DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD
DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD: Design DRIVE AHEAD: Study Design • Background : Randomized, double-blind, active- controlled, phase 3 study evaluating the efficacy and safety of doravirine-tenofovir DF-lamivudine DOR-TDF-3TC (DOR-TDF-3TC) versus efavirenz-tenofovir DF- (n = 364) emtricitabine (EFV-TDF-FTC) for treatment-naïve individuals • Inclusion Criteria - Age ≥18 - Antiretroviral-naïve - HIV RNA ≥1,000 copies/mL EFV-TDF-FTC - No resistance to any study drug (n = 364) - Chronic HBV or HCV allowed • Regimens - Doravirine-TDF-3TC (100/300/300 mg) - Efavirenz-TDF-FTC (600/300/200 mg) Source: Orkin C, et al. Clin Infect Dis. 2019:68:535-44.
DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD: Results Week 48 Virologic Response (Observed Failure) Doravirine-Tenofovir DF-Lamivudine Efavirenz-Tenofovir DF-Emtricitabine 100 HIV RNA <50 copies/mL (%) 91.1 90.6 88.7 88.8 80 81.2 80.8 60 40 20 307/346 294/331 251/277 235/258 56/69 59/73 0 ≤100,000 copies/mL All >100,000 copies/mL Baseline HIV RNA Source: Orkin C, et al. Clin Infect Dis. 2019:68:535-44.
DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD: Results Week 48 Virologic Response (FDA Snapshot: All missing data= Failure) Doravirine-Tenofovir DF-Lamivudine Efavirenz-Tenofovir DF-Emtricitabine 100 84.3 80.8 80 Response (%) 60 40 20 10.7 10.2 307/364 294/364 39/364 37/364 0 HIV RNA ≤50 copies/mL HIV RNA >50 copies/mL Source: Orkin C, et al. Clin Infect Dis. 2019:68:535-44.
DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD: Results Treatment Emergent Adverse Events in DRIVE AHEAD Through Week 48 DOR/TDF/3TC EFV/TDF/FTC (n = 364) (n = 364) Drug- related AE’s, % 31 63 Discontinued due to drug-related AE, % 3 7 Headache, % 13 12 Diarrhea, % 11 13 Nausea, % 8 11 Vomiting, % 4 7 Abnormal Dreams, % 5 12 Rash, % 5 12 Source: Orkin C, et al. Clin Infect Dis. 2019:68:535-44.
DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD: Results Proportion with Pre-Defined Neuropsychiatric Side Effects at Week 48 Doravirine-Tenofovir DF-Lamivudine Efavirenz-Tenofovir DF-Emtricitabine 50 p < 0.05 p < 0.05 p < 0.05 Percent of Participants 40 37.1 30 25.5 20 12.1 8.8 8.2 10 6.6 4.4 4.1 0 Dizziness Sleep disorder, Altered sensorium Depression, disturbance suicide, self-injury Source: Orkin C, et al. Clin Infect Dis. 2019:68:535-44.
DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD: Results Change in Baseline Fasting Lipids at Week 48 Doravirine-Tenofovir DF-Lamivudine Efavirenz-Tenofovir DF-Emtricitabine 30 Change from Baseline, mg/dL 22.0 21.8 20 8.7 8.5 10 1.9 0 -1.6 -2.0 -10 -12.4 -20 Cholesterol LDL Cholesterol HDL Cholesterol Triglycerides Source: Orkin C, et al. Clin Infect Dis. 2019:68:535-44.
DOR-TDF-3TC vs. EFV-TDF-FTC as Initial Therapy DRIVE AHEAD: Summary Conclusions : “ In HIV-1 treatment-naive adults, doravirine/lamivudine/tenofovir DF demonstrated non-inferior efficacy to efavirenz/emtricitabine/tenofovir DF at week 48 and was well tolerated, with significantly fewer neuropsychiatric events and minimal changes in LDL-C and non-HDL-C compared with efavirenz/emtricitabine/tenofovir DF .” Source: Orkin C, et al. Clin Infect Dis. 2019:68:535-44.
Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $800,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program. The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.
Recommend
More recommend
