title: Safety and durability in a cohort of HIV-1 positive patients treated with once and twice daily darunavir-based therapy (SCOLTA Project).
abstract: OBJECTIVE
  To evaluate safety and durability of once-daily and twice-daily darunavir/ritonavir (DRV/r)-based treatment in HIV patients in clinical practice.
  
  
  METHODS
  The Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) project is a prospective, observational, multicenter cohort created to assess the incidence of adverse events in patients receiving new antiretroviral drugs. Twenty-five Italian infectious diseases centers enroll patients and collect their data through this on-line system. Periodical evaluations of these patients, including physical examination and laboratory tests, were performed at baseline and every 6 months.
  
  
  RESULTS
  Four hundred and twenty-nine patients were enrolled since May 2006. Eighty-five patients (19.8%) were prescribed once-daily DRV/r; 31 of them were treatment-naïve (36.5%). Among 54 (63.5%) treatment-experienced patients, 21 (38.9%) had undetectable viral load and started once-daily DRV/r as a simplification regimen. Patients on twice-daily regimen were older, more frequently lipodystrophic, HCV-coinfected, and in CDC stage C. In the following 24 months of follow-up, the viral load steadily decreased as well as the CD4 cell count rose. The reason for discontinuation did not significantly differ between groups. Mean blood glucose (BG) change from baseline did not show significant difference between groups, as well as high density lipoprotein cholesterol (HDL-C), triglycerides (TGL) and alanine transaminase (ALT). The survival curve shows that patients in the once-daily regimen withdrew treatment more frequently than those on twice-daily regimen (Log Rank Chi(2)P=0.009).
  
  
  CONCLUSIONS
  Our study showed that DRV/r administrated both once daily or twice daily was safe and well tolerated with few discontinuations due to adverse events.
authors: Unit of Infectious Diseases, Busto Arsizio Hospital, Busto Arsizio, Italy. barbaramenzaghi@libero.it
authors: Barbara
authors: B
authors: Menzaghi
authors: Elena
authors: E
authors: Ricci
authors: Laura
authors: L
authors: Carenzi
authors: Giustino
authors: G
authors: Parruti
authors: Giancarlo
authors: G
authors: Orofino
authors: Marta
authors: M
authors: Guastavigna
authors: Giordano
authors: G
authors: Madeddu
authors: Paolo
authors: P
authors: Maggi
authors: Antonio
authors: A
authors: Di Biagio
authors: Paola
authors: P
authors: Corsi
authors: Giovanni
authors: G
authors: Penco
authors: Giuseppe
authors: G
authors: De Socio
authors: Canio
authors: C
authors: Martinelli
authors: Francesca
authors: F
authors: Vichi
authors: Benedetto Maurizio
authors: BM
authors: Celesia
authors: Marco
authors: M
authors: Franzetti
authors: Carmela
authors: C
authors: Grosso
authors: Chiara
authors: C
authors: Molteni
authors: Paolo
authors: P
authors: Bonfanti
authors: Tiziana
authors: T
authors: Quirino
mesh_terms: D000328:Adult; D000367:Age Factors; D015331:Cohort Studies; D000069454:Darunavir; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D020407:Internet; D007558:Italy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D013997:Time Factors; D019562:Viral Load / Q000187:drug effects
chemical_list: D004338:Drug Combinations; D017320:HIV Protease Inhibitors; D013449:Sulfonamides; D019438:Ritonavir; D000069454:Darunavir