Abstract
Background & Aims: Sequential therapy posed a high risk of emergence of multidrug resistance and presented a management issue in chronic hepatitis B (CHB) treatment. We evaluated the antiviral efficacy and safety of entecavir (ETV) plus tenofovir (TDF) combination therapy in multidrug-resistant (MDR) CHB patients. Methods: In this prospective, multicentre study, MDR CHB patients, defined as measurable serum HBV DNA (≥60 IU/ml) while on any rescue treatment regimen for at least 24 weeks and the presence of documented prior genotypic resistance to both nucleoside analogue(s) and nucleotide analogue, were treated with ETV 1.0 mg and TDF 300 mg combination therapy for 48 weeks. Results: A total of 64 eligible patients who had previously failed to a median three lines of antiviral therapy (range, 2–6) were included. At baseline, median age was 47.0 years, 89.1% were HBeAg(+), and median HBV DNA was 4.24 (range, 2.11–6.73) log 10 IU/ml. By week 4, 12, 24 and 48, 15/64 (23.4%), 36/64 (56.3%), 43/64 (67.2%) and 55/64 (85.9%) patients achieved a HBV DNA <60 IU/ml respectively. The mean reduction of HBV DNA from baseline to 4 and 48 weeks was 1.23 log 10 IU/ml and 2.38 log 10 IU/ml respectively. Although five patients experienced virological breakthrough, all were transient and no resistant mutation to TDF or novel mutation was detected in any patients. Conclusions: In difficult-to-treat MDR CHB patients with a high exposure to multiple antiviral drugs, ETV plus TDF combination therapy can provide a very high rate of viral suppression through 48 weeks of treatment.
| Original language | English |
|---|---|
| Pages (from-to) | 1108-1115 |
| Number of pages | 8 |
| Journal | Liver International |
| Volume | 36 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 2016 Aug 1 |
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All Science Journal Classification (ASJC) codes
- Hepatology
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Entecavir plus tenofovir combination therapy in patients with multidrug-resistant chronic hepatitis B : results of a multicentre, prospective study. / Park, Junyong; Kim, Chang Wook; Bae, Si Hyun; Jung, Kyu Sik; Kim, Hee Yeon; Yoon, Seung Kew; Han, KwangHyub; Ahn, SangHoon.
In: Liver International, Vol. 36, No. 8, 01.08.2016, p. 1108-1115.Research output: Contribution to journal › Article
TY - JOUR
T1 - Entecavir plus tenofovir combination therapy in patients with multidrug-resistant chronic hepatitis B
T2 - results of a multicentre, prospective study
AU - Park, Junyong
AU - Kim, Chang Wook
AU - Bae, Si Hyun
AU - Jung, Kyu Sik
AU - Kim, Hee Yeon
AU - Yoon, Seung Kew
AU - Han, KwangHyub
AU - Ahn, SangHoon
PY - 2016/8/1
Y1 - 2016/8/1
N2 - Background & Aims: Sequential therapy posed a high risk of emergence of multidrug resistance and presented a management issue in chronic hepatitis B (CHB) treatment. We evaluated the antiviral efficacy and safety of entecavir (ETV) plus tenofovir (TDF) combination therapy in multidrug-resistant (MDR) CHB patients. Methods: In this prospective, multicentre study, MDR CHB patients, defined as measurable serum HBV DNA (≥60 IU/ml) while on any rescue treatment regimen for at least 24 weeks and the presence of documented prior genotypic resistance to both nucleoside analogue(s) and nucleotide analogue, were treated with ETV 1.0 mg and TDF 300 mg combination therapy for 48 weeks. Results: A total of 64 eligible patients who had previously failed to a median three lines of antiviral therapy (range, 2–6) were included. At baseline, median age was 47.0 years, 89.1% were HBeAg(+), and median HBV DNA was 4.24 (range, 2.11–6.73) log 10 IU/ml. By week 4, 12, 24 and 48, 15/64 (23.4%), 36/64 (56.3%), 43/64 (67.2%) and 55/64 (85.9%) patients achieved a HBV DNA <60 IU/ml respectively. The mean reduction of HBV DNA from baseline to 4 and 48 weeks was 1.23 log 10 IU/ml and 2.38 log 10 IU/ml respectively. Although five patients experienced virological breakthrough, all were transient and no resistant mutation to TDF or novel mutation was detected in any patients. Conclusions: In difficult-to-treat MDR CHB patients with a high exposure to multiple antiviral drugs, ETV plus TDF combination therapy can provide a very high rate of viral suppression through 48 weeks of treatment.
AB - Background & Aims: Sequential therapy posed a high risk of emergence of multidrug resistance and presented a management issue in chronic hepatitis B (CHB) treatment. We evaluated the antiviral efficacy and safety of entecavir (ETV) plus tenofovir (TDF) combination therapy in multidrug-resistant (MDR) CHB patients. Methods: In this prospective, multicentre study, MDR CHB patients, defined as measurable serum HBV DNA (≥60 IU/ml) while on any rescue treatment regimen for at least 24 weeks and the presence of documented prior genotypic resistance to both nucleoside analogue(s) and nucleotide analogue, were treated with ETV 1.0 mg and TDF 300 mg combination therapy for 48 weeks. Results: A total of 64 eligible patients who had previously failed to a median three lines of antiviral therapy (range, 2–6) were included. At baseline, median age was 47.0 years, 89.1% were HBeAg(+), and median HBV DNA was 4.24 (range, 2.11–6.73) log 10 IU/ml. By week 4, 12, 24 and 48, 15/64 (23.4%), 36/64 (56.3%), 43/64 (67.2%) and 55/64 (85.9%) patients achieved a HBV DNA <60 IU/ml respectively. The mean reduction of HBV DNA from baseline to 4 and 48 weeks was 1.23 log 10 IU/ml and 2.38 log 10 IU/ml respectively. Although five patients experienced virological breakthrough, all were transient and no resistant mutation to TDF or novel mutation was detected in any patients. Conclusions: In difficult-to-treat MDR CHB patients with a high exposure to multiple antiviral drugs, ETV plus TDF combination therapy can provide a very high rate of viral suppression through 48 weeks of treatment.
UR - http://www.scopus.com/inward/record.url?scp=84978884037&partnerID=8YFLogxK
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U2 - 10.1111/liv.13059
DO - 10.1111/liv.13059
M3 - Article
C2 - 26781724
AN - SCOPUS:84978884037
VL - 36
SP - 1108
EP - 1115
JO - Liver International
JF - Liver International
SN - 1478-3223
IS - 8
ER -