title: Virologic outcomes of changing enfuvirtide to raltegravir in HIV-1 patients well controlled on an enfuvirtide based regimen: 24-week results of the CHEER study.
abstract: OBJECTIVE
  To determine the safety and efficacy of changing enfuvirtide to raltegravir in HIV-1-infected patients with HIV-1 RNA below the level of quantification for at least 6 months on an enfuvirtide-containing antiretroviral regimen.
  
  
  METHODS
  Prospective, nonrandomized, historical control study.
  
  
  METHODS
  Patients were recruited from 11 Kaiser Permanente HIV clinics in California. Those patients eligible for inclusion (>or=18 years old, well controlled on antiretroviral medications) had enfuvirtide changed to raltegravir 400 mg, given twice daily orally; all other background antiretrovirals remained unchanged. The primary end point was percentage of patients with HIV-1 RNA below the limit of quantification after 24 weeks of raltegravir therapy. Analyses were by intention to treat.
  
  
  RESULTS
  Fifty-two patients were enrolled in the trial. After 24 weeks of therapy with raltegravir, 49 (94.2%, confidence interval: 1.2% to 15.9%) patients had HIV-1 RNA levels below the limit of quantification. Patients had a median CD4 cell increase of 32 cells per cubic millimeter after 24 weeks of raltegravir therapy. Treatment satisfaction as measured by patient questionnaires improved with the raltegravir-containing regimen. Adverse events were infrequent and generally mild in nature.
  
  
  CONCLUSIONS
  In treatment-experienced patients on a stable virologically suppressive enfuvirtide-containing regimen, raltegravir can safely be substituted for enfuvirtide.
authors.affiliation: Department of Internal Medicine, Kaiser Permanente, Los Angeles, CA 90027, USA. william.j.towner@kp.org
authors.forename: William
authors.initials: W
authors.lastname: Towner
authors.forename: Daniel
authors.initials: D
authors.lastname: Klein
authors.forename: Hai Linh
authors.initials: HL
authors.lastname: Kerrigan
authors.forename: Stephen
authors.initials: S
authors.lastname: Follansbee
authors.forename: Kalvin
authors.initials: K
authors.lastname: Yu
authors.forename: Michael
authors.initials: M
authors.lastname: Horberg
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000627:therapeutic use*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011446:Prospective Studies; D011760:Pyrrolidinones / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D015700:HIV Envelope Protein gp41; D010446:Peptide Fragments; D011760:Pyrrolidinones; D012367:RNA, Viral; D000077560:Enfuvirtide; D000068898:Raltegravir Potassium