Otilia Elisabeta Benea1, Adrian Streinu-Cercel2, Carmen Dorobăţ3, Sorin Rugină4, Lucian Negruţiu5, Augustin Cupşa6, Dan Duiculescu7, Carmen Chiriac8, Corina Itu9, Liviu Jany Prisăcariu10, Ionel Iosif11. 1. 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. 2. 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. 3. MD, PhD, Professor, Clinic of Infectious Diseases, "Gr.T.Popa" University of Medicine and Pharmacy, Iaşi, Romania. 4. MD, PhD, Professor, Ovidius University of Constanţa; Clinical Hospital of Infectious Diseases, Constanţa, Romania. 5. MD, PhD, Professor, Head of I-st Clinic of Infectious Diseases, Timişoara, Romania. 6. MD, PhD, Professor, Clinical Hospital of Infectious Diseases "Victor Babeş" Craiova, Romania. 7. MD, PhD, "Dr. Victor Babeş" Hospital for Infectious and Tropical Diseases, Bucharest, Romania. 8. MD, PhD, Senior Lecturer, University of Medicine and Pharmacy Tîrgu-Mureş, Department of Infectious Diseases, Tîrgu-Mureş, Romania. 9. MD, PhD, Clinical Hospital of Infectious Diseases, Cluj-Napoca, Romania. 10. MD, Clinic of Infectious Diseases, "Gr.T.Popa" University of Medicine and Pharmacy, Iaşi, Romania. 11. MD, Epidemiology, Drug Trial Design, Bioequivalence and Biodistribution Studies, Bucharest, Romania.
Abstract
INTRODUCTION: 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. CONCLUSION: 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. TRIAL REGISTRATION: NCT01253967.
INTRODUCTION: 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. CONCLUSION: 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. TRIAL REGISTRATION: NCT01253967.
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