Addition of PEG‐interferon to long‐term nucleos(t)ide analogue therapy enhances HBsAg decline and clearance in HBeAg‐negative chronic hepatitis B: Multicentre Randomized Trial (PAS Study).
| Title: | Addition of PEG‐interferon to long‐term nucleos(t)ide analogue therapy enhances HBsAg decline and clearance in HBeAg‐negative chronic hepatitis B: Multicentre Randomized Trial (PAS Study). |
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| Authors: | Farag, Mina S., van Campenhout, Margo J. H., Sonneveld, M. J., Fung, Scott, van Erpecum, Karel J., Wong, David K., Verhey, Elke, de Man, Robert, De Knegt, Robert J., Brouwer, Johannes T., Baak, Hubertus C., Feld, Jordan J., Liem, Kin Seng, Boonstra, André, Hansen, Bettina E., Janssen, Harry L. A. |
| Source: | Journal of Viral Hepatitis; Apr2024, Vol. 31 Issue 4, p197-207, 11p |
| Subject Terms: | CHRONIC hepatitis B, IMMUNOREGULATION |
| Geographic Terms: | CANADA |
| Abstract: | We studied whether 48 weeks of PEG‐IFN alfa‐2a add‐on increases HBsAg‐decline and clearance in HBeAg‐negative patients on long‐term nucleo(s)tide analogue (NA) therapy. In this investigator‐initiated, randomized, controlled trial conducted in Europe and Canada, HBeAg‐negative patients treated with NA > 12 months, with HBVDNA < 200 IU/mL, were enrolled. Patients were randomized 2:1 to 48 weeks of PEG‐IFN alfa‐2a add‐on (180 μg per week) or continued NA‐monotherapy with subsequent follow‐up to Week 72. Endpoints were HBsAg decline (≥1 log10 IU/mL) and HBsAg clearance at Week 48. Of the 86 patients in the modified‐intention‐to‐treat analysis, 58 patients received PEG‐IFN add‐on, and 28 continued NA monotherapy. At Week 48, 16(28%) patients achieved HBsAg decline ≥1 log10 in the add‐on arm versus none on NA‐monotherapy (p <.001), and HBsAg clearance was observed in 6 (10%) PEG‐IFN add‐on patients versus 0% NA‐monotherapy (p =.01). HBVRNA was only detected in 2% after PEG‐IFN treatment versus 19% in NA‐monotherapy (p =.002) at Week 48. PEG‐IFN add‐on therapy was well tolerated in majority of patients. Low baseline HBsAg levels (<10 IU/mL) identified patients most likely to achieve HBsAg loss with PEG‐IFN add‐on, whereas an HBsAg level > 200 IU/mL at on‐treatment Week 12 was highly predictive of non‐response (NPV = 100%). Addition of PEG‐IFN to long‐term NA enhanced HBsAg decline and increased the chance of HBsAg clearance in HBeAg‐negative patients on long‐term NA. On‐treatment HBsAg levels >200 IU/mL identify patients unlikely to benefit from PEG‐IFN add‐on and could be used as a potential stopping‐rule for PEG‐IFN therapy. Our findings support further exploration of immune modulation add‐on to antiviral therapy, preferably using response‐guided strategies, to increase functional cure rates in patients with CHB. [ABSTRACT FROM AUTHOR] |
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| Database: | Complementary Index |
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| Header | DbId: edb DbLabel: Complementary Index An: 176078334 RelevancyScore: 1023 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 1022.78845214844 |
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| Items | – Name: Title Label: Title Group: Ti Data: Addition of PEG‐interferon to long‐term nucleos(t)ide analogue therapy enhances HBsAg decline and clearance in HBeAg‐negative chronic hepatitis B: Multicentre Randomized Trial (PAS Study). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Farag%2C+Mina+S%2E%22">Farag, Mina S.</searchLink><br /><searchLink fieldCode="AR" term="%22van+Campenhout%2C+Margo+J%2E+H%2E%22">van Campenhout, Margo J. H.</searchLink><br /><searchLink fieldCode="AR" term="%22Sonneveld%2C+M%2E+J%2E%22">Sonneveld, M. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Fung%2C+Scott%22">Fung, Scott</searchLink><br /><searchLink fieldCode="AR" term="%22van+Erpecum%2C+Karel+J%2E%22">van Erpecum, Karel J.</searchLink><br /><searchLink fieldCode="AR" term="%22Wong%2C+David+K%2E%22">Wong, David K.</searchLink><br /><searchLink fieldCode="AR" term="%22Verhey%2C+Elke%22">Verhey, Elke</searchLink><br /><searchLink fieldCode="AR" term="%22de+Man%2C+Robert%22">de Man, Robert</searchLink><br /><searchLink fieldCode="AR" term="%22De Knegt%2C+Robert+J%2E%22">De Knegt, Robert J.</searchLink><br /><searchLink fieldCode="AR" term="%22Brouwer%2C+Johannes+T%2E%22">Brouwer, Johannes T.</searchLink><br /><searchLink fieldCode="AR" term="%22Baak%2C+Hubertus+C%2E%22">Baak, Hubertus C.</searchLink><br /><searchLink fieldCode="AR" term="%22Feld%2C+Jordan+J%2E%22">Feld, Jordan J.</searchLink><br /><searchLink fieldCode="AR" term="%22Liem%2C+Kin+Seng%22">Liem, Kin Seng</searchLink><br /><searchLink fieldCode="AR" term="%22Boonstra%2C+André%22">Boonstra, André</searchLink><br /><searchLink fieldCode="AR" term="%22Hansen%2C+Bettina+E%2E%22">Hansen, Bettina E.</searchLink><br /><searchLink fieldCode="AR" term="%22Janssen%2C+Harry+L%2E+A%2E%22">Janssen, Harry L. A.</searchLink> – Name: TitleSource Label: Source Group: Src Data: Journal of Viral Hepatitis; Apr2024, Vol. 31 Issue 4, p197-207, 11p – Name: Subject Label: Subject Terms Group: Su Data: <searchLink fieldCode="DE" term="%22CHRONIC+hepatitis+B%22">CHRONIC hepatitis B</searchLink><br /><searchLink fieldCode="DE" term="%22IMMUNOREGULATION%22">IMMUNOREGULATION</searchLink> – Name: SubjectGeographic Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22CANADA%22">CANADA</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: We studied whether 48 weeks of PEG‐IFN alfa‐2a add‐on increases HBsAg‐decline and clearance in HBeAg‐negative patients on long‐term nucleo(s)tide analogue (NA) therapy. In this investigator‐initiated, randomized, controlled trial conducted in Europe and Canada, HBeAg‐negative patients treated with NA > 12 months, with HBVDNA < 200 IU/mL, were enrolled. Patients were randomized 2:1 to 48 weeks of PEG‐IFN alfa‐2a add‐on (180 μg per week) or continued NA‐monotherapy with subsequent follow‐up to Week 72. Endpoints were HBsAg decline (≥1 log10 IU/mL) and HBsAg clearance at Week 48. Of the 86 patients in the modified‐intention‐to‐treat analysis, 58 patients received PEG‐IFN add‐on, and 28 continued NA monotherapy. At Week 48, 16(28%) patients achieved HBsAg decline ≥1 log10 in the add‐on arm versus none on NA‐monotherapy (p <.001), and HBsAg clearance was observed in 6 (10%) PEG‐IFN add‐on patients versus 0% NA‐monotherapy (p =.01). HBVRNA was only detected in 2% after PEG‐IFN treatment versus 19% in NA‐monotherapy (p =.002) at Week 48. PEG‐IFN add‐on therapy was well tolerated in majority of patients. Low baseline HBsAg levels (<10 IU/mL) identified patients most likely to achieve HBsAg loss with PEG‐IFN add‐on, whereas an HBsAg level > 200 IU/mL at on‐treatment Week 12 was highly predictive of non‐response (NPV = 100%). Addition of PEG‐IFN to long‐term NA enhanced HBsAg decline and increased the chance of HBsAg clearance in HBeAg‐negative patients on long‐term NA. On‐treatment HBsAg levels >200 IU/mL identify patients unlikely to benefit from PEG‐IFN add‐on and could be used as a potential stopping‐rule for PEG‐IFN therapy. Our findings support further exploration of immune modulation add‐on to antiviral therapy, preferably using response‐guided strategies, to increase functional cure rates in patients with CHB. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of Journal of Viral Hepatitis is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1111/jvh.13918 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 11 StartPage: 197 Subjects: – SubjectFull: CANADA Type: general – SubjectFull: CHRONIC hepatitis B Type: general – SubjectFull: IMMUNOREGULATION Type: general Titles: – TitleFull: Addition of PEG‐interferon to long‐term nucleos(t)ide analogue therapy enhances HBsAg decline and clearance in HBeAg‐negative chronic hepatitis B: Multicentre Randomized Trial (PAS Study). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Farag, Mina S. – PersonEntity: Name: NameFull: van Campenhout, Margo J. H. – PersonEntity: Name: NameFull: Sonneveld, M. J. – PersonEntity: Name: NameFull: Fung, Scott – PersonEntity: Name: NameFull: van Erpecum, Karel J. – PersonEntity: Name: NameFull: Wong, David K. – PersonEntity: Name: NameFull: Verhey, Elke – PersonEntity: Name: NameFull: de Man, Robert – PersonEntity: Name: NameFull: De Knegt, Robert J. – PersonEntity: Name: NameFull: Brouwer, Johannes T. – PersonEntity: Name: NameFull: Baak, Hubertus C. – PersonEntity: Name: NameFull: Feld, Jordan J. – PersonEntity: Name: NameFull: Liem, Kin Seng – PersonEntity: Name: NameFull: Boonstra, André – PersonEntity: Name: NameFull: Hansen, Bettina E. – PersonEntity: Name: NameFull: Janssen, Harry L. A. IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 04 Text: Apr2024 Type: published Y: 2024 Identifiers: – Type: issn-print Value: 13520504 Numbering: – Type: volume Value: 31 – Type: issue Value: 4 Titles: – TitleFull: Journal of Viral Hepatitis Type: main |
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