title: Incidence and risk factors for developing cytomegalovirus retinitis in HIV-infected patients receiving protease inhibitor therapy. Spanish CMV-AIDS Study Group.
abstract: OBJECTIVE
  To assess the incidence and risk factors for cytomegalovirus (CMV) retinitis in HIV-infected patients who initiated protease inhibitor-containing antiretroviral therapy.
  
  
  METHODS
  Prospective, multicentre study.
  
  
  METHODS
  A cohort of 172 HIV-infected patients with a CD4 cell count below 100x10(6) cells/l at the time of protease inhibitor introduction.
  
  
  METHODS
  Confirmed CMV retinitis and mortality, according to CD4 cell count, HIV load, and CMV viraemia.
  
  
  RESULTS
  The cumulative incidence of CMV retinitis was 5% at 1 year and 6% at 2 years. Only a positive CMV polymerase chain reaction (PCR) test at therapy initiation was significantly associated with the development of disease (relative hazard, 4.41; 95% confidence interval, 2.12-8.93; P<0.00001). The 12-month Kaplan-Meier CMV retinitis event rate was 38% in patients who were CMV PCR-positive compared with 2% in those who were CMV PCR-negative (P<0.001). Mean CMV load was significantly higher in those individuals who went on to develop CMV retinitis (3700 versus 384 copies/ml, P = 0.002). Only 2% of patients remained CMV PCR-positive after 3 months of protease inhibitor therapy, and CMV viraemia was not associated with a worse therapy response or shorter survival. Transient CMV positivity without a higher risk of disease was observed in 7% of patients at the first month on therapy.
  
  
  CONCLUSIONS
  Protease inhibitor-containing antiretroviral therapy significantly reduces the incidence of CMV viraemia and disease. Although a positive CMV PCR test identifies those patients on therapy at highest risk of CMV retinitis, it is not associated with an increased risk of death or a worse response to protease inhibitor therapy.
authors.affiliation: Infectious Diseases Unit, Hospital Ramon y Cajal, Madrid, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Casado
authors.forename: J
authors.initials: J
authors.lastname: Arrizabalaga
authors.forename: M
authors.initials: M
authors.lastname: Montes
authors.forename: P
authors.initials: P
authors.lastname: Martí-Belda
authors.forename: C
authors.initials: C
authors.lastname: Tural
authors.forename: J
authors.initials: J
authors.lastname: Pinilla
authors.forename: C
authors.initials: C
authors.lastname: Gutierrez
authors.forename: J
authors.initials: J
authors.lastname: Portu
authors.forename: R
authors.initials: R
authors.lastname: Schuurman
authors.forename: K
authors.initials: K
authors.lastname: Aguirrebengoa
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000175:diagnosis / Q000453:epidemiology* / Q000821:virology; D018791:CD4 Lymphocyte Count; D003587:Cytomegalovirus / Q000302:isolation & purification / Q000502:physiology; D017726:Cytomegalovirus Retinitis / Q000175:diagnosis / Q000453:epidemiology* / Q000821:virology; D004279:DNA, Viral / Q000032:analysis; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D015994:Incidence; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D012307:Risk Factors; D019562:Viral Load; D014766:Viremia / Q000821:virology
chemical_list: D004279:DNA, Viral; D017320:HIV Protease Inhibitors