Anti-HBe-positive chronic hepatitis B with HBV-DNA in the serum response to a 6-month course of lymphoblastoid interferon

Pastore, Giuseppe; Santantonio, T.; Milella, Michele Stanislaw; Monno, Laura; Mariano, Natalie F.; Moschetta, R.; Pollice, L

doi:10.1016/0168-8278(92)90161-h

Cited by 105 publications

(59 citation statements)

References 17 publications

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“…The 12-month sustained response rates varied from 10% to 47% (average 24%) among the treated patients and 0% in the controls. [158][159][160][161] Neither pretreatment factors nor IFN-␣ dose was predictive of response but longer duration of treatment (12 vs. Ͻ6 months) was associated with a doubling of the sustained response rates. 1,162,163 A major problem with IFN-␣ treatment of HBeAg-negative chronic hepatitis B is relapse, approximately half of the responders relapse when therapy is discontinued, and relapses can occur up to 5 years post-therapy.…”

Section: Hbeag-negative Chronic Hepatitis Bmentioning

confidence: 99%

Chronic hepatitis B

2001

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PREAMBLEThese guidelines have been written to assist physicians and other health care providers in the recognition, diagnosis, and management of patients chronically infected with the hepatitis B virus (HBV). They are intended to suggest preferable approaches to the clinical management of chronic hepatitis B. The recommendations are flexible and are not intended as the only acceptable approach to management and treatment. As the appropriate course of treatment will vary in light of the relevant facts and circumstances surrounding each individual patient with chronic hepatitis B, guidelines are not intended to define the applicable standard of medical care and may be updated periodically as new information becomes available.These guidelines were developed under the auspices of, and approved by, the Practice Guidelines Committee of the American Association for the Study of Liver Diseases. They should be taken as guidelines and not "standards of care." Data used to support the recommendations made were obtained by a literature search of peer-reviewed articles concerning the natural history, diagnosis, and treatment of chronic hepatitis B. In addition, the proceedings of a recent National Institutes of Health workshop on the "Management of Hepatitis B" were considered in the development of these guidelines. 1 The strength of each recommendation is categorized based on the quality of evidence in the literature according to the rating system indicated in Table 1. 2

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Section: Hbeag-negative Chronic Hepatitis Bmentioning

confidence: 99%

Chronic hepatitis B

2001

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“…[4][5][6][7][8] Because the unfavorable outcome of hepatitis depends primarily on either persistent or intermittent reactivation of virus replication, 3,9,10 antiviral agents such as interferon and lamivudine are seen as the best options for preventing long-term sequelae of HBV infection. Short-term interferon therapy was almost invariably unable to suppress hepatitis B long term, 5,[11][12][13] and hepatitis frequently recurred on discontinuation of treatment, but treatments longer than 6 months seemed to provide more lasting antiviral effects. In a large study in Greece, 22% of the patients treated for 12 months had sustained virologic responses compared with 11% of those treated for only 6 months.…”

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Long-Term suppression of hepatitis B e antigen-negative chronic hepatitis B by 24-month interferon therapy

2003

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To assess whether extended treatment with interferon improves the outcome of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B, 101 consecutive patients were treated with 6 MU of interferon alfa 2b 3 times weekly for 24 months. During the 68-month study, 30 patients (30%) had a sustained response (i.e., normal serum transaminase levels and undetectable hepatitis B virus DNA by non-polymerase chain reaction [PCR] assays), and 15 cleared serum surface antigen. Twenty-five nonresponders, 16 relapsers, and 30 who discontinued treatment were considered treatment failures. Multivariate analysis predicted a sustained response for young age (odds ratio, 0.94; 95% confidence interval, 0.89-0.99; P ‫؍‬ .041) and high pretreatment serum levels of immunoglobulin M (IgM) anti-hepatitis B core antigen (HBc) (odds ratio, 4.52; 95% confidence interval, 1.63-12.5; P ‫؍‬ .004). Liver disease progressed in none of the sustained responders but in 16 with treatment failure (0% vs. 22%, P ‫؍‬ .002); hepatocellular carcinoma (HCC) developed with similar frequency in both groups (7%). Overall, estimated 8-year complication-free survival was longer for the 30 sustained responders than the 71 patients with treatment failure (90% vs. 60%, P < .001), but 8-year patient survival was similar in the 2 groups (100% and 90%). Short complicationfree survival was predicted by failure to respond to interferon (hazard ratio, 7.8; 95% confidence interval, 1.8-34.0; P ‫؍‬ .006) and high scores for liver fibrosis (hazard ratio, 1.71; 95% confidence interval, 1.17-2.50; P ‫؍‬ .005). In conclusion, 24 months of treatment with interferon alfa 2b led to sustained disease suppression in a significant proportion of patients with HBeAg-negative chronic hepatitis B. (HEPATOLOGY 2003;37:756-763.)

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“…8,10,19,20 Other studies have shown higher on-treatment and sustained response rates. [30][31][32] Sustained response to lamivudine posttreatment is currently under evaluation.…”

Section: Discussionmentioning

confidence: 99%

“…17,18 Several studies have shown that the presence of precore mutations correlates with suboptimal responses to interferon therapy and is associated with a high rate of relapse. 8,10,19,20 Furthermore, alfa-interferon must be given by subcutaneous injection and has potentially doselimiting side effects. Therefore, there is clearly a need to evaluate alternative therapies for this group of chronic hepatitis B patients.…”

mentioning

confidence: 99%

Efficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis befficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis befficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis befficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-posi

et al. 1999

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This placebo controlled, double-blind study evaluated the efficacy and safety of lamivudine in patients with hepatitis B e antigen (HBeAg)-negative/hepatitis B virus (HBV) DNA-positive chronic hepatitis B. Patients were randomized to receive 100 mg lamivudine orally once daily for 52 weeks (n ‫؍‬ 60) or placebo for 26 weeks (n ‫؍‬ 65). Patients who were HBV DNA positive at week 24 were withdrawn at week 26. The primary efficacy endpoint was loss of serum HBV DNA plus normalization of alanine transaminase (ALT) at week 24. A significantly higher proportion of patients receiving lamivudine (63%) had a complete response at week 24 compared with patients receiving placebo (6%) (P F .001). Secondary efficacy parameters included histological response from baseline to week 52 in the lamivudine-treated patients. At week 52, 60% of lamivudine-treated patients with liver biopsy specimens available showed histological improvement (H2-point reduction in Knodell necro-inflammatory score), 29% showed no change, and 12% worsened. In a ranked assessment of pretreatment and post-treatment biopsy pairs 11% improved, 86% showed no change, and 2% worsened in fibrosis. At week 52, 27% of patients receiving lamivudine had YMDD (tyrosine-methionine-aspartate-aspartate amino acid motif of HBV polymerase) variant HBV. The incidence of adverse events and laboratory abnormalities was similar in both groups. In conclusion, lamivudine treatment results in a significant virological and biochemical improvement compared with placebo, induces an improvement or no change in histology in most patients, and is well tolerated. The response to lamivudine therapy in HBeAg-negative patients is similar to the response reported in previous studies of patients with HBeAg-positive chronic hepatitis B. (HEPATOLOGY 1999;29:889-896.)

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Anti-HBe-positive chronic hepatitis B with HBV-DNA in the serum response to a 6-month course of lymphoblastoid interferon

Cited by 105 publications

References 17 publications

Chronic hepatitis B

Chronic hepatitis B

Long-Term suppression of hepatitis B e antigen-negative chronic hepatitis B by 24-month interferon therapy

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