Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR Trial

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Presentation transcript:

Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR Trial

Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR Study: Design Study Design: STaR Study Background: Randomized, open label, phase 3b trial comparing safety and efficacy of two single- tablet regimens, RPV-TDF-FTC and EFV-TDF- FTC, in treatment-naïve HIV-infected patients Inclusion Criteria (n = 786) - Antiretroviral-naïve patients - Age > 18 - HIV RNA ≥ 2500 copies/mL - No resistance to EFV, RPV, TDF, or FTC Treatment Arms - Rilpivirine-tenofovir DF-emtricitabine - Efavirenz-tenofovir DF-emtricitabine Rilpivirine-TDF-FTC QD (n = 394) Efavirenz-TDF-FTC QD (n = 392) Source: Cohen C, et al. AIDS. 2014;28:989-97.

Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR: Result Week 48 Virologic Response (Intent-to-Treat Analysis) 338/394 320/392 231/260 204/250 107/134 110/142 Source: Cohen C, et al. AIDS. 2014;28:989-97.

Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR: Result 48 Week Virologic Outcomes Source: Cohen C, et al. AIDS. 2014;28:989-97.

Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR Study: Common Adverse Events Treatment Emergent Adverse Events in > 5% of Subjects in Either Arm RPV-TDF-FTC (n = 392) EFV-TDF-FTC (n= 394) Dizziness 6.6% 22.2% Insomnia 9.6% 14.0% Somnolence 2.5% 6.9% Headache 12.4% 13.5% Abnormal Dreams 5.8% 24.5% Depression 8.9% Anxiety 5.1% 8.4% Folliculitis 5.3% 1.0% Rash 6.1% 12.0% Source: Cohen C, et al. AIDS. 2014;28:989-97.

RPV-FTC-TDF versus EFV-FTC-TDF STaR Study: Conclusions from Primary Analysis Conclusion: “In treatment-naive participants, RPV/FTC/TDF demonstrated noninferior efficacy and improved tolerability compared with EFV/FTC/TDF, as well as a statistically significant difference in efficacy for participants with baseline HIV-1 RNA 100,000 copies/mL or less at week 48.” Source: Cohen C, et al. AIDS. 2014;28:989-97.

Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR Study: Result Development of Genotypic Resistance at Week 48 Source: Porter D, et al. J Acquir Immune Defic Syndr. 2014;65:318-26.

Rilpivirine-TDF-FTC versus Efavirenz-TDF-FTC STaR Study: Result Development of Resistance to Study Drugs at 48 weeks, by Viral Load Source: Porter D, et al. J Acquir Immune Defic Syndr. 2014;65:318-26. .

RPV-FTC-TDF versus EFV-FTC-TDF STaR Study: Conclusions from Resistance Analysis Population Conclusions: “Among subjects in the primary resistance associated populations (RAP), resistance development to RPV/FTC/TDF consisted of NNRTI and NRTI mutations and was more frequent than resistance development to EFV/FTC/TDF. In subjects with baseline viral load ≤ 100,000 copies/mL, resistance development was low (<2%) for both RPV/FTC/TDF and EFV/FTC/TDF arms and less frequent compared with subjects with baseline viral load >100,000 copies/mL, for RPV/FTC/TDF.” Source: Porter D, et al. J Acquir Immune Defic Syndr. 2014;65:318-26.