POWER REIMAGINED

AN INNOVATIVE NEW TREATMENT FOR YOUR PATIENTS LIVING WITH HIV

DOVATO is indicated for the treatment of HIV-1 in adults and adolescents above 12 years weighing

at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

For Your

TREATMENT-NAÏVE PATIENTS

For Your

VIROLOGICALLY SUPPRESSED PATIENTS

Supporting Downloads:

GEMINI 96-Week Infographic

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 Studies1

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

POWERFUL EFFICACY IN TREATMENT-NAÏVE ADULTS

RAPID, POWERFUL AND DURABLE EFFICACY

DOVATO Non-Inferior to DTG + TDF/FTC at 96 Weeks1

DOVATO Virological
Suppression


Rapid

72.0% at Week 4

Powerful

91.5% at Week 48

Durable

86.0% at Week 96
  • At Week 48, efficacy by subgroup was consistent with overall study results2

Adapted from Cahn et al, 2019.1

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

POWERFUL SUPPRESSION ACROSS VIRAL LOAD STRATA

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

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

Adapted from Cahn et al, 2019.1

ROBUST VIROLOGICAL CONTROL COMPARABLE TO DTG + TDF/FTC

Similar Viral Blip* Frequencies Across Both Arms Through Week 483

Adapted from Underwood 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/FTC3

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.

DOVATO Efficacy Confirmed by Suppression Assessment at 48 Weeks4

An assessment of virological suppression, known as target–not-detected (TND), was provided by a sub-analysis of the GEMINI data at 48 weeks.


Watch Jean van Wyk, Global Medical Lead for Dolutegravir at ViiV Healthcare, discuss results from the GEMINI 48-week sub-analysis.

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

See More Less

Virological Outcomes by Baseline CD4+ T-cell Count Strata at 96 Weeks1

  • 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.1

See more less

A DURABLE HIGH BARRIER TO RESISTANCE UP TO 96 WEEKS

No Treatment-Emergent INI or NRTI Mutations Observed in Both Arms

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/mL after confirmed consecutive HIV-1 RNA <200 copies/mL.
 

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.


Reflection of key opinion leaders on the 96 weeks Naive studies results

OVERALL ADVERSE EVENT PROFILES WERE COMPARABLE ACROSS BOTH ARMS AT 96 WEEKS1

LOWER RATE OF DRUG-RELATED ADVERSE EVENTS vs DTG + TDF/FTC AT 96 WEEKS

Adapted from Cahn et al, 2019.1

 

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

§The relative risk ratio (95% Cl) for DOVATO vs DTG + TDF/FTC was 0.78 (0.64, 0.95).1
|| 3 deaths (acute myocardial infarction, n=1; Burkitt'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

METABOLIC PARAMETERS vs A TDF-CONTAINING REGIMEN AT 96 WEEKS

Changes in bone 

turnover biomarkers

significantly favour

DOVATO vs DTG + TDF/FTC

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

Changes in renal 

function biomarkers

significantly favour

DOVATO vs DTG + TDF/FTC1

The Gemini studies did not determine whether these changes translate to clinical differences, AEs due to renal and urinary disorders were comparable across both arms (~5%)

Improvements

in TC/HDL ratio occurred in

both arms with a

statistically greater reduction 

in the DTG + TDF/FTC arm1

Overall mean weight 

change from baseline was

+3.1 kg in the DOVATO arm

and +2.1 kg in the

DTG + TDF/FTC arm1

       

Supporting Downloads:

TANGO 48-Week Infographic

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

Phase III, Randomised, Multicentre, Parallel-Group, Non-Inferiority Switch Study7

CONFIDENCE WITH POWERFUL EFFICACY MAINTAINED AT WEEK 48

No Increased Risk of Virological Failure vs TAF-Containing Regimens7

ITT–E Snapshot analysis.

Adapted from van Wyk et al, 2019.7

REASSURANCE WITH A HIGH BARRIER TO RESISTANCE UP TO 48 WEEKS

No INI or NRTI Mutations Observed at Confirmed Virological Withdrawal in Both Arms#

DTG 50 mg/3TC 300 mg used in the TANGO study
#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.


Reflection of key opinion leaders on the 48 weeks Switch studies results.

SUMMARY OF ADVERSE EVENTS (AEs) AT 48 WEEKS7

FOR THE MAJORITY OF THE PATIENTS IN THE DOVATO ARM THE INTRODUCTION OF 2 NEW ANTIRETROVIRALS MAY HAVE CONTRIBUTED TO THE NUMERICAL DIFFERENCES IN DRUG-RELATED AEs GRADE 2 TO GRADE 5.
Click to see all commonly reported AEs, drug-related AEs Grade 2 to Grade 5 and drug-related AEs leading to withdrawal.
 
Adapted from van Wyk et al, 2019. 1
 
**1 fatal AE occurred (homicide) in the DOVATO arm. No serious AEs were drug related. 7
 

METABOLIC PARAMETERS AT 48 WEEKS

INCREASED PROPORTION OF PATIENTS WITH OPTIMAL TC/HDL RATIO

in the DOVATO arm while remaining constant in the TAF-containing regimens arm vs baseline7

MINIMAL CHANGES

oin weight (≈0.8 kg) over 48 weeks from baseline in both treatment arms7

MINIMAL CHANGES

oin bone turnover biomarkers sin both treatment Arms. The TANGO study did not determine whether these changes translate to clinical differences††

MINIMAL CHANGES

in renal function biomarkers
sin both treatment Arms. The TANGO study did not determine whether these changes translate to clinical differences††

     

For Your

TREATMENT-NAÏVE PATIENTS

For Your

VIROLOGICALLY SUPPRESSED PATIENTS

A COMPLETE REGIMEN OFFERING CONVENIENT DOSING FOR YOUR PATIENTS6

ONE PILL,
ONCE A DAY
NO TIME-OF-DAY
RESTRICTIONS
CAN BE TAKEN WITH
OR WITHOUT FOOD
aaa
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
  • The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin. As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered approximately 12 hours after Dovato for the duration of the rifampicin co-administration (a separate formulation of dolutegravir is available for this dose)
  • Avoid chronic co-administration of sorbitol and similar solutions
  • The combination of Dovato with cladribine is not recommended
  • A dose adjustment of metformin should be considered when starting and stopping co administration of Dovato, to maintain glycaemic control. In patients with moderate renal impairment a dose adjustment of metformin should be considered when co-administered with Dovato, because of the increased risk for lactic acidosis in patients with moderate renal impairment due to increased metformin concentration
  • TThe recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, oxcarbazepine, carbamazepine, phenytoin, phenobarbital, St John’s wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, tipranavir/ritonavir. As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered approximately 12 hours after Dovato for the duration of co-administration
  • Polyvalent cation-containing antacids are recommended to be taken 2 hours after or 6 hours before Dovato and should not be co-administered at the same time
  • Supplements or multivitamins containing calcium, iron or magnesium can be taken at the same time as Dovato when with food. When Dovato is taken without food, it is recommended that the supplement is taken 2 hours after or 6 hours before Dovato

POWERED BY DOLUTEGRAVIR
AT THE CORE

DURABLE, NON-INFERIOR EFFICACY WITH 0 RESISTANCE vs A 3-DRUG REGIMEN

FEWER ANTIRETROVIRALS
vs A 3-DRUG REGIMEN:
TDF, TAF AND ABC FREE6

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 infection: 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, Sievers J, et al. HIV replication at <40 c/mL for DTG + 3TC vs DTG + TDF/FTC in the GEMINI-1 & -2 studies. Presented at: Conference on Retroviruses and Opportunistic Infections; 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.
  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, Mexico. Slides WEAB0403LB.

 

Date of Preparation: December 2019 | PM-GB-DLL-WCNT-190001

Nav Array - [Ljava.lang.String;@d3b1e0c [EDIT]