Add-on PD-1 inhibitor with Peg-IFNα therapy favors functional cure of chronic hepatitis B patients.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
33 patients and the Peg-IFNα group included 31 patients.
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[CONCLUSIONS] Quarterly sintilimab add-on therapy triples the short-term HBsAg clearance rate in interferon-refractory CHB without major additional toxicity. A week-12 ALT surge and elevated OAS1 may serve as early biomarkers of response, but confirmation in larger randomized trials is needed.
[BACKGROUND AND OBJECTIVES] The treatment options for hepatitis B surface antigen (HBsAg) clearance are limited for patients who have failed pegylated interferon-α (Peg-IFNα) therapy.
- 연구 설계 randomized controlled trial
APA
Li Y, Liu C, et al. (2026). Add-on PD-1 inhibitor with Peg-IFNα therapy favors functional cure of chronic hepatitis B patients.. Journal of translational internal medicine, 14(1), 123-133. https://doi.org/10.1515/jtim-2026-0018
MLA
Li Y, et al.. "Add-on PD-1 inhibitor with Peg-IFNα therapy favors functional cure of chronic hepatitis B patients.." Journal of translational internal medicine, vol. 14, no. 1, 2026, pp. 123-133.
PMID
41727963 ↗
Abstract 한글 요약
[BACKGROUND AND OBJECTIVES] The treatment options for hepatitis B surface antigen (HBsAg) clearance are limited for patients who have failed pegylated interferon-α (Peg-IFNα) therapy. Given preclinical evidence that PD-1 blockade boosts antiviral immunity, this study aims to evaluate the efficacy and safety of PD-1 inhibitors in chronic hepatitis B (CHB) patients who have failed interferon therapy.
[METHODS] This non-randomized controlled trial was conducted in CHB patients who failed to achieve HBsAg clearance after 48 weeks of Peg-IFNα therapy. Including two groups: (i) a PD-1 inhibitor plus Peg-IFNα group receiving sintilimab 1 mg/kg/12 weeks plus Peg-IFNα 180 μg/week ( = 33) or (ii) a Peg-IFNα group continuing Peg-IFNα therapy ( = 31). The primary endpoint was HBsAg clearance at week 24.
[RESULTS] The PD-1 inhibitor plus Peg-IFNα group included 33 patients and the Peg-IFNα group included 31 patients. At week 24, HBsAg clearance occurred in 30.3% of PD-1 inhibitor plus Peg-IFNα group 9.7% of Peg-IFNα group ( = 0.047). Median HBsAg declined by -0.916 log IU/mL in the PD-1 inhibitor plus Peg-IFNα group compared with -0.067 log IU/mL in Peg-IFNα group ( = 0.013). In the PD-1 inhibitor plus Peg-IFNα group, alanine transaminase (ALT) rose transiently at week 12 only among patients who ultimately cleared HBsAg. Sintilimab increased stomatitis (12.1%) and recurrent fever (36.4%), but the frequency of grade ≥ 3 adverse events did not differ from Peg-IFNα group. Enzyme-linked immunosorbent assay (ELISA) profiling showed progressive induction of ISG15 after sintilimab, and patients achieving HBsAg clearance displayed higher baseline and week-12 OAS1 concentrations than non-clearers (both < 0.05).
[CONCLUSIONS] Quarterly sintilimab add-on therapy triples the short-term HBsAg clearance rate in interferon-refractory CHB without major additional toxicity. A week-12 ALT surge and elevated OAS1 may serve as early biomarkers of response, but confirmation in larger randomized trials is needed.
[METHODS] This non-randomized controlled trial was conducted in CHB patients who failed to achieve HBsAg clearance after 48 weeks of Peg-IFNα therapy. Including two groups: (i) a PD-1 inhibitor plus Peg-IFNα group receiving sintilimab 1 mg/kg/12 weeks plus Peg-IFNα 180 μg/week ( = 33) or (ii) a Peg-IFNα group continuing Peg-IFNα therapy ( = 31). The primary endpoint was HBsAg clearance at week 24.
[RESULTS] The PD-1 inhibitor plus Peg-IFNα group included 33 patients and the Peg-IFNα group included 31 patients. At week 24, HBsAg clearance occurred in 30.3% of PD-1 inhibitor plus Peg-IFNα group 9.7% of Peg-IFNα group ( = 0.047). Median HBsAg declined by -0.916 log IU/mL in the PD-1 inhibitor plus Peg-IFNα group compared with -0.067 log IU/mL in Peg-IFNα group ( = 0.013). In the PD-1 inhibitor plus Peg-IFNα group, alanine transaminase (ALT) rose transiently at week 12 only among patients who ultimately cleared HBsAg. Sintilimab increased stomatitis (12.1%) and recurrent fever (36.4%), but the frequency of grade ≥ 3 adverse events did not differ from Peg-IFNα group. Enzyme-linked immunosorbent assay (ELISA) profiling showed progressive induction of ISG15 after sintilimab, and patients achieving HBsAg clearance displayed higher baseline and week-12 OAS1 concentrations than non-clearers (both < 0.05).
[CONCLUSIONS] Quarterly sintilimab add-on therapy triples the short-term HBsAg clearance rate in interferon-refractory CHB without major additional toxicity. A week-12 ALT surge and elevated OAS1 may serve as early biomarkers of response, but confirmation in larger randomized trials is needed.
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