title: Darunavir-based dual therapy of treatment-experienced HIV-infected patients: analysis from a national multicenter database.
abstract: BACKGROUND
  We assessed the virological response of dual therapy with DRV/r, plus raltegravir, maraviroc or etravirine, in virological failure patients and in virologically suppressed patients collected in the Italian Antiretroviral Resistance Database (ARCA).
  
  
  METHODS
  The primary endpoint was the percentage of patients remaining free of virological failure (confirmed >50 copies/mL or any change in the regimen). Subjects had a resistance test and at least one follow-up visit. Observation was censored at last visit under dual therapy and survival analysis and proportional hazard models were used.
  
  
  RESULTS
  Sixty-seven percent of the 221 patients started DRV/r with RAL, 20.4 % with ETV, and 12.2 % with MAR; 31.2 % virological failures were observed. At survival analysis, the overall proportion of failure was 29.2 % at 1 year and 33.8 % at 2 years. The proportion of failure was lower in patients starting with undetectable vs. detectable viral load (13.3 and 25.2 % vs. 37.4 and 38.8 % at 1 and 2 years, respectively, p = 0.001 for both analyses) and in patients treated with DRV 600 BID vs. 800 QD (HR: 0.56, 95 % CI: 0.31-0.99, p < 0.05). By regimen, the adjusted proportional model showed no significant difference among the three regimens. A significant lower risk of failure was associated with higher GSS (HIV-DB HR: 0.53, 95 % CI: 0.32-0.88, p = 0.014; Rega 0.60, 0.40-0.88, p < 0.01; ANRS 0.55, 0.34-0.90, p = 0.017), while a higher risk of failure with detectable HIV-RNA (3.02, 1.70-5.72, p < 0.001).
  
  
  CONCLUSIONS
  Among experienced patients, the best candidates for dual-therapy regimens including DRV/r are those with undetectable viral load and higher GSS.
authors.affiliation: Malattie Infettive e Tropicali, Azienda Ospedaliera Universitaria Careggi, Largo Brambilla 3, 50134, Florence, Italy, sterrantinok@gmail.com.
authors.forename: Gaetana
authors.initials: G
authors.lastname: Sterrantino
authors.forename: Mauro
authors.initials: M
authors.lastname: Zaccarelli
authors.forename: Antonio
authors.initials: A
authors.lastname: Di Biagio
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Biondi
authors.forename: Andrea
authors.initials: A
authors.lastname: Antinori
authors.forename: Giovanni
authors.initials: G
authors.lastname: Penco
mesh_terms: D000328:Adult; D000818:Animals; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000069454:Darunavir / Q000627:therapeutic use*; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006678:HIV / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D000069454:Darunavir
references.citation: Lancet. 2013 Jun 15;381(9883):2091-9
references.pmid: 23769235
references.citation: J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):233-4
references.pmid: 19155770
references.citation: AIDS. 2011 Nov 13;25(17):2113-22
references.pmid: 21857490
references.citation: New Microbiol. 2012 Jul;35(3):259-77
references.pmid: 22842596
references.citation: AIDS. 2014 Apr 24;28(7):943-7
references.pmid: 24401641
references.citation: Infection. 2012 Jun;40(3):311-8
references.pmid: 22237471
references.citation: AIDS. 2010 Jan 2;24(1):123-37
references.pmid: 19770621
references.citation: Infection. 2009 Jun;37(3):203-9
references.pmid: 19274429
references.citation: AIDS Res Hum Retroviruses. 2012 Oct;28(10):1196-206
references.pmid: 22364141
references.citation: HIV Med. 2012 Aug;13(7):398-405
references.pmid: 22413874
references.citation: N Engl J Med. 2014 Jul 17;371(3):234-47
references.pmid: 25014688
references.citation: J Antimicrob Chemother. 2012 Jun;67(6):1453-8
references.pmid: 22378681
references.citation: J Antimicrob Chemother. 2012 Mar;67(3):691-5
references.pmid: 22160145
references.citation: J Int AIDS Soc. 2014 Nov 02;17(4 Suppl 3):19788
references.pmid: 25397532
references.citation: Lancet. 2014 Nov 29;384(9958):1942-51
references.pmid: 25103176
references.citation: Lancet Infect Dis. 2014 Jul;14(7):572-80
references.pmid: 24783988