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POWER 1 and 2: combined final 144-week efficacy and safety results for darunavir/ritonavir (DRV/r) 600/100 mg BID in treatment-experienced HIV patients

Background

POWER 1 and 2 (TMC114-C213 and C202) are randomised, controlled, Phase IIb trials designed to evaluate the long-term efficacy and safety of darunavir co-administered with low-dose ritonavir (DRV/r) in comparison with control protease inhibitor (CPIs) in treatment-experienced HIV patients. This combined analysis evaluates the final 144-week efficacy, safety and tolerability results for DRV/r 600/100 mg BID.

Methods

Patients had documented HIV-1 infection, with ≥1 primary PI mutation and HIV-RNA >1,000 copies/mL at baseline. The analysis included patients in POWER 1 and 2 randomised to receive DRV/r 600/100 mg BID or CPI(s), plus an optimised background regimen (OBR; NRTIs ± enfuvirtide). The primary efficacy end-point was the proportion of patients with ≥1 log10 HIV-RNA reduction at week 144 from baseline (time-to-loss of virological response [TLOVR] algorithm) in the intent-to-treat (ITT) population.

Summary of results

There were 513 patients in the DRV/r group (of whom 131 received DRV/r 600/100 mg BID) and 124 patients in the CPI group. Baseline data for the DRV/r 600/100 mg BID group were: 89% male, 81% Caucasian, mean age 44 years, mean duration of infection 12 years, mean log10 HIV-RNA 4.6 copies/mL, median CD4 cell count 153 cells/mm3, 36% CDC category C, median primary PI mutations 3. More than 90% of patients had previously used ≥4 NRTIs, ≥1 NNRTI or ≥2 PIs. All patients had reached week 144 or discontinued earlier (discontinuations: DRV/r 600/100 mg BID n = 49 [37%]; CPI n = 108 [87%]). At week 144, 48 (37%) patients in the DRV/r 600/100 mg BID group and 11 (9%) patients in the CPI group achieved HIV-RNA <50 copies/mL (p < 0.001; ITT-TLOVR). A ≥1 log10 HIV-RNA reduction was achieved by 67 (51%) patients in the DRV/r 600/100 mg BID group and 12 (10%) patients in the CPI group (p < 0.001; ITT-TLOVR). The median CD4 cell count increased from baseline by 97 cells/mm3 in the DRV/r 600/100 mg BID group and 4 cells/mm3 in the CPI group (p < 0.001; last observation carried forward analysis). The most common treatment-emergent adverse events from week 24 onwards in patients receiving DRV/r 600/100 mg BID over a median exposure of 120 weeks were diarrhoea (16%), nasopharyngitis (14%), sinusitis (13%) and bronchitis (13%). Most adverse events were grade 1 or 2.

Conclusion

Combined final efficacy and safety results for POWER 1 and 2 confirm that DRV/r 600/100 mg BID has long-term efficacy and is a well-tolerated treatment option in treatment-experienced patients.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Katlama, C., Bellos, N., Grinsztejn, B. et al. POWER 1 and 2: combined final 144-week efficacy and safety results for darunavir/ritonavir (DRV/r) 600/100 mg BID in treatment-experienced HIV patients. JIAS 11, P21 (2008). https://doi.org/10.1186/1758-2652-11-S1-P21

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-P21

Keywords

  • Sinusitis
  • Ritonavir
  • Darunavir
  • Enfuvirtide
  • Nasopharyngitis