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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
POWERFUL EFFICACY IN TREATMENT-NAÏVE ADULT
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Efficacy
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Baseline Viral Load Strata
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Viral Blips
ROBUST VIROLOGICAL CONTROL COMPARABLE TO DTG + TDF/FTC
Similar Viral Blip* Frequencies Across Both Arms Through Week 48 3
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.
- 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
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A DURABLE HIGH BARRIER TO RESISTANCE UP TO 96 WEEKS
A DURABLE HIGH BARRIER TO RESISTANCE UP TO 96 WEEKS
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).
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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
METABOLIC BIOMARKERS vs A TDF-CONTAINING REGIMEN AT 96 WEEKS
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
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
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CONFIDENCE WITH POWERFUL EFFICACY MAINTAINED AT WEEK 48
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REASSURANCE WITH A HIGH BARRIER TO RESISTANCE UP TO 48 WEEKS
REASSURANCE WITH A HIGH BARRIER TO RESISTANCE UP TO 48 WEEKS
§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
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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).
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
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
MINIMAL CHANGES
in bone turnover biomarkers in both treatment arms 7††
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
ONE PILL,
ONCE A DAY
NO TIME-OF-DAY
RESTRICTIONS
CAN BE TAKEN WITH OR WITHOUT FOOD
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
References:
- 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.
- 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.
- 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.
- 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.
- 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.
- DOVATO Summary of Product Characteristics , July 2019. https://www.medicines.ie/medicines/dovato-50-mg-300-mg-film-coated-tablets-34871/smpc
- 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.
