title: Sofosbuvir and daclatasvir in mono- and HIV-coinfected patients with recurrent hepatitis C after liver transplant.
abstract: Background and aims. Pegylated interferon (Peg-INF) and ribavirin (RBV) based therapy is suboptimal and poorly tolerated. We evaluated the safety, tolerability and efficacy of a 24-week course of sofosbuvir plus daclatasvir without ribavirin for the treatment of hepatitis C virus (HCV) recurrence after liver transplantation (LT) in both HCV-monoinfected and human immunodeficiency virus (HIV)-HCV coinfected patients.
  
  
  METHODS
  We retrospectively evaluated 22 consecutive adult LT recipients (16 monoinfected and 6 coinfected with HIV) who received a 24-week course of sofosbuvir plus daclatasvir treatment under an international compassionate access program.
  
  
  RESULTS
  Most patients were male (86%), with a median age of 58 years (r:58-81y). Median time from LT to treatment onset was 70 months (r: 20-116 m). HCV genotype 1b was the most frequent (45%), 55% had not responded to previous treatment with Peg-INF and RBV and 14% to regiments including first generation protease inhibitors. Fifty-six percent of the patients had histologically proven cirrhosis and 6 had ascites at baseline. All patients completed the 24-week treatment course without significant side effects except for one episode of severe bradicardya, with only minor adjustments in immunosuppressive treatment in some cases. Viral suppression was very rapid with undetectable HCV-RNA in all patients at 12 weeks. All 22 patients achieved a sustained virological response 12 weeks after treatment completion.
  
  
  CONCLUSIONS
  The combination of sofosbuvir plus daclatasvir without ribavirin is a safe and effective treatment of HCV recurrence after LT in both monoinfected and HIV-coinfected patients, including those with decompensated cirrhosis.
authors.affiliation: LIver Unit. Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona. Spain.
authors.forename: Lluís
authors.initials: L
authors.lastname: Castells
authors.affiliation: LIver Unit. Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona. Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Llaneras
authors.affiliation: Universidade de Santiago de Compostela (CLINURSID); Department of Internal Medicine, Hospital of Santiago de Compostela. Santiago de Compostela, Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Campos-Varela
authors.affiliation: Liver Transplant Unit, Department of HPB-Surgery and Transplant, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona. Spain.
authors.forename: Itxarone
authors.initials: I
authors.lastname: Bilbao
authors.affiliation: Department of Infectious Diseases. Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona. Spain.
authors.forename: Manel
authors.initials: M
authors.lastname: Crespo
authors.affiliation: Department of Infectious Diseases. Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona. Spain.
authors.forename: Oscar
authors.initials: O
authors.lastname: Len
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III, Madrid, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Rodríguez-Frías
authors.affiliation: Liver Transplant Unit, Department of HPB-Surgery and Transplant, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona. Spain.
authors.forename: Ramon
authors.initials: R
authors.lastname: Charco
authors.affiliation: Pathology Department. Hospital Universitari Vall d'Hebron. Universitat Autònoma de Barcelona. Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Salcedo
authors.affiliation: LIver Unit. Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona. Spain.
authors.forename: Juan Ignacio
authors.initials: JI
authors.lastname: Esteban
authors.affiliation: LIver Unit. Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona. Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Esteban-Mur
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002219:Carbamates; D060085:Coinfection; D057176:Compassionate Use Trials; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D058625:End Stage Liver Disease / Q000175:diagnosis / Q000601:surgery* / Q000821:virology; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000821:virology*; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics / Q000472:pathogenicity; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D016031:Liver Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines; D012367:RNA, Viral / Q000235:genetics; D012008:Recurrence; D012189:Retrospective Studies; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014633:Valine / Q000031:analogs & derivatives; D019562:Viral Load; D014775:Virus Activation
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D007166:Immunosuppressive Agents; D011759:Pyrrolidines; D012367:RNA, Viral; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir