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      Efficacy of a reduced dose of DARUNAVIR/RTV in a cohort of antiretroviral-naïve and experienced HIV-infected patients: a medium-term follow-up

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          Abstract

          Background

          The currently approved dose of darunavir/ritonavir is 800/100 mg once daily for PI-naïve patients, and 600/100 mg twice daily for PI-pretreated patients. However, in DRV-sensitive patients at baseline in the POWER 1/2 trials, similar rates of HIV RNA suppression (1 log reduction) were achieved with doses ranging from 400/100 mg once daily to 600/100 mg twice daily. In previously virologically suppressed patients, a reduced dose of DRV (600/100 QD) is non-inferior to the standard dose (800 mg QD)[ 1] and DRV concentrations in plasma and CSF are similar in patients receiving the above different doses [ 1, 2].

          Methods

          Twelve treatment-naïve patients were started on darunavir/ritonavir 600/100mg once daily, with TDF/FTC (8) or ABC/3TC (4). Seven patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (2), ABC/3TC (2), NVP (1), AZT/3TC (1). One was on monotherapy with DRV. Seven treatment-experienced patients were switched to darunavir/ritonavir 600/100 mg once daily, with TDF/FTC (5), ABC/3TC (1), RAL (1).

          Results

          Of the 12 naïve patients (mean baseline HIV RNA 134,024 log10 copies/mL, range 4,256-397,932), 11 had HIV RNA <20 c/mL after a mean 27.4 months of follow-up (range 12–33). Mean PK level was 2,920 ng/mL (1,268–4,562). One patient had virological failure after 14 months (HIV RNA 39,300 copies/mL); no mutations were detected and after introduction of DRV/r 600 mg b.i.d., he returned aviremic. All switched patients maintained HIV RNA suppression (<20 c/mL) for a mean of 32.8 months (range 21-54). PK level was available for one patient only (Ctrough 3,442 ng/mL). Of the treatment-experienced patients (mean baseline HIV RNA 24,167 log10 copies/mL, range 112–111,426), five maintained HIV RNA suppression for a mean of 46.2 months (range 31–67). One patient interrupted HAART for three months and then restarted it, the latest HIV RNA level being 628 copies/mL after five weeks of therapy. One patient failed after 42 months (HIV RNA 3,930 copies/mL); after intensification (DRV/r 600 twice daily), he returned aviremic. PK levels were available for three patients (mean 2,502 ng/mL; range 844–4,518).

          Conclusions

          In this pilot study of 26 patients, use of DRV/r at 600/100 mg OD dose led to sustained HIV RNA suppression in 23 patients with acceptable PK exposures to DRV. Large non-inferiority trials are warranted to establish its efficacy.

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          Most cited references4

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          Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients

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            Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients

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              CSF viral load and darunavir concentrations in patients receiving DRV/r 600/100 mg or 800/100 mg once daily (OD) plus two nucleosides

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                Author and article information

                Journal
                J Int AIDS Soc
                J Int AIDS Soc
                JIAS
                Journal of the International AIDS Society
                International AIDS Society
                1758-2652
                02 November 2014
                2014
                : 17
                : 4Suppl 3
                : 19822
                Affiliations
                [1 ]Infectious Diseases Unit, Department of Internal Medicine, “G.B. Rossi” Hospital, Verona, Italy
                [2 ]Unit of Pharmacology, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK
                [3 ]Internal Medicine Unit, Department of Internal Medicine, Faculty of Medicine, University of Botswana, Gaborone, Botswana
                Article
                19822
                10.7448/IAS.17.4.19822
                4225444
                a2ff56c2-904f-4af7-a3ba-e4473cf6149e
                © 2014 Lanzafame M et al; licensee International AIDS Society

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Poster Sessions – Abstract P290

                Infectious disease & Microbiology
                Infectious disease & Microbiology

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