DRIVE-FORWARD trial

PIFELTRO® DRIVE-FORWARD trial*

PIFELTRO® was studied in a Phase 3 non-inferiority trial1

Randomized, international, multicenter, double-blind, active-controlled trial to assess efficacy and safety profile (48- and 96-week duration)2

Pifeltro Drive Forward Trial

Entry criteria:1

  • Adults ≥18 years of age
  • Plasma HIV-1 RNA ≥1000 copies/mL (at screening)
  • Naïve to antiretroviral therapy
  • No documented or known resistance to any of the study drugs
  • Calculated creatinine clearance ≥50 mL/min
  • Alkaline phosphatase concentrations ≤3X ULN
  • Aminotransferase concentration ≤5X ULN

PIFELTRO® demonstrated a non-inferior proportion of patients achieving HIV RNA <50 copies/mL at 48 weeks vs. DRV/r, each in combination with FTC/TDF or ABC/3TC and at Week 96, efficacy in the PIFELTRO® group was higher vs. the DRV/r group (using the FDA snapshot approach, secondary endpoint) supporting the non-inferiority previously established at Week 482,*

Proportion of patients achieving HIV RNA <50 copies/mL at 48 weeks*

Treatment Week Graph

NRTIs=FTC/TDF or ABC/3TC
Adapted from Molina JM et al1 and PIFELTRO® Product Monograph2

See demographic and baseline prognostic factors

Efficacy data in patients with baseline HIV-1 of ≤100,000 or >100,000 copies/mL (secondary endpoint) at Week 48

PIFELTRO® vs. DRV/r each with 2 NRTIs

PIFELTRO® vs. DRV/r each with 2 NRTIs

20%

NRTIs=FTC/TDF or ABC/3TC
Adapted from PIFELTRO® Product Monograph2

* DRIVE-FORWARD: Randomized, multicenter, double-blind, active-controlled trial. Adult ART-naïve patients (n=766) were randomized to PIFELTRO® or DRV/r orally, each in combination with FTC/TDF or ABC/3TC once daily, for 48 weeks. Patients also received placebos that matched the other treatment. The prespecified non-inferiority margin at Week 48 was -10%.

NRTI=nucleoside reverse-transcriptase inhibitor; FTC=emtricitabine; TDF=tenofovir disoproxil fumarate; ABC= abacavir; 3TC= lamivudine; DRV/r=darunavir boosted with ritonavir; ULN=upper limit of normal; CI=confidence interval; ART=antiretroviral therapy

References: 1. Molina JM et al. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naïve adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. Lancet HIV. 2018;5(5):e211-e220. doi: 10.1016/S2352-3018(18)30021-3. 2. PIFELTRO® Product Monograph. Merck Canada Inc. December 10, 2024.

CA-DOR-00155