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Safety and durability in a cohort of HIV-1 positive patients treated with once and twice daily darunavir-based therapy (SCOLTA Project).

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Menzaghi, Barbara Ricci, Elena Carenzi, Laura Parruti, Giustino Orofino, Giancarlo Guastavigna, Marta Madeddu, Giordano Maggi, Paolo Di Biagio, Antonio Corsi, Paola Penco, Giovanni De Socio, Giuseppe Martinelli, Canio Vichi, Francesca Celesia, Benedetto Maurizio Franzetti, Marco Grosso, Carmela Molteni, Chiara Bonfanti, Paolo Quirino, Tiziana
Spatial Coverage	Italy
Description	Country affiliation: Italy Author Affiliation: Menzaghi B ( Unit of Infectious Diseases, Busto Arsizio Hospital, Busto Arsizio, Italy. barbaramenzaghi@libero.it)
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). CONCLUSION: 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.
File Format	HTM / HTML
ISSN	07533322
Issue Number	4
Volume Number	67
e-ISSN	19506007
Journal	Biomedicine & Pharmacotherapy
Language	English
Publisher	Elsevier
Publisher Date	2013-05-01
Publisher Place	France
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Hiv Infections Drug Therapy Hiv Protease Inhibitors Therapeutic Use Ritonavir Sulfonamides Adult Age Factors Cohort Studies Darunavir Drug Administration Schedule Drug Combinations Female Follow-up Studies Virology Administration & Dosage Adverse Effects Hiv-1 Isolation & Purification Humans Internet Italy Male Middle Aged Prospective Studies Survival Analysis Time Factors Viral Load Drug Effects Comparative Study Controlled Clinical Trial Journal Article Multicenter Study
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology

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Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study.

Safety and durability in a cohort of HIV-1 positive patients treated with once and twice daily darunavir-based therapy (SCOLTA Project).

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