease in HBV DNA level. |
| first_indexed | 2024-12-21T11:07:43Z |
| format | Article |
| id | doaj.art-e0c7ad22c4404a92b17f74e195606702 |
| institution | Directory Open Access Journal |
| issn | 2287-2728 2287-285X |
| language | English |
| last_indexed | 2024-12-21T11:07:43Z |
| publishDate | 2017-06-01 |
| publisher | Korean Association for the Study of the Liver |
| record_format | Article |
| series | Clinical and Molecular Hepatology |
| spelling | doaj.art-e0c7ad22c4404a92b17f74e1956067022022-12-21T19:06:11ZengKorean Association for the Study of the LiverClinical and Molecular Hepatology2287-27282287-285X2017-06-0123215415910.3350/cmh.2016.00671354Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis BHee Yeon Seo0Han Ah Lee1Soon Young Ko2Joon Ho Wang3Jeong Han Kim4Won Hyeok Choe5So Young Kwon6 Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea Department of Internal Medicine, Konkuk University School of Medicine, Chungju, Korea Department of Internal Medicine, Konkuk University School of Medicine, Chungju, KoreaBackground/Aims Little is known about the effect of early flares on response during first-line tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB). The aim of this study was to investigate the incidence and outcome of early alanine aminotransferase (ALT) flare in treatment-naive patients with CHB during long-term TDF monotherapy. Methods One hundred eighty-one treatment-naive CHB patients were treated with a 300-mg once-daily dose of TDF for more than 12 weeks. Virological markers of hepatitis B virus (HBV) and biochemical data were measured at baseline and every 4-12 weeks during the therapy. The proportion of patients with undetectable HBV DNA level (< 100 copies/mL) was noted. Results The median age was 48.3 years and 122 patients (67.4%) were men. Hepatitis B envelope antigen (HBeAg) was positive in 101 patients (55.8%). No patient had cirrhosis. The median follow-up duration was 45 weeks (12-155 weeks). ALT flare (>5 × upper limit of the normal range) occurred in seven patients (3%) without viral breakthrough within the first 8 weeks after the start of TDF monotherapy. Among them, six patients were HBeAg-positive and one patient was HBeAg-negative. All cases of early ALT flares resolved within 4 weeks and virologic response was observed in all patients without interruption or discontinuation of treatment. Conclusions Continuous TDF monotherapy was effective and safe in treatment-naive patients with CHB who experienced early ALT flares followed by a decrease in HBV DNA level.http://e-cmh.org/upload/pdf/cmh-2016-0067.pdfTenofovirChronic hepatitis B |
| spellingShingle | Hee Yeon Seo Han Ah Lee Soon Young Ko Joon Ho Wang Jeong Han Kim Won Hyeok Choe So Young Kwon Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B Clinical and Molecular Hepatology Tenofovir Chronic hepatitis B |
| title | Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B |
| title_full | Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B |
| title_fullStr | Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B |
| title_full_unstemmed | Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B |
| title_short | Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B |
| title_sort | clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment naive patients with chronic hepatitis b |
| topic | Tenofovir Chronic hepatitis B |
| url | http://e-cmh.org/upload/pdf/cmh-2016-0067.pdf |
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