SLIDE 9 12/7/17 9
Case 3 –switch to “NRTI-Sparing” 2-drug ART
.
65 65 yo yo wo woman with CKD (eGFR 40), severe osteopenia, CAD. On stable suppressive TAF/FTC + DTG, ne needs ds to switch h to a NRTI-spa sparing ng regimen. n.
- Q1: 2 drugs vs 3 drugs?
- Q2: does 3TC/FTC count as a NRTI? – we can go either
way on this
- A good 2-drug regimen likely to be sufficient; she is
an excellent candidate:
- She has proved her ability to adhere closely to ART
- Stable viral suppression
- Likely wildtype virus
Case 3 – switch to 2-drug regimen
. 65 65 yo yo wo woman with CKD (eG eGFR 40), 40), severe os
- steop
- penia, CAD
- CAD. On stable suppressive
TA TAF/FTC + DTG, needs to switch to a NRTI-sp spari ring regimen
- LOTS of good new data!
- DTG/RPV
- DTG + 3TC
- DTG + DRV/r
- DRV/r + 3TC
Switch to DTG + RPV: SW
SWORD 1/2
Llibre et al. CROI 2017; Seattle, WA. Abstract
- 44LB. McComsey G, IAS 2017.
Virologic outcomes, Week 48
- N=1024, viral suppression ≥12
months, stable ART ≥6 mos
- DTG + RPV non-inferior to CAR,
incl in subgroups (age, gender, race)
- VF in 2 in dual arm, 1 w/
K101K/E, resuppressed
- BMD improved on DTG/RPV after
switch from TDF (DEXA substudy)
20 40 60 80 100 Virologic success Virologic non-response No virologic data HIV-1 RNA <50 c/mL, % DTG + RPV (n=513) CAR (n=511)
95 95 <1 1 5 4
aAdjusted for age and baseline 3rd agent.
DTG/RPV approved by FDA Nov 2017 (Juluca): switch from stable ART, VS, no VF, no resistance
Switch to DTG + 3TC (and remember the Naive trials- Case 1)
Study N Baseline Results Ref
LAMIDOL Single arm, prospective,
104 VL <50 x ≥2 yrs, no R Wk 48: VL <50 101/104 -- 1 rebound to 77 c/mL, 1 LTFU, 1 interrupted. No IN resistance, 1 w/ L74V/L.
Joly V, EACS 2017.
DTG/3TC vs DTG mono vs 3-drug RTC 91 VL <50 x ≥12 mos, no VF or resistance to 3TC or INI Wk 24: DTG/3TC: 1 VF (low level VL, no resistance) DTG mono: 2 VF with INI R (this arm stopped)
Blanco JL, EACS 2017.
ASPIRE DTG/3TC vs current ART; RCT 89 VL <50 on any 3-d ART No VF, no R Wk 24: VL <50 in 93% vs 91% Wk 48: 91% vs 89% 1 VF in DTG/3TC, no R
Taiwo BO, EACS 2017.
DTG/3TC vs DRV/r/3TC vs ATV/r/3TC
selected
183 DTG, 170 DRV, 141 ATV VL <50, no VF with INI resistance Up to 2 yrs VF: 3 (DTG), 6 (DRV), 4 (ATV)
Borghetti, EACS 2017.
DTG/3TC vs historic control
72 (vs 86 control) Wd 96: VL <50 in 97% in both gps Blips in 1 vs 6
Tau L, EACS 2017.
Single arm, prospective, open label 203 VL <50 ≥6 mos, median 72 mos VF: 0 (295 pt-yrs of f/u) d/c: 12
Maggiolo F, EACS 2017; BMC ID 2017.
Retrospective 105 96% VL <50 Median 23 wks: VL <50 97% (82/84) 1 VL=55, 1 VL=239
Hidalgo- Tenorio C, EACS 2017.
Metaanalysis of 4 DTG/3TC studies 261 VL <50 VF in 1 DTG/3TC, no mutations
Buzzi M, EACS 2017.