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POWER 3 analysis: 144-week efficacy and safety results for darunavir/ritonavir (DRV/r) 600/100 mg BID in treatment-experienced HIV patients

Purpose of the Study

The POWER 3 analysis is based on a non-randomised, open-label study (TMC114-C215) investigating the long-term efficacy and safety of the protease inhibitor (PI) darunavir co-administered with low-dose ritonavir (DRV/r). This analysis evaluates the virological and immunological efficacy, safety and tolerability of DRV/r after 144 weeks of follow-up in TMC114-C215 patients who initiated treatment at 600/100 mg BID, the recommended dose for treatment-experienced HIV patients based on the POWER 1 and 2 (TMC114-C213 and C202) studies.

Methods

Treatment-experienced HIV-1-infected patients with HIV-1 RNA >1,000 copies/mL and ≥1 primary PI mutation were included. Patients received DRV/r 600/100 mg BID plus an optimised background regimen (OBR; NRTIs ± enfuvirtide) based on resistance testing at screening and treatment history. Intent-to-treat (ITT) efficacy and safety analyses were used. Virological response was assessed using the time-to-loss of virological response (TLOVR) algorithm.

Summary of Results

Of a total of 453 patients recruited in trial TMC114-C215, 336 were included in the POWER 3 analysis as they started treatment with DRV/r 600/100 mg BID using the DRV commercial 300 mg tablet formulation. Baseline data for these patients were: male = 87%, Caucasian = 75%, median age = 43 years, mean duration of HIV-1 infection = 13.0 years, mean baseline log10 HIV RNA = 4.58 copies/mL, median CD4 cell count = 120 cells/mm3, CDC category C = 55%, median number of primary PI mutations = 4. These patients had a mean treatment duration of 110.6 weeks. Data for 325 patients were available for efficacy evaluation at week 144. 32% (105/325) and 39% (127/325) of patients achieved HIV-RNA <50 copies/mL and ≥1 log10 HIV-RNA reduction using the TLOVR algorithm, respectively. The mean CD4 increase from baseline at week 144 was 84 cells/mm3 (non-completer status equals failure imputation algorithm). 34% (113/336) of patients experienced Grade 2–4 adverse events at least possibly related to study medication, with diarrhoea (4%), vomiting (3%) and hypertriglyceridaemia (3%) being the most common.

Conclusion

The POWER 3 144-week efficacy and safety results confirm and extend those observed at 24, 48 and 96 weeks. DRV/r 600/100 mg BID with an OBR was effective in HIV-1 infected patients with advanced disease and a high level of PI resistance, and was well-tolerated over time, indicating a sustained clinical benefit in this highly treatment-experienced population.

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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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Pozniak, A., Arastéh, K., Molina, J. et al. POWER 3 analysis: 144-week efficacy and safety results for darunavir/ritonavir (DRV/r) 600/100 mg BID in treatment-experienced HIV patients. JIAS 11, P24 (2008). https://doi.org/10.1186/1758-2652-11-S1-P24

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-P24

Keywords

  • Ritonavir
  • Virological Response
  • Darunavir
  • Enfuvirtide
  • Background Regimen