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Tenofovir Monotherapy and Tenofovir Plus Entecavir Combination as Rescue Therapy for Entecavir Partial Responders

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Abstract

Background and Aims

Despite high potency, a significant proportion of patients treated with entecavir achieve only partial viral suppression. Our goal was to examine the complete viral suppression rate (undetectable HBV DNA PCR levels) with alternative therapies in such patients.

Methods

We retrospectively studied 42 consecutive patients with partial response to entecavir (detectable HBV DNA at ≥12 months of therapy) who were treated at three clinics with rescue therapies: entecavir + adefovir (n = 5), tenofovir (n = 6), and entecavir + tenofovir (n = 31). Antiviral resistance was excluded by negative mutation analysis and/or absence of virologic breakthrough (increase >1 log10IU/mL from nadir).

Results

All patients were Asian and 57 % were male with a median age of 36 (22–64) years. Only a few patients had prior exposure to lamivudine (7 %) or adefovir (7 %). Almost all patients (95 %) had positive HBeAg. Overall, the complete viral suppression rate was 79 %, and the alanine aminotransferase normalization rate was 83 % in entecavir partial responders after 6 months on rescue therapies. Cumulative complete viral suppression rates were significantly different (P = 0.0164) among the entecavir + adefovir, tenofovir, and entecavir + tenofovir treatment groups at 6 months (20 vs. 83 vs. 83 %, respectively) and 12 months (20 vs. 100 vs. 97 %). All three patients without complete viral suppression on entecavir + adefovir became aviremic 6 months after switching to entecavir + tenofovir.

Conclusions

Virologic response to entecavir + tenofovir combination therapy and tenofovir monotherapy appeared to be similar in most patients, but not with the entecavir + adefovir combination.

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Abbreviations

ADV:

Adefovir

CHB:

Chronic hepatitis B

ETV:

Entecavir

HBV:

Hepatitis B virus

HCC:

Hepatocellular carcinoma

HCV:

Hepatitis C virus

HIV:

Human immunodeficiency virus

LAM:

Lamivudine

TDF:

Tenofovir

ALT:

Alanine aminotransferase

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Conflict of interest

Benjamin Yip, Kevin Chaung, and Carrie Wong have no financial relationship with a commercial interest. Huy N. Trinh has served as a speaker for Bristol–Myers Squibb, a consultant for Bristol–Myers Squibb, and an advisory board member for Gilead Sciences Inc. and Bristol-Myers Squibb, has received funding from Gilead Sciences Inc. and Roche, and owns stocks and shares in Gilead Sciences Inc. Huy A. Nguyen has served as a speaker for Gilead Sciences Inc. Aijaz Ahmed has served as a consultant for Bristol–Myers Squibb and Gilead Sciences Inc. Ramsey Cheung has received research support from Gilead Sciences Inc. Mindie H. Nguyen has served as a consultant for Bristol–Myers Squibb and Gilead Sciences Inc. and has received funding from Bristol–Myers Squibb, Novartis Pharmaceuticals, and Roche.

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Correspondence to Mindie H. Nguyen.

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Yip, B., Chaung, K., Wong, C.R. et al. Tenofovir Monotherapy and Tenofovir Plus Entecavir Combination as Rescue Therapy for Entecavir Partial Responders. Dig Dis Sci 57, 3011–3016 (2012). https://doi.org/10.1007/s10620-012-2402-2

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  • DOI: https://doi.org/10.1007/s10620-012-2402-2

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