Low-dose, titratable interferon alfa in decompensated liver disease caused by chronic infection with hepatitis B virus

Perrillo, Robert P.; Tamburro, Carlo H.; Regenstein, Fredric; Balart, Luis A.; Bodenheimer, Henry C.; Silva, Marcelo; Schiff, Eugene R.; Bodicky, Carol J.; Miller, Bess; Denham, Cheryl; Brodeur, Carmel; Roach, Kathy; Albrecht, Janice K.

doi:10.1016/0016-5085(95)90401-8

Cited by 180 publications

(109 citation statements)

References 8 publications

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“…29,30 Thus, it was reassuring to observe that nontransplanted patients in the current study often showed marked biochemical as well as virologic improvement. Furthermore, 1 patient clinically improved to the point that transplantation was no longer required.…”

Section: Discussionmentioning

confidence: 51%

A multicenter United States—Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B

Perrillo¹

2001

Hepatology

402

357

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Seventy-seven liver transplant candidates were enrolled in a multicenter study in which patients were treated with lamivudine (100 mg daily) without the adjunctive use of hepatitis B immune globulin. Treatment was begun while patients awaited liver transplantation and continued after transplantation. All were hepatitis B surface antigen (HBsAg) positive, and 61% had detectable hepatitis B e antigen (HBeAg) and HBV DNA when treatment was begun. Fortyseven underwent liver transplantation and 30 did not. Median study participation was 38 months (range, 2.7-48.5) in the transplanted patients and 26 months (range, 0.1-37) in the nontransplanted group. Twenty-five of 42 (60%) transplanted patients with 12 or more weeks of posttransplantation follow-up were HBsAg negative at the last study visit. At treatment week 156, 13 of 22 (59%) remained HBsAg negative, and all 9 reinfected patients were HBV-DNA positive before treatment. In the nontransplanted patients, HBeAg was initially detectable in 20 of 27 (74%) but this decreased to 3 of 17 (18%) after 104 weeks of treatment, and significant improvement in biochemical parameters was observed. HBV-DNA polymerase mutants were detected in 15 (21%) and 6 (20%) of the transplanted and nontransplanted patients, respectively. When compared with historical cohorts, lamivudine-treated patients appeared to have improved survival, and transplanted patients had a decrease in the rate of recurrent HBV infection. Lamivudine therapy was partially effective in preventing recurrent HBV infection when given before and after transplantation. Thus, future trials using a combination of HBIg and lamivudine are needed to assess the optimal prophylactic therapy. (HEPATOLOGY 2001;33:424-432.)

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Section: Discussionmentioning

confidence: 51%

A multicenter United States—Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B

Perrillo¹

2001

Hepatology

402

357

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“…5 Finally, preexisting hepatic decompensation resolved in 1 patient during lamivudine therapy; in contrast, among decompensated patients with hepatitis B, interferon therapy is rarely effective and associated with serious adverse effects. 16,17 Improvements in serum ALT levels accompanied prolonged HBV DNA suppression, and last-visit ALT levels were normal in all but 1 of the 9 patients who achieved a confirmed loss of HBeAg. As observed during previous trials, 3 before ultimate improvement in ALT, we observed transient ALT elevations, most commonly during weeks 8 to 24 of treatment, in approximately one third of patients.…”

Section: Discussionmentioning

confidence: 99%

Extended lamivudine retreatment for chronic hepatitis B: Maintenance of viral suppression after discontinuation of therapy

