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  • Open Access

Efficacy and tolerability of darunavir/r 600/100 mg bid in treatment-experienced patients: 48-week data from a German outpatient cohort

  • 1,
  • 2,
  • 3,
  • 4,
  • 5,
  • 6 and
  • 7
Journal of the International AIDS Society201013 (Suppl 4) :P28

https://doi.org/10.1186/1758-2652-13-S4-P28

  • Published:

Keywords

  • Clinical Practice
  • Viral Load
  • Median Time
  • Immunological Response
  • Good Efficacy

Background

Darunavir/Ritonavir (DRV/r) dosed 600/100 mg bid has shown good efficacy and tolerability in treatment-experienced patients in clinical trials (POWER, TITAN). To assess whether these results can be transferred to clinical practice and a more diverse patient population this prospective non-interventional Janssen-sponsored cohort study was established.

Methods

Between August 2007 and March 2009, 340 HIV-1 infected antiretroviral-experienced patients from 62 German centers enrolled in this non-interventional cohort. All patients received DRV/r 600/100 mg bid as part of their HAART. Virological and immunological response was monitored every 3 months. Patients were followed for up to 48 weeks.

Results

296/340 (87%) patients were male with a mean age of 47 years (SD 9.9); median time since HIV diagnosis was 12 years. At baseline, mean viral load (VL) was 4.7 log10 copies/mL (SD 5.44) with a mean CD4 count of 392 cells/mm3 (SD 251); 213 (63%) patients started therapy with CD4 < 200 cells/mm3. Patients had been pretreated with NRTIs (94%), PIs (88%), NNRTIs (63%), FI (11%), INI (5%) and/or CCR5 (3%). No data is available for 17 patients. At baseline, only 138 patients received DRV/r in combination with 2 NRTIs; the majority (202/340) of patients received DRV/r in different combinations based on the individual pretreatment situation. Of note, 116 patients received a combination containing DRV/r, RAL + other antiretrovirals. ETR and DRV/r plus other ARVs were used in 23 patients. 51 patients received an NRTI-sparing regimen. At the time of this analysis, 32 patients had discontinued prematurely and 251/340 patients had reached week 48. VL and CD4 measurements at week 48 are available for 186 patients, 80.6 % patients achieved a VL < 50 copies/ml (VL < 400 copies/ml: 94.6 %), mean CD4 count in these patients (n=185) increased from 402 at baseline to 476 cells/ mm3 (SD: 262; p <0.001). 10 patients (2.9%) discontinued DRV/r due to adverse events. Virological failure (VL >50 copies/mL at 2 visits) was documented in 10 patients (2.9%). 3 patients were genotyped; primary PI mutations were detected in all 3 patients, DRV-RAMs in none of them.

Conclusions

Overall, Darunavir/r, dosed at 600/100 mg bid in combination with other antiretrovirals, showed good efficacy and safety in treatment-experienced patients in clinical practice.

Authors’ Affiliations

(1)
Universitätsklinikum Eppendorf, Ambulanzzentrum des UKE, Bereich Infektiologie, Hamburg, Germany
(2)
Private Practice, München, Germany
(3)
Private Practice, Berlin, Germany
(4)
Praxis Driesener Strasse, Berlin, Germany
(5)
Infektiologikum Frankfurt, Frankfurt, Germany
(6)
ICH Hamburg, Hamburg, Germany
(7)
Janssen, Johnson&Johnson-Platz 1, Neuss, Germany

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