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(dolutegravir/lamivudine)

Power reimagined
gemini 1
gemini 2

2 FULLY POWERED CLINICAL TRIALS WITH MORE THAN 1,400 TREATMENT-NAÏVE PATIENTS COMBINED

Phase III, Identically Designed, Double-Blind, Parallel-Group, Multicentre Non-Inferiority Studies 1

2 fully powdered clinical trails
2 fully powdered clinical trails

POWERFUL EFFICACY IN TREATMENT-NAÏVE ADULT

  • Efficacy

    RAPID, POWERFUL AND DURABLE EFFICACY

    DOVATO Non-Inferior to DTG + TDF/FTC at 96 Weeks 1

    Efficacy graph
    Efficacy graph

    ITT–E Snapshot analysis.

    Adapted from Cahn et al, 2019. 1

  • Baseline Viral Load Strata

    POWERFUL SUPPRESSION ACROSS VIRAL LOAD STRATA

    Virological Outcomes by Baseline Viral Load at 96 Weeks (ITT–E Pooled Analysis) 1

    Baseline viral load strata

    DTG 50 mg + 3TC 300 mg used in the GEMINI studies.

    Adapted from Cahn et al, 2019. 1

  • Viral Blips

    ROBUST VIROLOGICAL CONTROL COMPARABLE TO DTG + TDF/FTC

    Similar Viral Blip* Frequencies Across Both Arms Through Week 48 3

    Viral blips
    Viral blips

    Adapted from Cahn et al, 2019. 3

    • Proportion of patients with viral blips was similar across both arms: 12% (83/716) in DOVATO vs 13% (93/717) in DTG + TDF/FTC  3

    DTG 50 mg + 3TC 300 mg used in the GEMINI studies.

    *A viral blip is a transient increase in viral load ≥50 copies/mL to <200 copies/mL bounded by viral loads <50 copies/mL. Note: individual patients could have had ≥1 blip.

  • Virological Outcomes by Baseline CD4+ T-cell Count Strata at 96 Weeks 1

    • ITT-E: >200 cells/mm3 DOVATO 88% (573/653) vs DTG + TDF/FTC 90% (594/662) 
    • When treatment-related discontinuation=failure (TRDF)* analysis is applied: >200 cells/mm3  DOVATO 97% (633/653) vs DTG + TDF/FTC 96% (638/662) 
    • ITT-E: ≤200 cells/mm3 DOVATO 68% (43/63) vs DTG + TDF/FTC 87% (48/55) 
    • When TRDF analysis is applied: ≤200 cells/mm3 DOVATO 94% (59/63) vs DTG + TDF/FTC 96% (53/55)

    DTG 50 mg + 3TC 300 mg used in the GEMINI studies

    *Treatment-related discontinuation=failure was a pre-planned analysis for Week 96 and accounts for confirmed virological withdrawal, withdrawal due to lack of efficacy, withdrawal due to treatment-related adverse events and patients who met protocol-defined stopping criteria.

  • A DURABLE HIGH BARRIER TO RESISTANCE UP TO 96 WEEKS

    A DURABLE HIGH BARRIER TO RESISTANCE UP TO 96 WEEKS

    Mutations observation

    DTG 50 mg + 3TC 300 mg used in the GEMINI studies.

    patients met confirmed virological withdrawal criteria if a second and consecutive HIV-1 RNA value met any of the following definitions: decrease from baseline in HIV-1 RNA of <1 log10 copies/mL, unless HIV-1 RNA of <200 copies/mL, by Week 12; confirmed plasma HIV-1 RNA of ≥200 copies at or after Week 24; or confirmed rebound (HIV-1 RNA ≥200 copies/mL after confirmed consecutive HIV-1 RNA <200 copies/mL).

  • Why does DOVATO have a high barrier to resistance?

    Why does DOVATO have a high barrier to resistance?

