A Randomized, Controlled Trial of Combination Therapy for Chronic Hepatitis B: Comparing Pegylated Interferon-α2b and Lamivudine with Lamivudine Alone

Chan, Henry Lik‐Yuen; Leung, Nancy; Hui, Alex; Wong, Vincent Wai‐Sun; Liew, C. T.; Chim, Angel Mei‐Ling; Chan, Francis K.L.; Hung, Lawrence Cheung–Tsui; Lee, Yuk-Tong; Tam, John S.; Lam, Christopher Wai‐Kei; Sung, Joseph J.Y.

doi:10.7326/0003-4819-142-4-200502150-00006

Cited by 260 publications

(250 citation statements)

References 33 publications

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“…The development of pegylated IFNs with improved pharmacokinetics has been shown to yield a better efficacy and convenience than the conventional IFNs in the treatment of chronic hepatitis C. [41][42][43][44][45] Regarding the treatment of chronic hepatitis B, recent pilot trials also demonstrated that pegylated IFN was more effective than conventional IFN or other nucleotide/nucleoside analogues in either HBeAg-positive or -negative chronic hepatitis B. 8,10,15,25,45 Whether pegylated IFN-based therapy in combination with other antiviral agents such as ribavirin could enhance the treatment efficacy in patients with chronic hepatitis B awaits further clinical trials.…”

Section: Discussionmentioning

confidence: 99%

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Interferon α-2b with and without ribavirin in the treatment of hepatitis B e antigen–positive chronic hepatitis B: A randomized study

et al. 2006

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To study whether interferon (IFN) ␣ and ribavirin combination therapy has a beneficial effect for hepatitis B e antigen (HBeAg)-positive chronic hepatitis B, we enrolled 119 such patients in a randomized study. Fifty-nine patients received 5 million units of IFN-␣2b daily for 4 weeks followed by 5 million units three times a week for 28 weeks, plus 1,200 mg ribavirin daily. Sixty patients received the same dosage of IFN plus placebo. They were followed up for 24 weeks posttreatment, and 105 patients (88%) completed the entire course of 56 weeks. By intention-to-treat analysis, the rate of combined response (serum hepatitis B virus [HBV] DNA <2.5 pg/mL and HBeAg seroconversion) was 17% versus 25% between the IFN/ribavirin and IFN/placebo group, respectively, at the end of treatment (P ‫؍‬ .35) and 25% vs. 20% at the end of follow-up (P ‫؍‬ .32). Using quantitative real-time polymerase chain reaction assay, the log(10) reduction of serum HBV DNA was 1.05 ؎ 1.72 (mean ؎ SD) versus 1.29 ؎ 1.91 between the two groups at the end of treatment (P ‫؍‬ .49) and was 2.15 ؎ 2.15 versus 1.21 ؎ 2.48 at the end of follow-up (P ‫؍‬ .04). Prolonged observations in 83 patients suggested that the combined response was 29% (n ‫؍‬ 17) versus 20% (n ‫؍‬ 12) at 48 weeks after the end of treatment, respectively (P ‫؍‬ .17). The safety profile was similar, except that the IFN/ribavirin group had a higher risk of anemia (15% vs. 0%; P ‫؍‬ .002). In conclusion, for the treatment of HBeAg-positive chronic hepatitis B, adding ribavirin does not seem to increase the efficacy of IFN. (HEPATOLOGY 2006;43:742-749.)

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Section: Discussionmentioning

confidence: 99%

“…8,10,15,25,45 Whether pegylated IFN-based therapy in combination with other antiviral agents such as ribavirin could enhance the treatment efficacy in patients with chronic hepatitis B awaits further clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Interferon α-2b with and without ribavirin in the treatment of hepatitis B e antigen–positive chronic hepatitis B: A randomized study

et al. 2006

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“…PegIFN-a therapy results in HBeAg seroconversion rates of up to 32% and 48%, respectively, when assessed at weeks 24 and 48 post-treatment [43][44][45][46] and sustained after cessation of therapy in the majority (80-90%) of HBeAgpositive patients [47]. Baseline HBV and ALT levels are predictive factors for HBeAg seroconversion [47].…”

