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The Level of HBV DNA at Month 12 Is an Important Predictor of Virological Breakthrough During Adefovir Monotherapy in Chronic Hepatitis B Patients with Lamivudine Resistance

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Dig Dis Sci. 2011 Jan 8. [Epub ahead of print]

The Level of HBV DNA at Month 12 Is an Important Predictor of Virological

Breakthrough During Adefovir Monotherapy in Chronic Hepatitis B Patients with

Lamivudine Resistance.

Kim MC, Jung SW, Shin JW, Park NH.

Department of Family Medicine, University of Ulsan College of Medicine, Ulsan

University Hospital, Ulsan, South Korea.

Abstract

BACKGROUND AND AIMS: The aim of this study was to determine the optimal time and

HBV DNA levels during the treatment period for prediction of virological

breakthrough (VBT) 3 years after adefovir monotherapy in chronic hepatitis B

(CHB) patients with lamivudine resistance.

METHODS: We consecutively analyzed HBV DNA levels within 12 months in 210

lamivudine-resistant CHB patients treated with adefovir monotherapy for more

than 36 months.

RESULTS: VBT, genotypic adefovir mutations, and virologic responses were

observed in 52 (24.8%), 37 (17.6%), and 117 (55.7%) cases within 3 years of

treatment, respectively. Using receiver-operating characteristic curve analysis,

HBV DNA levels at month 12 had a greater power (AUROC, 0.839; 95% CI,

0.759-0.919; p < 0.001) to predict VBT after 3 years of treatment. The best

cut-off value of HBV DNA levels at month 12 for predicting VBT at 3 years of

treatment was 200 IU/ml with a sensitivity and negative predictive value of 88.5

and 94.3%, respectively. Using this time and cut-off value, VBT had developed in

six (5.7%) of the patients with HBV DNA levels <200 IU/ml (n = 105) and 46

(43.8%) of the patients with HBV DNA levels ™200 IU/ml (n = 105) at month 12 (p

< 0.001). Moreover, virological response or HBeAg seroconversion remained higher

at 82.9 and 81.2%, respectively.

CONCLUSIONS: In patients who were switched to adefovir monotherapy as rescue

therapy for lamivudine resistance before the introduction of current therapeutic

guidelines, measurements of HBV DNA levels at month 12 should be performed to

predict VBT. Early termination of adefovir monotherapy should be considered for

patients who still have HBV DNA ™200 IU/ml (3 log(10) copies/ml) at 12 months of

treatment.

PMID: 21221793 [PubMed - as supplied by publisher]

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Dig Dis Sci. 2011 Jan 8. [Epub ahead of print]

The Level of HBV DNA at Month 12 Is an Important Predictor of Virological

Breakthrough During Adefovir Monotherapy in Chronic Hepatitis B Patients with

Lamivudine Resistance.

Kim MC, Jung SW, Shin JW, Park NH.

Department of Family Medicine, University of Ulsan College of Medicine, Ulsan

University Hospital, Ulsan, South Korea.

Abstract

BACKGROUND AND AIMS: The aim of this study was to determine the optimal time and

HBV DNA levels during the treatment period for prediction of virological

breakthrough (VBT) 3 years after adefovir monotherapy in chronic hepatitis B

(CHB) patients with lamivudine resistance.

METHODS: We consecutively analyzed HBV DNA levels within 12 months in 210

lamivudine-resistant CHB patients treated with adefovir monotherapy for more

than 36 months.

RESULTS: VBT, genotypic adefovir mutations, and virologic responses were

observed in 52 (24.8%), 37 (17.6%), and 117 (55.7%) cases within 3 years of

treatment, respectively. Using receiver-operating characteristic curve analysis,

HBV DNA levels at month 12 had a greater power (AUROC, 0.839; 95% CI,

0.759-0.919; p < 0.001) to predict VBT after 3 years of treatment. The best

cut-off value of HBV DNA levels at month 12 for predicting VBT at 3 years of

treatment was 200 IU/ml with a sensitivity and negative predictive value of 88.5

and 94.3%, respectively. Using this time and cut-off value, VBT had developed in

six (5.7%) of the patients with HBV DNA levels <200 IU/ml (n = 105) and 46

(43.8%) of the patients with HBV DNA levels ™200 IU/ml (n = 105) at month 12 (p

< 0.001). Moreover, virological response or HBeAg seroconversion remained higher

at 82.9 and 81.2%, respectively.

CONCLUSIONS: In patients who were switched to adefovir monotherapy as rescue

therapy for lamivudine resistance before the introduction of current therapeutic

guidelines, measurements of HBV DNA levels at month 12 should be performed to

predict VBT. Early termination of adefovir monotherapy should be considered for

patients who still have HBV DNA ™200 IU/ml (3 log(10) copies/ml) at 12 months of

treatment.

