Validation of a stopping rule at week 12 using HBsAg and HBV DNA for HBeAg-negative patients treated with peginterferon alfa-2a

Rijckborst, Vincent; Hansen, Bettina E.; Ferenci, Péter; Brunetto, Maurizia Rossana; Tabak, Fehmı; Çakalǒglu, Yılmaz; Lanza, A; Messina, Vito; Iannacone, Claudio; Massetto, Benedetta; Regep, Loredana; Colombo, Massimo; Janssen, Harry L.A.; Lampertico, Pietro

doi:10.1016/j.jhep.2011.12.007

Cited by 156 publications

(156 citation statements)

References 25 publications

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“…In the present study we evaluated HBsAg levels in the selected group of HBeAg-negative patients who did not fulfill the "stopping rule" at week-12 of Peg-IFN therapy (16). Our results confirmed the beneficial effect that could be achieved by applying the discussed stopping rule in the management of HBeAg-negative patients during standard Peg-IFN therapy.…”

Section: Discussionsupporting

confidence: 70%

“…The optimal on-treatment HBsAg cut off level that predicts response in HBeAg-positive patients is probably 1500 IU/ml at treatment week-12 or 24 (13,14). In contrast, an absence of any HBsAg decline together with <2 log reduction in HBV DNA at week-12 was proposed as a stopping rule in HBeAg-negative patients, including those with HBV genotype D infectionresponse guided therapy (15,16).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

HBsAg-guided extension of Peg-IFN therapy in HBeAg-negative responders

Nikolova¹,

Jelev²,

Antonov³

et al. 2015

MedInform

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Background: The ideal treatment end point in the management of patients with chronic HBV infection is loss of HBsAg. It could be achieved only in a few cases, especially in HBeAg -negative patients. The aim of the present study was to evaluate serum HBsAg levels in HBeAg-negative Bulgarian patients responding to the standard therapy with Peg-IFN as an attempt to navigate treatment duration according to the on-treatment HBsAg decline and appearance of anti-HBs. Methods: Twelve patients with HBeAg-negative chronic hepatitis B were studied. Subjects were treated with Peg-IFN alfa-2a. None of the studied patients fulfilled the "stopping rule" at the 3rd month of Peg-IFN therapy. Results: In 7/12 patients there was a sharp decline of the HBsAg levels with more than 90% reduction at treatment week-48 (and the levels were <100 IU/ml) and serum HBV DNA was undetectable. In 4 of these patients the therapy was extended for more than 48-weeks. HBsAg-loss was observed in two of them, which occurred at treatment week-48 and week-72, respectively. HBsAg-loss was associated with the development of anti-HBs (>100 IU/L) at treatment week-72 in these patients. In the 3rd patient an anti-HBs titer of 6-10 IU/L was detected at treatment week-72 and after that (96 week). In the 4th patient there was anti-HBs at week-108 (26 IU/L). Conclusion: Extension of Peg-IFN treatment is reasonable in patients who demonstrated a sharp HBsAg decline during the standard 48-week therapy. Probably, subjects with HBsAg level < 100 IU/ml will mostly gain from prolongation of Peg-IFN. In these cases we propose the term "extended rule".

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Section: Discussionsupporting

confidence: 70%

Section: Introductionmentioning

confidence: 99%

HBsAg-guided extension of Peg-IFN therapy in HBeAg-negative responders

Nikolova¹,

Jelev²,

Antonov³

et al. 2015

MedInform

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“…This stopping rule would allow approximately 20% of patients to discontinue PegIFNa. 1,117,118 No robust on-treatment stopping rules have been developed for HBeAg-negative CHB patients with genotype B or C and very few data are available for those with genotype A and E. 118 Some studies have also looked for Table 6. Cross-resistance data for the most frequent resistant HBV variants.…”

Section: 114mentioning

confidence: 99%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

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“…According to this rule, we can identify early, with a NPV of 100%, all CHB, HBeAg-negative, genotype D patients who will not achieve sustained response at 48 or 96 weeks of treatment with Peg-IFN α-2a [30]. A less than 10% decline of HBsAg levels at 12 weeks for patients with nongenotype D infections and at 24 weeks for genotype D has been shown to be associated with 16% probability of treatment response at 1 year posttherapy [31].…”

Section: Response-guided Therapy Based On Serum Hbsag and Hbv Dna Kinmentioning

confidence: 99%

Response-Guided Therapy Based on the Combination of Quantitative HBsAg and HBV DNA Kinetics in Chronic Hepatitis B Patients

Gheorghiță¹,

Căruntu²

2017

Advances in Treatment of Hepatitis C and B

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Chronic hepatitis B (CHB) remains a difficult-to-treat disease because no current treatments provide an optimal virological and immunological control, there is a high rate of relapse following any antiviral therapy, and there are no identified clinical useful treatment stopping rules, especially in hepatitis B e antigen (HBeAg)-negative patients treated with nucleoside or nucleotide analogues (NUCs). Taking into account the limited options of antiviral drugs, the response-guided therapy seems to be the best approach for optimization of treatment response. Hepatitis B surface antigen (HBsAg) can be considered a surrogate marker of HBV immune control during antiviral therapy, regardless of virological response reflected by serum HBV DNA. Thus, the decrease of HBV DNA level represents a reduction of viral replication, while serum HBsAg decline signifies a reduction of messenger RNA translation. The most important on-treatment predictors of the antiviral treatment response, especially Peg-IFN α-2a, are the quantitative HBsAg and HBV DNA evolution during therapy. A combination of no HBsAg decline and <2 log10 IU/mL decrease of HBV DNA seems to be a predictor of nonresponse in European HBeAg-negative patients with genotype D. The reduction of HBsAg levels during NUCs treatment in HBeAg-positive patients may identify cases with subsequent HBeAg or HBsAg loss.

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Validation of a stopping rule at week 12 using HBsAg and HBV DNA for HBeAg-negative patients treated with peginterferon alfa-2a

Cited by 156 publications

References 25 publications

HBsAg-guided extension of Peg-IFN therapy in HBeAg-negative responders

HBsAg-guided extension of Peg-IFN therapy in HBeAg-negative responders

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Response-Guided Therapy Based on the Combination of Quantitative HBsAg and HBV DNA Kinetics in Chronic Hepatitis B Patients

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