Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naïve patients with chronic hepatitis B: a multicenter real-life study

Batırel, Ayşe; Güçlü, Ertuğrul; Arslan, Ferhat; Koçak, Funda; Karabay, Oğuz; Özer, Serdar; Turanli, Münevver; Mert, Ali

doi:10.1016/j.ijid.2014.09.004

Cited by 44 publications

(53 citation statements)

References 28 publications

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“…[5] At present, there are many clinical studies of multicenter, large-scale samples of TDF here and abroad. [67891011121314] Among them, TDF in vitro experiments showed that it had a strong antiviral capacity against both hepatotropic viruses and retroviruses, and it can inhibit the activity of HBV DNA polymerase, which had a good inhibitory effect on HBV DNA replication in wild-type HBV. In vitro studies of TDF treatment for HBV infection with lamivudine (LAM) and adefovir dipivoxil (ADV) resistance also showed that TDF has a good inhibitory effect on viral replication.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Tenofovir Disoproxil Treatment for Chronic Hepatitis B Patients with Genotypic Resistance to Other Nucleoside Analogues

Zhou

Liu

Lian

et al. 2017

Chinese Medical Journal

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Background:Tenofovir disoproxil (TDF) is a promising salvage therapy for patients with chronic hepatitis B (CHB) who failed regimens of other nucleoside analogues (NAs). In this study, we aimed to investigate the clinical efficacy and safety of TDF monotherapy in Chinese CHB patients with genotypic resistance.Methods:A total of 33 CHB patients who had failed treatment with other NAs and had genotypic resistance were switched to TDF monotherapy for 48 weeks. Patients’ demographic data (age, sex, history of hepatitis B virus [HBV] therapy), laboratory testing results (hepatitis B e antigen [HBeAg] status, HBV DNA levels, alanine aminotransferase [ALT] levels, serum creatinine, urinary protein, genotypic assay), clinical symptoms, and liver color ultrasound examinations were collected for evaluation at day 0 (baseline) and the 12th, 24th, 36th, and 48th weeks after initiating treatment. Statistical analyses were carried out using rank sum test or rank correlation.Results:With regard to efficacy, the study found that all patients who switched to TDF monotherapy had undetectable HBV DNA levels after 48 weeks. In addition, patients with lower baseline HBV DNA levels realized earlier virological undetectability (rs = 0.39, P = 0.030). ALT levels were normal in 30 of 33 patients (91%). HBeAg negative conversion occurred in 7 of 25 patients (28%), among whom HBeAg seroconversion (12%) and HBeAg seroclearance (16%) occurred. The time of complete virological response was significantly affected by the number of resistance loci (rs = 0.36, P = 0.040). Concerning safety, the study found that no adverse events were observed during the 48 weeks.Conclusion:TDF monotherapy is an effective and safe salvage treatment for CHB patients who are resistant to other NAs.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Tenofovir Disoproxil Treatment for Chronic Hepatitis B Patients with Genotypic Resistance to Other Nucleoside Analogues

Zhou

Liu

Lian

et al. 2017

Chinese Medical Journal

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“…The use of tenofovir and entecavir was compared in 13 studies with average sample sizes of 62 per treatment group (range, 22‐148). The first RCT of HBV‐infected adults with decompensated cirrhosis showed no significant difference in serum creatinine or creatinine clearance over 48 weeks of tenofovir (n = 45) or entecavir (n = 22) . The second RCT of 200 HBV‐infected adults (100 on tenofovir, 100 on entecavir) showed no significant decline in renal function and no difference in adverse events .…”

Section: Renal and Bone Disease In Persons On Na Therapymentioning

confidence: 99%

AASLD guidelines for treatment of chronic hepatitis B

Terrault¹,

Bzowej²,

Chang³

et al. 2015

Hepatology

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2,022

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“…Previous studies have described rates of virological breakthrough ranging between 0% and 55.8% [11,[18][19][20][21], with lower rates reported in patients receiving second generation medications such as entecavir (ETV) and tenofovir (TDF) [21]. Hongthanakorn et al (2011) were the first to highlight that non-adherence to HBV antiviral medications posed a problem [11].…”

Section: Virological Breakthrough Is Defined By the American Associatmentioning

confidence: 99%

Factors associated with HBV Virological Breakthrough

et al. 2017

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BREAKTHROUGHBackground: Little is known about non-adherence to Hepatitis B virus (HBV) therapy.This study aimed to investigate the relationship between self-reported missed days of anti-viral therapy and HBV virological breakthrough and factors associated with virological breakthrough.Methods: A cross-sectional survey of 211 HBV patients receiving oral anti-viral therapies was undertaken at three tertiary hospitals in Sydney, Australia. Associations between 0 to > 6 missed days in the last 30 days and virological breakthrough (defined as > 10-fold rise in serum HBV DNA above nadir or after achieving virological response in the last 12 months) were examined. Logistic regression analyses determined the number of missed days most strongly associated with virological breakthrough and the associated factors. We report odds ratios and relative risks.Results: Of the 204, 32 participants (15.6%) had quantifiable HBV DNA levels (> 20 IU/mL); 15 (46.8%) of them experienced virological breakthrough. Participants reported never missing medication (n=130, 63.7%) or missing one day (n=23, 11.3%), >one day (n=23, 11.3%), 2-6 days (n=15, 7.3%) and >6 days (n=13, 6.4%). The most discriminating definition of non-adherence was missing > one day of medication

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Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naïve patients with chronic hepatitis B: a multicenter real-life study

Abstract: The two drugs appear to have similar efficacy in CHB patients. However, 7% of patients on ETV therapy had virological breakthrough, while none of the patients on TDF therapy did.

Cited by 44 publications

References 28 publications

Efficacy and Safety of Tenofovir Disoproxil Treatment for Chronic Hepatitis B Patients with Genotypic Resistance to Other Nucleoside Analogues

Efficacy and Safety of Tenofovir Disoproxil Treatment for Chronic Hepatitis B Patients with Genotypic Resistance to Other Nucleoside Analogues

AASLD guidelines for treatment of chronic hepatitis B

Factors associated with HBV Virological Breakthrough

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