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SIMILAR EFFICACY & SAFETY BY SUBGROUP IN DRIVE-AHEAD: DOR/3TC/TDF VERSUS EFV/FTC/TDF
Chloe Orkin1, Kathleen E. Squires2, Jean-Michel Molina3, Paul E. Sax4, Wing-Wai Wong5, Otto Sussmann6, Richard Kaplan7, Anthony Rodgers8, Xia Xu8, Gina Lin8, Sushma Kumar8, George G. Hanna8, Carey Hwang8, Elizabeth Martin8
1Royal London Hospital, London, UK,2Thomas Jefferson University, Philadelphia, PA, USA,3University Paris Diderot, Paris, France,4Brigham and Women's Hospital, Boston, MA, USA,5Taipei Medical University, Taipei, Taiwan,6Asistencia Cientifica de Alta Complejidad SAS, Bogota, Columbia,7Desmond Tutu HIV Foundation, Cape Town, South Africa,8Merck & Co, Inc, Kenilworth, NJ, USA
In the phase 3 DRIVE-AHEAD trial, a once-daily single-tablet regimen of doravirine 100 mg, lamivudine 300 mg, and tenofovir DF 300 mg (DOR/3TC/TDF) demonstrated non-inferior efficacy and a superior safety profile for neuropsychiatric events and fasting lipids compared to efavirenz 600 mg, emtricitabine 200 mg, and tenofovir DF 300 mg (EFV/FTC/TDF) at Week 48. To further characterize the effects of DOR/3TC/TDF, Week 48 results were examined by pre-specified subgroups (efficacy) and selected prognostic subgroups (safety).
DRIVE-AHEAD is a randomized (1:1), multicenter, double-blind, 96-week non-inferiority trial of DOR/3TC/TDF vs EFV/FTC/TDF in HIV-1 infected treatment-naïve adults. Randomization was stratified by screening HIV-1 RNA (≤/>100,000 copies/mL) and hepatitis B/C co-infection (yes/no). The primary endpoint was the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 (FDA Snapshot approach). For the current analysis, Week 48 efficacy results were summarized within pre-specified subgroups using the Observed Failure approach (participants with data missing for reasons other than lack of efficacy were excluded). Adverse events were also summarized by selected subgroups (gender, race/ethnicity, hepatitis co-infection, and baseline CD4+ T-cell count).
Baseline characteristics were balanced across the treatment groups. In the primary analysis, HIV-1 RNA <50 copies/mL was achieved by 84% of DOR/3TC/TDF recipients and 81% of EFV/FTC/TDF recipients at Week 48 (difference 3.5%, 95% CI [-2.0, 9.0]). Of the 728 participants who received study drug (364 in each treatment group), 677 (93%) were included in the subgroup efficacy analyses. Across the prespecified and selected demographic and baseline prognostic factors, the proportions of participants with HIV-1 RNA <50 copies/mL at Week 48 were comparable between the treatment regimens (table). Similar results were observed using the HIV-1 RNA cutoffs of 40 and 200 copies/mL and in the change from baseline in CD4+ T-cell counts. In the safety analysis, similar adverse event rates between treatment groups were observed across the subgroups.
At Week 48, across all baseline subgroups and prognostic factors, DOR/3TC/TDF demonstrated virologic and immunologic efficacy and safety comparable to that of EFV/FTC/TDF in HIV-1 treatment-naïve adults.