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Tenofovir-based combination therapy or monotherapy for multidrug-resistant chronic hepatitis B: Long-term data from a multicenter cohort study

Authors
Yim, Hyung JoonSuh, Sang JunJung, Young KulHwang, Seong GyuSeo, Yeon SeokUm, Soon HoLee, Sae HwanKim, Young SeokJang, Jae YoungKim, In HeeKim, Hyoung SuKim, Ji HoonLee, Young SunYoon, Eileen L.Song, Myeong JunPark, Jun Yong
Issue Date
Dec-2020
Publisher
WILEY
Keywords
chronic hepatitis B; multidrug resistance; tenofovir; therapy
Citation
Journal of Viral Hepatitis, v.27, no.12, pp.1306 - 1318
Indexed
SCIE
SCOPUS
Journal Title
Journal of Viral Hepatitis
Volume
27
Number
12
Start Page
1306
End Page
1318
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/33946
DOI
10.1111/jvh.13363
ISSN
1352-0504
Abstract
The treatment of multidrug-resistant (MDR) chronic hepatitis B (CHB) is challenging. Herein, we report a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB in a real-life setting. The inclusion criteria comprised patients with resistance to more than two nucleos(t)ide analogue (NA) classes and hepatitis B virus (HBV) DNA level of >= 200 IU/mL. The primary end-point was virologic response (VR), defined as undetectable HBV DNA (<20 IU/mL) after 60 months. A total of 236 patients met the inclusion criteria. The mean HBV DNA level was 4.16 +/- 1.44 log IU/mL; 26.7% of patients had liver cirrhosis. Before the initiation of TDF, 33.5%, 44.9% and 21.6% of patients had mutations resistant to L-NA + adefovir, L-NA + entecavir (ETV) and L-NA + adefovir + ETV, respectively. A total of 184 patients received TDF-based combination therapy [TDF + ETV (n = 178) or TDF + L-NA (n = 6)], and 52 patients received TDF monotherapy. In the entire cohort, the VR rates were 77.2%, 89.9% and 92.2% at 12, 36 and 60 months, respectively. The VR rates were not significantly different between the combination therapy and the monotherapy group after 12 (76.2% vs 80.4%,P = .533), 36 (89.8% vs 90.3%,P = 1.000) or 60 (92.9% vs 87.5%,P = .499) months. Also, there was no significant difference in the cumulative VR rates for 5 years between the treatment groups (P = .910). Newly developed antiviral resistance was not observed. TDF-based therapy was effective for the treatment of MDR CHB. The efficacy of TDF monotherapy was not different from that of the TDF-based combination therapy.
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Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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