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Purpose: Antiretroviral regimen simplification improves both quality of life and long-term medication adherence while reducing risk of HIV virologic failure (VF) and long-term drug-related toxicities. FTC/RPV/TDF is a well-tolerated, once daily STR treatment option. This is the first study to evaluate the efficacy and safety of switching from a ritonavir-boosted (PI+RTV) based HAART to the STR FTC/RPV/TDF.
Methods: This randomized, open-label, international, 48-week study evaluated the safety and efficacy of switching from PI+RTV regimens to the STR FTC/RPV/TDF in virologically-suppressed [HIV-1 RNA (VL)<50copies/mL], HIV-1 infected subjects. Subjects were randomized 2:1 to switch to the STR FTC/RPV/TDF or maintain their current PI+RTV based therapy. The primary endpoint was non-inferiority (12% margin) of the STR FTC/RPV/TDF relative to PI+RTV in maintaining VL<50copies/mL at Wk24 (Snapshot analysis). Changes in fasting lipids from baseline were evaluated.
Results: 476 subjects were randomized to the STR FTC/RPV/TDF (n=317) and PI+RTV (n=159). Baseline characteristics were similar. Switching to STR FTC/RPV/TDF was non-inferior to maintaining a PI+RTV regimen (93.7% vs 89.9%; 95%CI -1.6%,9.1%) at Wk24 for VL<50copies/mL. Fewer subjects in the STR FTC/RPV/TDF arm than the PI+RTV arm had VF (0.9% vs 5.0%). Two subjects in the STR FTC/RPV/TDF arm had emergent resistance and one in the PI arm. Mean change in lipids from baseline at Wk24 for the STR FTC/RPV/TDF vs PI were TC -25 vs-1, LDL-16 vs 0, TG-53 vs 3 (mg/dL, p<0.0001), respectively. The mean Wholesale Acquisition Cost (WAC) for switching to FTC/RPV/TDF was 16% less at $10,275 versus staying on a PI+RTV regimen $12,272 for 24 weeks.
Conclusions: Switching to the STR FTC/RPV/TDF from a PI+RTV based regimen in virologically-suppressed, HIV-1-infected subjects maintained virologic suppression with low risk of VF, decreased pill burden, improved total cholesterol, LDL, triglycerides and was $1,997 (16%) less per subject over 24 weeks in medication costs per WAC evaluation.