The POWER and TITAN trials: darunavir/ritonavir in the management of HIV-infected patients. (May 2008)

• Record Type: Journal Article
• Authors: Katlama, Christine
• Is Part Of: Future HIV therapy. Volume 2:Number 3(2008)
• Page Start: 229
• Page End: 245
• Publication Date: 2008-05
• Subjects: antiretroviral -- darunavir -- efficacy -- HIV -- POWER -- protease inhibitor -- safety -- TITAN -- TMC114 -- treatment experienced; HIV (Viruses) -- Treatment -- Periodicals; HIV (Viruses) -- Research -- Periodicals; 616.979206
• DOI: 10.2217/17469600.2.3.229
• Languages: English
• ISSNs: 1746-9600

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.