2. Academic Validation
  3. JNJ-4178 (adafosbuvir, odalasvir, and simeprevir) in Japanese patients with chronic hepatitis C virus genotype 1 or 2 infection with or without compensated cirrhosis: the Phase IIa OMEGA-3 study

JNJ-4178 (adafosbuvir, odalasvir, and simeprevir) in Japanese patients with chronic hepatitis C virus genotype 1 or 2 infection with or without compensated cirrhosis: the Phase IIa OMEGA-3 study

  • J Gastroenterol. 2020 Jun;55(6):640-652. doi: 10.1007/s00535-020-01672-0.
Tetsuo Takehara 1,  Kazuaki Chayama 2,  Masayuki Kurosaki 3,  Hiroshi Yatsuhashi 4,  Yasuhito Tanaka 5,  Naoki Hiramatsu 6,  Naoya Sakamoto 7,  Yasuhiro Asahina 8,  Akito Nozaki 9,  Toshikazu Nakano 10,  Yosuke Hagiwara 10,  Hiroko Shimizu 11,  Hiroki Yoshida 12,  Yuhan Huang 13,  Michael Biermer 14,  Leen Vijgen 14,  Norio Hayashi 15
Affiliations

Affiliations

  • 1 Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. takehara@gh.med.osaka-u.ac.jp.
  • 2 Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
  • 3 Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1, Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan.
  • 4 Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Kubara 2-1001-1, Omura, Nagasaki, 856-8562, Japan.
  • 5 Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Kawasumi, Mizuho, Nagoya, 467-8601, Japan.
  • 6 Osaka Rosai Hospital, 1179-3 Kita, Sakai, Osaka, 591-8025, Japan.
  • 7 Department of Gastroenterology and Hepatology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7 Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
  • 8 Department of Liver Disease Control, Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
  • 9 Gastroenterological Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
  • 10 Janssen Pharmaceutical K.K, 5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo, 101-0065, Japan.
  • 11 Clinical Pharmacology, Quantitative Sciences Division, R&D, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo, 101-0065, Japan.
  • 12 Clinical Biostatistics Group 1 Biostatistics Department, 5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo, 101-0065, Japan.
  • 13 Statistics and Decision Sciences, Janssen (China) Research and Development, LLC., 6F, Building A, Xinyan Mansion, No. 65 Guiqing Road, Xuhui District, Shanghai, People's Republic of China.
  • 14 Janssen Research and Development, Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340, Beerse, Belgium.
  • 15 Kansai Rosai Hospital, Inabasou 3-1-69, Amagasaki-shi, Hyogo, 660-8511, Japan.
PMID: 32065330 DOI: 10.1007/s00535-020-01672-0
Abstract

Background: The efficacy, safety, and pharmacokinetics of the combination of three direct-acting Antiviral (DAA) agents (adafosbuvir [also known as AL-335], odalasvir, and simeprevir) were investigated in DAA treatment-naïve Japanese patients with genotype (GT)1 or GT2 chronic hepatitis C virus (HCV) Infection, with or without compensated cirrhosis.

Methods: In this Phase IIa, open-label, multicenter study-OMEGA-3 (NCT02993250)-patients received JNJ-4178 (adafosbuvir 800 mg once daily [QD], odalasvir 25 mg QD, and simeprevir 75 mg QD) for 8 (non-cirrhotic patients; Cohort 1) or 12 (cirrhotic patients; Cohort 2) weeks. Patients were followed-up to 24 weeks following the end of treatment (EOT). The primary endpoint was safety, including adverse events (AEs).

Results: Overall, 33 patients were enrolled into Cohort 1 (N = 22) or 2 (N = 11) and received combined treatment with JNJ-4178. During the treatment and follow-up phases, a higher percentage of patients in Cohort 2 (81.8%) experienced AEs compared with Cohort 1 (68.2%), but the incidence of treatment-related AEs was similar. Most AEs were mild-to-moderate in severity and no patients discontinued due to an AE. There was one serious AE (cataract) in a patient in Cohort 2, which was not considered related to treatment. All patients achieved sustained virologic response 12 weeks after EOT (SVR12). No incidences of viral relapse were observed during follow-up.

Conclusions: In HCV GT1- and GT2-infected Japanese patients, treatment with JNJ-4178 was well tolerated and resulted in 100% of patients achieving SVR12.

Keywords

AL-335; Hepatitis C virus; Japanese; Odalasvir; Simeprevir.

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