دورية أكاديمية
JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analog suppressed patients with chronic hepatitis B : REEF-2
| العنوان: | JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analog suppressed patients with chronic hepatitis B : REEF-2 |
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| المؤلفون: | Agarwal, Kosh, Buti, Maria, van Bömmel, Florian, Lampertico, Pietro, Janczewska, Ewa, Bourliere, Marc, Vanwolleghem, Thomas, Lenz, Oliver, Verbinnen, Thierry, Kakuda, Thomas N., Mayer, Cristiana, Jezorwski, John, Muenz, Daniel, Beumont, Maria, Kalmeijer, Ronald, Biermer, Michael, Lonjon-Domanec, Isabelle |
| المصدر: | 0168-8278 ; Journal of hepatology |
| سنة النشر: | 2024 |
| المجموعة: | IRUA - Institutional Repository van de Universiteit Antwerpen |
| مصطلحات موضوعية: | Human medicine |
| الوصف: | Background & Aims Functional cure (FC) for chronic hepatitis B (CHB) requires finite treatment. Two agents under investigation aimed at achieving FC are small interfering RNA JNJ-73763989 (JNJ-3989) and capsid assembly modulator JNJ-56136379 (JNJ-6379; bersacapavir). Methods REEF-2, a phase 2b, double-blind, placebo-controlled, randomized study (ClinicalTrials.gov Identifier: NCT04129554), enrolled 130 nucleos(t)ide analog (NA)–suppressed hepatitis B e-antigen (HBeAg)–negative CHB patients who received JNJ-3989 (200 mg subcutaneously every 4 weeks)+JNJ-6379 (250 mg oral daily)+NA (oral daily; active arm) or placebos for JNJ-3989 and JNJ-6379 + active NA (control arm) for 48 weeks followed by 48 weeks off-treatment follow-up. Results At Follow-up Week 24, no patients achieved the primary endpoint of FC (off-treatment hepatitis B surface antigen [HBsAg] seroclearance). No patients achieved FC at Follow-up Week 48. There was pronounced on-treatment reduction in mean HBsAg from baseline at Week 48 in the active arm versus no decline in the control arm (1.89 vs 0.06 log10 IU/mL; P = 0.001). At Follow-up Week 48, reductions from baseline were >1 log10 IU/mL in 81.5% versus 12.5% of patients in the active and control arms, respectively, and 38/81 (46.9%) patients in the active arm achieved HBsAg <100 IU/mL versus 6/40 (15.0%) patients in the control arm. Off-treatment HBV DNA relapse and alanine aminotransferase (ALT) increases were less frequent in the active arm with 7/77 (9.1%) and 11/41 (26.8%) patients in the active and control arms, respectively, restarting NA during follow-up. Conclusions Finite 48-week treatment with JNJ-3989+JNJ-6379+NA resulted in fewer and less severe posttreatment HBV DNA increases and ALT flares, and a higher proportion of patients with off-treatment HBV DNA suppression, with or without HBsAg suppression, but did not result in FC. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| الإتاحة: | https://doi.org/10.1016/J.JHEP.2024.03.046Test https://hdl.handle.net/10067/2050990151162165141Test https://repository.uantwerpen.be/docstore/d:irua:22929Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.8A27B3CC |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |