Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial

Bárbaro, Giuseppe; Zechini, F; Pellicelli, A.; Francavilla, Ruggiero; Scotto, Gaetano; Bacca, D.; Bruno, Marcello; Babudieri, Sergio; Annese, Mauro; Matarazzo, Filippo; Stefano, Gabriele Di; Barbarini, Giorgio

doi:10.1016/s0168-8278(01)00145-3

Cited by 111 publications

(75 citation statements)

References 17 publications

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“…In fact, 1 of the 16 patients who were continued on lamivudine developed severe acute hepatitis by virological breakthrough, and he was treated successfully with interferon. Synergetic effects of lamivudine and interferon, which have distinct pharmacological activities, have been reported [18]. It is necessary that the care given by the attending doctor is thorough so that hepatitis flares are not missed and immediate treatment can be given if required.…”

Section: Discussionmentioning

confidence: 99%

Continued Lamivudine Therapy in Patients with Chronic Hepatitis B

Kumada¹

2003

Intervirology

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From September 1995 through April 2002, 286 patients with chronic hepatitis B were started on lamivudine at the Toranomon Hospital in Tokyo, Japan, and most of them continued with it. At present, 16 patients received lamivudine for 5 years, 7 of whom for 7 years or longer. YMDD mutants increased gradually and developed in 69% of them during the 7 years on lamivudine. Biochemical and virological responses were achieved in 9 of the 16 patients (56%) at 5 years, and in 4 of the 7 patients (57%) at 7 years. Histological assessments were performed at 3 years in the 16 patients and further at 4 and 7 years in the 7 patients. Necroinflammatory changes improved remarkably with a decrease in the total histological activity score from 11.3 ± 3.0 to 4.1 ± 1.7 (p < 0.0001) at 3 years in the 16 patients. Histological improvements continued in 4 of the 7 patients (57%) at 7 years on lamivudine, while the pathology was unchanged in 2 patients (29%) and aggravated in the remaining 1 patient (14%). Severe acute exacerbation of hepatitis developed in 1 patient, who received additional interferon-α therapy to cope with it. Based on my experience, the continuation of lamivudine in patients with chronic hepatitis B benefits approximately two thirds of them with persistent virological and biochemical responses accompanied by histological improvements. Breakthrough hepatitis induced by YMDD mutants along the way in a small number of patients needs to be diagnosed promptly by regular monitoring for transaminases and, if it develops, it can be treated with interferon or other antiviral agents.

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Section: Discussionmentioning

confidence: 99%

Continued Lamivudine Therapy in Patients with Chronic Hepatitis B

Kumada¹

2003

Intervirology

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“…HBeAg seroconversion rates were higher (29-33%) in patients receiving the combination than either drug alone (15-18%) [20,82] . Histological improvement was seen in 46 and 27% of patients, respectively.…”

Section: Combination Therapymentioning

confidence: 95%

Established and Emerging Therapies for the Treatment of Viral Hepatitis

Forton¹,

Karayiannis²

2006

Dig Dis

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Patients who are chronically infected with either hepatitis B or C viruses run the risk of developing cirrhosis and hepatocellular carcinoma in later life. Antiviral treatment offers the only means of interrupting this progression. To date, recombinant interferon alpha and the nucleos(t)ide analogues lamivudine and adefovir dipivoxil are the only licensed drugs for the treatment of chronic hepatitis B, whilst recombinant or pegylated interferons in combination with ribavirin are the ones used for chronic hepatitis C virus infections. The efficacy of these treatments, reasons for treatment failure, drug resistance and future options are discussed in the present review.

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“…Em pacientes HBeAg positivo, em um ano de tratamento, ocorreu soroconversão HBeAg (8%-44% vs. 11%-12%) com manutenção, na maioria dos estudos, dessa soroconversão após dois anos de tratamento em pacientes que não desenvolveram resistência ao medicamento 23,24,25,26,27,28,29 . A soroconversão HBeAg foi maior naqueles pacientes com níveis elevados de ALT no pré-tratamento (ALT > 5 vezes o limite normal superior (42% vs. 12%) 23 .…”

Section: Lamunclassified

“…Modelos multivariados demonstraram que os níveis de ALT no pré-tratamento (p < 0,001) e o índice de atividade histológica (p < 0,001) foram considerados um importante marcador de prognóstico de queda do HBeAg em asiáticos e caucasianos 23 . Soroconversão de DNA do HBV variaram de 10%-37% vs. 16% e maiores reduções também foram referenciadas com níveis mais elevados de ALT no pré-tratamento 27,29 . Soroconversão HBsAg ocorreu em 20% dos pacientes, após um ano de tratamento 26 .…”

Section: Lamunclassified

“…Melhorias histológicas em torno de 59% também foram referidas, após um ano de tratamento considerando-se acréscimo igual ou superior a dois pontos nos escores de Knodell em necroinflamação 27 . Resistência com mutação YMDD foi percebida em 12%-57% dos pacientes tratados por até dois anos 24,27,28,29,31,32 . Identificou-se no seguimento desenvolvimento progressivo da resistência em período acima de quatro anos (71%-76%) 24,26 .…”

Section: Lamunclassified

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Revisão sistemática da eficácia do interferon alfa (convencional, peguilado) e lamivudina para o tratamento da hepatite crônica B

et al. 2009

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Chronic hepatitis B is considered a major public health problem, and its treatment entails increasing health budget expenses with high-cost drugs covered by Unified NationalHealth System. The objective of this study was to compare the efficacy of interferon (conventional; IntroduçãoA hepatite crônica B constitui um grave problema de saúde pública, pois afeta mais de 400 milhões de pessoas no mundo, sendo contabilizado mais de um milhão de mortes anualmente 1 . Esses pacientes apresentam risco aumentado de desenvolvimento de cirrose, hepatite descompensada e carcinoma hepatocelular 2 . O objetivo do tratamento é alcançar a supressão contínua da replicação do vírus da hepatite B (HBV) e remissão da doença do fígado 3 .O tratamento para hepatite B depende de vá-rios fatores, como o estágio da doença, a presença ou ausência do antígeno "e", o potencial de resistência ao medicamento e a subseqüente incapacidade de utilização de um medicamento, em particular nos estágios finais da doença crônica do fígado. Esses e outros fatores são importantes para avaliar o momento de início de tratamento, o tipo de tratamento indicado e sua duração 4 .Entre as alternativas medicamentosas preconizadas nos protocolos clínicos e diretrizes terapêuticas para medicamentos excepcionais do Ministério da Saúde 5 , o interferon alfa 2a e interferon alfa 2b (IFN 2a e 2b) tem sido utilizados, por muitos anos, como primeira escolha de tratamento com baixos níveis de HBV do DNA, altos níveis de alanina amino transferase (ALT) e com biópsia hepática ativa. A meta do tratamento é ativar resposta imunológica em termos de soroconversão HBeAg, queda ou negativação REVISÃO REVIEW

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Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial

Cited by 111 publications

References 17 publications

Continued Lamivudine Therapy in Patients with Chronic Hepatitis B

Continued Lamivudine Therapy in Patients with Chronic Hepatitis B

Established and Emerging Therapies for the Treatment of Viral Hepatitis

Revisão sistemática da eficácia do interferon alfa (convencional, peguilado) e lamivudina para o tratamento da hepatite crônica B

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