Objectives: The DUAL study is a phase III, randomized, open-label, multicenter, 96 weeks-long pilot study in virologically suppressed HIV-1+ patients with the aim of evaluating the efficacy and the impact on non-HIV related morbidity of switching to a dual therapy with darunavir-ritonavir (DRV/r) and rilpivirine (RPV). Methods: We recruited patients who received a PI/r-containing HAART for >=6 months, HIV-RNA< 50 cp/mL for >=3 months, eGFR>60 mL/min/1,73m2, without DRV or RPV RAMs. We randomized patients in arm A: RPV+DRV/r QD or arm B: triple therapy. Primary endpoint: percentage of patients with HIV-RNA< 50 cp/mL at week 48 (ITT). VACS index, Framingham CVD risk (FRS) and urinary RBP were calculated. We used Chi-square or Fisher statistics for categorical variables and Mann-Whitney U for continuous ones. Results: Forty-two patients were enrolled (23 in arm A, 14 in arm B, plus 5 screening failures): 26 patients reached 48 weeks: 17/17 had HIV-RNA< 50 cp/mL in arm A versus 8/9 in arm B (Figure). One patient in arm A showed detectable HIV-RNA at baseline (955 cp/mL), reported scarce adherence and was discontinued at week 4. Similar changes were observed in median CD4/mL between baseline and week 48 (-14 versus -116, p n.s.). Thirty-one in arm A and 20 in arm B adverse events took place, whereas only 1 serious (arm A, unrelated to HAART). Among the 7 discontinuations (4 in A, 3 in B), only 1 was related to adverse event (arm A: G3 depression, insomnia, weakness). The tolerability parameters (FRS, VACS index, uRBP) did not vary from baseline to week 48.
Dual Therapy with Darunavir/rtv Plus Rilpivirine QD versus Triple Therapy in Patients with Suppressed Viraemia: Evaluation of Virological Efficacy and Non-HIV Related Morbidity at 48 Weeks
F Adorni;
2017
Abstract
Objectives: The DUAL study is a phase III, randomized, open-label, multicenter, 96 weeks-long pilot study in virologically suppressed HIV-1+ patients with the aim of evaluating the efficacy and the impact on non-HIV related morbidity of switching to a dual therapy with darunavir-ritonavir (DRV/r) and rilpivirine (RPV). Methods: We recruited patients who received a PI/r-containing HAART for >=6 months, HIV-RNA< 50 cp/mL for >=3 months, eGFR>60 mL/min/1,73m2, without DRV or RPV RAMs. We randomized patients in arm A: RPV+DRV/r QD or arm B: triple therapy. Primary endpoint: percentage of patients with HIV-RNA< 50 cp/mL at week 48 (ITT). VACS index, Framingham CVD risk (FRS) and urinary RBP were calculated. We used Chi-square or Fisher statistics for categorical variables and Mann-Whitney U for continuous ones. Results: Forty-two patients were enrolled (23 in arm A, 14 in arm B, plus 5 screening failures): 26 patients reached 48 weeks: 17/17 had HIV-RNA< 50 cp/mL in arm A versus 8/9 in arm B (Figure). One patient in arm A showed detectable HIV-RNA at baseline (955 cp/mL), reported scarce adherence and was discontinued at week 4. Similar changes were observed in median CD4/mL between baseline and week 48 (-14 versus -116, p n.s.). Thirty-one in arm A and 20 in arm B adverse events took place, whereas only 1 serious (arm A, unrelated to HAART). Among the 7 discontinuations (4 in A, 3 in B), only 1 was related to adverse event (arm A: G3 depression, insomnia, weakness). The tolerability parameters (FRS, VACS index, uRBP) did not vary from baseline to week 48.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