Dienstag¹,

Schiff²,

Mitchell³

et al. 1999

Hepatology

188

128

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In patients with chronic hepatitis B, brief lamivudine therapy suppresses hepatitis B virus (HBV) DNA but results infrequently in sustained losses of virus replication posttreatment. We evaluated treatment response and its posttreatment durability during up to 18 months of lamivudine therapy (100 mg/d) in 24 patients who had hepatitis B e antigen (HBeAg) despite 1 to 3 months of prior therapy. Therapy was to be stopped after HBeAg loss or seroconversion (acquisition of antibody to HBeAg); posttreatment monitoring continued for 6 months. During therapy, which was well tolerated, HBV DNA became undetectable in all evaluable patients, accompanied by reduced alanine transaminase (ALT) activity. The cumulative 18-month confirmed loss of HBeAg during therapy was 9 of 24 (38%) and seroconversion was 5 of 24 (21%). Therapy was discontinued after HBeAg loss/seroconversion in 7 patients, and Chronic hepatitis B virus (HBV) infection occurs in approximately 5% of the world' s population and is among the top 10 causes of death. Although interferon alfa has been approved as therapy for chronic hepatitis B, such treatment is suboptimal, yielding clinical benefit in a minority of patients. Lamivudine is an oral dideoxynucleoside that inhibits reverse transcription by causing chain termination of nascent viral DNA in human immunodeficiency virus (HIV) and HBV infection. 1 As reported previously, phase-II dose-ranging trials in North American and western European patients with chronic hepatitis B included daily doses of 5 to 600 mg administered for 1 to 6 months. 2-4 Therapy was well tolerated, doses of 100 mg or more suppressed serum HBV DNA levels consistently during therapy, and no significant advantage was identified for doses above 100 mg. 3,4 A sustained response posttreatment, however, defined as the loss of hepatitis B e antigen (HBeAg) and failure of HBV DNA to reappear after discontinuation of therapy, occurred in only 4% to 12% of patients in these dose-ranging studies. In a recently completed placebo-controlled phase-III trial involving 358 Chinese patients, Lai et al. 5 reported that 12 months of lamivudine therapy at a dose of 100 mg/d was associated with histological improvement in 67% of patients and HBeAg seroconversion in 16%, which is significantly better than response rates observed in concurrent placebo controls. This study in Asian patients, however, did not address treatmentstopping criteria; regardless of HBeAg status at the end of 12 months of therapy, all patients were enrolled in a continuingtreatment follow-up study. 5 In the present study, we wished to determine whether prolonged lamivudine therapy in Western patients would be safe and tolerable and result in loss of HBeAg and HBeAg seroconversion in a higher proportion of patients compared with the shorter dosing regimens studied previously. We also sought to determine whether lamivudine therapy could be withdrawn after HBeAg loss or HBeAg seroconversion. Therefore, we undertook an extended-treatment trial in previously Abbreviations: HBV, hepatitis...

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“…Dekompanse sirozu olan hastaların tedavisinde de yüksek potensli antiviraller yeğlenir. Düşük dozlarda bile hepatit alevlenmelerine ve infeksiyöz komplikasyonlara neden olabileceğin-den, dekompanse sirozlu hastalarda IFN kullanılmamalıdır (3,4). Dekompanse sirozu olan KHB hastalarında ölümlerin çoğunun tedavinin ilk 6 ayında meydana geldiği ve tedavi öncesindeki bilirübin, kreatinin ve HBV DNA düzeylerinin artmış olmasının yüksek risk faktörleri olduğu saptanmış-tır.…”

Section: Kompanse Ve Dekompanse Sirozlu Hastalarda Kronik Hepatit B Tunclassified

“…Koinfekte olguların tedavisine ilişkin eldeki veriler yetersizdir ve bu konuda kılavuz düzeyinde öneride bulunulamaz (4,5). Koinfekte hastaların bir bölümünde serum HBV DNA düzeyleri dalgalanmalar gösterir (6).…”

Section: Hbv Ve Hcv Koinfeksiyonunun Yönetimiunclassified

Management of Chronic Hepatitis in Special Hosts and Special Situations: A Consensus Report of the Study Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases

Mıstık¹,

Aydın²,

Aksoy³

et al. 2015

Klimik Dergisi

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ÖzetTürk Klinik Mikrobiyoloji ve İnfeksiyon Hastalıkları Derneği Viral Hepatit Çalışma Grubu, özel konaklarda ve özel durumlarda kronik hepatit yönetimine ilişkin bir uzlaşı raporu hazırlamak üzere bir toplantı düzenlemiştir. Raporda konuyla ilgili literatür ve uluslararası kılavuzlar, hepatit B virusu (HBV) için sırasıyla kompanse ve dekompanse sirozlu hastalarda kronik hepatit B (KHB) tedavisi, karaciğer nakli sonrası HBV infeksiyonunun nüks etmesinden korunma ve nüks gelişen hastalarda tedavi, fülminan hepatit B tedavisi, hemodiyaliz hastalarında KHB teda- AbstractStudy Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases convened a meeting to develop a consensus report on management of chronic hepatitis in special hosts and special situations. Relevant literature and international guidelines were reviewed, and recommendations agreed are presented at the end of each section such as therapy of chronic hepatitis B (CHB) in patients with compensated and decompensated cirrhosis, prevention and therapy of recurrent hepatitis B after liver transplantation, management of fulminant

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Low-dose, titratable interferon alfa in decompensated liver disease caused by chronic infection with hepatitis B virus

Cited by 180 publications

References 8 publications

A multicenter United States—Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B

A multicenter United States—Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B

Extended lamivudine retreatment for chronic hepatitis B: Maintenance of viral suppression after discontinuation of therapy

Management of Chronic Hepatitis in Special Hosts and Special Situations: A Consensus Report of the Study Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases

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