Tenofovir Disoproxil Fumarate Monotherapy is Superior to Entecavir-Adefovir Combination Therapy in Patients with Suboptimal Response to Lamivudine-Adefovir Therapy for Nucleoside-Resistant HBV: A 96-Week Prospective Multicentre Trial

Lee, Sae Hwan; Cheon, Gab Jin; Kim, Hong Soo; Kim, Sang Gyune; Kim, Young Seok; Jeong, Soung Won; Jang, Jae Young; Kim, Boo Sung; Jun, Baek Gyu; Kim, Young Don; Jun, Dae Won; Sohn, Joo Hyun; Kim, Tae Yeob; Lee, Byung Seok

doi:10.3851/imp3169

Cited by 11 publications

(6 citation statements)

References 36 publications

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“…Some previous studies demonstrated that previous ADV-experienced patients have inferior efficacy of TDF compared with NA-naïve patients 28. Some reported TDF mono-therapy showed superior efficacy compared with LMV plus ADV or ETV plus ADV in LAM-R CHB patients 29,30. As a combination strategy, regarding previous reports, the efficacy of TDF mono- and combination treatments was similar,31 and TDF-ETV combination therapy revealed a high rate of achieving virologic suppression regardless of prior treatment experience without resistance 32…”

Section: Discussionmentioning

confidence: 99%

Treatment Outcome and Renal Safety of 3-Year Tenofovir Disoproxil Fumarate Therapy in Chronic Hepatitis B Patients with Preserved Glomerular Filtration Rate

et al. 2019

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Background/AimsTo investigate the treatment efficacy and renal safety of long-term tenofovir disoproxil fumarate (TDF) therapy in chronic hepatitis B (CHB) patients with preserved renal function.MethodsThe medical records of 919 CHB patients who were treated with TDF therapy were reviewed. All patients had preserved renal function with an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m2.ResultsA total of 426 patients (184 treatment-naïve and 242 treatment-experienced) were included for analysis. A virologic response (VR) was defined as achieving an undetectable serum hepatitis B virus (HBV) DNA level, and the overall VR was 74.9%, 86.7%, and 89.4% at the 1, 2, and 3-year follow-ups, respectively. Achieving a VR was not influenced by previous treatment experience, TDF combination therapy, or antiviral resistance. In a multivariate analysis, being hepatitis B e antigen positive at baseline and having a serum HBV DNA level ≥2,000 IU/mL at 12 months were associated with lower VR rates during the long-term TDF therapy. The overall renal impairment was 2.9%, 1.8%, and 1.7% at the 1, 2, and 3-year follow-ups, respectively. With regard to renal safety, underlying diabetes mellitus (DM) and an initial eGFR of 60 to 89 mL/min/1.73 m2 were significant independent predictors of renal impairment.ConclusionsTDF therapy appears to be an effective treatment option for CHB patients with a preserved GFR. However, patients with underlying DM and initial mild renal dysfunction (eGFR, 60 to 89 mL/min/1.73 m2) have an increased risk of renal impairment.

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Section: Discussionmentioning

confidence: 99%

Treatment Outcome and Renal Safety of 3-Year Tenofovir Disoproxil Fumarate Therapy in Chronic Hepatitis B Patients with Preserved Glomerular Filtration Rate

et al. 2019

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“…[1 [1][2][3][4][5][6][7][8][9][10][11][12] Currently, the US Food and Drug Administration (FDA) has approved two types of anti-hepatitis B virus drugs: interferon (IFN) and nucleos(t)ide analogs (entecavir, lamivudine, telbivudine, adefovir, and tenofovir), although nucleoside analogues are well tolerated and exhibit an early and potent antiviral effect, the selection of resistant mutants and nephrotoxicity during long-term therapy limit their use. [ [13][14] Chinese herbal medicine (CHM), as one of the most popular complementary and alternative therapies of CHB, a large number of studies have reported its anti-hepatitis B virus effect. CHMs have two major characteristics: a) it is flexible and variable in various kinds of herbal medicines, it has complex compositions which means not easy causing drug resistance.…”

Section: Abstract Chronic Hepatitis B Cirrhosis Traditional Chinesementioning

confidence: 99%

Efficacy and safety of YinQiSanHuang-antiviral decoction on chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