Section: Treatment-induced Hbeag Seroconversion and Disease Progressionmentioning

confidence: 99%

HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B

2009

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During the natural history of chronic hepatitis B virus (HBV) infection, the loss of serum hepatitis B e antigen (HBeAg) and the development of anti-HBe antibodies (HBeAg seroconversion) mark a transition from the immune-active phase of disease to the inactive carrier state. This review examines the evidence from natural history and cohort studies on the relationship between HBeAg seroconversion and disease progression. The role of HBeAg seroconversion as an important milestone in the management of HBeAg-positive patients with chronic hepatitis B (CHB), as well as the advantages and disadvantages of administering a finite course of therapy for HBeAg-positive CHB, is also discussed. The evidence from natural history and cohort studies indicates that spontaneous or treatment-induced HBeAg seroconversion is associated with lower rates of disease progression to cirrhosis and hepatocellular carcinoma, a potential of hepatitis B surface antigen seroconversion, and improved survival rates. Updated guidelines developed by major liver associations recommend stopping oral therapy for HBeAgpositive patients who achieve sustained HBeAg seroconversion with polymerase chain reaction-undetectable HBV-DNA on two separate occasions for 6 or more months apart, taking into consideration the individual's clinical and virologic response to therapy, as well as the severity of liver disease. Thus, early induction of HBeAg seroconversion with interferon-based therapy or oral nucleos(t)ide analogues has important clinical and socioeconomic implications for the management of CHB.

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“…62 One way to use the serum HBV-DNA as a predictor of response during treatment is to establish a withdrawal rule. In a combined post hoc analysis of two clinical trials using a combination of PEG-IFN alpha-2b and lamivudine in HBeAg-positive patients with chronic hepatitis B, 52,59 failure to decrease HBV-DNA to 10,000 copies/mL as early as in week 8 has a negative predictive value of 92% for SVR. 60 Based on the data of a randomized international study using PEG-IFN alpha-2a as monotherapy, a much higher cutoff, of 9 log copies/mL in week 24, was described as presenting a negative predictive value of 86% for sustained seroconversion of HBeAg.…”

Section: Serum Hbv-dnamentioning

confidence: 99%

“…59,67 In 26 HBeAg-positive patients that completed the combined treatment of PEG-IFN alpha-2b for 32 weeks and lamivudine for two years, a level of HBsAg < 1,500 UI/ mL presents 71% sensitivity and 84% specificity to predict SVR. 51 In an international study with PEG-IFN alpha-2a, in HBeAg patients, a level < 10 UI/mL in week 48 and decline during the treatment > 1 log UI/mL can predict a sustained disappearance of HBsAg three years after the use of PEG-IFN alpha-2a, with or without the concomitant use of lamivudine.…”

Section: Quantitative Hbsagmentioning

confidence: 99%

Response predictors to treatment with pegylated interferon in chronic hepatitis B

Ferreira

Tenore

2010

Braz J Infect Dis

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The clinical and epidemiological importance of chronic B hepatitis is currently unquestionable as a cause of end-stage liver disease and hepatocellular carcinoma. Recently, predictors of treatment response of this disease have been studied, both before and during the course of medication. Therapy stopping rules have been proposed, which may be useful in patients presenting poor treatment tolerance. This review discusses the treatment response predictors usefulness, with emphasis on ALT, quantitative HBsAg and HBeAg, quantitative HBV-DNA and HBV genotyp

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A Randomized, Controlled Trial of Combination Therapy for Chronic Hepatitis B: Comparing Pegylated Interferon-α2b and Lamivudine with Lamivudine Alone

Abstract: In patients with HBeAg-positive chronic hepatitis B, staggered combination treatment with pegylated interferon-alpha2b and lamivudine may lead to a higher rate of virologic response than lamivudine monotherapy.

Cited by 260 publications

References 33 publications

Interferon α-2b with and without ribavirin in the treatment of hepatitis B e antigen–positive chronic hepatitis B: A randomized study

Interferon α-2b with and without ribavirin in the treatment of hepatitis B e antigen–positive chronic hepatitis B: A randomized study

HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B

Response predictors to treatment with pegylated interferon in chronic hepatitis B

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