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Effectiveness and safety of ledipasvir/sofosbuvir±ribavirin in the treatment of HCV infection: The real-world HARVEST study.
Flisiak, Robert; Lucejko, Mariusz; Mazur, Wlodzimierz; Janczewska, Ewa; Berak, Hanna; Tomasiewicz, Krzysztof; Mozer-Lisewska, Iwona; Kozielewicz, Dorota; Gietka, Andrzej; Sikorska, Katarzyna; Wawrzynowicz-Syczewska, Marta; Nowak, Krzysztof; Zarebska-Michaluk, Dorota; Musialik, Joanna; Simon, Krzysztof; Garlicki, Aleksander; Plesniak, Robert; Baka-Cwierz, Barbara; Olszok, Iwona; Augustyniak, Krystyna; Stolarz, Wojciech; Bialkowska, Jolanta; Badurek, Anna; Piekarska, Anna.
Afiliación
  • Flisiak R; Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland. Electronic address: robert.flisiak@umb.edu.pl.
  • Lucejko M; Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
  • Mazur W; Clinical Department of Infectious Diseases, Medical University of Silesia, Katowice, Poland.
  • Janczewska E; Hepatology Outpatient Clinic, ID Clinic, Myslowice, Poland.
  • Berak H; Daily Unit, Hospital of Infectious Diseases in Warsaw, Warsaw, Poland.
  • Tomasiewicz K; Department of Infectious Diseases and Hepatology, Medical University of Lublin, Lublin, Poland.
  • Mozer-Lisewska I; Department of Infectious Diseases, Poznan University of Medical Sciences, Poznan, Poland.
  • Kozielewicz D; Department of Infectious Diseases and Hepatology, Faculty of Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz Poland.
  • Gietka A; Department of the Internal Medicine and Hepatology, Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw, Poland, Warsaw, Poland.
  • Sikorska K; Department of Infectious Diseases, Department of Tropical Medicine and Epidemiology, Medical University of Gdansk, Gdansk, Poland.
  • Wawrzynowicz-Syczewska M; Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland.
  • Nowak K; NZOZ-LSPCHW Sp. z o.o., Zielona Góra, Poland.
  • Zarebska-Michaluk D; Department of Infectious Diseases, Voivodship Hospital in Kielce and Jan Kochanowski University, Kielce, Poland.
  • Musialik J; Department of Gastroenterology and Hepatology and Department of Basic Biomedical Science, Medical University of Silesia in Katowice, Poland.
  • Simon K; Division of Infectious Diseases and Hepatology, Wroclaw Medical University, Wroclaw, Poland.
  • Garlicki A; Department of Infectious and Tropical Diseases, Jagiellonian University Medical College, Krakow, Poland.
  • Plesniak R; Medical Center in Lancut, Clinical Department Of Infectious Diseases, Lancut, Poland.
  • Baka-Cwierz B; Regional Center for Diagnosis and Treatment of Viral Hepatitis and Hepatology, John Paul II Hospital, Krakow, Poland.
  • Olszok I; Infectious Diseases Ward, Raciborz District Hospital, Raciborz, Poland.
  • Augustyniak K; Infectious Diseases Ward, Alfred Sokolowski Specialistic Hospital, Walbrzych, Poland.
  • Stolarz W; Department of Infectious Diseases, School of Medicine with the Division of Dentistry, Medical University of Silesia, Zabrze, Poland.
  • Bialkowska J; Department of Infectious and Liver Diseases, Medical University of Lodz, Poland.
  • Badurek A; Hepatology Ward, Voivodship Specialistic Hospital, Torun, Poland.
  • Piekarska A; Department of Infectious Diseases and Hepatology, Medical University of Lodz, Poland.
Adv Med Sci ; 62(2): 387-392, 2017 Sep.
Article en En | MEDLINE | ID: mdl-28554119
BACKGROUND: To evaluate the effectiveness and safety of ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen in a real-world setting. METHODS: Patients received a fixed-dose combination tablet containing LDV and SOF with or without RBV, for 8, 12 or 24 weeks. Patients were assessed at baseline, end of treatment, and 12 weeks after the end of treatment. The primary effectiveness endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). RESULTS: Of the 86 patients, aged 20-80 years, 82.6% were HCV genotype 1b-infected and 50.0% were cirrhotic. More than half (52.3%) had previously followed pegylated interferon-containing (PEG-IFN) treatment regimens, and 38.5% were null-responders. SVR12 was achieved by 94.2% of patients. All non-responders were cirrhotic: two demonstrated virologic breakthrough and the remaining three relapsed. All patients treated with an 8-week regimen achieved SVR12 despite having high viral load at baseline (HCV RNA of >1 million IU/mL in 8/10 patients, including one with a viral load of >6 million IU/mL). Adverse events were generally mild and transient. Most frequently, fatigue (22.1%), headache (15.1%), and arthralgia (7.0%) were observed. Laboratory abnormalities included anemia and hyperbilirubinemia. CONCLUSIONS: Treatment with LDV/SOF±RBV is an effective and safe option for patients with HCV, including those with advanced liver disease or a history of non-response to PEG-IFN-based therapy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Ribavirina / Bencimidazoles / Hepatitis C / Hepacivirus / Fluorenos / Sofosbuvir Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Adv Med Sci Asunto de la revista: MEDICINA Año: 2017 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Ribavirina / Bencimidazoles / Hepatitis C / Hepacivirus / Fluorenos / Sofosbuvir Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Adv Med Sci Asunto de la revista: MEDICINA Año: 2017 Tipo del documento: Article Pais de publicación: Países Bajos