title: Effect of an induction period of pegylated interferon-α2a and ribavirin on early virological response in HIV-HCV-coinfected patients: results from the CORAL-2 study.
abstract: BACKGROUND
  It is uncertain whether a 4-week induction period of pegylated interferon and ribavirin increases early virological response (EVR) in HIV-HCV-coinfected patients.
  
  
  METHODS
  HIV and HCV genotype 1- and 4-coinfected subjects were randomized to receive pegylated interferon-α2a 270 μg/week plus ribavirin 1,600 mg daily and epoetin-β for 4 weeks, followed by pegylated interferon-α2a at standard dosages plus weight-based ribavirin (WBR) dosage for 8 weeks (induction arm [IA]), or pegylated interferon-α2a plus WBR for 12 weeks (standard therapy arm [SA]). HCV RNA was determined at weeks 0, 1, 2, 3, 4, 8 and 12. Ribavirin plasma trough concentrations were determined at weeks 4 (RBV-C(4)) and 12 (RBV-C(12)).
  
  
  RESULTS
  A total of 67 patients were included; 33 in the SA and 34 in the IA. Overall, 25% received nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. More patients achieved an HCV RNA decrease ≥1 log(10) at week 4 in the IA than in the SA (62% versus 38%; P=0.017), but EVR rates were similar in the two groups (74% versus 59% in the IA and SA, respectively; P=0.15). Independent predictors of faster HCV RNA decrease at 12 weeks were higher RBV-C(4) and younger age. RBV-C(4) were higher in patients allocated in the IA and in those receiving NRTIs (P=0.039).
  
  
  CONCLUSIONS
  A 4-week induction with pegylated interferon-α2a plus ribavirin was associated with a greater decrease in HCV RNA at week 4; however, this did not translate into higher EVR rates. Higher RBV doses and avoidance of NRTI-sparing antiretroviral regimens might improve HCV treatment efficacy.
authors: HIV Clinical Unit, Internal Medicine Department and Fundació de la Lluita contra la SIDA, University Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain. ctural@flsida.org
authors: Cristina
authors: C
authors: Tural
authors: Ricard
authors: R
authors: Solà
authors: Núria Pérez
authors: NP
authors: Alvarez
authors: José
authors: J
authors: Moltó
authors: Matilde
authors: M
authors: Sánchez
authors: Ana Moreno
authors: AM
authors: Zamora
authors: Arelly
authors: A
authors: Ornelas
authors: Montserrat
authors: M
authors: Laguno
authors: Juan
authors: J
authors: González
authors: Miguel Ángel
authors: MÁ
authors: von Wichmann
authors: Maria Jesús
authors: MJ
authors: Téllez
authors: Roger
authors: R
authors: Paredes
authors: Bonaventura
authors: B
authors: Clotet
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D060085:Coinfection / Q000188:drug therapy* / Q000821:virology; D005260:Female; D006678:HIV / Q000235:genetics; D015658:HIV Infections / Q000150:complications*; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000150:complications* / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a