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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• 作者：Barbara Menzaghi^a ; ^{barbaramenzaghi@libero.it} ; Elena Ricci^b ; ^{ricci@epi2004.it} ; Laura Carenzi^b ; ^{laura.carenzi@libero.it} ; Giustino Parruti^c ; ^{parruti@tin.it} ; Giancarlo Orofino^d ; ^{orofino@asl3.to.it} ; Marta Guastavigna^d ; ^{martaguastavigna@inwind.it} ; Giordano Madeddu^e ; ^{giordano.madeddu@tin.it} ; Paolo Maggi^f ; ^{p_maggi@yahoo.com} ; Antonio Di Biagio^g ; ^{antonio.dibiagio@hsanmartino.it} ; Paola Corsi^h ; Giovanni Pencoⁱ ; ^{Giovanni.penco@galliera.it} ; Giuseppe De Socio^j ; ^{giuseppedesocio@yahoo.it} ; Canio Martinelli^h ; ^{canio.martinelli@libero.it} ; Francesca Vichi^k ; ^{francesca.vichi@asf.toscana.it} ; Benedetto Maurizio Celesia^l ; ^{bmcelesia@tin.it} ; Marco Franzetti^m ; ^{m.franzetti2@virgilio.it} ; Carmela Grossoⁿ ; ^{c.grosso1@virgilio.it} ; Chiara Molteni^o ; ^{c.molteni@ospedale.lecco.it} ; Paolo Bonfanti^o ; ^{pa.bonfanti@ospedale.lecco.it} ; Tiziana Quirino^a ; ¹ ; ^{tiziana.quirino@gmail.com}
• 关键词：HIV ; Safety ; Darunavir ; Antiretroviral therapy ; Protease inhibitors
• 刊名：Biomedicine and Pharmacotherapy
• 出版年：2013
• 出版时间：May, 2013
• 年：2013
• 卷：67
• 期：4
• 页码：293-298
• 全文大小：390 K

文摘

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-na?ve (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 Chi² 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.