Randomized clinical trial: efficacy and safety of telbivudine and lamivudine in treatment‐naïve patients with HBV‐related decompensated cirrhosis

Chan, H.L.-Y.; Chen, Y. C.; Gane, Edward; Sarin, Shiv Kumar; Suh, Dong Jin; Piratvisuth, Teerha; Prabhakar, B.; Hwang, Sun-Jin; Choudhuri, G; Safadi, Rifaat; Tanwandee, Tawesak; Chutaputti, Anuchit; Yurdaydın, Cihan; Bao, Weibin; Avila, Claudio; Trylesinski, Aldo

doi:10.1111/j.1365-2893.2012.01600.x

Cited by 91 publications

(98 citation statements)

References 34 publications

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“…Chan and associates suggested that telbivudine could increase blood flow to improve tubular dysfunction. 15 McKeage and team proposed another mech anism of renal protection of telbivudine excretion through passive diffusion, which would not result in mitochondrial DNA depletion or toxic effects on function of renal tubule cells. 16 Liang and associates showed that downstream effects by telbivudine decreased serum angiotensin-converting enzyme levels to inhibit the renin-angiotensin aldosterone regulatory system, with eGFR significantly increasing after long-term telbivudine treatment.…”

Section: Resultsmentioning

confidence: 99%

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Lin

Chen²,

Lin³

et al. 2017

Exp Clin Transplant

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Objectives: Preservation of renal function is an important issue after living donor liver transplant. We aimed to examine the renal protective efficacy of telbivudine in hepatitis B virus-infected patients after living donor liver transplant. Materials and Methods:In this retrospective study, we compared 18 patients who received telbivudine 600 mg once per day and 23 patients who received entecavir 1 mg once per day after living donor liver transplant. Clinical data were obtained through chart review and included Model for End-Stage Liver Disease score and pre-and postoperative aspartate aminotransferase, alanine aminotransferase, and creatinine levels and estimated glomerular filtration rate. Results: Posttransplant estimated glomerular filtration rates and creatinine levels were calculated, and improvement of renal function was found in the group of patients who received telbivudine. Significant improvements were shown in estimated glomerular filtration rates started after 9 months of administration and creatinine levels after 12 months compared with patients who received entecavir. Conclusions: In our study, long-term telbivudine therapy is associated with a sustained improvement of renal function in patients with hepatitis B virus infection after living donor liver transplant.

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Section: Resultsmentioning

confidence: 99%

Untitled

Lin

Chen²,

Lin³

et al. 2017

Exp Clin Transplant

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“…Indeed, patients with baseline eGFRs from 60 to 89 mL/min/1.73 m 2 , older than 50 years, and with liver fibrosis/cirrhosis achieved an eGFR improvement of 17.2%, 11.4%, and 7.2%, respectively (66). In decompensated patients with a high renal risk, eGFR declined during LAM treatment (−4.6%), whereas it improved in LtD-treated patients (+2.0%; p=0.023) (67).…”

Section: Telbivudine and Renal Functionmentioning

confidence: 99%

“…Besides, LtD in comparison with other NAs showed a potential renal protective effect. In a double-blind randomized trial involving 232 treatment-naïve patients with decompensated CHB, LtD treatment was associated with a significant improvement in estimated glomerular filtration rate (eGFR) compared to LAM after 52 weeks of treatment (67). More importantly, Gane et al (66) gathered data of CHB patients who participated in the GLOBE trial for 2 years and in the long-term extension studies (4-6 years) as well as patients with decompensated cirrhosis (A2303 trial; a 2-year study) to assess renal function in CHB patients receiving LtD treatment.…”

