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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

Flow diagram of the study population. LAM, lamivudine; HBV, hepatitis B virus; NA, nucleos(t)ide analogue; HCV, hepatitis C virus; VB, virologic breakthrough.
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Figure 1: Flow diagram of the study population. LAM, lamivudine; HBV, hepatitis B virus; NA, nucleos(t)ide analogue; HCV, hepatitis C virus; VB, virologic breakthrough.

Mentions: A 358 patients with chronic hepatitis B were screened. Twenty-one patients did not fulfill the criteria and were excluded from the analysis: six had LAM resistance, six had a baseline HBV DNA level <2,000 IU/mL, four had a history of treatment with adefovir dipivoxil, or clevudine prior to ETV therapy, respectively, and one patient was co-infected with hepatitis C virus. Therefore, a 337 patients were included in this analysis (Fig. 1).


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)

Flow diagram of the study population. LAM, lamivudine; HBV, hepatitis B virus; NA, nucleos(t)ide analogue; HCV, hepatitis C virus; VB, virologic breakthrough.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 1: Flow diagram of the study population. LAM, lamivudine; HBV, hepatitis B virus; NA, nucleos(t)ide analogue; HCV, hepatitis C virus; VB, virologic breakthrough.
Mentions: A 358 patients with chronic hepatitis B were screened. Twenty-one patients did not fulfill the criteria and were excluded from the analysis: six had LAM resistance, six had a baseline HBV DNA level <2,000 IU/mL, four had a history of treatment with adefovir dipivoxil, or clevudine prior to ETV therapy, respectively, and one patient was co-infected with hepatitis C virus. Therefore, a 337 patients were included in this analysis (Fig. 1).

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