title: Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naïve patients. I.CO.N.A. Study Group. Italian Cohort of Antiretroviral-Naïve Patients.
abstract: OBJECTIVE
  To evaluate the frequency of discontinuation of the first highly active antiretroviral regimen (HAART) and the factors predictive of discontinuing for toxicity and failure in a population-based cohort of HIV-positive individuals in Italy, naïve from antiretrovirals at enrolment.
  
  
  METHODS
  The study population consisted of individuals who initiated HAART and had at least one follow-up visit. The primary end-points were discontinuation of any component of HAART for drug toxicity and discontinuation for failure. Survival analyses were performed to identify predictive factors for reaching the two end-points.
  
  
  RESULTS
  Eight hundred and sixty-two individuals initiated HAART; in 727 of them (84.3%) this consisted of two nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (PI). Over a median follow-up of 45 weeks, 312 patients (36.2%) discontinued therapy: 182 (21.1%) discontinued due to toxicity, 44 (5.1%) due to failure. The probability of discontinuing HAART at 1 year was 25.5% [95% confidence interval (CI), 21.9-28.9] due to toxicity and 7.6% (95% CI, 4.9-1 0.3) due to failure. Independent factors associated with discontinuation for toxicity were: gender [relative hazard (RH) = 0.51; 95% CI, 0.32-0.80 for men versus women], type of treatment (indinavir-containing regimens, RH = 1.94; 95% CI, 1.10-3.41 and ritonavir-containing regimens, RH = 3.83; 95% CI, 2.09-7.03 versus hard-gell saquinavir) and time spent on treatment (RH = 0.89; 95% CI, 0.80-0.98 for each additional month). Discontinuation due to failure was independently associated with the most recent HIV-RNA (RH = 3.20; 95% CI, 1.74-5.88 for log10 copies/ml higher), and with type of treatment (indinavir-containing regimens, RH = 0.21; 95% CI, 0.06-0.78 and ritonavir-containing regimens, RH = 0.23; 95% CI, 0.04-1.26 versus hard-gell saquinavir).
  
  
  CONCLUSIONS
  If the current HAART regimen caused no toxicity, less than 10% of naïve patients discontinue their first HAART regimen because of failure after 1 year from starting therapy.
authors.affiliation: Institute of Infectious and Tropical Diseases, University of Milan, Italy. adarmin@tin.it
authors.forename: A
authors.initials: A
authors.lastname: d'Arminio Monforte
authors.forename: A C
authors.initials: AC
authors.lastname: Lepri
authors.forename: G
authors.initials: G
authors.lastname: Rezza
authors.forename: P
authors.initials: P
authors.lastname: Pezzotti
authors.forename: A
authors.initials: A
authors.lastname: Antinori
authors.forename: A N
authors.initials: AN
authors.lastname: Phillips
authors.forename: G
authors.initials: G
authors.lastname: Angarano
authors.forename: V
authors.initials: V
authors.lastname: Colangeli
authors.forename: A
authors.initials: A
authors.lastname: De Luca
authors.forename: G
authors.initials: G
authors.lastname: Ippolito
authors.forename: L
authors.initials: L
authors.lastname: Caggese
authors.forename: F
authors.initials: F
authors.lastname: Soscia
authors.forename: G
authors.initials: G
authors.lastname: Filice
authors.forename: F
authors.initials: F
authors.lastname: Gritti
authors.forename: P
authors.initials: P
authors.lastname: Narciso
authors.forename: U
authors.initials: U
authors.lastname: Tirelli
authors.forename: M
authors.initials: M
authors.lastname: Moroni
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D006679:HIV Seropositivity / Q000188:drug therapy; D006801:Humans; D019469:Indinavir / Q000627:therapeutic use; D007558:Italy; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D019438:Ritonavir / Q000627:therapeutic use; D019258:Saquinavir / Q000627:therapeutic use; D013997:Time Factors; D017211:Treatment Failure; D016312:Treatment Refusal
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019469:Indinavir; D019258:Saquinavir; D019438:Ritonavir