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GERMS is published by MDPI from Volume 25 Issue 4 (2025). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with the former publisher Infection Science Forum S.R.L..
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Article

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

by
Otilia Elisabeta Benea
1,2,*,
Adrian Streinu-Cercel
1,2,
Carmen Dorobăț
3,
Sorin Rugină
4,
Lucian Negruțiu
5,
Augustin Cupșa
6,
Dan Duiculescu
7,
Carmen Chiriac
8,
Corina Itu
9,
Liviu Jany Prisăcariu
3 and
Ionel Iosif
10
1
Department of Infectious Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania
2
National Institute for Infectious Diseases “Prof.Dr. Matei Balş”, Bucharest, Romania
3
Clinic of Infectious Diseases, “Gr.T.Popa” University of Medicine and Pharmacy, Iași, Romania
4
Clinical Hospital of Infectious Diseases, Constanța, Romania
5
I-st Clinic of Infectious Diseases, Timișoara, Romania
6
Clinical Hospital of Infectious Diseases “Victor Babeș” Craiova, Romania
7
“Dr. Victor Babeş” Hospital for Infectious and Tropical Diseases, Bucharest, Romania
8
Department of Infectious Diseases, University of Medicine and Pharmacy Tîrgu-Mureș, Tîrgu-Mureș, Romania
9
Clinical Hospital of Infectious Diseases, Cluj-Napoca, Romania
10
Epidemiology, Drug Trial Design, Bioequivalence and Biodistribution Studies, Bucharest, Romania
*
Author to whom correspondence should be addressed.
GERMS 2014, 4(3), 59-69; https://doi.org/10.11599/germs.2014.1057
Submission received: 10 April 2014 / Revised: 20 June 2014 / Accepted: 16 July 2014 / Published: 1 September 2014
Versions Notes

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
Keywords: darunavir; ritonavir; antiretroviral therapy; HIV-1; safety; efficacy; prospective study darunavir; ritonavir; antiretroviral therapy; HIV-1; safety; efficacy; prospective study

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MDPI and ACS Style

Benea, O.E.; Streinu-Cercel, A.; Dorobăț, C.; Rugină, S.; Negruțiu, L.; Cupșa, A.; Duiculescu, D.; Chiriac, C.; Itu, C.; Prisăcariu, L.J.; et al. 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. GERMS 2014, 4, 59-69. https://doi.org/10.11599/germs.2014.1057

AMA Style

Benea OE, Streinu-Cercel A, Dorobăț C, Rugină S, Negruțiu L, Cupșa A, Duiculescu D, Chiriac C, Itu C, Prisăcariu LJ, et al. 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. GERMS. 2014; 4(3):59-69. https://doi.org/10.11599/germs.2014.1057

Chicago/Turabian Style

Benea, Otilia Elisabeta, Adrian Streinu-Cercel, Carmen Dorobăț, Sorin Rugină, Lucian Negruțiu, Augustin Cupșa, Dan Duiculescu, Carmen Chiriac, Corina Itu, Liviu Jany Prisăcariu, and et al. 2014. "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" GERMS 4, no. 3: 59-69. https://doi.org/10.11599/germs.2014.1057

APA Style

Benea, O. E., Streinu-Cercel, A., Dorobăț, C., Rugină, S., Negruțiu, L., Cupșa, A., Duiculescu, D., Chiriac, C., Itu, C., Prisăcariu, L. J., & Iosif, I. (2014). 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. GERMS, 4(3), 59-69. https://doi.org/10.11599/germs.2014.1057

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