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Real-world clinical outcomes of sofosbuvir and velpatasvir treatment in HCV genotype 1- and 2-infected patients with decompensated cirrhosis: A nationwide multicenter study by the Japanese Red Cross Liver Study Group.
Tada, Toshifumi; Kurosaki, Masayuki; Nakamura, Shinichiro; Hasebe, Chitomi; Kojima, Yuji; Furuta, Koichiro; Kobashi, Haruhiko; Kimura, Hiroyuki; Ogawa, Chikara; Yagisawa, Hitoshi; Uchida, Yasushi; Joko, Kouji; Akahane, Takehiro; Arai, Hirotaka; Marusawa, Hiroyuki; Narita, Ryoichi; Ide, Yasushi; Sato, Takashi; Kusakabe, Atsunori; Tsuji, Keiji; Mori, Nami; Kondo, Masahiko; Mitsuda, Akeri; Izumi, Namiki.
Afiliación
  • Tada T; Department of Internal medicine, Japanese Red Cross Himeji Hospital, Hyogo, Japan.
  • Kurosaki M; Department of Gastroenterology and Hepatology, Japanese Red Cross Musashino Hospital, Tokyo, Japan.
  • Nakamura S; Department of Internal medicine, Japanese Red Cross Himeji Hospital, Hyogo, Japan.
  • Hasebe C; Department of Gastroenterology, Japanese Red Cross Asahikawa Hospital, Hokkaido, Japan.
  • Kojima Y; Department of Hepatology, Japanese Red Cross Ise Hospital, Ise, Mie, Japan.
  • Furuta K; Department of Gastroenterology, Japanese Red Cross Masuda Hospital, Shimane, Japan.
  • Kobashi H; Department of Hepatology, Japanese Red Cross Okayama Hospital, Okayama, Japan.
  • Kimura H; Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
  • Ogawa C; Department of Gastroenterology, Takamatsu Red Cross Hospital, Kagawa, Japan.
  • Yagisawa H; Department of Gastroenterology, Japanese Red Cross Akita Hospital, Akita, Japan.
  • Uchida Y; Department of Gastroenterology, Japanese Red Cross Matsue Hospital, Shimane, Japan.
  • Joko K; Center for Liver-Biliary-Pancreatic Diseases, Matsuyama Red Cross Hospital, Ehime, Japan.
  • Akahane T; Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Miyagi, Japan.
  • Arai H; Department of Gastroenterology, Japanese Red Cross Maebashi Hospital, Gunma, Japan.
  • Marusawa H; Department of Gastroenterology, Japanese Red Cross Osaka Hospital, Osaka, Japan.
  • Narita R; Department of Gastroenterology, Japanese Red Cross Oita Hospital, Oita, Japan.
  • Ide Y; Department of Gastroenterology, Japanese Red Cross Karatsu Hospital, Saga, Japan.
  • Sato T; Department of Gastroenterology, Japanese Red Cross Nasu Hospital, Tochigi, Japan.
  • Kusakabe A; Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
  • Tsuji K; Department of Gastroenterology, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
  • Mori N; Department of Gastroenterology, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
  • Kondo M; Department of Gastroenterology, Japanese Red Cross Otsu Hospital, Shiga, Japan.
  • Mitsuda A; Department of Internal Medicine, Japanese Red Cross Tottori Hospital, Tottori, Japan.
  • Izumi N; Department of Gastroenterology and Hepatology, Japanese Red Cross Musashino Hospital, Tokyo, Japan.
J Med Virol ; 93(11): 6247-6256, 2021 11.
Article en En | MEDLINE | ID: mdl-34170517
The real-world virological efficacy and safety of interferon-free direct-acting antiviral (DAA) therapy with sofosbuvir (SOF) and velpatasvir (VEL) were assessed in hepatitis C virus (HCV) genotype 1- and 2-infected patients with decompensated cirrhosis. A total of 65 patients with HCV-related decompensated cirrhosis (Child-Pugh score of 7 points or more) who were treated with the SOF/VEL regimen were enrolled. The sustained virological response (SVR) rate and safety profile were analyzed. SVR was defined as undetectable serum HCV RNA at 12 weeks after the end of treatment (SVR12). The percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 81.2% (95% confidence interval [CI], 69.5-89.9) (52/64), 98.4% (95% CI, 91.2-100.0) (60/61), and 98.5% (95% CI, 91.7-100.0) (64/65), respectively. The overall SVR rate was 92.3% (95% CI, 83.0-97.5) (60/65). Albumin-bilirubin (ALBI) scores decreased during and after treatment (p < 0.001), and there were significant differences between baseline and end of treatment and between baseline and SVR12. Subgroup analyses showed no significant differences in SVR rates according to patient age, sex, HCV genotype (subtype), Child-Pugh classification, modified ALBI grade, presence of ascites, presence of hepatic coma, or history of hepatocellular carcinoma. In all subpopulations, the SVR rates were higher than 80%. There were no severe adverse events associated with the treatment. The SOF/VEL regimen showed good virological efficacy and acceptable safety even in patients with HCV-related decompensated cirrhosis.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Carbamatos / Hepacivirus / Hepatitis C Crónica / Sofosbuvir / Compuestos Heterocíclicos de 4 o más Anillos / Cirrosis Hepática Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: J Med Virol Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
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XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Carbamatos / Hepacivirus / Hepatitis C Crónica / Sofosbuvir / Compuestos Heterocíclicos de 4 o más Anillos / Cirrosis Hepática Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: J Med Virol Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos