TUPE284 - Poster Exhibition
STaR study: single tablet regimen rilpivirine/emtricitabine/tenofovir DF has non-inferior efficacy compared to efavirenz/emtricitabine/tenofovir DF and improves patient reported outcomes
Community Research Initiative of New England, Boston, United States
Background: Rilpivirine/Emtricitabine/Tenofovir DF (RPV/FTC/TDF) and Efavirenz/Emtricitabine/Tenofovir DF (EFV/FTC/TDF) are once-daily, single tablet regimen (STR) HIV treatment options. This is the first study to directly compare safety and efficacy of the two STRs, RPV/FTC/TDF and EFV/FTC/TDF in treatment-naïve adults.
Methods: STaR is an ongoing, open-label, international, 96-week study evaluating safety and efficacy of the STR RPV/FTC/TDF vs the STR EFV/FTC/TDF in ARV-naïve HIV-1 infected subjects. Subjects were randomized 1:1 to RPV/FTC/TDF (n=394) or EFV/FTC/TDF(n=392). Eligibility criteria included screening HIV-1 RNA ≥2,500 copies/mL, genotypic sensitivity to EFV, FTC, TFV, and RPV, and no prior ARV therapy. The primary endpoint was proportion of subjects with HIV-1 RNA < 50 copies/mL at W48 per FDA snapshot analysis (12% non-inferiority margin). Subjects completed the HIV Symptom Index (HIVSI) questionnaire at all study visits.
Results: RPV/FTC/TDF met the primary endpoint of non-inferiority compared to EFV/FTC/TDF (86% vs 82%) at W48 for HIV RNA < 50 copies/mL (difference 4.1%, 95% CI [-1.1%, 9.2%]). In the RPV/FTC/TDF arm, there were fewer Grade 2-4 study drug-related treatment emergent adverse events than in the EFV/FTC/TDF arm (10% vs 30%). Intra-arm analysis demonstrated that subjects treated with RPV/FTC/TDF who completed the HIVSI (n=392) reported experiencing fewer symptoms at W48 compared to baseline, including psychiatric (feeling depressed, anxiety, problems falling asleep), gastrointestinal (diarrhea, loss of appetite), constitutional (fatigue, fevers, muscle aches, weight loss), lightheadedness, cough, headaches, lack of sexual interest, peripheral neuropathy (“tingling in the hands and feet”) and rash. No significant changes were reported for perceptions in hair loss or body image, nausea or trouble remembering. Additionally, interarm analysis showed at W48 significantly fewer subjects treated with RPV/FTC/TDF reported symptoms of diarrhea (p< 0.001) and peripheral neuropathy (p=0.027) than those treated with EFV/FTC/TDF who completed the HIVSI (n=388). There were no symptoms that were reported in significantly fewer subjects in the EFV/FTC/TDF arm than the RPV/FTC/TDF arm.
Conclusion: The STR RPV/FTC/TDF demonstrated overall non-inferior efficacy compared to the STR EFV/FTC/TDF in treatment-naïve HIV-1-infected subjects through 48 weeks. Subjects randomized to RPV/FTC/TDF reported improvement in nervous system, psychiatric, gastrointestinal and rash symptoms on the HIVSI at W48 compared to baseline.
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