671. STaR Study: Association of Efficacy Outcomes with Baseline HIV-1 RNA and CD4 Count and Adherence Rate for the Single-Tablet Regimens Rilpivirine/Emtricitabine/Tenofovir DF and Efavirenz/Emtricitabine/Tenofovir DF in ART-Na´ve Adults
Session: Oral Abstract Session: HIV Clinical Trials and Outcomes
Friday, October 4, 2013: 10:45 AM
Room: The Moscone Center: 250-262
Background:

Simplified antiretroviral regimens improve quality of life and adherence. Rilpivirine/Emtricitabine/Tenofovir DF (RPV/FTC/TDF) is a well-tolerated once-daily single-tablet regimen (STR) treatment option. This is the first study to directly compare the two STRs, RPV/FTC/TDF and Efavirenz/FTC/TDF (EFV/FTC/TDF) in treatment-naïve adults.

Methods:

STaR is a randomized, open-label, 96-week study to evaluate the safety and efficacy of the STR RPV/FTC/TDF to the STR EFV/FTC/TDF in treatment-naïve HIV-1 infected subjects, who were randomized 1:1 to RPV/FTC/TDF or EFV/FTC/TDF. Randomization was stratified by HIV-1 RNA level (≤100,000 c/mL or >100,000 c/mL) at screening. The primary endpoint was the proportion of subjects with HIV-1 RNA <50 c/mL (virologic suppression; VS) at Week (W) 48 (FDA snapshot algorithm; 12% pre-specified non-inferiority margin).

Results:

786 subjects were randomized and received at least 1 dose of study drug (394 RPV/FTC/TDF; 392 EFV/FTC/TDF). Baseline characteristics were similar in both treatment arms with mean CD4 count 391 cells/mm3 and HIV-1 RNA 4.8 log10 c/mL. RPV/FTC/TDF was non-inferior to EFV/FTC/TDF (86% vs 82%) at W48 for VS (difference 4.1%, 95% CI [-1.1%, 9.2%]). Overall, virologic failure (VF) was 8% RPV/FTC/TDF vs 6% EFV/FTC/TDF (difference 2.7%, 95% CI [-0.9%, 6.2%]). VS results by ordinal levels of adherence rate and baseline HIV-1 RNA and CD4 count at W48 are summarized in Table 1 (excluding 9 subjects with missing adherence measure).

                            Table 1*

 

 

 

 

VS

 

HIV-1 RNA

CD4

Adherence

N

RPVFTC/TDF

EFV/FTC/TDF

≤100,000

>200

≥95%

357

93% (171/184)

89% (154/173)

 

 

<95%

112

82% (46/56)

68% (38/56)

 

≤200

≥95%

23

80% (8/10)

77% (10/13)

 

 

<95%

12

67% (6/9)

67% (2/3)

>100,000

>200

≥95%

163

87% (69/79)

90% (76/84) 

 

 

<95%

42

70% (14/20)

72% (16/22)

 

≤200

≥95%

53

77% (20/26)

81% (22/27)

 

 

<95%

15

50% (4/8)

29% (2/7)

 

*Subjects with missing data were excluded

Conclusion:

RPV/FTC/TDF demonstrated overall non-inferior efficacy compared to EFV/FTC/TDF in treatment-naïve HIV-1-infected subjects.  The analysis showed the subgroup with adherence rate ≥95% had better virologic outcomes across both treatment arms and all HIV-1 RNA and CD4 categories, with most favorable results in the strata consisting of those with baseline HIV-1 RNA ≤100,000 c/mL, CD4 >200 cells/mm3 and adherence rate ≥95%. 

Calvin Cohen, MD, MSc1, David Wohl, MD2, Keith Henry, MD3, William Towner, MD4, Edmund Wilkins, MD5, Ramin Ebrahimi6, Danielle Porter6, Valeska Scharen-Guivel, Ph.D. MBA6, Todd Fralich6 and Shampa De-Oertel6, (1)Community Research Initiative of New England, Boston, MA, (2)University of North Carolina, Chapel Hill, NC, (3)University of Minnesota/HIV program Hennepin County Medical Center, Minneapolis, MN, (4)Kaiser Permanente, Los Angeles, CA, (5)North Manchester General Hospital, Manchester, United Kingdom, (6)Gilead Sciences, Foster City, CA

Disclosures:

C. Cohen, Gilead Sciences: Consultant, Investigator and Scientific Advisor, Consulting fee and Research support
Bristol Myers Squibb: Scientific Advisor, Consulting fee
Merck: Scientific Advisor, Consulting fee
Janssen: Scientific Advisor, Consulting fee
Tobira: Scientific Advisor, Consulting fee
Abbeive: Consultant, Consulting fee

D. Wohl, None

K. Henry, None

W. Towner, None

E. Wilkins, Janssen: Speaker's Bureau, Speaker honorarium
BMS: Speaker's Bureau, Speaker honorarium
MSD: Speaker's Bureau, Speaker honorarium
Abbott: Speaker's Bureau, Speaker honorarium
Tibotec: Speaker's Bureau, Speaker honorarium
Gilead: Speaker's Bureau, Speaker honorarium

R. Ebrahimi, Gilead Sciences: Employee, Salary

D. Porter, Gilead Sciences: Employee, Salary

V. Scharen-Guivel, None

T. Fralich, Gilead Sciences: Employee, Salary

S. De-Oertel, Gilead Sciences: Employee, Salary

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