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. 2014 Sep 1;4(3):59-69.
doi: 10.11599/germs.2014.1057. eCollection 2014 Sep.

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

Otilia Elisabeta Benea  1 , Adrian Streinu-Cercel  2 , Carmen Dorobăţ  3 , Sorin Rugină  4 , Lucian Negruţiu  5 , Augustin Cupşa  6 , Dan Duiculescu  7 , Carmen Chiriac  8 , Corina Itu  9 , Liviu Jany Prisăcariu  10 , Ionel Iosif  11
Affiliations

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

Otilia Elisabeta Benea et al. Germs. .

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; HIV-1; antiretroviral therapy; efficacy; prospective study; ritonavir; safety.

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Conflict of interest statement

Conflicts of interest Prof. Dr. Augustin Cupşa received honoraria as coordinating and principal investigator in the Speranţe study from Johnson & Johnson Romania Medical Affairs. He is occasionally consultant in advisory boards for Abbott, MSD, Roche, GSK, J&J, BMS Romanian local branches and sometimes speaker for the same groups.

Figures

Figure 1.
Figure 1.. Treatment adherence during the study
See this image and copyright information in PMC

References

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