Section: Telbivudine and Renal Functionmentioning

confidence: 99%

Chronic Hepatitis B Treatment: Current Perspectives on Telbivudine

Caviglia¹,

Rosso²,

Olivero³

et al. 2017

Istanbul Med J

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Hepatitis B virus (HBV) is a small-enveloped DNA virus that belongs to the Hepadnaviridae family, representing the second greatest cause of chronic viral hepatitis worldwide (1). Despite decades of vaccination, HBV infection is still a major global burden, with 257 million persons chronically infected and approximately 880,000 deaths per year (2). Chronic hepatitis B (CHB) is the result of an acute, unresolved infection that induces an immune-mediated liver damage followed by fibrotic tissue deposition leading overtime to a complete alteration of the hepatic architecture toward cirrhosis and its complications, such as liver failure and hepatocellular carcinoma (HCC) (3, 4).Remarkable advances have been made in the setting of CHB treatment (5). In particular, the development of new molecular biology techniques in association with an ever deeper understanding of the different phases of HBV infection and primarily the introduction of nucleos(t)ide analogs (NAs) are the main features that may lead to the virological cure in the near term and the functional cure in the long-term follow-up (6).This review discusses the current available drugs and treatment guidelines for CHB therapy focusing on telbivudine (LtD), a thymidine analog that has demonstrated unique features that make the abovementioned drug still valid even in the era of new powerful anti-viral agents. HBV Virology and Replication CycleHBV structure Hepatitis B virus structure consists of an outer envelope made of three viral surface proteins named preS1 (large), preS2 (middle), and S (small), which correspond to the serologic HBsantigen (HBsAg), and an inner nucleocapsid formed by core proteins, which correspond to HBcore-antigen (HBcAg) (7). Within the nucleocapsid is present the full-length HBV genome as a partially double-stranded relaxed circular (rc) DNA linked to the viral polymerase protein by a phosphotyrosine bond (8). The genome has an extremely compact organization displaying four partially overlapped major open reading frames (ORFs): the preS/S that encodes the three viral surface proteins, the pre-core/core that encodes both the nucleocapsid core protein and the non-structural core protein known as the e-antigen (HBeAg); the polymerase ORF that encodes the viral polymerase; and the X ORF that encodes the regulatory X protein that is essential for viral replication (9). Chronic Hepatitis B Treatment: Current Perspectives on TelbivudineHepatitis B virus (HBV) is the primary cause of chronic viral hepatitis worldwide. Currently, there are 5 oral nucleos(t)ide analogs (NAs) approved for chronic hepatitis B (CHB) treatment and include lamivudine, adefovir, telbivudine (LtD), entecavir (ETV), and tenofovir disoproxil fumarate (TDF). ETV and TDF are those with higher anti-viral efficacy and lower resistance rates, whereas LtD shows similar efficacy but has a higher risk for viral resistance in long-term monotherapy. However, LtD carries several advantages that must be considered and are worthy of discussion. Compared to other NAs, LtD showed a poten...

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“…No cases of renal insufficiency are, on the contrary, reported with LAM. Moreover, renal function improvement (expressed as an increase in estimated glomerular filtration rate from baseline) was significantly greater in patients treated with LdT with respect to patients on LAM therapy (3.3 ± 3.3 mL vs 4.3 ± 3.1 mL, P = 0.02), according to a prospective randomised controlled trial on LdT and LAM [45] . The frequency of renal insufficiency at 1-year after starting antiviral treatment was reportedly similar between ETVand TDF-treated patients (5% vs 9%, P = 0.53) in a different study [44] .…”

Section: Antiviral Therapy and Decompensated Liver Diseasementioning

confidence: 99%

Role of antiviral therapy in the natural history of hepatitis B virus-related chronic liver disease

Russo

Rodríguez–Castro

Scribano

et al. 2015

WJH

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interactions among HBV, hepatocytes, and the host immune system. Natural history studies of chronic hepatitis B (CHB) infection have shown an association between active viral replication and adverse clinical outcomes such as cirrhosis and hepatocellular carcinoma. The goal of therapy for CHB is to improve quality of life and survival by preventing progression of the disease to cirrhosis, decompensation, end-stage liver disease, hepatocellular carcinoma (HCC) and death. This goal can be achieved if HBV replication is suppressed in a sustained manner. The accompanying reduction in histological activity of CHB lessens the risk of cirrhosis and of HCC, particularly in non-cirrhotic patients. However, CHB infection cannot be completely eradicated, due to the persistence of covalently closed circular DNA in the nucleus of infected hepatocytes, which may explain HBV reactivation. Moreover, the integration of the HBV genome into the host genome may favour oncogenesis, development of HCC and may also contribute to HBV reactivation. Core tip: The goal of therapy for chronic hepatitis B is to improve quality of life and survival by preventing progression of the disease to cirrhosis, decompensation, end-stage liver disease, hepatocellular carcinoma and death. Current therapeutic options do not eradicate hepatitis B virus (HBV) infection, since HBV remains either integrated in the host genome or in the nuclei of hepatocytes as covalently closed circular DNA, a fact that may favour oncogenesis towards the development of hepatocellular carcinoma, and explains HBV reactivation. It is mandatory for clinicians to start viral suppression in patients with active chronic liver disease, particularly in

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Randomized clinical trial: efficacy and safety of telbivudine and lamivudine in treatment‐naïve patients with HBV‐related decompensated cirrhosis

Cited by 91 publications

References 34 publications

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Chronic Hepatitis B Treatment: Current Perspectives on Telbivudine

Role of antiviral therapy in the natural history of hepatitis B virus-related chronic liver disease

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