Lv²,

et al. 2020

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Introduction: Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies shown that combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation, and has shown its effect on anti-hepatitis B virus and slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial, which objective is “the combination of YinQiSanHuang-antiviral decoction with entecavir reduce the annual incidence of liver fibrosis / cirrhosis to 1%”.Methods: This is a multicenter, randomized, placebo-controlled, double-blinded trial, 5 hospitals involved in. Totally 802 patients are randomly allocated to two groups: the YQSH group (n=401) or the placebo group (n=401). The YQSH group receives YQSH with Entecavir, the placebo group receives granule of placebo with Entecavir. Patients receive treatment for 52 weeks, and then are followed up for 52±2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are HBV-DNA negative rate, HBsAg negative rate, HBeAg seroconversion rate, liver function (Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), serum albumin (ALB) and total bilirubin (TBIL)), spleen thickness, evaluation scores of patients’ clinical symptoms and safety assessment. Outcomes will be assessed at baseline and after treatment.Discussion: Combination therapy could become a trendy of treatment of CHB, this trial expecting to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.Trial registration: ChiCTR1900021521, this protocol was registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn) on February 25th, 2019.

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“…It was reported that long-term treatment with ETV, Lamivudine(LDV), or Tenofovir(TDF) could reverse HBV-related cirrhosis to milder brosis [4] . However, the selection of resistant mutants and nephrotoxicity during long-term therapy limit its use [5][6] . Therefore, the treatment goals for LC patient are to maximize long-term inhibition of HBV replication [7] , reducing liver cell in ammation and necrosis and liver brous tissue hyperplasia, delaying and reducing the occurrence of liver failure, decompensation of LC, HCC and other complications, improving the quality of life of patients, and extending their survival time, and for some patients could pursued the clinical cure [8][9] .…”

Section: Introductionmentioning

confidence: 99%

YinQiSanHuang Jiedu decoction for the treatment of hepatitis B-related compensated liver cirrhosis: study protocol for a multicentre randomised controlled trial.

et al. 2021

Preprint

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Introduction: Hepatitis B-related compensated liver cirrhosis is related to higher risk of hepatocellular carcinoma, anti-viral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aim to test the integrative medicine (chinese medicine plus anti-riral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis B-related compensated liver cirrhosis.Methods and Analysis: This is a multicentre randomised controlled trial, total 5 hospitals and 802 patients will involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction(YQSHD) group (n=401) or the placebo group (n=401). The YQSHD group receives YQSHD granule with Entecavir(ETV), the placebo group receives YQSHD placebo with ETV. Treatment period will last for 52 weeks, and follow-up period for 52±2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. Objective of this trial is “the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%”.Ethics and dissemination:The protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China (No.2019-006-KY), and the other centres in the trial will not begin recruiting until local ethical approval has been obtained.Trial final results will be disseminated via publication. Trial registration: ChiCTR1900021532, this protocol was registered in the Chinese Clinical Trial Registry (URL: http://www.chictr.org.cn/searchproj.aspx) on February 26th, 2019.

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Tenofovir Disoproxil Fumarate Monotherapy is Superior to Entecavir-Adefovir Combination Therapy in Patients with Suboptimal Response to Lamivudine-Adefovir Therapy for Nucleoside-Resistant HBV: A 96-Week Prospective Multicentre Trial

Abstract: TDF therapy achieved a better complete virological response than ETV-ADV therapy in chronic hepatitis B patients with suboptimal response to long-term LAM-ADV rescue therapy. (KCT0000627).

Cited by 11 publications

References 36 publications

Treatment Outcome and Renal Safety of 3-Year Tenofovir Disoproxil Fumarate Therapy in Chronic Hepatitis B Patients with Preserved Glomerular Filtration Rate

Treatment Outcome and Renal Safety of 3-Year Tenofovir Disoproxil Fumarate Therapy in Chronic Hepatitis B Patients with Preserved Glomerular Filtration Rate

Efficacy and safety of YinQiSanHuang-antiviral decoction on chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial

YinQiSanHuang Jiedu decoction for the treatment of hepatitis B-related compensated liver cirrhosis: study protocol for a multicentre randomised controlled trial.

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