LPV/r Monotherapy Study: MOST Trial Outcomes
Explore the outcomes of the MOST study regarding the switch to LPV/r monotherapy in HIV patients, focusing on virologic failure, clinical symptoms, CD4 cell counts, and CSF analysis after a median follow-up of 48 weeks. The study aimed to assess the non-inferiority of LPV/r monotherapy compared to continued ART therapy in maintaining HIV-1 RNA levels below 50 c/mL. Results showed virologic failure in 6 out of 29 patients in the monotherapy group, with clinical symptoms at failure and low nadir CD4 cell counts, but no marked elevation of HIV-1 RNA in genital secretions.
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Switch to LPV/r monotherapy Pilot LPV/r M03-613 LPV/r Mono KalMo OK OK04 KALESOLO MOST HIV-NAT 077
MOST Study: Switch to LPV/r monotherapy Design Randomisation 1 : 1 Open-label W96 Continuation current antiretroviral therapy (cART)* N = 31 Target of 100 HIV+ On cART > 6 months HIV-1 RNA < 50 c/mL > 3 months Baseline determination of HIV-1 RNA in CSF and genital secretions N = 29 LPV/r 400/100 mg bid * Possibility offered to switch to LPV/r monotherapy at W48 delayed switch) Objective Non inferiority of the monotherapy group in the proportion of patients with HIV-1 RNA < 50 c/mL in the plasma and treatment failure in the CNS or the genital compartment without modification of treatment (per-protocol analysis) ; lower limit of CI for the difference = - 12%, 80% power Study was prematurely stopped before full recruitment when 6 patients on monotherapy (none in cART group) demonstrated a virologic failure in blood Gutmann C, AIDS 2010;24:2347-54 MOST
MOST Study: Switch to LPV/r monotherapy Baseline characteristics Continuation of cART N = 31 LPV/r monotherapy N = 29 Mean age, years Female CDC stage C CD4 cell count at baseline, median/mm3 CD4 cell count at nadir, median/mm3 HIV-RNA set point, mean log10c/ml ARV at inclusion 46 23% 23% 465 160 4.7 42 34% 34% 498 160 4.9 PI-based 74% 23% 73% 24% NNRTI-based 3% 3% 3 NRTIs Gutmann C, AIDS 2010;24:2347-54 MOST
MOST Study: Switch to LPV/r monotherapy Outcome Median follow-up: 48 weeks Virologic failure (2 consecutive plasma HIV-1 RNA > 400 c/mL) occurred in 6/29 patients in the LPV/r monotherapy group, after a median of 12 weeks, vs 0/31 in the continued antiretroviral therapy group In these 6 failures, the median duration of HIV-1 RNA < 50 c/mL was 50 months ; 5/6 patients had clinical symptoms at the time of failure, all symptoms resolving after treatment switch ; all 6 patients had a nadir CD4 cell count < 200/mm3 CSF was examined in 45 patients at study termination (25 on LPV/r monotherapy and plasma HIV-1 RNA < 400 c/mL, 5 failing monotherapy and 15 continuing prior ARV therapy with plasma HIV-1 RNA < 50 c/mL) CSF HIV-1 RNA was > 40 c/mL 8/25 patients on monotherapy none of the 15 patients still on continued treatment (p = 0.01) No marked elevation of HIV-1 RNA in the genital secretions Gutmann C, AIDS 2010;24:2347-54 MOST
MOST Study: Switch to LPV/r monotherapy Patients with treatment failure in blood or detection of elevated HIV-1 RNA in CSF Week on study/on monotherapy HIV-1 RNA plasma, log10c/ml 4.3 4.2 4.1 HIV-1 RNA CSF, log10c/mL 5.1 3.1 5.0 CD4 nadir /mm3 Treatment arm Sex Pre-Treatment 1 2 3 Male Female Female TDF/FTC/ATV/r ZDV/3TC/LPV/r ABC/3TC/LPV/r 57 5 149 LPV/r mono Delayed Switch LPV/r mono 12 Blood failure (HIV-1 RNA > 400 c/mL) 60/12 12 4 5 6 Male Male Female ZDV/3TC/EFV TDF/3TC/LPV/r TDF/3TC/EFV 7 54 160 LPV/r mono LPV/r mono LPV/r mono 24 6 24 3.0 5.0 3.0 4.1 ND 3.7 1 2 3 4 Male Male Female Male TDF/FTC/LPV/r TDF/3TC/ATV/r ABC/3TC/LPV/r TDF/3TC/ZDV/EFV 211 370 100 130 Delayed Switch Delayed Switch LPV/r mono Delayed Switch 96/48 66/18 63 68/20 < 1.6 2.2 2.3 2.1 2.9 3.4 4.3 3.4 HIV-RNA detectable in CSF Monotherapy arm 5 6 7 8 9 10 11 12 Male Male Female Female Male Male Male Male ZDV/3TC/LPV/r TDF/FTC/LPV/r ABC/3TC/ZDV/LPV/r ZDV/3TC/LPV/r TDF/FTC/LPV/r TDF/FTC/ATV/r TDF/3TC/EFV TDF/3TC/ATV/r 120 20 220 17 20 126 185 370 Delayed Switch LPV/r mono LPV/r mono LPV/r mono cART at baseline cART at baseline cART at baseline Delayed Switch 72/24 37 48 44 0 0 0 48/0 < 1.6 < 1.6 1.9 < 1.6 < 1.6 < 1.6 < 1.6 < 1.6 2.1 2.4 2.5 1.9 1.6 1.7 1.9 1.6 HIV-RNA detectable in CSF Continuation therapy arm Gutmann C, AIDS 2010;24:2347-54 MOST
MOST Study: Switch to LPV/r monotherapy Conclusions Maintenance of HIV treatment with LPV/r monotherapy should not be recommended as a standard strategy ; this is particularly evident in patients with a CD4 cell count < 200/mm3at nadir The proportion of patients with detectable HIV-1 RNA in CSF was not only significantly higher on LPV/r monotherapy than on continued combination therapy (32% vs 0% ; p = 0.01), but the difference appears biologically (CSF inflammation) and clinically (acute symptoms) relevant Gutmann C, AIDS 2010;24:2347-54 MOST
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