1. Switch to PI/r + 3TC vs PI/r monotherapy
ARV-trial.com
Switch to PI/r + 3TC vs PI/r monotherapy
Study PIVOT
Study MOBIDIP 1

2. MOBIDIP Study: switch to PI/r + 3TC vs PI/r monotherapy
Design
Randomisation
1: 1
Open-label
W48
W96
≥ 18 years
HIV RNA < 200 c/mL > 6 months on 2LADY study (2nd line study in Cameroon, Senegal, Burkina Faso) on LPV/r + TDF + FTC or LPV/r + ABC + ddI or DRV/r + TDF + FTC
Stable cART in past 3 months
No prior virological failure
CD4 > 100/mm3
Adherence ≥ 90%
HBs Ag negative
LPV/r monotherapy (N = 82)
LPV/r +
TDF + FTC (N = 152)
ABC + ddI (N = 147)
LPV/r + 3TC 300 mg QD (N = 82)
DRV/r monotherapy (N = 50)
DRV/r +
TDF + FTC (N = 155)
DRV/r + 3TC 300 mg QD (N = 50)
Objective
Primary endpoint: failure rate at W96 by ITT, defined as 1) a confirmed HIV RNA > 500 c/mL, 2) reintroduction of the NRTI backbone or 3) interruption of the PI
March 2016: Monotherapy arm discontinued following DSMB meeting
MOBIDIP
Ciaffi L, Lancet HIV 2017; 4:e384-92

3. Baseline characteristics and primary outcome at W48
MOBIDIP Study: switch to PI/r + 3TC vs PI/r monotherapy
Baseline characteristics and primary outcome at W48
PI/r monotherapy
N = 133
PI/r + 3TC
N = 132
Median age, years 41 43
Female, % 76 70
HIV RNA < 50 c/mL, % 80 83
CD4/mm3, median
498
472
Nadir CD4 < 100/mm3, % 56 52
PI/r = DRV, % 42 33
Months on first-line cART, median 50
Months on second-line cART, median 37 38
M184V at first failure, %
Resistance to one 2nd line-drug, %
Resistance to two 2nd line-drug, %
95 61 15 97 60 11
Failure, ITT, % (95% CI)
Virological failure, N
NRTI reintroduction, N
Death, lost to follow-up, N
24.8 ( )
28 * 2 3
3.0 ( ) (p < 0.001)
3 * 1
* All failures resuppressed to HIV RNA < 200 c/mL a median of 10 weeks after NRTI reintroduction
MOBIDIP
Ciaffi L, Lancet HIV 2017; 4:e384-92

4. MOBIDIP Study: switch to PI/r + 3TC vs PI/r monotherapy
Other results at W48
Failure not associated with
Adherence
Nadir CD4 count PI
CD4 gain similar in both groups at W48
No differences in safety (PI/r monotherapy vs PI/r + 3TC)
Severe adverse events = 11% (13% vs 10%)
AIDS-defining events = 3% (5% vs 2%)
No treatment interruptions for intolerance
Laboratory parameters : no differences
Changes in eGFR similar
Minimal changes in lipid parameters
MOBIDIP
Ciaffi L, Lancet HIV 2017; 4:e384-92

5. MOBIDIP Study: switch to PI/r + 3TC vs PI/r monotherapy
Follow-up of dual therapy (PI/r + 3TC) arm at W96, N = 132
Confirmed virological failure (2 consecutive HIV RNA > 500 c/mL)
N = 8 (virological success = 94% [ HIV RNA < 50 c/mL: 79%])
Genotype testing in 7/8: 2 lost M184V mutation, none developed PI or new NRTI mutations
Reintroduction of TDF in 5/8 participants: 4/5 resuppressed, 1 data missing
No change in 3 participants: resuppressed without change
3 discontinuations for non virological failure
Global treatment success rate at W96: 91.7%
MOBIDIP
Ciaffi L, Lancet HIV 2017; 4:e384-92

6. MOBIDIP Study: switch to PI/r + 3TC vs PI/r monotherapy
Conclusion
After viral suppression with a second-line cART of PI/r plus 2 NRTIs, maintenance with PI/r plus 3TC is associated with
A higher rate of success than PI/r monotherapy despite the presence of M184V mutation
Significant more virological failures with PI/r (24.8% vs 3.0%)
A similar CD4 response and adherence
No differences in safety outcomes
MOBIDIP
Ciaffi L, Lancet HIV 2017; 4:e384-92