title: No evidence of autoimmune disorders in antiretroviral-experienced HIV-1-infected individuals after long-term treatment with raltegravir.
abstract: BACKGROUND
  The HIV integrase inhibitor raltegravir (RAL) can exacerbate autoimmune diseases in genetically predisposed mice. To evaluate whether this may occur in clinical practice, we clinically monitored HIV-positive patients treated with RAL and measured a panel of autoantibodies (auto-Abs) during the first year of RAL treatment.
  
  
  METHODS
  This was a longitudinal study in 109 antiretroviral-experienced patients who started a RAL-based regimen and were followed up for more than 2 years. A total of 45 patients were tested at baseline (before starting RAL) and after 12 months for the presence of the following auto-Abs: anti-nuclear antibodies, anti-double-stranded DNA, anti-smooth-muscle antibodies, anti-thyreoglobulin and anti-thyroid peroxidase antibodies, anti-cardiolipin immunoglobulin G and immunoglobulin M and anti-nuclear extractable antigens, including anti-SM ribonucleoprotein antigen, anti-Ro antigen and anti-La antigen.
  
  
  RESULTS
  A low rate of clinically relevant autoimmune diseases was observed at study entry (3/109; 2.8%; 95% CI 0.004, 0.059). No exacerbations were observed during follow-up. During the second year of RAL-based therapy a previously healthy patient developed psoriasis. At baseline, 17/45 (37.8%) patients tested for the presence of auto-Abs were positive. Most patients (n=13) were positive for anti-cardiolipin. After 12 months of RAL exposure, 9/45 patients were positive (20%; P=0.063). A positive correlation was found between HIV-1 RNA and anti-cardiolipin antibody concentration (P=0.010).
  
  
  CONCLUSIONS
  According to these results, RAL does not promote antibody-mediated immune disorders, at least not in the mid-term. A prolonged follow-up and an extension of the panel of auto-Abs are recommended to support these results.
authors.affiliation: Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Baroncelli
authors.forename: Ivano
authors.initials: I
authors.lastname: Mezzaroma
authors.forename: Alessandra
authors.initials: A
authors.lastname: Fantauzzi
authors.forename: Clementina M
authors.initials: CM
authors.lastname: Galluzzo
authors.forename: Anna Degli
authors.initials: AD
authors.lastname: Antoni
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Vullo
authors.forename: Daniela
authors.initials: D
authors.lastname: Francisci
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Ladisa
authors.forename: Angela
authors.initials: A
authors.lastname: Vivarelli
authors.forename: Oscar
authors.initials: O
authors.lastname: Cirioni
authors.forename: Laura
authors.initials: L
authors.lastname: Sighinolfi
authors.forename: Liliana E
authors.initials: LE
authors.lastname: Weimer
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Fragola
authors.forename: Rina
authors.initials: R
authors.lastname: Fidanza
authors.forename: Andrea
authors.initials: A
authors.lastname: Cara
authors.forename: Lucia
authors.initials: L
authors.lastname: Palmisano
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001323:Autoantibodies / Q000097:blood / Q000276:immunology; D001327:Autoimmune Diseases / Q000150:complications*; D018791:CD4 Lymphocyte Count; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000276:immunology*; D019428:HIV Integrase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D011760:Pyrrolidinones / Q000009:adverse effects / Q000627:therapeutic use; D000068898:Raltegravir Potassium; D017455:Receptors, IgE / Q000097:blood / Q000276:immunology; D012189:Retrospective Studies; D019562:Viral Load
chemical_list: D001323:Autoantibodies; D019428:HIV Integrase Inhibitors; D011760:Pyrrolidinones; D017455:Receptors, IgE; D000068898:Raltegravir Potassium