Background.
HIV treatment outcomes and adverse events (AEs) may vary by gender. STaR is the first
study to directly compare the safety and efficacy of the two single-tablet regimens
(STRs), rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF) and efavirenz (EFV)/FTC/TDF.
Methods.
STaR was an open-label, 1:1 randomized, 96-week study in treatment-naïve HIV-1 infected
subjects. The primary endpoint was the proportion of subjects with HIV-1 RNA <50 copies/mL
at W48 (12% non-inferiority margin; Snapshot analysis). Post-hoc analyses included
safety and efficacy by gender through W96.
Results.
for the primary endpoint, RPV/FTC/TDF (n = 394) was non-inferior to EFV/FTC/TDF (n
= 392) for HIV RNA <50 copies/mL (85.8% RPV/FTC/TDF vs 81.6% EFV/FTC/TDF; difference
4.1%, 95% CI [-1.1%, 9.2%]) at W48 and also at W96 (77.9% vs 72.4%; difference 5.5%,
95% CI [-0.6%, 11.5%]) with p = 0.76 for testing homogeneity of response between males
and females at W96.
For important AEs listed in the RPV and EFV prescribing information, rates of nervous
system AEs were 27.0% RPV/FTC/TDF vs 48.4% EFV/FTC/TDF in males and 28.6% vs 35.7%
in females with dizziness and headache being the most frequently reported; psychiatric
AEs were 29.0% vs 50.3% in males and 17.9% vs 32.1% in females with abnormal dreams,
anxiety, depression and insomnia being the most reported; and for rash events, 16.1%
vs 23.4% in males and 10.7% vs 35.7% in females. Rates of Grade 3-4 TEAEs were 9.6%
(35/366) RPV/FTC/TDF vs 16.2% (59/364) EFV/FTC/TDF in males, and 17.9% (5/28) vs 21.4%
(6/28) in females. Rates of discontinuation due to AEs were 2.7% (10/366) vs 11.0%
(40/364) in males and 7.1% (2/28) vs 10.7% (3/28) in females.
W96 Virologic Suppression by Gender
RPV/FTC/TDF
EFV/FTC/TDF
Strata Adjusted Diff (95% CI)
Males
78.7% (288/366)
73.6% (268/364)
5.1% (-1.1% to 11.3%)
Females
67.9% (19/28)
57.1% (16/28)
12.0% (-15.5% to 39.5%)
Conclusion.
Overall, treatment with RPV/FTC/TDF was non-inferior to EFV/FTC/TDF at W48 and W96.
Though the number of females enrolled was small, there was no difference in rates
of virologic suppression between genders. In the female subpopulation, there were
lower rates of important nervous system, psychiatric, and rash AEs and lower rates
of discontinuations due to AEs in the RPV/FTC/TDF arm.
Disclosures.
C. Creticos, Gilead: Investigator, research fees to institution C. Brinson, Bristol-Myers
Squibb: Grant Investigator, received monies for conducting the trial; Gilead: Investigator,
Scientific Advisor, Speaker's Bureau and Speaker, Sit on Advisory Board, sit on education
Board, personal fees; Achillion: Investigator, Contract Principal Investigator for
clinical trials; BI: Investigator, Contract Principal Investigator for clinical trials;
BMS: Investigator, Contract Principal Investigator for clinical trials; ViiV: Investigator,
Contract Principal Investigator for clinical trials; GSK: Investigator, Contract Principal
Investigator for clinical trials; Gilead: Investigator, Contract Principal Investigator
for clinical trials; Shionggi: Investigator, Contract Principal Investigator for clinical
trials; AstraZeneca: Investigator, Contract Principal Investigator for clinical trials;
Pfizer: Investigator, Contract Principal Investigator for clinical trials; Jansen:
Investigator, Contract Principal Investigator for clinical trials; Sangamo: Investigator,
Contract Principal Investigator for clinical trials; Taimed: Investigator, Contract
Principal Investigator for clinical trials; Theratechnology: Investigator, Contract
Principal Investigator for clinical trials; Serono: Investigator, Contract Principal
Investigator for clinical trials C. Mcdonald, Gilead: Investigator and Speaker's Bureau,
Research support and Speaker honorarium; BMS: Investigator and Speaker's Bureau, Research
support and Speaker honorarium; Merck: Investigator, Research support; Boehringer-Ingleheim:
Investigator, Research support I. Brar, Gilead: Investigator, Shareholder, Speaker's
Bureau, Truvada® for this study was provided, Research grant and Speaker honorarium;
Merck: Funding and raltegravir for this study was provided, Grant Investigator, Research
support; ViiV: Investigator, Research grant B. Wade, Gilead: Investigator and Speaker's
Bureau, research funds to institution, Speaker honorarium W. Garner, Gilead: Employee
and Shareholder, Salary D. Porter, Gilead: Employee and Shareholder, Salary S. De-Oertel,
Gilead Sciences: Employee and Shareholder, Salary A. Weinberg, Gilead: Employee and
Shareholder, Salary T. Sparrow, Gilead: Employee and Shareholder, Salary