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| |  Once-Daily Darunavir/Ritonavir Suitable for Some Treatment-Experienced Patients With HIV: Presented at AIDS 2010 By Jenny Powers VIENNA -- July 26, 2010 -- Patients with HIV responded similarly to darunavir plus ritonavir (DRV/r) at doses given either once or twice per day, researchers said here on July 22 at the 18th International AIDS Conference. Factors that significantly affected virological response were levels of HIV-RNA and the presence of M184V/I mutations at baseline, as well as treatment adherence. Sally Hodder, MD, University of Medicine and Dentistry of New Jersey, Newark, New Jersey, presented results on behalf of an international team that performed a subgroup analysis that compared the virological response at week 48 of patients in the Once-Daily DRV/r in Treatment Experienced Patients (ODIN) trial. The subgroup factors that may predict virological response were also evaluated by multivariate analysis. In all, 590 treatment-experienced patients were randomised to receive once daily DRV/r 800/1,000 mg (n = 294) or twice daily DRV/r at 600/1,000 mg (n = 296). In total, 15.1% of patients discontinued the trial: 13.9 in the once-daily group and 16.2 in the twice-daily treatment group. The 2 most reported reasons for discontinuation included adverse events in 3.4% and 4.1% of the groups, respectively, and loss to follow-up (3.1% and 4.4%, respectively). Virological response to treatment was similar between the study arms and an overall higher response rate was observed in patients who had lower baseline HIV-RNA counts, regardless of treatment. In patients with HIV-RNA <50,000 copies/mL, 78.4% and 76.8% of patients in the once-daily and twice-daily arms, respectively, responded to treatment whereas in patients with HIV-RNA >50,000 copies/mL, 52.8% of patients in each treatment arm responded. Virological response rates were observed to improve proportionally with increasing CD4 cell counts; however, baseline CD4 cell count was not associated with virological response. Other factors not significantly associated with response were the number of prior protease inhibitors (PIs) administered to patients, the number of active nucleotide reverse transcriptase inhibitors (NRTIs), the presence of primary PI mutations, and PI resistance-associated mutations (RAMs). Factors that were determined by multivariate analysis to significantly associate with response were low baseline HIV-1 RNA (P = .0014), the presence of M184V/I mutations (P < .0001), and treatment adherence (P < .0001). Virological response was determined by HIV-1 RNA <50 copies/mL in samples taken at weeks 4, 8, 12, 24, 36, and 48 or time of withdrawal from study. The time-to-loss of virological response or viral rebound in this analysis was done at week 48 and was assessed by baseline stratification factor (HIV-1 RNA >=50,000 copies/mL). The factors used for multivariate analysis were baseline CD4 count, number of previously used PIs, number of active NRTIs in the optimised background regimen, presence of primary PI mutations, and PI RAMs or M184I/V mutation at baseline, and adherence (based on patient questionnaire). The authors concluded that once-daily treatment with DRV/r at 800/1,000 mg is suitable for treatment-experienced HIV-infected patients who have no DRV RAMS, regardless of baseline characteristics. Funding for this study was provided by Tibotec Inc. [Presentation title: Subgroup Analysis and Predictors of Virologic Response in Treatment-Experienced HIV-1-Infected Patients in the ODIN Trial. Abstract LBPE15]
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