Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B

Fung, Scott; Kwan, P.; Fabri, Milotka; Horban, Andrzéj; Pelemiš, Mijomir; Hann, Hie Won; Gürel, Selım; Căruntu, Florin Alexandru; Flaherty, John F.; Massetto, Benedetta; Dinh, Phillip; Corsa, Amoreena C.; Subramanian, G. Mani; McHutchison, John G.; Husa, Petr; Gane, Edward

doi:10.1053/j.gastro.2013.12.028

Cited by 145 publications

(158 citation statements)

References 34 publications

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“…This result is comparable to the previous results in treatment-naïve patients [14,25] . The response rates are also comparable with previous clinical trial data by Fung et al, even though higher proportion of patients in our study was HBeAg positive and more cases were exposed to ADV compared with the previous study [18] . The baseline HBV DNA level of the patients was 3.3 log10 IU/mL which was lower than that in the clinical trial.…”

Section: Conflicts Of Interestsupporting

confidence: 91%

“…TDF is currently recommended for the first-line agents for chronic hepatitis B patients [16,17] . Randomized controlled trial of TDF therapy in LAM-resistant HBV was recently demonstrated that TDF achieved excellent viral suppression at at a rate of 89% of undetectable HBV DNA at 96 weeks [18,19] . Several studies in small number of patients showed efficacy of TDF-based therapy for LAM-resistant patients, however, real life data of TDF in the patens is currently limited.…”

Section: Resultsmentioning

confidence: 99%

“…Regarding safety profile, TDF was well tolerated without renal impairment during the follow up period. It has been suggested that long-term use of TDF results in renal impairment and proximal tubular dysfunction [8,18,30] . The risk of renal dysfunction is higher in patients with decompensated liver disease, hypertension, diabetes mellitus, and organ transplantation [8,18] .…”

Section: Discussionmentioning

confidence: 99%

“…patients [18] . They showed that addition of emtricitabine to TDF did not increase the virologic response.…”

Section: Conflicts Of Interestmentioning

confidence: 99%

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Efficacy and Safety of Tenofovir Disoproxil Furmarate for Patients with Lamivudine-Resistant Hepatitis B Virus Infection

Kwon

Yeon

Yoo

et al. 2016

Journal of Gastroenterology and Hepatology Research

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and 89.7%, respectively. The mean change from baseline in HBV DNA was -2.05 log10IU/mL, and -2.14 log10IU/mL, respectively. Multivariate Cox regression analysis showed that baseline HBV DNA level was a significant predictive factor of virologic response at 12 months. (HR = 0.645; 95% CI 0.504-0.826; p = 0.001). Two patients (2.4%) showed HBeAg loss, and no patient lost HBsAg during the treatment period. Serious adverse events or renal impairment was not observed. CONCLUSION: TDF is safe and effective for complete viral suppression in patients with lamivudine-resistant HBV infection.

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Section: Conflicts Of Interestsupporting

confidence: 91%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…patients [18] . They showed that addition of emtricitabine to TDF did not increase the virologic response.…”

Section: Conflicts Of Interestmentioning

confidence: 99%

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Efficacy and Safety of Tenofovir Disoproxil Furmarate for Patients with Lamivudine-Resistant Hepatitis B Virus Infection

Kwon

Yeon

Yoo

et al. 2016

Journal of Gastroenterology and Hepatology Research

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“…Patients with decompensated cirrhosis receiving LDV plus ADV therapy are at risk of early death and HCC development despite the antiviral effects [37]. Renal disturbance (creatinine clearance less than 50 mL/ min) and hypophosphatemia (phosphate level less than 2 mg/dL) were very rare (less than 1 %) in group receiving TDF therapy for 96 weeks [38], whereas the incidences of serum creatinine level elevation and hypophosphatemia (phosphate level less than 2.5 mg/dL) in the group receiving LDV plus ADV add-on therapy for 15-68 weeks were 38 and 16 %, respectively [39].…”

Section: Antiviral Therapy For Hepatitis B Virus Related Cirrhosismentioning

confidence: 99%

Evidence-based clinical practice guidelines for liver cirrhosis 2015

et al. 2016

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The Japanese Society of Gastroenterology revised the evidence-based clinical practice guidelines for liver cirrhosis in 2015. Eighty-three clinical questions were selected, and a literature search was performed for the clinical questions with use of the MEDLINE, Cochrane, and Igaku Chuo Zasshi databases for the period between 1983 and June 2012. Manual searching of the latest important literature was added until August 2015. The guidelines were developed with use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. This digest version in English introduces selected clinical questions and statements related to the management of liver cirrhosis and its complications. Branched-chain amino acids relieve hypoalbuminemia and hepatic encephalopathy and improve quality of life. Nucleoside analogues and peginterferon plus ribavirin combination therapy improve the prognosis of patients with hepatitis B virus related liver cirrhosis and hepatitis C related compensated liver cirrhosis, respectively, although the latter therapy may be replaced by direct-acting antivirals. For liver cirrhosis caused by primary biliary cirrhosis and active autoimmune hepatitis, urosodeoxycholic acid and steroid are recommended, respectively. The most adequate modalities for the management of variceal bleeding are the endoscopic injection sclerotherapy for esophageal varices and the balloon-occluded retrograde transvenous obliteration following endoscopic obturation with cyanoacrylate for gastric varices. Beta-blockers are useful for primary prophylaxis of esophageal variceal bleeding. The V 2 receptor antagonist tolvaptan is a useful add-on therapy in careful diuretic therapy for ascites. Albumin infusion is useful for the prevention of paracentesis-induced circulatory disturbance and renal failure. In addition to disaccharides, the nonabsorbable antibiotic rifaximin is useful for the management of encephalopathy. Anticoagulation therapy is proposed for patients with acute-onset or progressive portal vein thrombosis.

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Hepatitis B

Lok

2018

Sherlock's Diseases of the Liver and Biliary System

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Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B

Cited by 145 publications

References 34 publications

Efficacy and Safety of Tenofovir Disoproxil Furmarate for Patients with Lamivudine-Resistant Hepatitis B Virus Infection

Efficacy and Safety of Tenofovir Disoproxil Furmarate for Patients with Lamivudine-Resistant Hepatitis B Virus Infection

Evidence-based clinical practice guidelines for liver cirrhosis 2015

Hepatitis B

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