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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

Efficacy

DELSTRIGO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
PIFELTRO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Doravirine/3TC/TDF = DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate)

144 Week Efficacy in Virologically Suppressed Adults with HIV-1 who switched to DELSTRIGO® (doravirine/3TC/TDF)

Using FDA snapshot approach:

 

Participants in the DRIVE SHIFT study switched from a baseline regimen consisting of 2 NRTIs in combination with a PI plus either ritonavir or cobicistat, or elvitegravir plus cobicistat, or an NNRTI1

Virologic suppression was maintained for over 2 years in adults with HIV-1 who switched to DOR/3TC/TDF (DELSTRIGO) from a boosted PI, boosted elvitegravir, or an NNRTI*2

Primary efficacy outcome

The proportion of participants with HIV-1 RNA <50 copies/ml at Week 48 in the immediate switch group compared to Week 24 in the delayed switch group.

The study demonstrated switching to DOR/3TC/TDF is non-inferior to continuing the baseline regimen for 24 weeks.

Virologic outcomes after switch to DOR/3TC/TDF

Graph illustrating 48 Week Efficacy in Virologically Suppressed Adults with HIV-1 who switched to DELSTRIGO

Adapted from Kumar P. et al. 2021*2

Drive Shift logo

80.1% vs. 83.7%

The proportion of participants with HIV-1 RNA <50 copies/ml at Week 144 in the immediate switch group compared to Week 144 in the delayed switch group.

* Participants who completed the base study (Week 48) but did not continue to extension-1 (up to Week 144) were excluded from the efficacy analysis after week 48.

DRIVE-SHIFT study design

Two 48-week studies of treatment-naïve adult participants with HIV-1 showed:

Efficacy regardless of baseline viral load

Using FDA snapshot approach:

 

DELSTRIGO was shown to be non-inferior to EFV/FTC/TDF as defined by HIV-1 RNA <50 copies/mL at Week 48 (84% vs. 81%)3

Graph compares 48-week studies of treatment-naïve adult participants with HIV-1 shows efficacy regardless of baseline viral load

Adapted from Orkin et al. 20193

Drive Ahead logo

21%

Proportion of participants who at baseline had HIV-1 RNA >100,000 copies/mL

DRIVE-AHEAD study design
 

PIFELTRO® (doravirine) + 2 NRTIs was shown to be non-inferior to DRV/r + 2 NRTIs as defined by HIV-1 RNA <50 copies/mL at Week 48 (84% vs. 80%)4

Graph indicates PIFELTRO+2 NRTIs shown non-inferior to DRV/r+2 NRTIs defined by HIV-1 RNA <50 copies/mL at wk 48 (84% vs. 80%)

Adapted from Molina et al. 20184

Drive Forward logo

22%

Proportion of participants who at baseline had HIV-1 RNA >100,000 copies/mL

DRIVE-FORWARD study design
Abbreviations

CI = Confidence Interval
DOR = Doravirine
EFV = Efavirenz
FDA = Food and Drug Administration
FTC = Emtricitabine
HIV-1 = Human Immunodeficiency Virus type 1
NNRTI = Non-nucleoside Reverse Transcriptase Inhibitor
NRTI = Nucleoside Reverse Transcriptase Inhibitor
PI = Protease Inhibitor
RNA = Ribonucleic Acid
TDF = Tenofovir Disoproxil Fumarate
3TC = Lamivudine

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References

  1. Johnson M, Kumar P, Molina JM, 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(4):463-472.
  2. Kumar P et al. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial. JAIDS Journal of Acquired Immune Deficiency Syndromes Publish Ahead of Print DOI: 10.1097/QAI.0000000000002642
  3. Orkin C, Squires KE, Molina JM, et al.; and DRIVE-AHEAD Study Group. Doravirine/lamivudine/ tenofovir disoproxil fumarate is non-inferior to efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults with human immunodeficiency virus–1 infection: week 48 results of the DRIVE-AHEAD trial. Clin Infect Dis. 2019;68(4):535–544.
  4. Molina JM, Squires K, Sax PE, et al.; for the DRIVE-FORWARD Study Group. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive 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. Epub. 2018 March 25.

Supporting documentation

DELSTRIGO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
PIFELTRO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website

GB-DOR-00160 | Date of Preparation: March 2021