title: Efficacy and safety of darunavir (Prezista(®)) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study.
abstract: BACKGROUND
  The aim of the study was to assess the safety and efficacy of darunavir (Prezista(®)) used in subtype F human immunodeficiency virus - type 1 (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in routine clinical practice.
  
  
  METHODS
  This was a post-authorization, open-label, one-cohort, non-interventional, prospective study conducted at multiple sites in Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) and safety ([serious] adverse events, clinical laboratory evaluation, and vital signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in naturalistic settings. Seventy-eight subjects were recruited by 9 investigational sites and received 600/100 mg DRV/r twice daily.
  
  
  RESULTS
  Treatment with DRV/r administered with other ARV medications resulted in the expected, statistically relevant improvement of CD4 cell count and viral load in subjects eligible for such treatment. In addition, adherence to treatment was high and the treatment-emergent safety profile observed during this study was consistent with the established safety profile of darunavir.
  
  
  CONCLUSIONS
  DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania.
  
  
  BACKGROUND
  NCT01253967.
authors.affiliation: MD, PhD, Associate Professor, Department of Infectious Diseases, Carol Davila University of Medicine and Pharmacy; National Institute for Infectious Diseases "Prof. Dr. Matei Balş", Bucharest, Romania.
authors.forename: Otilia Elisabeta
authors.initials: OE
authors.lastname: Benea
authors.affiliation: MD, PhD, Professor, Department of Infectious Diseases, Carol Davila University of Medicine and Pharmacy; National Institute for Infectious Diseases "Prof.Dr. Matei Balş", Bucharest, Romania.
authors.forename: Adrian
authors.initials: A
authors.lastname: Streinu-Cercel
authors.affiliation: MD, PhD, Professor, Clinic of Infectious Diseases, "Gr.T.Popa" University of Medicine and Pharmacy, Iaşi, Romania.
authors.forename: Carmen
authors.initials: C
authors.lastname: Dorobăţ
authors.affiliation: MD, PhD, Professor, Ovidius University of Constanţa; Clinical Hospital of Infectious Diseases, Constanţa, Romania.
authors.forename: Sorin
authors.initials: S
authors.lastname: Rugină
authors.affiliation: MD, PhD, Professor, Head of I-st Clinic of Infectious Diseases, Timişoara, Romania.
authors.forename: Lucian
authors.initials: L
authors.lastname: Negruţiu
authors.affiliation: MD, PhD, Professor, Clinical Hospital of Infectious Diseases "Victor Babeş" Craiova, Romania.
authors.forename: Augustin
authors.initials: A
authors.lastname: Cupşa
authors.affiliation: MD, PhD, "Dr. Victor Babeş" Hospital for Infectious and Tropical Diseases, Bucharest, Romania.
authors.forename: Dan
authors.initials: D
authors.lastname: Duiculescu
authors.affiliation: MD, PhD, Senior Lecturer, University of Medicine and Pharmacy Tîrgu-Mureş, Department of Infectious Diseases, Tîrgu-Mureş, Romania.
authors.forename: Carmen
authors.initials: C
authors.lastname: Chiriac
authors.affiliation: MD, PhD, Clinical Hospital of Infectious Diseases, Cluj-Napoca, Romania.
authors.forename: Corina
authors.initials: C
authors.lastname: Itu
authors.affiliation: MD, Clinic of Infectious Diseases, "Gr.T.Popa" University of Medicine and Pharmacy, Iaşi, Romania.
authors.forename: Liviu Jany
authors.initials: LJ
authors.lastname: Prisăcariu
authors.affiliation: MD, Epidemiology, Drug Trial Design, Bioequivalence and Biodistribution Studies, Bucharest, Romania.
authors.forename: Ionel
authors.initials: I
authors.lastname: Iosif
keywords: Darunavir; HIV-1; antiretroviral therapy; efficacy; prospective study; ritonavir; safety