Measuring patient satisfaction with HIV treatments: comparing dolutegravir with darunavir/r in the FLAMINGO study
Background: Satisfaction with HIV therapy is being evaluated more frequently in HIV clinical studies. The FLAMINGO study compares treatment satisfaction with dolutegravir (DTG) versus ritonavir-boosted darunavir (DRV/r) based regimens in antiretroviral therapy (ART)-naive subjects. FLAMINGO, a multi-centre, open-label, non-inferiority study, demonstrated superiority of DTG compared to DRV/r, based on the FDA''s “snapshot” analysis, with 90% and 83% achieving virologic suppression
(HIV-1 RNA < 50c/mL) at 48 weeks, respectively.
Methods: Satisfaction with treatment was measured with the HIV treatment satisfaction questionnaire (HIVTSQ). The HIVTSQ [1,2] is a 10-item self-reported scale that measures overall satisfaction with
treatment and by specific domains such as convenience, ease of use, and flexibility. The HIVTSQ included 420 subjects from the United States, France, Germany, Italy and Spain, for which valid translations were available. The HIVTSQ total scores, convenience item scores and lifestyle/ease sub-scores were compared between the DTG and DRV/r treatment groups at Week 4, Week 24, and Week 48 using Wilcoxon rank sum tests.
Results: Median HIVTSQ total scores were higher in the DTG treatment group compared to the DRV/r treatment group at all evaluated time points; however, differences were statistically significant at Week 24 (p=0.005) only.
|DTG 50 mg once daily (N=214) Median (range)||DRV/r 800 mg/100mg once daily (N=206) Median (range)||p-value|
|Week 4||56.0 (21, 60)||54.0 (22, 60)||0.050|
|Week 24||58.0 (29, 60)||57 (21, 60)||0.005|
|Week 48||58.0 (40, 60)||57.0 (29, 60)||0.060|
The HIVTSQ lifestyle/ease sub-score showed differences consistent with the total scores, although differences between treatment groups were significant at both Week 24 (p=0.017) and Week 48 (p=0.044). The convenience item score was statistically significantly higher in the DTG group compared to the DRV/r treatment group at Weeks 4 (p<0.001), 24 (p=0.002), and 48 (p=0.003).
Conclusions: In addition to showing improvement in treatment efficacy, DTG showed improvements in treatment satisfaction over DRV/RTV in the FLAMINGO study.
References: Woodcock A, Bradley C. Validation of the HIV treatment satisfaction questionnaire (HIVTSQ). Qual Life Res. 2001; 10(6):517-31.Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006; 9(5): 20-33.
M. Murray1, B. Goodqin2, D. Hagins3, S. Gallien4, C. Brennan5, S. Min2
1ViiV Heatlhcare, Health Outcomes, London, United Kingdom, 2GSK, RTP, United States, 3Chatham Care Center, Savannah, United States, 4Hopital St Louis, Universite Paris Diderot, Paris, France, 5GSK, London, United Kingdom