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      STaR: Single-Tablet Regimen Rilpivirine/Emtricitabine/Tenofovir DF has Similar Efficacy and is Well-Tolerated Compared to Efavirenz/Emtricitabine/Tenofovir DF in ART-Naïve Females at Week 96

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          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

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          Author and article information

          Journal
          Open Forum Infect Dis
          Open Forum Infect Dis
          ofid
          ofids
          Open Forum Infectious Diseases
          Oxford University Press
          2328-8957
          December 2014
          December 2014
          : 1
          : Suppl 1 , IDWeek 2014 Abstracts
          : S21
          Affiliations
          [1 ]Howard Brown Health Center, Chicago, IL
          [2 ]Central Texas Clinical Research, Austin, TX
          [3 ]Tarrant County Infection Disease Associates, Fort Worth, TX
          [4 ]Infectious Disease, New York Hospital Queens, Flushing, NY
          [5 ]Infectious Diseases, Henry Ford Hospital, Detroit, MI
          [6 ]Center for the Prevention and Treatment of Infections, Pensacola, FL
          [7 ]Gilead Sciences, Foster City, CA
          [8 ]Gilead Sciences, Fostser City, CA
          Author notes

          Session: 64. HIV Antiretroviral Therapy

          Thursday, October 9, 2014: 2:00 PM

          Article
          ofu051
          10.1093/ofid/ofu051.56
          5782352
          5f436919-af02-4757-b721-28fa0b27dfae
          © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America
          History
          Categories
          IDWeek 2014 Abstracts
          Oral Abstracts

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