Eltrombopag enables initiation and completion of pegylated interferon/ribavirin therapy in Japanese HCV-infected patients with chronic liver disease and thrombocytopenia.

chronic hepatitis C chronic liver disease eltrombopag ethnic difference pegylated interferon/ribavirin therapy thrombocytopenia

Journal

Experimental and therapeutic medicine
ISSN: 1792-0981
Titre abrégé: Exp Ther Med
Pays: Greece
ID NLM: 101531947

Informations de publication

Date de publication:
Jul 2019
Historique:
received: 21 09 2018
accepted: 27 02 2019
entrez: 2 7 2019
pubmed: 2 7 2019
medline: 2 7 2019
Statut: ppublish

Résumé

To investigate the efficacy of eltrombopag for the treatment of thrombocytopenia in patients with chronic hepatitis C, a phase II, single-arm, open-label study with a 9-week pre-antiviral phase was conducted, followed by a 48-week antiviral phase and a 24-week follow-up phase. The proportion of patients who achieved a platelet count threshold, the proportion of patients who maintained a platelet count >50,000/µl, sustained virological response (SVR) rates and safety parameters were evaluated. Of the 45 enrolled patients (median age, 59 years; median platelet count, 63,000/µl; 98% with Child-Pugh class A), 43 (96%) achieved the platelet count threshold during the pre-antiviral phase. A total of 13 patients (29%) experienced ≥1 adverse event (AE), of which headache and vomiting were the most common, and 41 patients (mostly receiving eltrombopag 12.5 mg or 25 mg) entered the antiviral phase, of which 36 (88%) maintained the platelet count threshold; no patient platelet count decreased below 25,000/µl. Nine patients (22%) achieved an SVR at the 24-week follow-up. Grade ≥3 AEs occurred in 25 patients (61%). A total of 8 serious AEs occurred in five patients (12%). No mortality, thromboembolic events (TEEs), or cataract progression were reported. Eltrombopag increased the platelet count in chronic hepatitis C virus-infected patients with cirrhosis and thrombocytopenia and enabled them to initiate and complete interferon-based antiviral therapy (NCT01636778; first submitted: July 05, 2012).

Identifiants

pubmed: 31258695
doi: 10.3892/etm.2019.7616
pii: ETM-0-0-7616
pmc: PMC6566053
doi:

Banques de données

ClinicalTrials.gov
['NCT01636778']

Types de publication

Journal Article

Langues

eng

Pagination

596-604

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Auteurs

Takumi Kawaguchi (T)

Department of Medicine, Division of Gastroenterology, Kurume University School of Medicine, Kurume, Fukuoka 830-0011, Japan.

Atsumasa Komori (A)

Clinical Research Center, National Hospital Organization (NHO) Nagasaki Medical Center, Omura, Nagasaki 856-8562, Japan.
Department of Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8523, Japan.

Kunio Fujisaki (K)

Kirishima Medical Center, Kirishima, Kagoshima 899-5112, Japan.

Shuhei Nishiguchi (S)

Division of Hepatobiliary and Pancreatic Disease, Hyogo College of Medicine, Nishinomiya, Hyogo 663-8501, Japan.

Michio Kato (M)

National Hospital Organization Minami Wakayama Medical Center, Tanabe, Wakayama 646-8558, Japan.

Hitoshi Takagi (H)

Department of Gastroenterology, National Hospital Organization, Takasaki General Center Hospital, Takasaki, Gunma 370-0829, Japan.

Yasuhito Tanaka (Y)

Liver Disease Center, Nagoya University Hospital, Nagoya, Aichi 467-8602, Japan.

Kazuo Notsumata (K)

Department of Internal Medicine, Fukuiken Saiseikai Hospital, Fukui 918-8503, Japan.

Eiji Mita (E)

Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka 540-0006, Japan.

Hideyuki Nomura (H)

Center for Liver Disease, Shin-kokura Hospital, Kitakyushu, Fukuoka 803-8505, Japan.

Mitsushige Shibatoge (M)

Department of Gastroenterology, Takamatsu Red-Cross Hospital, Takamatsu, Kagawa 760-0017, Japan.

Koichi Takaguchi (K)

Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa 760-8557, Japan.

Toshihiro Hattori (T)

Novartis Pharma KK, Tokyo 105-6333, Japan.

Michio Sata (M)

Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Fukuoka 830-0011, Japan.

Kazuhiko Koike (K)

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, Japan.

Classifications MeSH