title: Drug safety profile of integrase strand transfer inhibitors.
abstract: BACKGROUND
  HIV-1 integrase strand transfer inhibitors (INSTIs) are a novel class of antiretroviral drugs with a good safety profile. Several INSTIs have been developed clinically.
  
  
  METHODS
  The purpose of this review is to examine the safety data of the three FDA-approved INSTIs: Raltegravir (RAL), Elvitegravir (EVG) and Dolutegravir (DTG). The most relevant papers related to the safety profile of integrase inhibitors were selected and summarized.
  
  
  CONCLUSIONS
  INSTIs have demonstrated a favorable safety profile in Phase II and III trials. The most common clinical adverse events reported were diarrhea, nausea and headache. DTG and cobicistat, a component of Stribild(™), increase serum creatinine and decrease estimated creatinine clearance due to inhibition of active tubular secretion of creatinine without affecting renal glomerular function. INSTIs intrinsic potency, together with an outstanding safety profile, preludes an important role for these drugs to build up highly active antiretroviral treatment (HAART) in the near future.
authors.affiliation: Universitat Autònoma de Barcelona, Hospital de la Santa Creu i Sant Pau, Infectious Diseases Unit , Av. Sant Antoni Ma Claret, 167, 08025 Barcelona , Spain +34935565624 ; +34935565938 ; pdomingo@santpau.cat.
authors.forename: Maria del Mar
authors.initials: Mdel M
authors.lastname: Gutierrez
authors.forename: Maria Gracia
authors.initials: MG
authors.lastname: Mateo
authors.forename: Francesc
authors.initials: F
authors.lastname: Vidal
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
mesh_terms: D044966:Anti-Retroviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D015658:HIV Infections / Q000188:drug therapy; D019427:HIV Integrase / Q000378:metabolism*; D019428:HIV Integrase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D012449:Safety
chemical_list: D044966:Anti-Retroviral Agents; D019428:HIV Integrase Inhibitors; D019427:HIV Integrase