Studies

Question 1

What did the ATLAS study look at?

Answer 1

Suppressed switch to injectable RPV/CAB vs continuing oral therapy
End point - VL <50 at 48 weeks

Question 2

What was the outcome of ATLAS study

Answer 2

Monthly CAB/RPV injectables non inferior to oral therapy

Question 3

What did ATLAS 2M look at?

Answer 3

2 monthly vs 1 monthly injectable CAB/RPV

Question 4

Outcome of ATLAS 2M

Answer 4

2 monthly injections non inferior to monthly.
However 1.5% on 2 monthly had CVF (<1 on monthly) hence strict criteria for having injectables ‘caution if patient has at least 2 of bmi > 30, subtype a1/a6, incomplete resistance testing and tx history’

Question 5

Outcome of DUALIS study

Answer 5

Switching to dolutegravir plus boosted darunavir non inferior to continuing 3Dr with boosted darunavir in suppressed patients already on bDRV

Question 6

ACTG 5257

Answer 6

Raltegravir superior to darunavir/ritonavir which is superior to atazanavir ritonavir

Question 7

DAWNING study

Answer 7

In treatment failure with with NNRTI resistance - DTG is superior to lop/r

Question 8

NADIA

Answer 8

If treatment failure with NNRTI resistance DTG non inferior to darunavir/r

Question 9

What study compared AZT/3TC with TDF/3TC risk of virological failure?

Answer 9

NADIA
TDF/3TC associated with reduced risk of VF at 96wks
Risk of emergence of DTG resistance also less in TDF group

Question 10

RAKAI study

Answer 10

If undetectable cannot pass virus on

Question 11

DAD study

Answer 11

Ongoing use of abacavir increase risk of stroke and heart attack particularly in those already at high risk (>10%)

Question 12

ADNES study

Answer 12

3TC/drv/r vs 3TC/drv/r/tdf

2 drug arm non inferior
No significant adverse events
Significantly greater total cholesterol in 2Dr so TDF may have favourable impact on lipids

Question 13

GEMINI 1 and 2

Answer 13

Dtg/3TC - individual components vs dtg/tdf/ftc
1 and 2 in different studies
Naive adults
Now at week 144
VL 1000-500000, no mutations, no HBV or HCV

At 48 weeks non inferiority of 2drug arm
One significant failure between 96 and 144 weeks - found to have m184v and II resistance mutations

Question 14

TANGO

Answer 14

Stable switch from 3DR to DTG/3TC as dovato

All had to be on TAF based regimen prior to switch

Dovato noninferior at 48weeks
Therefore is recommended as a stable switch option

Question 15

TANGO - m184v?

Answer 15

Proviral m184v looked at - these patients still suppressed

Question 16

SALSA

Answer 16

Stable switch from diverse baseline regimens to DTG/3TC

Dovato non inferior at week 48

Question 17

Gs1489

Answer 17

Biktarvy vs TMQ
Non inferiority
Naives

Question 18

Gs1490

Answer 18

Naives
Biktarvy vs descovy DTG
non inferiority at 96 weeks

Question 19

DRIVE-AHEAD

Answer 19

Naives delstrigo vs atripla
No resistance, VL >1000
Non inferiority
Neuropsychiatric SEs less in delstrigo than atripla arm

Question 20

DRIVE-FORWARD

Answer 20

2NRTI + doravirine vs 2NRTI+drv/r
Non inferiority

Question 21

SWORD

Answer 21

Switch vs continuing on 1st or 2nd combination
Showed non inferiority
One k101k/e at 36 weeks - virological withdrawl- had been non adherent. Resuppreased on juluca. No II resistance.

Question 22

LATTE studies 1 and 2

Answer 22

Phase 2 studies of injectables

Question 23

DRIVE-SWITCH

Answer 23

Delstrigo switch study
Non inferior

Question 24

FLAIR

Answer 24

‘Recently naive’
All had 20 weeks TMQ
After this continues TMQ or went onto cab/RPV
CAB/RPV Non inferior to TMQ

Question 25

BRIGHTE

Answer 25

Fostemsavir study
Phase 3 study

Question 26

CALIBRATE

Answer 26

lenacapavir
4 treatment groups
2 arms 2DR and 2 3DR

Equivalent viral suppression groups
Some failure with resistance in Lenacapavir 6 monthly arms - ?missing oral doses

Question 27

CAPELLA

Answer 27

Highly treatment experienced individuals
Adding LEN to optimised background regimen - this lead to reasonable viral suppression
Again some failure in 6/12 s/c LEN with resistance ?not adhering to oral whence

Question 28

START study

Answer 28

Immediate ART vs deferred therapy until CD4 <350

53% risk reduction at interim review
Trial stopped early
Guidelines changed for treatment to be started irrespective of CD4 count

Question 29

Which trial demonstrated increased neonatal death and prematurity with combo of TDF/FTC LOP/r?

Answer 29

PROMISE

Question 30

Partner 1

Answer 30

MSM and heterosexual couples - no transmissions when positive partner suppressed

Question 31

Partner 2

Answer 31

Further data on MSM - 76000 episodes condomless sex zero transmissions

Question 32

Opposites attract

Answer 32

MSM serodifferent - zero transmissions

Question 33

Actg 5164 - when to start therapy in context of aids defining infection or bacterial infection and cd4 <200

Answer 33

Fewer aids progressions/deaths and improved cost effectiveness with ART initiated within 14 days compared to after tx of compared to waiting until infection treated
No increased IRIS but most had pcp

Question 34

COAT study

Answer 34

Cryptococcal meningitis - higher risk of death with early art initiation in those with decreased level of consciousness or acellular spinal fluid

Therefore defer ART 2 weeks

Question 35

START

Answer 35

For those with CD4 > 500 art was associated with significant reduction in relative risk of disease progression but absolute risk relatively small (4.1% deferred arm 1.8% immediate treatment arm)

Question 36

ADVANCE study

Answer 36

Week 48 DTG non inferior to EFV but DTG arm less discontinuation due to adverse events

Question 37

Spring2

Answer 37

Dtg vs RAL
48 weeks no significant difference
96 weeks favoured success with DTG

Less virological failure on DTG
Less failure with resistance on DTG

Question 38

FLAMINGO

Answer 38

DTG vs DRV/r

DTG superior - fever discontinuations but no difference in rates of virological failure or resistance

Question 39

Actg 5257 RAL VS DRV/r

Answer 39

DRV/r higher proportion of failure but those on RAL more likely to develop resistance