NON-INFERIORITY IN ITT–E ANALYSIS VS TAF-CONTAINING REGIMENS AT 144 WEEKS
Virological Outcomes At 144 weeks
ITT–E Snapshot analysis.
- 48-week primary endpoint (HIV-1 RNA ≥50 copies/mL): DOVATO 0.3% (1/369) vs TAF-containing regimens 0.5% (2/372)
EFFICACY CONFIRMED IN POST HOC ANALYSIS WITH MORE STRINGENT VIRAL LOAD (VL) MEASURES
- The proportion of patients with VL <40 copies/mL and target-not-detected (TND) at each visit was high and comparable across arms
- The proportion of patients who maintained post baseline TND through Week 144 was comparable across arms
- >90% of participants in the DOVATO arm with TND at baseline never had a VL ≥40 copies/mL
- The frequency of blips* was low and similar across arms (5% DOVATO vs 7% TAF-containing regimens)
These long-term virology data continue to demonstrate the potency and durability of DOVATO compared with 3DRs in maintaining virological suppression.
*”Blips”, defined as VLs between 50 and 200 copies/mL with adjacent VL value of <50 copies/mL, are included in this category.
†Five participants with baseline VL <40 copies/mL in the DOVATO arm and 1 participant with baseline VL ≥50 copies/mL in TBR arm not presented due to no post baseline VL data.
DURABLE SUPPRESSION ACROSS DIVERSE VIROLOGICALLY SUPPRESSED PATIENTS
*In all 8 Snapshot non-responders on DOVATO with baseline CD4+ T-cell count <350 cells/mm, Snapshot non-response occurred for non-virological reasons.
TANGO Study Design
DOVATO VS TAF-CONTAINING REGIMENS IN MORE THAN 700 VIROLOGICALLY SUPPRESSED PATIENTS
Phase III, Randomised, Non-Inferiority Switch Study
*Historical resistance results (post hoc analysis) provided at screening were not included in the electronic case report form nor were they part of the locked database but are data on file that have been source verified and archived in the study trial master file.
A TOLERABILITY PROFILE YOU EXPECT FROM DOVATO
*One participant was excluded for receiving a TDF-containing regimen instead of a TAF-containing regimen.
†All drug-related AEs through Week 96 were Grade 1 or 2; most drug-related AEs through Week 144 were Grade 1 or 2, except for 2 Grade 3 events (suicidal ideation and increased transaminases in the DTG/3TC group) and 1 Grade 4 event (angioedema in the TAF-containing regimen group). In the post Week 48 analysis of AEs, rates of drug-related AEs, serious AEs and AEs leading to discontinuation were similar between groups.
‡Participants may have had ≥1 AE leading to withdrawal.
§n=342 for both arms. Two drug-related serious AEs occurred through Week 144 (increased transaminases in the DTG/3TC group and angioedema in the TAF-containing group); 2 fatal AEs occurred in the DTG/3TC group through Week 96 (gunshot wound [homicide] and substance abuse [acute intoxication]), which were unrelated to study treatment; 1 additional fatal AE occurred in the DTG/3TC group through Week 144 (ischaemic hepatitis) and was unrelated to study treatment. 1 additional fatal AE occurred in the DTG/3TC group through Week 144 (ischaemic hepatitis) and was unrelated to study treatment. In the post Week 48 analysis of AEs, rates of drug-related AEs, serious AEs and AEs leading to discontinuation were similar between group.
Want to hear from the experts, including past webinar recordings?
- Osiyemi O, De Wit S, Ajana F, et al. Efficacy and the safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, non-inferiority TANGO randomized trial. Clin Infect Dis. 2022;ciac036 and suppl 1-18. doi:10.1093/cid/ciac036
- van Wyk J, Ajana F, Bisshop F, et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1: phase 3, randomized, noninferiority TANGO study. Clin Infect Dis. 2020;71(8):1920-1929. doi:10.1093/cid/ciz1243
- Wang R, George N, Ait-Khaled M, et al. Low-level HIV-1 replication for DTG/3TC vs TAF-based regimen in TANGO through week 144. Presented at: Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; Virtual. Poster 484.
- Scholten S, Ajana F, Benson P, et al. Switching to DTG/3TC is non-inferior to continuing a TAF-based regimen at week 144: TANGO subgroup analyses. Presented at: 18th European AIDS Conference; October 27-30, 2021; London, England. Poster PE2/71.
October 2022 PM-GB-DLL-WCNT-220004
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