
Antiretroviral regimen simplification improves quality of life and medication adherence while reducing the risk of HIV virologic failure and long-term drug-related toxicities. Rilpivirine/Emtricitabine/Tenofovir DF (RPV/FTC/TDF) is a well-tolerated, efficacious once daily single-tablet regimen (STR) treatment option.
Methods:
SPIRIT is a phase 3b, open-label, 48-week study to evaluate the safety and efficacy of simplifying from PI+RTV+2NRTI to RPV/FTC/TDF in virologically-suppressed HIV-1 infected subjects, who were randomized 2:1 to switch to RPV/FTC/TDF at baseline (n=317) or maintain their current PI+RTV+2NRTI regimen until a delayed switch to RPV/FTC/TDF at Week (W) 24 (n=159). The primary endpoint was non-inferiority (12% margin) of RPV/FTC/TDF to PI+RTV+2NRTI in maintaining plasma HIV-1 RNA <50 c/mL (virologic suppression; VS) at W24 by FDA snapshot analysis
Results:
The primary endpoint of non-inferiority at W24 was met (VS 93.7% RPV/FTC/TDF vs 89.9% PI+RTV+2NRTI; difference 3.8%, 95% CI [-1.6 to 9.1]). Through W48, 89.3% of subjects simplifying to RPV/FTC/TDF at baseline and 92.1% of subjects who simplified at W24 maintained VS. Changes in fasting lipids and NCEP categories are in the table.
|
Mean Change from Baseline
|
% of Patients in National Cholesterol Educational Program (NCEP) Target Categories |
||||||||
|
RPV/FTCV/TDF (Immediate switch) at W24 |
PI+RTV+2NRTI at W24 |
RPV/FTCV/TDF (Delayed switch) W24 – W48 |
RPV/FTCV/TDF (Immediate switch) at W48 |
NCEP Category |
RPV/FTCV/TDF (Immediate switch) at W24 |
PI+RTV+2NRTI at W24 |
RPV/FTCV/TDF (Delayed switch) W24 – W48 |
RPV/FTCV/TDF (Immediate switch) at W48 |
|
Total Cholesterol (mg/dL) |
-25 p<0.001 |
-1 |
-24 |
-24 |
Desirable<200 |
83.9% p<0.001 |
57.5% |
85.6% |
83.0% |
|
LDL (mg/dL) |
-16 p<0.001 |
0 |
-14 |
-16 |
Optimal <100 |
45.1% p<0.001 |
21.4% |
41.0% |
44.0% |
|
Triglycerides (mg/dL) |
-53 p<0.001 |
+3 |
-80 |
-64 |
Normal <150 |
81.1% p<0.001 |
53.4% |
84.9% |
86.5% |
|
HDL (mg/dL) |
-4 p<0.001 |
-1
|
-2 |
-2 |
High ≥60 |
17.2% p=0.48 |
16.0% |
15.4% |
22.9% |
|
Conclusion:
Through W48, VS was maintained regardless of whether subjects simplified to RPV/FTC/TDF at baseline or W24. Simplifying to RPV/FTC/TDF also led to significant improvement in fasting total cholesterol, LDL, and triglycerides, including significant changes in those NCEP categories.

P. Tebas,
Gilead Sciences: Investigator, Paid directly to the University of Pennsylvania and Research support
Merck: Consultant, Consulting fee
Up To Date: Consultant, Licensing agreement or royalty
Glaxo: Serve in adjudicationn committee of a vaccine study, Consulting fee
Cyntheris: Scientific Advisor, Consulting fee
Gilead Sciences: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Janssen Pharmaceuticals: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Bristol-Myers Squibb: Consultant and Shareholder, Consulting fee and Speaker honorarium
P. Ruane, Gilead Sciences: Consultant, Shareholder and Speaker's Bureau, <$20,000, Consulting fee and Speaker honorarium
D. Shamblaw, Gilead Sciences: Investigator and Speaker's Bureau, Research support and Speaker honorarium
ViiV Healthcare: Speaker's Bureau, Speaker honorarium
Bristol Myers Squibb: Speaker's Bureau, Speaker honorarium
Abbott: Speaker's Bureau, Speaker honorarium
Auxilium: Speaker's Bureau, Speaker honorarium
J. Flamm, Gilead Sciences: Investigator, goes directly to Kaiser Permanente for research
R. Ebrahimi, Gilead Sciences: Employee, Salary
D. Porter, Gilead Sciences: Employee, Salary
S. Williams, Gilead Sciences: Employee, Salary
T. Sparrow, Gilead Sciences: Employee, Salary
T. Fralich, Gilead Sciences: Employee, Salary
S. De-Oertel, Gilead Sciences: Employee, Salary