DELSTRIGO® DRIVE-SHIFT trial*

DELSTRIGO® was studied in a Phase 3 non-inferiority trial in virologically-suppressed patients^1,*

DRIVE-SHIFT was a randomized, multicenter, open-label, active-controlled, non-inferiority trial. Patients who demonstrated virologic suppression on ART for ≥6 months were randomized to switch to DELSTRIGO® immediately (immediate switch group, ISG; n=447) or to continue the baseline regimen until Week 24 and then switch to DELSTRIGO® (delayed switch group, DSG; n=223). The baseline regimen consisted of 2 NRTIs + an NNRTI (24%), a PI (70%), or cobicistat-boosted elvitegravir (an INSTI) (6%).^1,2,*

Entry criteria:²

Virologically suppressed (HIV-1 RNA <50 copies/mL) on baseline regimen for ≥6 months prior to trial entry
No history of virologic failure

Time of evaluation of primary endpoint for each treatment group

Adapted from Johnson M et al.¹ and DELSTRIGO® Product Monograph²

DELSTRIGO® ISG at Week 48 was demonstrated non-inferior to the continued baseline regimen DSG at Week 24 in maintaining viral suppression (HIV RNA <50 copies/mL)²

Proportion of patients with HIV RNA <50 copies/mL

Difference

(95% CI):

-3.8% (-7.9, 0.3)

Consistent results with the primary endpoint was seen for the comparison at Week 24 in each treatment group (secondary endpoint).²

DELSTRIGO® was non-inferior to the baseline regimen if the lower bound of the 95% CI was above -8 percentage points.

Adapted from DELSTRIGO® Product Monograph²

DELSTRIGO® as studied in the Phase 3 extension of the DRIVE-SHIFT* trial in virologically suppressed patients through Week 144³

At week 144

HIV-1 RNA <50 copies/mL:
80.1% of the ISG (n=351/438)
83.7% of the DSG (175/209)

Tolerability profile³

The mean weight change from switch to Week 144 was +1.4 kg for ISG and +1.2 kg for DSG

Safety profile^3,4

The most common adverse events were nasopharyngitis (16.2%), headache (12.3%), and diarrhea (9.1%). Overall, 4.1% discontinued because of adverse events

The duration of this study is longer than that of the data in the Product Monograph.

* DRIVE-SHIFT: Randomized, international, multicenter, open-label, active-controlled, non-inferiority trial. Patients who demonstrated virologic suppression on ART for ≥6 months were randomized to switch to DELSTRIGO® immediately (immediate switch group, ISG; n=447) or to continue the baseline regimen until Week 24 and then switch to DELSTRIGO® (delayed switch group, DSG; n=223). The primary endpoint (snapshot approach) was the proportion of participants with HIV-1 RNA <50 copies/mL, with the primary comparison between the ISG at Week 48 vs. the DSG at Week 24. DELSTRIGO® was non-inferior to the baseline regimen if the lower bound of the 95% CI was above -8 percentage points. Baseline ART was a ritonavir- or cobicistat-boosted PI (atazanavir, darunavir or lopinavir), cobicistat-boosted elvitegravir, or an NNRTI (efavirenz, nevirapine, or rilpivirine), each in combination with two NRTIs. Participants who completed the Week 48 visit were eligible to enter study extension-1 and continue receiving open-label DOR/3TC/TDF for an additional 96 weeks (up to Week 144). Participants with protocol-defined virologic failure were discontinued from the trial, regardless of adherence to study therapy.

ART=antiretroviral therapy; DOR/3TC/TDF=doravirine/lamivudine/tenofovir disoproxil fumarate; DSG=Delayed Switch Group; ISG=Immediate Switch Group; NRTI=nucleoside reverse transcriptase inhibitor; NNRTI=non-nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; INSTI=integrase strand transfer inhibitor; EVG=elvitegravir; CI=confidence interval

References: 1. Johnson M et al. Switching to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) maintains HIV-1 virologic suppression through 48 weeks: results of the DRIVE-SHIFT trial. J Acquir Immune Defic Syndr 2019;81:463-72. 2. DELSTRIGO® Product Monograph. Merck Canada Inc. December 10, 2024. 3. Kumar P et al. Switching to DOR/3TC/TDF Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr 2021;87(2):801-805. 4. Medical Regulatory Letter. Merck Canada. September 21, 2023.

CA-DOR-00155