title: Telaprevir-based therapy for treatment of HIV-1 and hepatitis C virus co-infected patients: An early access programme.
abstract: OBJECTIVE
  HPC3005 is a multicentre, open-label, telaprevir trial in HCV/HIV coinfected patients with severe fibrosis or compensated cirrhosis.
  
  
  METHODS
  Patients were treated with telaprevir 750 mg every 8 h (1125 mg if on efavirenz) plus pegylated interferon-alpha (PEG-IFN, 180 μg once-weekly) and ribavirin (RBV, 800 mg/day) for 12 weeks, followed by 36 weeks of PEG-IFN/RBV.
  
  
  RESULTS
  Mean age was 44 years, 97/118 patients were male and all were Caucasian, 68 had severe fibrosis and 50 had cirrhosis. Seventy-eight had HCV RNA levels ≥800 000 IU/mL, 72 had HCV genotype 1a, baseline HIV RNA was <50 copies/mL in 112 patients. Overall, 114/118 patients continued antiretroviral treatment, 4 were untreated. Seventy-five patients received tenofovir and 74 emtricitabine; in addition 53 received atazanavir/ritonavir, 43 raltegravir, and 24 efavirenz. By intention-to-treat, 78 (66%) patients achieved SVR24. Nineteen discontinued telaprevir, 8 for virological endpoint, 5 for adverse events (2 anaemia, 2 rash, 1 asthenia), 5 for non-compliance and 1 withdrew consent. The most common adverse events were anaemia (36 patients), thrombocytopaenia (33), rash (26), bilirubin increase (17), and neutropenia (16).
  
  
  CONCLUSIONS
  In this early access programme in coinfected patients with severe fibrosis or cirrhosis, 66% of patients achieved SVR. The most common adverse events were haematological.
  
  
  BACKGROUND
  NCT01500616.
authors.affiliation: Clinic of Infectious Diseases, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy. Electronic address: andrea.gori@unimbi.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gori
authors.affiliation: Servico de Doencas Infecciosas, Hospital de Santa Maria, Lisbon, Portugal.
authors.forename: Manuela
authors.initials: M
authors.lastname: Doroana
authors.affiliation: State Healthcare Institution, Tolyatti, Russian Federation.
authors.forename: Oksana
authors.initials: O
authors.lastname: Chernova
authors.affiliation: Department of Internal Medicine, University Hospital Bonn, Bonn, Germany.
authors.forename: Jürgen K
authors.initials: JK
authors.lastname: Rockstroh
authors.affiliation: Szent Laszlo Hospital, Budapest, Hungary.
authors.forename: Denes
authors.initials: D
authors.lastname: Banhegyi
authors.affiliation: Department of Genitourinary Medicine and Infectious Diseases, St James Hospital, Dublin, Ireland.
authors.forename: Colm
authors.initials: C
authors.lastname: Bergin
authors.affiliation: Division of Infectious Diseases, University of Bologna, Bologna, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Verucchi
authors.affiliation: Janssen Research & Development LLC, Titusville, NJ, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Liu
authors.affiliation: Janssen Research & Development LLC, Titusville, NJ, USA.
authors.forename: Ralph
authors.initials: R
authors.lastname: DeMasi
authors.affiliation: Janssen Pharmaceuticals, Paris, France.
authors.forename: Blanca
authors.initials: B
authors.lastname: Hadacek
authors.affiliation: Chelsea and Westminster Hospital, London, United Kingdom.
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001663:Bilirubin / Q000097:blood; D060085:Coinfection / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000150:complications; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000209:etiology / Q000821:virology; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D012367:RNA, Viral; D012254:Ribavirin; C486464:telaprevir; D001663:Bilirubin
keywords: Bridging fibrosis; Cirrhosis; Coinfection; HIV; Hepatitis C; Telaprevir