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Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial.
Yuen MF, Asselah T, Jacobson IM, Brunetto MR, Janssen HLA, Takehara T, Hou JL, Kakuda TN, Lambrecht T, Beumont M, Kalmeijer R, Guinard-Azadian C, Mayer C, Jezorwski J, Verbinnen T, Lenz O, Shukla U, Biermer M; REEF-1 Study Group. Yuen MF, et al. Among authors: biermer m. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):790-802. doi: 10.1016/S2468-1253(23)00148-6. Epub 2023 Jul 10. Lancet Gastroenterol Hepatol. 2023. PMID: 37442152 Clinical Trial.
JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analog suppressed patients with chronic hepatitis B: REEF-2.
Agarwal K, Buti M, van Bömmel F, Lampertico P, Janczewska E, Bourliere M, Vanwolleghem T, Lenz O, Verbinnen T, Kakuda TN, Mayer C, Jezorwski J, Muenz D, Beumont M, Kalmeijer R, Biermer M, Lonjon-Domanec I. Agarwal K, et al. Among authors: biermer m. J Hepatol. 2024 Apr 5:S0168-8278(24)00231-9. doi: 10.1016/j.jhep.2024.03.046. Online ahead of print. J Hepatol. 2024. PMID: 38583491 Free article.
Randomised phase 2 study (JADE) of the HBV capsid assembly modulator JNJ-56136379 with or without a nucleos(t)ide analogue in patients with chronic hepatitis B infection.
Janssen HLA, Hou J, Asselah T, Chan HLY, Zoulim F, Tanaka Y, Janczewska E, Nahass RG, Bourgeois S, Buti M, Lampertico P, Lenz O, Verbinnen T, Vandenbossche J, Talloen W, Kalmeijer R, Beumont M, Biermer M, Shukla U. Janssen HLA, et al. Among authors: biermer m. Gut. 2023 Jul;72(7):1385-1398. doi: 10.1136/gutjnl-2022-328041. Epub 2023 Jan 25. Gut. 2023. PMID: 36697207 Free PMC article. Clinical Trial.
Drug-Drug Interactions With the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379 (Bersacapavir).
Vandenbossche J, Yogaratnam J, Hillewaert V, Rasschaert F, Talloen W, Biewenga J, Snoeys J, Kakuda TN, Palmer M, Nangosyah J, Biermer M. Vandenbossche J, et al. Among authors: biermer m. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1419-1429. doi: 10.1002/cpdd.1164. Epub 2022 Sep 5. Clin Pharmacol Drug Dev. 2022. PMID: 36062869 Free PMC article. Clinical Trial.
Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB.
Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert W, Cheng W, Thompson AJ, Given BD, Schluep T, Hamilton J, Biermer M, Kalmeijer R, Beumont M, Lenz O, De Ridder F, Cloherty G, Ka-Ho Wong D, Schwabe C, Jackson K, Lai CL, Gish RG, Gane E. Yuen MF, et al. Among authors: biermer m. J Hepatol. 2022 Nov;77(5):1287-1298. doi: 10.1016/j.jhep.2022.07.010. Epub 2022 Jul 20. J Hepatol. 2022. PMID: 35870702 Free article. Clinical Trial.
JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B.
Gane E, Yuen MF, Kakuda TN, Ogawa T, Takahashi Y, Goeyvaerts N, Lonjon-Domanec I, Vaughan T, Schluep T, Hamilton J, Njumbe Ediage E, Hillewaert V, Snoeys J, Lenz O, Talloen W, Biermer M. Gane E, et al. Among authors: biermer m. Antivir Ther. 2022 Jun;27(3):13596535221093856. doi: 10.1177/13596535221093856. Antivir Ther. 2022. PMID: 35695169 Free article. Clinical Trial.
29 results