title: Twelve week post-treatment follow-up predicts sustained virological response to pegylated interferon and ribavirin therapy in HIV/hepatitis C virus co-infected patients.
abstract: OBJECTIVE
  The aim of this study was to evaluate whether the assessment of hepatitis C virus (HCV) RNA serum at 12 weeks after the end of treatment (W12) was as informative as after 24 weeks (W24) for determining sustained virological response (SVR) in HIV/HCV co-infected patients who received a combination of pegylated interferon (PEG-INF) plus ribavirin (PEG-INF/RBV) and had a virological response at the end of treatment.
  
  
  METHODS
  Treatment-naive HIV/HCV patients were included in this prospective study if they had completed a full course of therapy with PEG-INF/RBV, had an undetectable serum HCV RNA at the end of treatment and complied with the W12 and W24 schedule for determining HCV RNA. HCV RNA levels were measured using a quantitative PCR assay (detection limit = 15 IU/mL). Positive predictive value (PPV) was defined as the probability of an undetectable serum HCV RNA at W12 and W24 after the end of treatment.
  
  
  RESULTS
  Of 186 patients treated during the study period, 104 (55.9%) were included in the study. At W24, 83 (79.8%) patients had an SVR and 21 (20.2%) had a virological relapse. At W12, HCV RNA was undetectable in 83 (79.8%) patients and all of these had SVR. Undetectable HCV RNA at W12 had a 100% PPV [95% confidence interval (CI) 96.5%-100%] for SVR.
  
  
  CONCLUSIONS
  Our results show that undetectable HCV RNA at W12 post-treatment has a high PPV for SVR. Testing for HCV RNA at this moment may therefore be considered an appropriate point in time for identifying SVR and relapse in HIV/HCV co-infected patients receiving treatment with PEG-INF/RBV.
authors.affiliation: Infectious Diseases Unit, Maimonides Institute for Biomedical Research (IMIBIC), University Hospital Reina Sofia, Cordoba, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero-Juárez
authors.forename: José A
authors.initials: JA
authors.lastname: Mira
authors.forename: Inés
authors.initials: I
authors.lastname: Pérez-Camacho
authors.forename: Juan
authors.initials: J
authors.lastname: Macías
authors.forename: Angela
authors.initials: A
authors.lastname: Camacho
authors.forename: Karin
authors.initials: K
authors.lastname: Neukam
authors.forename: Julián
authors.initials: J
authors.lastname: Torre-Cisneros
authors.forename: Nicolás
authors.initials: N
authors.lastname: Merchante
authors.forename: Juan A
authors.initials: JA
authors.lastname: Pineda
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage; D004359:Drug Therapy, Combination / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications*; D006526:Hepatitis C / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012189:Retrospective Studies; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods; D012254:Ribavirin / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load / Q000379:methods
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a