PMID: 21221793 [PubMed - as supplied by publisher]

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Share on other sites

Dig Dis Sci. 2011 Jan 8. [Epub ahead of print]

The Level of HBV DNA at Month 12 Is an Important Predictor of Virological

Breakthrough During Adefovir Monotherapy in Chronic Hepatitis B Patients with

Lamivudine Resistance.

Kim MC, Jung SW, Shin JW, Park NH.

Department of Family Medicine, University of Ulsan College of Medicine, Ulsan

University Hospital, Ulsan, South Korea.

Abstract

BACKGROUND AND AIMS: The aim of this study was to determine the optimal time and

HBV DNA levels during the treatment period for prediction of virological

breakthrough (VBT) 3 years after adefovir monotherapy in chronic hepatitis B

(CHB) patients with lamivudine resistance.

METHODS: We consecutively analyzed HBV DNA levels within 12 months in 210

lamivudine-resistant CHB patients treated with adefovir monotherapy for more

than 36 months.

RESULTS: VBT, genotypic adefovir mutations, and virologic responses were

observed in 52 (24.8%), 37 (17.6%), and 117 (55.7%) cases within 3 years of

treatment, respectively. Using receiver-operating characteristic curve analysis,

HBV DNA levels at month 12 had a greater power (AUROC, 0.839; 95% CI,

0.759-0.919; p < 0.001) to predict VBT after 3 years of treatment. The best

cut-off value of HBV DNA levels at month 12 for predicting VBT at 3 years of

treatment was 200 IU/ml with a sensitivity and negative predictive value of 88.5

and 94.3%, respectively. Using this time and cut-off value, VBT had developed in

six (5.7%) of the patients with HBV DNA levels <200 IU/ml (n = 105) and 46

(43.8%) of the patients with HBV DNA levels ™200 IU/ml (n = 105) at month 12 (p

< 0.001). Moreover, virological response or HBeAg seroconversion remained higher

at 82.9 and 81.2%, respectively.

CONCLUSIONS: In patients who were switched to adefovir monotherapy as rescue

therapy for lamivudine resistance before the introduction of current therapeutic

guidelines, measurements of HBV DNA levels at month 12 should be performed to

predict VBT. Early termination of adefovir monotherapy should be considered for

patients who still have HBV DNA ™200 IU/ml (3 log(10) copies/ml) at 12 months of

treatment.

PMID: 21221793 [PubMed - as supplied by publisher]

Link to comment
Share on other sites

Dig Dis Sci. 2011 Jan 8. [Epub ahead of print]

The Level of HBV DNA at Month 12 Is an Important Predictor of Virological

Breakthrough During Adefovir Monotherapy in Chronic Hepatitis B Patients with

Lamivudine Resistance.

Kim MC, Jung SW, Shin JW, Park NH.

Department of Family Medicine, University of Ulsan College of Medicine, Ulsan

University Hospital, Ulsan, South Korea.

Abstract

BACKGROUND AND AIMS: The aim of this study was to determine the optimal time and

HBV DNA levels during the treatment period for prediction of virological

breakthrough (VBT) 3 years after adefovir monotherapy in chronic hepatitis B

(CHB) patients with lamivudine resistance.

METHODS: We consecutively analyzed HBV DNA levels within 12 months in 210

lamivudine-resistant CHB patients treated with adefovir monotherapy for more

than 36 months.

RESULTS: VBT, genotypic adefovir mutations, and virologic responses were

observed in 52 (24.8%), 37 (17.6%), and 117 (55.7%) cases within 3 years of

treatment, respectively. Using receiver-operating characteristic curve analysis,

HBV DNA levels at month 12 had a greater power (AUROC, 0.839; 95% CI,

0.759-0.919; p < 0.001) to predict VBT after 3 years of treatment. The best

cut-off value of HBV DNA levels at month 12 for predicting VBT at 3 years of

treatment was 200 IU/ml with a sensitivity and negative predictive value of 88.5

and 94.3%, respectively. Using this time and cut-off value, VBT had developed in

six (5.7%) of the patients with HBV DNA levels <200 IU/ml (n = 105) and 46

(43.8%) of the patients with HBV DNA levels ™200 IU/ml (n = 105) at month 12 (p

< 0.001). Moreover, virological response or HBeAg seroconversion remained higher

at 82.9 and 81.2%, respectively.

CONCLUSIONS: In patients who were switched to adefovir monotherapy as rescue

therapy for lamivudine resistance before the introduction of current therapeutic

guidelines, measurements of HBV DNA levels at month 12 should be performed to

predict VBT. Early termination of adefovir monotherapy should be considered for

patients who still have HBV DNA ™200 IU/ml (3 log(10) copies/ml) at 12 months of

treatment.

PMID: 21221793 [PubMed - as supplied by publisher]

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