    Watch Romina Querica, Global Director of Medical Virology at ViiV Healthcare, explain the contributing factors to the high barrier to resistance of DOVATO

    Video player requires JavaScript enabled. You can download this video here: https://videos.gskstatic.com/pharma/GSKpro/Ireland/MP4/barrier-to-resistance-video-dovato.mp4
  • OVERALL, ADVERSE EVENT (AE) PROFILES WERE COMPARABLE ACROSS BOTH ARMS

    OVERALL, ADVERSE EVENT (AE) PROFILES WERE COMPARABLE ACROSS BOTH ARMS 1

    Significantly Lower Rate Of Drug-Related Adverse Events vs DTG + TDF/FTC At 96 Weeks*

    Adapted from Cahn et al, 2019. 1

    *The relative risk ratio (95% CI) For Dovato vs DTG+ TDF/FTC was 0.78 (0.64,0.95). 1

    3 deaths (acute myocardial infarction, n=1; Burkitts's lymphoma, n=1; coronary artery disease, n=1); 1 in GEMINI-1 and 2 in GEMINI-2; all were in the DOVATO group and were considered unrelated to the study drug regimen. 1

    Minimal changes in overall mean weight. Change from baseline was +3.1 kg in the DOVATO arm and +2.1 kg in the DTG+TDF/FTC arm. 1

Mutations observation

METABOLIC BIOMARKERS vs A TDF-CONTAINING REGIMEN AT 96 WEEKS

Bone

Changes in bone turnover biomarkers

SIGNIFICANTLY FAVOUR

DOVATO vs DTG + TDF/FTC  1

Renal

Changes in renal function biomarkers 

SIGNIFICANTLY FAVOUR

DOVATO vs DTG + TDF/FTC  1

AEs due to renal and urinary disorders were comparable across both arms. 5

TC-HDL ratio



CHANGES IN TC/HDL RATIO

A statistically greater reduction in TC/HDL ratio occurred in the DTG+TDF/FTC arm vs DOVATO, however there was also an improvement in the DOVATO arm.  1

The GEMINI studies did not determine whether these changes translate to clinical differences.

DTG 50 mg + 3TC 300 mg used in the GEMINI studies

Tango

COMPARATIVE STUDY OF DOVATO vs TAF-CONTAINING REGIMENS IN MORE THAN 700 VIROLOGICALLY SUPPRESSED PATIENTS

Phase III, Randomised, Multicentre, Parallel-Group, Non-Inferiority Switch Study 7
Comparative study
Comparative study
  • CONFIDENCE WITH POWERFUL EFFICACY MAINTAINED AT WEEK 48

    CONFIDENCE WITH POWERFUL EFFICACY MAINTAINED AT WEEK 48

    No Increased Risk of Virological Failure vs TAF-Containing Regimens 7
    Powerful efficacy maintained at Wk48

    ITT–E Snapshot analysis.

    Adapted from van Wyk et al, 2019. 7

    Virologicial failure defined as HIV-1 RNA ≥50 copies/mL.

  • REASSURANCE WITH A HIGH BARRIER TO RESISTANCE UP TO 48 WEEKS

    REASSURANCE WITH A HIGH BARRIER TO RESISTANCE UP TO 48 WEEKS

    Reassurance with a high barrier

    §Patients met confirmed virological withdrawal criteria if they had 1 assessment with HIV-1 RNA ≥200 copies/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 copies/mL

  • OVERALL ADVERSE EVENTS WERE COMPARABLE ACROSS BOTH ARMS AT 48 WEEKS

    OVERALL ADVERSE EVENTS WERE COMPARABLE ACROSS BOTH ARMS AT 48 WEEKS 7

    Any drug related AE, grades 2-5 and AEs leading to withdrawal were higher in the Dovato arm vs the TAF-containing regimen arm. This is expected since the majority of patients were switching to a new regimen after suppression on their previous regimen for approx. 3 years (median).

    Overall adverse events
    Adapted from van Wyk et al, 2019. 1
    **1 fatal AE occurred (homicide) in the DOVATO arm. No serious AEs were drug related. 7
    Minimal changes in overall mean weight. Change from baseline was ≈0.8 kg over 48 weeks in both treatment arms. 1

METABOLIC BIOMARKERS AT 48 WEEKS

TC-HDL ratio


INCREASED PROPORTIONS OF PATIENTS WITH OPTIMAL TC/HDL RATIO (<3.5)

classified by NCEP category as 'Green' (<3.5) in the Dovato arm, while remaining constant in the TAF-containing regimen arm vs baseline 7

Bone

MINIMAL CHANGES

in bone turnover biomarkers in both treatment arms 7††

Renal

MINIMAL CHANGES

in renal function biomarkers in both treatment arms 7††

The TANGO study did not determine whether these effects translate to clinical differences.

A COMPLETE REGIMEN OFFERING CONVENIENT DOSING FOR YOUR PATIENTS 6

 Icon once daily

ONE PILL,
ONCE A DAY

24 hours

NO TIME-OF-DAY
RESTRICTIONS

No food

CAN BE TAKEN WITH OR WITHOUT FOOD

Risk of drug

FEW SIGNIFICANT DRUG-DRUG INTERACTIONS

  • Minimal effect on metabolism via the CYP3A4 pathway
  • No known interactions with contraceptives, antihypertensives, proton pump inhibitors, statins, PDE-5 inhibitors or recreational drugs
  • Avoid chronic co-administration of sorbitol and similar solutions
  • Dose adjustment of metformin may be required
  • Dose adjustment of DTG required for rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital and St. John's wort
  • Timing of dose will need to be adjusted if co-administered with polyvalent cation-antacids
  • Timing of dose may need to be adjusted with supplements or multivitamins containing calcium, iron or magnesium
Power reimagined
ower reimagined

References:

  1. Cahn P, Sierra Madero J, Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infections: 96-week results from the GEMINI studies, Presented at: International AIDS Conference; July 21-24, 2019; Mexico City, Mexico, Slides WEAB0404LB.
  2. Orkin C, Porteiro N, Berhe M, et al. Two-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) is non-inferior to dolutegravir plus tenofovir/ emtricitabine (DTG + TDF/FTC) at 48 weeks in antiretroviral treatment-naïve adults with HIV-1 infection: subgroup analyses in the GEMINI studies. Presented at: HIV Drug Therapy Glasgow; October 28-31, 2018; Glasgow, UK. Poster P021. 
  3. Underwood M, Wang R, Horton J, et al. Dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir/emtricitabine (TDF/FTC) fixed-dose combination in the GEMINI studies-viral load rebound including 'blips' through 48 weeks. Presented at: International AIDS Conference ; July 21-24, 2019; Mexico City, Mexico. Poster MOPEB231.
  4. Underwood M, Urbaityte R, Slevers J, et al. HIV replication at at <40 c/mL for DTG + 3TC vs DTG + TDF/FTC in the GEMINI-1 & 2 studies. Presented at: Conference on Retroviruses and Opportunistic Infection; March 4-7, 2019; Seattle, WA. Poster 490. 
  5. Data on file. GEMINI-1 and GEMINI-2 96-week renal and urinary disorders/adverse events; REF-31232. ViiV Healthcare group of companies. Research Triangle Park, NC. 
  6. DOVATO Summary of Product Characteristics , July 2019. https://www.medicines.ie/medicines/dovato-50-mg-300-mg-film-coated-tablets-34871/smpc
  7. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen in maintaining virologic suppression through 48 weeks (TANGO study). Presented at: International AIDS Conference; July 21-24, 2019; Mexico City. Slides WEAB0403LB.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

 These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse reactions.
Trade marks are owned by or licensed to the ViiV Healthcare group of companies.