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Clinical Trial Commentary

The POWER and TITAN trials: darunavir/ritonavir in the management of HIV-infected patients

    Christine Katlama

    Hôpital Pitié-Salpêtrière, Service des Maladies Infectieuses et Tropicales, Université Pierre et Marie Curie, Paris F-75013, France.

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    Email the corresponding author at christine.katlama@psl.ap-hop-paris.fr

    Published Online:6 May 2008https://doi.org/10.2217/17469600.2.3.229

    Abstract

    Darunavir is a new protease inhibitor (PI) active against wild-type and drug-resistant HIV-1 strains and has recently been approved for use in treatment-experienced adult patients. The main clinical trials, POWER and TITAN, have been conducted in treatment-experienced, HIV-1-infected patients. The Phase IIb POWER 1 and 2 trials compared the efficacy and safety of darunavir plus low-dose ritonavir (darunavir/ritonavir) with currently available PIs in highly treatment-experienced patients receiving an optimized background regimen. At 24 and 48 weeks in POWER 1 and 2, patients receiving darunavir/ritonavir had significantly higher efficacy responses than those receiving currently available PIs (45 vs 10% of patients reached a viral load <50 copies/ml at week 48). The highest responses were observed with the darunavir/ritonavir 600/100 mg twice daily dose (also evaluated in the POWER 3 analysis), which was selected for the subsequent Phase III TITAN study. TITAN evaluated darunavir/ritonavir 600/100 mg twice daily in comparison with lopinavir/ritonavir in early treatment-experienced, lopinavir-naive patients. For the primary end point of a viral load of less than 400 copies/ml, darunavir/ritonavir was noninferior to lopinavir/ritonavir (77 vs 68%; 95% confidence interval [CI]: 2–16); for a viral load of less than 50 copies/ml, darunavir/ritonavir was again noninferior to the lopinavir/ritonavir group (71 vs 60%; 95% CI: 3–19). Both regimens were well tolerated, although discontinuations due to diarrhea and liver and lipid abnormalities were less frequent in the darunavir/ritonavir group. Darunavir/ritonavir has been shown to be effective in patients with a broad range of treatment experience and has the potential to become used across the HIV treatment spectrum, including in antiretroviral-naive patients.

    Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.

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