title: Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease.
abstract: HIV-HCV-coinfected patients respond just as well to modern direct-acting antiviral HCV therapy as HCV-monoinfected patients. However, clinical data for all-oral HCV treatments are sparse in HIV-HCV-coinfected patients with an advanced stage of liver cirrhosis.
  
  
  
  A subanalysis of efficacy and safety for a daclatasvir (DCV) and sofosbuvir (SOF) regimen, with or without ribavirin (RBV), was undertaken in HIV-HCV-coinfected patients with advanced liver disease and no other treatment options enrolled into a European DCV compassionate use programme.
  
  
  
  Fifty five HIV-HCV (mostly genotypes 1, 3, 4) coinfected patients were treated with DCV+SOF with (n=16) or without RBV (n=39), mostly for 24 weeks. Patients were predominantly (95%) cirrhotic (50% were Child-Pugh class B or C) and were receiving a wide range of antiretrovirals; 40% were injection drug users and 25% were receiving oral opioid substitution. Sustained virological response at post-treatment week 12 (SVR12) by modified intention-to-treat analysis (n=52) was 92% overall (95% CI 81.5, 97.9), and was similar with (94% [95% CI 69.8, 99.8]) or without RBV (92% [95% CI 77.5, 98.2]). Only one patient relapsed (Child-Pugh class B). The overall SVR12 rate after excluding non-virological failures (n=49) was 98% (95% CI 89.1, 99.9). Four patients discontinued treatment for adverse events and one died during treatment (not treatment-related). No patient lost opioid maintenance or required a change of antiretrovirals due to drug-drug interactions.
  
  
  
  DCV+SOF, with or without RBV, showed high SVR12 rates and was well tolerated in this real-world cohort of HIV-HCV-coinfected patients with very advanced liver disease. ClinicalTrials.gov ID NCT02097966 (Study AI444-237).
authors.affiliation: Universitätsklinikum Bonn, Bonn, Germany.
authors.forename: Jürgen K
authors.initials: JK
authors.lastname: Rockstroh
authors.affiliation: Medizinisches Infektiologiezentrum Berlin, Berlin, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ingiliz
authors.affiliation: IFI-Medizin GmbH and the Asklepios Klinik St Georg, Hamburg, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Petersen
authors.affiliation: Medical University of Vienna, Vienna, Austria.|Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria.
authors.forename: Markus
authors.initials: M
authors.lastname: Peck-Radosavljevic
authors.affiliation: Universitätsklinikum der Johann Wolfgang Goethe-Universität, Frankfurt, Germany.
authors.forename: Tania M
authors.initials: TM
authors.lastname: Welzel
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: Van der Valk
authors.affiliation: Bristol-Myers Squibb, Global Biostatistics, Hopewell, NJ, USA.
authors.forename: Yue
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Bristol-Myers Squibb, Research and Development, Princeton, NJ, USA.
authors.forename: Maria Jesus
authors.initials: MJ
authors.lastname: Jimenez-Exposito
authors.affiliation: Universitätsklinikum der Johann Wolfgang Goethe-Universität, Frankfurt, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D002219:Carbamates; D060085:Coinfection / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000145:classification / Q000235:genetics; D016174:Hepacivirus / Q000145:classification / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008107:Liver Diseases / Q000175:diagnosis / Q000209:etiology*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines; D012254:Ribavirin / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000627:therapeutic use*; D016896:Treatment Outcome; D014633:Valine / Q000031:analogs & derivatives; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D012254:Ribavirin; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir