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( Young Min Shin ),( Kyung Hye Park ),( Seok Won Jung ),( Neung Hwa Park ),( Bo Ryung Park ),( Chang Jae Kim ),( Byung Uk Lee ),( Jae Ho Park ),( Byung Gyu Kim ),( In Du Jeong ),( Sung-jo Bang ),( Jun 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Currently, for patients with lamivudine (LAM)-resistant CHB infection,switching to or adding on tenofovir (TDF) are consideredas therapeutic options. Little data are available on the comparisonof long-term efficacy of TDF-based rescue therapy and LAM/adefovir(ADV) combination therapy in patients with LAM-resistant chronichepatitis B infection.Methods: One hundred ninety-seven patients received LAM plus ADV,and 53 patients received TDF-based rescue therapy. Patients whoreceived TDF-based rescue therapy were treated with TDF alone (n= 30) or TDF/LAM combination (n = 23). A matched study populationwas constructed to compare the antiviral efficacy of TDF-based rescuetherapy and LAM/ADV combination therapy by a propensity scoreanalysis.Results: Eighty-eight patients from the LAM/ADV therapy group and 44 patients from the TDF based rescue therapy group were selectedafter matching propensity score with 2:1 ratio. Virologic response(VR) was observed in 97.7% (43/44) of patients in the TDF groupand in 79.5% (70/88) of the patients in the LAM/ADV group. Therate of VR in the TDF group was higher than that of the LAM/ADVgroup (P = 0.004). To determine the impact of baseline viral loadon the response to treatment, a post hoc exploratory analysis wasperformed. Among the patients with baseline HBV DNA level > 104IU/mL, a higher proportion of patients in the TDF group than in theLAM/ADV group achieved VR (95.5 vs. 65.9%, P < 0.001). In contrast,among patients with baseline HBV DNA level < 104 IU/mL, VR rateswere not different between the LAM/ADV and TDF groups (73.0vs. 99.5% at month 12, and 93.2 vs. 100% at month 24; log rankP = 0.885). No major clinical side effects were reported during thetreatment with either TDF or LAM/ADV groups.Conclusions: long-term efficacy of TDF-based rescue therapy wouldbe more superior to the LAM/ADV combination therapy, in the managementof LAM- resistant patients. However, in the patients withbaseline HBV DNA level <104 IU/mL, LAM/ADV combination therapywas as effective as TDF-based rescue therapy in maintaining the viralsuppression.
( Young Min Shin ),( Kyung Hye Park ),( Seok Won Jung ),( Neung Hwa Park ),( Bo Ryung Park ),( Chang Jae Kim ),( Byung Uk Lee ),( Jae Ho Park ),( Byung Gyu Kim ),( In Du Jeong ),( Sung-jo Bang ),( Jun 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Tenofovir (TDF) monotherapy for 48 weeks provided a virological response comparable to that of TDF and entecavir (ETV) combination therapy in patients infected with ETV-resistant HBV. Little long-term clinical data is available regarding the optimal treatment of patients who had ETV-resistant HBV. Methods: We evaluated the long-term efficacy of TDF-based rescue therapy in the patients with ETV resistance CHB. We also investigated the antiviral efficacy of TDF/lamivudine (LAM) or TDF/ETV combination therapy as compared to that of TDF monotherapy in these patients. Results: Seventy three patients with ETV resistance CHB were included. The median duration of TDF therapy was 37 months (range 6-45 months). Sixty-three (86.3%) patients were HBeAg positive. The mean pre-treatment HBV-DNA levels were 4.39 ± 1.81 log10 IU/mL. Study subjects were treated with TDF monotherapy (n = 12), TDF/LAM (n = 19) or TDF/ETV combination therapy (n= 42) for more than 6 months. Virologic response (VR, HBV PCR negativity) was achieved in 63 (67.2%) patients. Of 63 patients with HBeAg-positive, 6 (9.5%) patient achieved HBeAg seroconversion. The rates of VR among the treatment groups were not statistically significant at 6 months (58.3 vs. 73.9 vs. 50.0 %), at 12 months (688.7 vs. 78.9 vs. 57.8 %), and at 24 months (84.4 vs. 100 vs. 84.2 %) in the TDF monotherapy, TDF/LAM, and TDF/ ETV combination, respectively (log rank P = 0.2). In the multivariate analysis, only lower baseline HBV DNA level remained an independent predictor for VR (OR, 0.644; 95% CI, 0.528-0.789; P< 0.001) Conclusions: Long-term efficacy of TDF-based therapy was effective in maintaining viral suppression in patients with ETV-resistant CHB. TDF monotherapy was as effective as TDF/LAM or TDF/ETV combination therapy. Therefore, TDF mono-rescue therapy is an appropriate treatment in patients with ETV-resistant CHB.
( Young Min Shin ),( Kyung Hye Park ),( Seok Won Jung ),( Neung Hwa Park ),( Bo Ryung Park ),( Chang Jae Kim ),( Byung Uk Lee ),( Jae Ho Park ),( Byung Gyu Kim ),( In Du Jeong ),( Sung-jo Bang ),( Jun 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: Very limited data are available on long-tern efficacy of Tenofovir (TDF) rescue regimens in patients with multi-drug resistance (MDR). In this study, we evaluated the efficacy of TDF-based rescue therapy in chronic hepatitis B (CHB) patients after the failure of multiple nucleos( t)ide (NA) therapies. We also investigated the efficacy of TDF monotherpy versus TDF/entecavir (ETV) or TDF/lamivudine (LAM) combination therapy, types of MDR in these patients. Methods: The study retrospectively analyzed 133 CHB patients who experienced failure with two or more NAs and who were switched to regimens containing TDF. Results: Prior to TDF-based rescue therapy, resistance to both LAM (rt180, rt204) and ADV (rt181, rt236) was present in 51 patients, and 73 patients had resistance to both LAM and ETV (rt173, rt184, rt202, rt250). The other 9 patients had resistance to LAM, ADV, and ETV. The mean HBV DNA level at baseline was 4.35 ± 1.75 log10 IU/mL. The study subjects were treated with TDF montherapy (n=22), TDF/LAM (n=49), or TDF/ETV combination therapy (n=62) for more than 6 months. Virologic response (VR) occurred in 111 (83.5%) patients. At a median duration of 38 months of TDF treatment, the cumulative probabilities of achieving VR were 55.6%, 63.8%, 82.2%, and 88.0% at 6, 12, 24, and 36 months, respectively. The VR rates were not different between TDF monotherapy or combination therapy with LAM or ETV (log rank P = 0.197), and were not affected by types of MDR (log rank P = 0. 402). In univariate and multivariate analyses, absolute HBV DNA level at the start of TDF rescue treatment (P<0.001; OR, 0.603; 95% CI, 0.516-0.705) was only significantly associated with VR. There were no significant clinical adverse events during rescue treatment. Conclusions: TDF was an efficient and safe rescue therapy for CHB patients after treatment failure with multiple NAs. On the current data, TDF-based combination therapy seemed to be no better than those achieved by monotherapy.
( Young Min Shin ),( Kyung Hye Park ),( Seok Won Jung ),( Neung Hwa Park ),( Bo Ryung Park ),( Chang Jae Kim ),( Byung Uk Lee ),( Jae Ho Park ),( Byung Gyu Kim ),( In Du Jeong ),( Sung-jo Bang ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: The clinical course of patients with partial virologic response diagnosed with chronic hepatitis B undergoing tenofovir (TDF) therapy is unclear. Methods: We retrospectively investigated the long-term clinical outcomes of TDF therapy for more than 12 months in 391 nucleos( t)ide-naive chronic hepatitis B patients, particularly those with partial virologic response (PVR; i.e., a detectable HBV-DNA level after 24 weeks of therapy). Results: The median duration of TDF therapy was 24 months (range 12-40 months). Two-hundred twenty five (57.5%) patients were HBeAg positive. The mean pre-treatment HBV-DNA levels were 6.25 ± 1.41 log10 IU/mL. Virologic response (VR) was achieved in 341 patients (87.2%). Among 225 HBeAg-positive patients, 39 (17.3%) achieved HBeAg seroconversion. Virologic breakthrough was observed in 14 patients (3.6%). PVR was evident in 123 (31.5%) patients. During continuous prolonged TDF therapy, VR of patients with PVR was achieved in 76 (61.8%) patients. Multivariate logistic regression analysis using selected baseline factors identified absolute HBV-DNA levels at baseline (P < 0.001; OR, 0.496; 95% CI, 1.369-1.969) and HBeAg positivity (P = 0.021; OR, 0.622; 95% CI, 1.096-3.167) as factors showing significant association with PVR. Conclusions: The vast majority of chronic hepatitis B patients in this study achieved virologic response through prolonged TDF therapy. This result suggests that adjustment of TDF therapy in patients with PVR is not necessary.
Seung Bum Lee,Joonho Jeong,Jae Ho Park,Seok Won Jung,In Du Jeong,Sung-Jo Bang,Jung Woo Shin,Bo Ryung Park,Eun Ji Park,Neung Hwa Park 대한간학회 2020 Clinical and Molecular Hepatology(대한간학회지) Vol.26 No.3
Background/Aims: Low-level viremia (LLV) after nucleos(t)ide analog treatment was presented as a possible cause of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). However, detailed information on patients’ adherence in the real world was lacking. This study aimed to evaluate the effects of LLV on HCC development, mortality, and cirrhotic complications among patients according to their adherence to entecavir (ETV) treatment. Methods: We performed a retrospective observational analysis of data from 894 consecutive adult patients with treatment-naïve CHB undergoing ETV treatment. LLV was defined according to either persistent or intermittent episodes of <2,000 IU/mL detectable hepatitis B virus DNA during the follow-up period. Good adherence to medication was defined as a cumulative adherence ≥90% per study period. Results: Without considering adherence in the entire cohort (n=894), multivariate analysis of the HCC incidence showed that LLV was an independent prognostic factor in addition to other traditional risk factors in the entire cohort (P=0.031). Good adherence group comprised 617 patients (69.0%). No significant difference was found between maintained virologic response and LLV groups in terms of the incidence of liver-related death or transplantation, HCC, and hepatic decompensation in good adherence group, according to multivariate analyses. Conclusions: In patients with treatment-naïve CHB and good adherence to ETV treatment in the real world, LLV during treatment is not a predictive factor for HCC and cirrhotic complications. It may be unnecessary to adjust their antiviral agent for patients with good adherence who experience LLV during ETV treatment.
( Young Min Shin ),( Kyung Hye Park ),( Seok Won Jung ),( Neung Hwa Park ),( Bo Ryung Park ),( Chang Jae Kim ),( Byung Uk Lee ),( Jae Ho Park ),( Byung Gyu Kim ),( In Du Jeong ),( Sung-jo Bang ),( Jun 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: In chronic hepatitis B (CHB) patients, lamivudine (LAM) and adefovir (ADV) combination therapy is commonly used as a rescue therapy for LAM resistance, but it often results in incomplete viral suppression. Tenofovir (TDF) alone or in combination with entecavir (ETV) or LAM has been recommended as a rescue strategy for patients with suboptimal responses during LAM and ADV combination therapy. Methods: We evaluated the long-term efficacy of TDF-based rescue therapy in 90 LAM-resistant CHB patients who failed to respond to LAM plus ADV rescue therapy. We also investigated the efficacy of TDF monotherpy versus TDF/LAM combination therapy, types of pre-existing ADV mutation. Results: Resistance to ADV (ADV-R) was present in 51 patients (56.7%); rtA181T/V, rtN236T and rtA181T/V +rtN236T in 29, 3 and 19 patients, respectively, and the remaining 39 patients (43.3%) had a partial virologic response to LAM/ADV combination (ADV-P). The study subjects were treated with TDF alone (n=23) or TDF/LAM combination (n=67). Virologic response (VR) was achieved in 78 patients (86.7%). The cumulative probabilities of achieving VR were 65.6%, 76.9%, 85.4%, and 89.3% at 6, 12, 24, and 36 months, respectively. HBeAg seroclearance occurred in 6 (12.5%). ALT levels were normalized in 69 (94.5%) of 73 patients with elevated ALT at baseline. A higher proportion of patients in the ADV-P group achieved a VR at 12 months (89.7% vs. 66.7 %) and 24 months (97.4% vs. 75.8%) than that of patients in the ADV-R group (log-rank test, P<0.001). The rates of VR were not significantly different between TDF monotherapy and TDF/LAM combination therapy groups. Treatment efficacy of TDF alone or TDF/LAM combination was not statistically different according to pre-existing ADV or LAM resistant strains. In multivariate analysis, absolute HBV DNA levels at the start of TDF rescue treatment (P<0.001; OR, 0.556; 95% CI, 0.445-0.695) were the only significantly associated with VR. Conclusions: Long-term efficacy of TDF-based therapy was effective in maintaining viral suppression in patients with LAM-resistant patients who failed to respond to LAM/ADV combination therapy. TDF monotherapy was as effective as TDF/LAM or TDF/ETV combination therapy. Therefore, TDF mono-rescue therapy is an appropriate treatment in these patients.