title: Short-term adverse effects from and discontinuation of antiretroviral post-exposure prophylaxis.
abstract: OBJECTIVE
  To evaluate short-term toxicity from and discontinuation of antiretroviral combination prophylaxis in HIV-exposed individuals in Italy.
  
  
  METHODS
  Longitudinal, open study conducted by prospective collection of data in the National Registry of PEP.
  
  
  METHODS
  All the Italian centres dedicated to HIV related care and licensed by the Ministry of Health to dispense antiretroviral drugs.
  
  
  METHODS
  Health care workers and other persons consenting to be treated with post exposure prophylaxis (PEP) after exposures to HIV.
  
  
  RESULTS
  Until October, 2000, 207 individuals receiving two nucleoside reverse transcriptase inhibitors (NRTIs), and 354 receiving two NRTIs plus a protease inhibitor (PI) were enrolled. More individuals experienced side-effects in the 3-drug group (53% and 62%, respectively; OR 0.68, (95% CI 0.48-0.98), p < 0.03). However, the proportion of individuals discontinuing prophylaxis because of side-effects did not differ significantly between the 2 groups (21% and 25% respectively; OR 0.82 (95% CI 0.53-1.26); p=0.4). The 43 individuals in the 2 NRTI group discontinued PEP after a mean of 10.4 days of treatment (median 8, range 1-27), similarly to the 88 discontinuations observed in the 3-drug group (mean duration 10.5 days, median 7.5, range 1-26). Type and incidence of specific adverse effects were similar to those reported in the literature.
  
  
  CONCLUSIONS
  Our study indicates that the difference in the proportion of individuals developing side effects and discontinuing PEP is not significant. The rate of discontinuation because of protease inhibitor side-effects does not justify per se the initial use of a less potent PEP regimen. We suggest initiating PEP with a three-drug regimen and discontinuing the protease inhibitor in the case of adverse effects.
authors.affiliation: Epidemiologic Department, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, Rome, Italy. puro@spallanzani.roma.it
authors.forename: V
authors.initials: V
authors.lastname: Puro
authors.forename: G
authors.initials: G
authors.lastname: De Carli
authors.forename: N
authors.initials: N
authors.lastname: Orchi
authors.forename: L
authors.initials: L
authors.lastname: Palvarini
authors.forename: A
authors.initials: A
authors.lastname: Chiodera
authors.forename: M
authors.initials: M
authors.lastname: Fantoni
authors.forename: C
authors.initials: C
authors.lastname: Del Borgo
authors.forename: E
authors.initials: E
authors.lastname: Iemoli
authors.forename: F
authors.initials: F
authors.lastname: Niero
authors.forename: M
authors.initials: M
authors.lastname: Monti
authors.forename: G
authors.initials: G
authors.lastname: Micheloni
authors.forename: L
authors.initials: L
authors.lastname: Caggese
authors.forename: C
authors.initials: C
authors.lastname: Lodesani
authors.forename: G
authors.initials: G
authors.lastname: Raineri
authors.forename: M
authors.initials: M
authors.lastname: Massari
authors.forename: D
authors.initials: D
authors.lastname: Drenaggi
authors.forename: G
authors.initials: G
authors.lastname: Ippolito
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects*; D015658:HIV Infections / Q000517:prevention & control*; D006282:Health Personnel; D006801:Humans; D016273:Occupational Exposure
chemical_list: D019380:Anti-HIV Agents