1. PrEP in Scotland - Local data and implementation issues
Dr Dan Clutterbuck
Consultant in Genitourinary & HIV medicine
NHS Lothian

2. Programme Local data Implementation challenges Some clinical questions
Monitoring issues
Start, stop and missed doses

3. Source of content An email to all Sexual Health Clinical Leads
The one or two greatest practical challenges you have encountered in providing NHS PrEP locally
One or two unanswered PrEP questions (clinical or otherwise)
If possible, at the end of August, the number of individuals you've started on PrEP in your board.
Prescribing PrEP
Updating the i-base UK Guide to PrEP
Contributing to the BASHH/BHIVA Guideline

4. Number of individuals commencing NHS funded PrEP, Scotland by mainland Health Board to 31st August 2017

5. Number of individuals commencing NHS funded PrEP, Scotland by mainland Health Board to 31st August 2017
A+A 6
Borders 3
D+G 2
Fife 15
FV 18
Grampian 50
GG&C 200
Highland 13
Lanarkshire 10
Lothian 84 (+37 DISCOVER trial)
Tayside 13
Scotland 404

6. Implementation challenges
Speed of implementation
Capacity building and planning
Staff confidence
Even among GUM trained staff
‘realising how few members of staff feel even slightly comfortable prescribing PrEP’
Increase in STIs
Difficult to quantify as yet

7. Capacity issues Capacity planning
Additional consultant/medical/nursing sessions
Appropriate expertise
Task shifting (nurses, CSWs)
Accommodating reviews and first returns
Decisions about reviewing results
Increasing STI and partner notification workload

8. Capacity planning

9. Clinic implementation
Appropriately trained staff vs flexibility
Training opportunities and capacity
Opportunistic starts (efficiency) vs waiting list (equity)
Reviewing results (safety) vs capacity (appointments)
1 month reviews

10. Eligibility criteria Residency Anxieties about establishing residency
‘Proof of residency’
Equivalent criteria
Criteria 4
Guidance from PHE imminent
Low(er) risk MSM

11. Positive effects Attendance of individuals at risk
Discussions about risk
Increased disclosure of risk
Referrals for behaviour change

12. Monitoring issues Waiting for and checking baseline biochemistry
Delayed samples
High potassium
High phosphate
Which tests to do?
Bone profiles
LFTs
Urinalysis, uPCR

13. Clinical challenges

14. What are the markers of toxicity?
Renal toxicity
Monitoring for significant reduction in eGFR
Or are we monitoring for tubular dysfunction with normal eGFR?
Proteinuria as a marker of reduced eGFR
? Relevance of low phosphate in isolation?

15. Dosing issues On demand (Event based) vs continuous
Starting and stopping
Missed doses
Indications for PEPSE
Defining by gender/position/genital mucosa
‘perhaps lead-in/out times could be defined by tissue/mucosal site and not by risk group’

16. Dosing – some pointers
Differences between absorption and time to steady state for anal, rectal and vaginal tissues and PBMCs
Good data on rectal concentrations, less on vaginal and none on male genital (urethra, glans, foreskin)
HIV takes 8-24 hours to be established – about 8 hours for the first round of replication. Drug levels at second round of replication is probably critical

17. Drug levels
FTC reaches protective levels faster (30mins, 4 hours for active metabolite), and concentrate more in vaginal tissue, but FTC-DP levels fall rapidly
TDF concentrates in rectal tissue and TDF-DP remains detectable for 14 days after a single dose
Both drugs concentrate in rectal tissue, TDF concentrates much more in PBMCs

18. Dosing advice
A lead time of seven days is sufficient for all individuals
There is considerable evidence that 3 days may be sufficient for anal AND receptive vaginal sex
Continue for 48 hours (2 doses) after last exposure for anal sex, insertive penile sex and 7 days for vaginal/frontal sex
For on-demand dosing (anal sex only), 24 hours pre exposure is ideal, but 2 hours before is effective and it is still worth taking the double dose AFTER exposure

19. Missed doses and PEPSE Missed doses
‘How bad does your adherence have to be before we advise PEP’
‘It would be great if we could have some missed pill rules as they do for COC’

20. Some missed pill rules for debate
PEPSE should hardly ever be indicated for anal sex exposures on PrEP
4 or more doses in the previous week – no PEPSE
Double dose prior to sex and 1 dose in the 48 hours after – no PEPSE?

21. Coding and data
Financial anxieties mean prescription data is well recorded
Reconciling attendance, NaSH prescribing and pharmacy data
STISS coding reinstated for PrEP
Guidance issued 4th September
Applies retrospectively
Clinical training and quality control required

22. Thanks Lothian PrEP and Discover trial teams
Scottish Lead Clinicians and PrEP clinicians
Rak and the PrEP SLWG members
Simon Collins, Sheena McCormack and the ibase leaflet co-authors
Monica Desai, Sheena McCormack and BHIVA guideline co-authors
PrEPMAR members

23. Discussion Sharing of learning Email forum?
PrEP seminar at BASHH/BHIVA Annual Conference 2018
Lead Clinicians discussions and SLWG subgroups
PrEP meeting?

24. IPrEx renal monitoring
Urine dipstick results
Urine dipstick results at follow-up included data from 1589 participants at 5081 visits; routine testing (764 participants and 2748 visits) was performed at five clinical sites. Of 5081 dipsticks, 613 were positive for proteinuria (12%) and 62 (1%) were positive for glucosuria. Of those positive for proteinuria, four were associated with a confirmed creatinine elevation [positive predictive value (PPV) for confirmed creatinine elevation 0.7%]. Of the 62 dipsticks positive for glucosuria, none were associated with a confirmed creatinine elevation (PPV forconfirmed creatinine elevation 0%).