672. SPIRIT:  Simplification to Rilpivirine/Emtricitabine/Tenofovir DF Single-Tablet Regimen from Boosted Protease Inhibitor Maintains HIV-1 Suppression and Improves Fasting Lipids at Week 48
Session: Oral Abstract Session: HIV Clinical Trials and Outcomes
Friday, October 4, 2013: 11:00 AM
Room: The Moscone Center: 250-262
Background:

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.

Pablo Tebas, MD1, Frank Palella, MD2, Peter Ruane, MD3, David Shamblaw, MD4, Jason Flamm, MD5, Ramin Ebrahimi6, Danielle Porter6, Scott Williams6, Toni Sparrow6, Todd Fralich6 and Shampa De-Oertel6, (1)University of Pennsylvania School of Medicine, Philadelphia, PA, (2)Northwestern University, Chicago, IL, (3)Peter J. Ruane, MD, Inc, Los Angeles, CA, (4)La Playa Medical Group, San Diego, CA, (5)Kaiser Permanente, Sacramento, CA, (6)Gilead Sciences, Foster City, CA

Disclosures:

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

F. Palella, Merk: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
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

Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 2nd with the exception of research findings presented at the IDWeek press conferences.