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Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection.
Takaoka, Yoshinari; Miura, Kouichi; Morimoto, Naoki; Ikegami, Tadashi; Kakizaki, Satoru; Sato, Ken; Ueno, Takashi; Naganuma, Atsushi; Kosone, Takashi; Arai, Hirotaka; Hatanaka, Takeshi; Tahara, Toshiyuki; Tano, Shigeo; Ohtake, Takaaki; Murohisa, Toshimitsu; Namikawa, Masashi; Asano, Takeharu; Kamoshida, Toshiro; Horiuchi, Katsuhiko; Nihei, Takeshi; Soeda, Atsuko; Kurata, Hidekazu; Fujieda, Takeshi; Ohtake, Toshiya; Fukaya, Yukimura; Iijima, Makoto; Watanabe, Shunji; Isoda, Norio; Yamamoto, Hironori.
Afiliación
  • Takaoka Y; Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.
  • Miura K; Department of Gastroenterology, Koga Red Cross Hospital, Koga, Japan.
  • Morimoto N; Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.
  • Ikegami T; Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.
  • Kakizaki S; Department of Gastroenterology, Ibaraki Medical Center, Tokyo Medical University, Ami, Japan.
  • Sato K; Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Maebashi, Japan.
  • Ueno T; Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Maebashi, Japan.
  • Naganuma A; Department of Hepatology, Heisei Hidaka Clinic, Takasaki, Japan.
  • Kosone T; Department of Internal Medicine, Isesaki Municipal Hospital, Isesaki, Japan.
  • Arai H; Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan.
  • Hatanaka T; Department of Gastroenterology and Hepatology, Kusunoki Hospital, Fujioka, Japan.
  • Tahara T; Department of Gastroenterology, Maebashi Red Cross Hospital, Maebashi, Japan.
  • Tano S; Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan.
  • Ohtake T; Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan.
  • Murohisa T; Department of Gastroenterology, Shin-Oyama City Hospital, Oyama, Japan.
  • Namikawa M; Department of Gastroenterology, International University of Health and Welfare Hospital, Nasushiobara, Japan.
  • Asano T; Department of Gastroenterology, Ashikaga Red Cross Hospital, Ashikaga, Japan.
  • Kamoshida T; Department of Internal Medicine, Kiryu Kosei General Hospital, Kiryu, Japan.
  • Horiuchi K; Department of Gastroenterology, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
  • Nihei T; Department of Gastroenterology, Hitachi General Hospital, Hitachi, Japan.
  • Soeda A; Department of Gastroenterology, Gunma Chuo Hospital, Japan Community Health care Organization, Maebashi, Japan.
  • Kurata H; Department of Gastroenterology, Mito Saiseikai General Hospital, Mito, Japan.
  • Fujieda T; Department of Gastroenterology, Tsukuba Memorial Hospital, Tsukuba, Japan.
  • Ohtake T; Department of Gastroenterology, Tochigi Medical Center Shimotsuga, Tochigi, Japan.
  • Fukaya Y; Department of Internal Medicine, Kitaibaraki City Hospital, Kitaibaraki, Japan.
  • Iijima M; Department of Gastroenterology, Josai Hospital, Yuki, Japan.
  • Watanabe S; Department of Internal Medicine, Nasu Minami Hospital, Nasukarasuyama, Japan.
  • Isoda N; Department of Gastroenterology, Dokkyo Medical University, Mibu, Japan.
  • Yamamoto H; Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.
Hepatol Res ; 51(1): 51-61, 2021 Jan.
Article en En | MEDLINE | ID: mdl-33021009
AIM: This study aimed to evaluate the real-world efficacy and safety of 12-week sofosbuvir/velpatasvir (SOF/VEL) treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus (HCV) infection. METHODS: A total 72 of patients with Child-Pugh (CP) class B or C were enrolled. We evaluated the sustained virologic response at 12 weeks after the end of treatment (SVR12), adverse events (AEs), and changes in the liver function. RESULTS: All participants had genotype 1 or 2 HCV infection. At baseline, the numbers of patients with CP class B and C were 59 and 13, respectively. The overall SVR12 rate was 95.8% (69/72); 94.9% (56/59) in CP class B and 100% (13/13) in CP class C. The serum albumin level, prothrombin time and ascites were significantly improved (P < 0.01); however, the serum bilirubin level and encephalopathy did not improve. Among patients who achieved SVR12, 75.0% showed an improvement in their CP score, while 5.9% showed a worsening. The presence of large portosystemic shunt (diameter ≥6 mm) and hyperbilirubinemia (≥2.0 mg/dL) were independent factors that interfered with the improvement in the CP score (P < 0.05). The most common AEs were encephalopathy (15.3%) and skin symptoms (7.9%). Two patients discontinued SOF/VEL due to AEs. CONCLUSIONS: Treatment with SOF/VEL for 12 weeks was relatively safe and effective for patients with decompensated cirrhosis. An SVR provided an improvement of the liver function in the majority of patients. However, large portosystemic shunt and hyperbilirubinemia were independent factors that interfered with the improvement in the CP score.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Hepatol Res Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Hepatol Res Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Países Bajos