428 Lamivudine-refractory hepatitis B patients can be safely switched directly to entecavir 1 mg daily therapy

Gish, Robert G.; Chang, Tsung-Hsien; Hadziyannis, S.; Cianciara, J; Rizzetto, Mario; Schiff, Eugene R.; Pastore, G; Jackson, R.; Thiry, Alexandra; Hindes, R.

doi:10.1016/s0168-8278(04)90428-x

Cited by 8 publications

(5 citation statements)

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“…70 It is effective in suppressing lamivudineresistant HBV, but the antiviral activity is less compared with wild-type HBV. 71 Clinical trials in patients with compensated liver disease showed that the safety profile of a 1-year course of entecavir is similar to that of lamivudine, but its safety in patients with decompensated cirrhosis has not been determined. Resistance to entecavir has not been observed after up to 2 years of treatment in nucleoside-naïve patients, but resistance to entecavir has been reported in 7% of patients with prior lamivudine resistance.…”

Section: Entecavirmentioning

confidence: 99%

Viral Hepatitis and Liver Transplantation

Sharma¹,

Lok²

2006

Semin Liver Dis

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Hepatitis C is the one of the most common indications for liver transplantation. Infection of the allograft after transplantation is universal, and recurrent hepatitis C progresses at an accelerated rate. Antiviral therapy in selected patients on the transplant waiting list may reduce the rate of hepatitis C virus reinfection. Preemptive antiviral therapy after transplantation has been disappointing. However, treatment of established histological disease with a combination of pegylated interferon and ribavirin is associated with sustained virologic response rates of 25 to 40%. Significant advances have been made in the prevention of hepatitis B reinfection after transplantation. Results are now excellent, with graft infection rates less than 10%. The challenges for the future include designing strategies to optimize the use of antiviral agents to prevent the need for transplantation and to avoid antiviral resistance and to determine the dose and duration of hepatitis B immunoglobulin needed in the era of multiple nucleoside analogs.

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Section: Entecavirmentioning

confidence: 99%

Viral Hepatitis and Liver Transplantation

Sharma¹,

Lok²

2006

Semin Liver Dis

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“…Because entecavir is 100-fold more potent than lamivudine in suppressing HBV replication, in vivo activity against lamivudine-resistant HBV can be achieved using higher doses of entecavir 1.0 mg versus 0.1-0.5 mg for wild-type HBV. Preliminary data from a Phase II trial in 181 lamivudine-refractory patients confirmed that entecavir in doses of 0.5 or 1.0 mg daily resulted in 4 log 10 decrease in serum HBV DNA after 52 weeks of therapy [78]. This study also suggested that lamivudine-resistant patients can be safely switched to entecavir without ongoing lamivudine therapy as ALT flares were observed in only four (2%) patients receiving 0.5 or 1.0 mg entecavir.…”

Section: Adefovir Dipivoxilmentioning

confidence: 88%

“…Addition of antiviral agents with activity against antiviral-resistant mutants is recommended particularly for patients with underlying cirrhosis, immunosuppressed patients and patients who develop worsening liver disease or moderate/severe hepatitis flares. Three antiviral agents (adefovir, tenofovir and entecavir) have demonstrated in vivo activity against lamivudineresistant HBV (Table 3) [6,[78][79][80]. Lamivudine and entecavir have in vivo activity against adefovir-resistant HBV and adefovir has in vivo activity against entecavir-resistant HBV [38].…”

Section: Adding Antiviral Agents With Activity Against Drugresistant Mutantsmentioning

confidence: 99%

Management of Hepatitis B Patients with Antiviral Resistance

Fung

Lok

2004

Antiviral Therapy

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Drug resistance is an expected consequence of antiviral therapy for chronic hepatitis B because of the high rate of hepatitis B virus (HBV) replication, the lack of proofreading during reverse transcription of the pregenomic RNA and the low efficacy of available therapies in eliminating covalently closed circular HBV DNA. Mutations involving the YMDD motif of the catalytic domain of HBV reverse transcriptase have been reported in patients who have received lamivudine, emtricitabine and telbivudine. Drug-resistant mutations affecting other regions of HBV polymerase have also been reported, but at much lower rates in patients who have received adefovir dipivoxil or entecavir. Antiviral resistance is initially manifested as virological breakthrough infection. In most patients, this is followed by biochemical breakthrough and, in some patients, hepatitis flares and hepatic decompensation. Monitoring drug resistance may improve the management of patients with antiviral-resistant HBV and can guide the selection of salvage therapy. The optimal management of patients with antiviral-resistant HBV continues to evolve. The ideal approach is to prevent antiviral resistance through judicious use of antiviral therapy and the use of more potent antiviral agents, possibly in combination.

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“…A recent report suggests that switching from lamivudine to entecavir does not result in such hepatitis-like flares (8), but in that study, the definition of a flare was confined to patients with ALT elevations that were >2 × baseline and >10 × ULN; thus, flares ≤10 × ULN were not counted, although they were included in the adefovir trial cited above. Similarly, in the registration trials of lamivudine, posttreatment flares were defined as 2-fold and 3-fold ALT elevations over baseline; in short, posttreatment flares, defined differently in different trials, are not readily comparable.…”

Section: Entecavirmentioning

confidence: 99%

Looking to the Future: New Agents for Chronic Hepatitis B

Dienstag

2006

Am J Gastroenterology

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New antiviral agents are currently being developed to treat patients with chronic hepatitis B. Both pegylated interferon alfa-2a and entecavir are now approved for the treatment of hepatitis B while telbivudine, tenofovir, emtricitabine, and pegylated interferon alfa-2b are in clinical development. Successive advances have resulted in more profound suppression of hepatitis B replication, a reduction in breakthrough resistance, and an increase in the frequency of attainment of virologic, serologic, biochemical, and histologic clinical endpoints.

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428 Lamivudine-refractory hepatitis B patients can be safely switched directly to entecavir 1 mg daily therapy

Cited by 8 publications

References 0 publications

Viral Hepatitis and Liver Transplantation

Viral Hepatitis and Liver Transplantation

Management of Hepatitis B Patients with Antiviral Resistance

Looking to the Future: New Agents for Chronic Hepatitis B

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