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Impact of prior lamivudine use on the antiviral efficacy and development of resistance to entecavir in chronic hepatitis B patients.

Hwang JA, Kim KB, Yang MJ, Lim SG, Hwang JC, Cheong JY, Cho SW, Kim SS - Clin Mol Hepatol (2015)

Bottom Line: In subgroup analysis, after excluding the 10 patients who were refractory to LAM therapy, the cumulative probability of ETV resistance did not differ significantly between the two groups (P=0.149).However, prior LAM use without refractoriness did not affect the development of ETV resistance.The serum hepatitis B virus DNA level at month 12 was a major predictor for the development of ETV resistance.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.

ABSTRACT

Background/aims: To determine the efficacies of entecavir (ETV) in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B (CHB) patients and in those with prior lamivudine (LAM) use who did not develop resistance.

Methods: We retrospectively enrolled 337 patients with CHB who were treated with ETV (0.5 mg daily) for at least 30 months. The study included 270 (80.1%) NA-naïve patients and 67 (19.9%) LAM-use patients. Ten of the LAM-use patients were refractory to LAM therapy without developing resistance.

Results: Genotypic resistance to ETV developed more frequently in the LAM-use group (13.1%) than in the NA-naïve group (2.6%) at 60 months (P=0.009). In subgroup analysis, after excluding the 10 patients who were refractory to LAM therapy, the cumulative probability of ETV resistance did not differ significantly between the two groups (P=0.149). Prior LAM refractoriness and a higher hepatitis B virus DNA level at month 12 were independent predictive factors for the development of ETV resistance.

Conclusions: ETV resistance developed more frequently in LAM-use patients with CHB. However, prior LAM use without refractoriness did not affect the development of ETV resistance. The serum hepatitis B virus DNA level at month 12 was a major predictor for the development of ETV resistance.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier curves for the cumulative probabilities of the development of entecavir (ETV) resistance according to serum hepatitis B virus (HBV) DNA level at 12 months. Patients with a higher HBV DNA level (≥250 IU/mL) at 12 months of ETV therapy were more likely to develop ETV resistance.
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Figure 4: Kaplan-Meier curves for the cumulative probabilities of the development of entecavir (ETV) resistance according to serum hepatitis B virus (HBV) DNA level at 12 months. Patients with a higher HBV DNA level (≥250 IU/mL) at 12 months of ETV therapy were more likely to develop ETV resistance.

Mentions: Baseline characteristics and serum HBV DNA levels at month 12 were analyzed to identify the predictive factors for the development of ETV resistance. On univariate and subsequent multivariate analysis of all study patients, high HBV DNA level (≥250 IU/mL) at 12 months of ETV treatment and previous LAM refractoriness were independent predictive factors for developing ETV resistance (Hazard ratio [HR], 10.36; 95% confidence interval [CI], 1.91-56.32; P=0.007 and HR, 9.00; 95% CI, 1.43-56.64; P=0.019, respectively) (Table 3, Fig. 4). Previous LAM use without refractoriness did not affect the development of ETV resistance. Baseline HBV DNA level, HBeAg positivity, and the presence of liver cirrhosis were also statistically insignificant factors for predicting ETV resistance.


Impact of prior lamivudine use on the antiviral efficacy and development of resistance to entecavir in chronic hepatitis B patients.

Hwang JA, Kim KB, Yang MJ, Lim SG, Hwang JC, Cheong JY, Cho SW, Kim SS - Clin Mol Hepatol (2015)

Kaplan-Meier curves for the cumulative probabilities of the development of entecavir (ETV) resistance according to serum hepatitis B virus (HBV) DNA level at 12 months. Patients with a higher HBV DNA level (≥250 IU/mL) at 12 months of ETV therapy were more likely to develop ETV resistance.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4493356&req=5

Figure 4: Kaplan-Meier curves for the cumulative probabilities of the development of entecavir (ETV) resistance according to serum hepatitis B virus (HBV) DNA level at 12 months. Patients with a higher HBV DNA level (≥250 IU/mL) at 12 months of ETV therapy were more likely to develop ETV resistance.
Mentions: Baseline characteristics and serum HBV DNA levels at month 12 were analyzed to identify the predictive factors for the development of ETV resistance. On univariate and subsequent multivariate analysis of all study patients, high HBV DNA level (≥250 IU/mL) at 12 months of ETV treatment and previous LAM refractoriness were independent predictive factors for developing ETV resistance (Hazard ratio [HR], 10.36; 95% confidence interval [CI], 1.91-56.32; P=0.007 and HR, 9.00; 95% CI, 1.43-56.64; P=0.019, respectively) (Table 3, Fig. 4). Previous LAM use without refractoriness did not affect the development of ETV resistance. Baseline HBV DNA level, HBeAg positivity, and the presence of liver cirrhosis were also statistically insignificant factors for predicting ETV resistance.

Bottom Line: In subgroup analysis, after excluding the 10 patients who were refractory to LAM therapy, the cumulative probability of ETV resistance did not differ significantly between the two groups (P=0.149).However, prior LAM use without refractoriness did not affect the development of ETV resistance.The serum hepatitis B virus DNA level at month 12 was a major predictor for the development of ETV resistance.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.

ABSTRACT

Background/aims: To determine the efficacies of entecavir (ETV) in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B (CHB) patients and in those with prior lamivudine (LAM) use who did not develop resistance.

Methods: We retrospectively enrolled 337 patients with CHB who were treated with ETV (0.5 mg daily) for at least 30 months. The study included 270 (80.1%) NA-naïve patients and 67 (19.9%) LAM-use patients. Ten of the LAM-use patients were refractory to LAM therapy without developing resistance.

Results: Genotypic resistance to ETV developed more frequently in the LAM-use group (13.1%) than in the NA-naïve group (2.6%) at 60 months (P=0.009). In subgroup analysis, after excluding the 10 patients who were refractory to LAM therapy, the cumulative probability of ETV resistance did not differ significantly between the two groups (P=0.149). Prior LAM refractoriness and a higher hepatitis B virus DNA level at month 12 were independent predictive factors for the development of ETV resistance.

Conclusions: ETV resistance developed more frequently in LAM-use patients with CHB. However, prior LAM use without refractoriness did not affect the development of ETV resistance. The serum hepatitis B virus DNA level at month 12 was a major predictor for the development of ETV resistance.

No MeSH data available.


Related in: MedlinePlus