title: Results of a study of prolonging treatment with pegylated interferon-alpha2a plus ribavirin in HIV/HCV-coinfected patients with no early virological response.
abstract: OBJECTIVE
  To assess the efficacy and safety of an extended treatment period in HIV/hepatitis C virus (HCV)-coinfected patients without early virological response (EVR).
  
  
  METHODS
  Patients received pegylated interferon (peg-INF)-alpha2a 180 microg/week plus ribavirin 800 mg/d for 12 weeks. Patients achieving EVR at week 12 continued under therapy for an additional 12 or 36 weeks depending on genotype. Patients without EVR were randomized to complete the standard treatment or treatment lasting 72 weeks (extension arm).
  
  
  RESULTS
  One hundred and ten patients were included (mean age 38.7 years, mean weight 68 kg, 74% males, 74% on highly active antiretroviral therapy, mean CD4+ T-cell count 564 cells/mm3). Fifty-one patients harboured genotype 1, 44 genotype 2/3, and 15 genotype 4. Fifty-three had an HCV load >800,000 IU/ml. Premature interruptions occurred in 32.7%. EVR was achieved in 63.6% (51% in genotype 1, 88.6% in genotype 2/3, 33.3% in genotype 4). End-of-treatment response was 52.7% (47.2% in genotype 1, 68.2% in genotype 2/3, 26.7% in genotype 4). Sustained virological response (SVR) was achieved in 41.8% (37.3% in genotype 1, 54.6% in genotype 2/3, 20% in genotype 4). Only one patient allocated to the extended arm achieved SVR. The rate of drop-outs in the extension arm was 68%. The negative predictive value of EVR was 97.5%.
  
  
  CONCLUSIONS
  This study shows no benefit of extending therapy in patients without EVR at week 12. Measures to improve adherence to HCV antiviral therapy should be considered when new approaches based on extended periods of treatment are investigated.
authors.affiliation: HIV Clinical Unit/ Fundació de Lluita contra la SIDA/ Internal Medicine Service University Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Fuster
authors.forename: Ramon
authors.initials: R
authors.lastname: Planas
authors.forename: Juan
authors.initials: J
authors.lastname: Gonzalez
authors.forename: Luís
authors.initials: L
authors.lastname: Force
authors.forename: Manel
authors.initials: M
authors.lastname: Cervantes
authors.forename: Josep
authors.initials: J
authors.lastname: Vilaró
authors.forename: Mercè
authors.initials: M
authors.lastname: Roget
authors.forename: Isabel
authors.initials: I
authors.lastname: García
authors.forename: Enric
authors.initials: E
authors.lastname: Pedrol
authors.forename: Jordi
authors.initials: J
authors.lastname: Tor
authors.forename: Angel L
authors.initials: AL
authors.lastname: Ballesteros
authors.forename: Anna
authors.initials: A
authors.lastname: Salas
authors.forename: Guillem
authors.initials: G
authors.lastname: Sirera
authors.forename: Sebastià
authors.initials: S
authors.lastname: Videla
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: Cristina
authors.initials: C
authors.lastname: Tural
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications*; D015497:HIV-1; D016174:Hepacivirus / Q000187:drug effects* / Q000502:physiology; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a