DTG Monotherapy in HIV Maintenance: Study Results
Explore the MONCAY Study on DTG monotherapy for HIV maintenance, focusing on virologic outcomes and non-inferiority to standard cART at Week 24. The study examines efficacy, safety, and patient characteristics in a randomized design with 78 participants. Results show promising virologic control with certain considerations for virologic failures in the monotherapy arm.
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Presentation Transcript
Switch to DTG monotherapy DOMONO Study MONCAY Study EARLY-SIMPLIFIED Study
MONCAY Study: DTG monotherapy for maintenance Design Randomisation 1:1 Open label 18 years On DTG/ABC/3TC > 1 month HIV RNA < 50 c/mL > 12 months CD4 nadir > 100/mm3 No previous AIDS event No history of failure on INSTI or resistance to INSTI Creatinine clearance 50 mL/min Positive HBs Ag excluded Continuation DTG/ABC/3TC (N = 80) DTG monotherapy (N = 78) D1 W48 Objective Primary: % HIV RNA < 50 c/mL at W24, by ITT, missing or switch equals failure ; non-inferiority if upper margin of a two-sided 95% CI for the difference = 12%, power 90% sensitivity analyses: mITT, per-protocol Secondary: safety, virologic failure at W48 Hocqueloux L, Clin Infect Dis 2019 ; Janv 2 , Epub ahead of print MONCAY
MONCAY Study: DTG monotherapy for maintenance Baseline characteristics and patient disposition Continuation DTG/ABC/3TC N = 80 DTG monotherapy N = 78 Median age, years 48 47 Female, % 30 26 Zenith HIV RNA, log10c/mL 4.8 4.9 Nadir CD4/mm3, median (IQR) 265 (198 - 377) 309 (215 - 415) Median duration of HIV infection, years 11 9 Median duration on cART, years 9 8 Median number of previous lines of cART 5 4 Current CD4/mm3, median 790 843 Discontinuation D1-W24, N Withdrew consent 2 1 3 3 Hocqueloux L, Clin Infect Dis 2019 ; Janv 2 , Epub ahead of print MONCAY
MONCAY Study: DTG monotherapy for maintenance HIV RNA < 50 c/mL at W24 Continuation DTG/ABC/3TC (N = 80) Difference (95% CI) DTG monotherapy (N = 78) % 2.7 98.7 97.3 98.7 97.1 100 96.3 ITT 93.6 10.8 - 5.0 1.4 80 mITT 8.1 - 4.5 60 1.6 Per protocol 8.8 - 4.5 40 + 12% 12% 0 20 0 DTG monotherapy DTG/ABC/3TC ITT mITT Per protocol Non inferiority achieved at W24 Hocqueloux L, Clin Infect Dis 2019 ; Janv 2 , Epub ahead of print MONCAY
MONCAY Study: DTG monotherapy for maintenance Virologic failures Virologic failures (2 consecutive HIV RNA > 50 c/mL) at W48 (Kaplan-Meier) in the DTG monotherapy arm (N = 7) * Maximum HIV RNA copies/mL at VF CD4 nadir /mm3 cART before enrolment, years Integrase genotype at VF (mutations) Week at VF % 100 W24 * 84 231 11 None W24 * 55 163 10 None 75 DTG/ABC/3TC DTG monotherapy W29 ** 604 197 5 None W36 * 43 600 252 19 S147G, N155H 50 W36 ** 110 200 2 None p = 0.005 (log-rank test) W48 ** 2 230 119 21 R263K *** 25 W48 ** 626 118 4 None * Self-reported adherence at W4: 100% ** Self-reported adherence at W4: 95% *** Presence also of a mutation in the 3 PPT region 0 0 12 24 36 48 Weeks By W48: 7 virologic failures in DTG monotherapy arm vs 0 in DTG/ABC/3TC (trial was discontinued) Hocqueloux L, Clin Infect Dis 2019 ; Janv 2 , Epub ahead of print MONCAY
MONCAY Study: DTG monotherapy for maintenance Adverse events Continuation DTG/ABC/3TC N = 80 DTG monotherapy N = 78 Any adverse event 81.3% 73.1% Adverse event related to study drug 10% 7.7% Adverse event leading to discontinuation N = 1 * N = 0 Any serious adverse event 16.3% 6.4% Serious adverse event related to study drug N = 1 ** N = 1 *** Serious adverse event leading to discontinuation N = 0 N = 0 Grade 3-4 laboratory abnormality 8.8% 11.5% * Mood disturbance ** Grade 4 CK elevation *** Spontaneous abortion Hocqueloux L, Clin Infect Dis 2019 ; Janv 2 , Epub ahead of print MONCAY
MONCAY Study: DTG monotherapy for maintenance Conclusion Although DTG monotherapy was virologically non inferior at W24 to DTG/ABC/3TC as a switch strategy in virologically suppressed HIV-1 infected patients, the risk of virologic failure was significantly higher in DTG monotherapy vs DTG/ABC/3TC (n = 7 vs 0), with emergence of INSTI resistance, leading to recommendation against use of DTG monotherapy as a maintenance HIV strategy Hocqueloux L, Clin Infect Dis 2019 ; Janv 2 , Epub ahead of print MONCAY
