PrEP

Question 1

What is the standard PrEP regime in terms of drugs

Answer 1

TDF or TD/FTC = tenofovir disoproxil 245mg/emtricitabine 200mg

Question 2

What is the efficacy of PrEP in MSM

Answer 2

highly effective - (can say in osce >99% effective)
different RCTs have demonstrated it to be > 95% effective
- PROUD (daily dosing) = 86% effectiveness
-IPERGAY/iPREX/iPREX-OLE (EBD): looked at together- more than 96% efficacy in preventing HIV
-IPERGAY-OLE (EBD): 97% efficacy in preventing HIV

Question 3

what are the most common SE of PrEP

Answer 3

PrEP is generally very well tolerated. Most common SE are nausea, dizziness, GI disturbance and headaches - often self limiting and settle quickly

important to note that rarely this could be a sign developing renal toxicity

Question 4

what do the studies suggest the efficacy of PrEP is in heterosexual populations?

Answer 4

no RCTS in the UK for PrEP in heterosexual populations, limited data on the use of PrEP for daily dosing - 4 RCTs in sub-Saharan Africa have evaluated daily oral PrEP, one showed high efficacy (PARTNERS study), one weak evidence and other two have discontinued - low efficacy is likely due to low adherence.

no RCTs have evaluated the use of EBD in heterosexual populations.

all this being said we expect that PrEP is highly effective and benefits otuweigh risks

Question 5

who would you recommend PrEP to?

Answer 5

HIV negative MSM or transwoman who are HIV negative having condomless anal sex in the last 6 months and ongoing at risk of acquiring HIV

Anyone having unprotected sex with partner known to be HIV positive, unless they have undetectable VL and established on ART for at least 6 months

Question 6

How can MSMs or transwomen having anal sex take PrEP

Answer 6

In MSMs or transwomen having anal sex only recommend they can take PrEP daily or EBD.

If transwomen having frontal/neo-vaginal sex would advise daily dosing.

Question 7

can heterosexual men and women be offered TDF PrEP alone if FTC (emtricitabine) is contra-indicated

Answer 7

yes - note can’t offer tenofovir PrEP alone to any other groups e.g. MSMs/trans

Question 8

how would you suggest heterosexual men and women have vaginal sex who want to take PrEP should take it?

Answer 8

daily dosing if having receptive vaginal sex.

Question 9

is PrEP recommended for PWID where needle exchange programmes are avaliable

Answer 9

no PrEP not recommended, however consider PrEP on an individual basis in PWID if there is an outbreak situation or other RF that place them at increased risk of HIV acquisition

Question 10

if having receptive frontal sex only how should you take PrEP

Answer 10

daily dosing

Question 11

how would you explain EBD to a patient

Answer 11

take a double dose up to 2-24 hours prior to the first episode of sex, then take another dose 24 hours after and continue for 48 hours after the last episode of UPSI

note can use EBD if MSM or transwomen having UPSI anal sex

Question 12

how would you explain daily dosing to a patient

Answer 12

take one tablet of PrEP OD, ideally same time each day to help with adherence
lead in time needed is 7 days so wait 7 days before having UPSI then need to continue to take PrEP for a further 7 days after last episode of UPSI if wanting to stop PrEP

Question 13

if someone is taking daily PrEP and having anal sex only when might they need PEP?

Answer 13

if < 4 doses taken in the last 7 days

Question 14

if someone is taking daily PrEP and having vaginal sex when might they need PEP?

Answer 14

if < 6 tablets taken in the last 7 days

Question 15

what does BHIVA guideline say in regards to DMPA and HIV acquisition risk

Answer 15

BHIVA guidelines state that if using DMPA this increases risk of HIV acquisition, based on data from a meta-analysis in South Africa. However using PrEP would counteract this risk. They suggest ideally alternative contraception options are considered.

Question 16

Is there any evidence that PrEP reduces efficacy of hormonal contraception? or that hormonal contraception reduces efficacy of PrEP

Answer 16

no

Question 17

what does the FSRH guideline state in reference to HIV acquisition when using DMPA

Answer 17

Data and evidence is inconclusive. several observational studies have reported statistically significant increased risk of HIV acquisition and transmission amongst DMPA users whilst other studies have not. A systematic review and WHO’s position suggests that a causal relationship cannot be entirely excluded but that there is insufficient evidence to change their current medical eligibility criteria for women at high risk of HIV or living with HIV.

Women requesting the progestogen-only injectable should be informed about safer sex and that the consistent and correct use of
condoms provides an effective means of protecting against HIV and other STIs.

UKMEC = 1 (regardless of HIV VL status)

Question 18

what other situations would the PrEP guidelines suggest you could ‘consider using PrEP’

e.g. clinical indicators, population factors, sexual behaviours, drug use, autonomy

Answer 18

Clinical indicators:-
rectal bacterial STI in the past 12 months
bacterial STI or HCV in last 12 months
Requiring PEP in last 12 months

Populational factors:-
Heterosexual men and women from high prevelance countries for HIV e.g. black -african
recent migrants to the UK
sex work
PWID

Sexual behaviours:-
high risk sex - group sex that includes anal sex, chemsex, reports anticipated future ‘high risk sex’

drug use:-
sharing needles
injecting in an unsafe setting
no access to needle exchange programmes

sexual health autonomy:-
inability to negotiate condom use
coercive or violent power dynamics
risk sexual exploitation or trafficking

note low threshold for starting PrEP when in the ‘consider category’

Question 19

if prescribing PrEP to PWID how would you advise them to take it

Answer 19

daily dosing, need a 7 day lead in and take for 7 days until last risk of HIV from injecting, this is because it takes longer for PrEP to reach protective levels in the blood.

Question 20

do we have any studies in heterosexual men and women for EBD

Answer 20

no.

Question 21

do we have any data on efficacy of PrEP in trans populations

Answer 21

limited date on prep effectiveness in transwomen, no data for transmen.
if transwomen just having anal sex likely same efficacy as MSM having anal sex

no data on frontal sex in transwomen and transmen

Question 22

what would you advise a trans patient taking hormonal treatment regarding interactions with PrEp

Answer 22

no evidence that PrEP interacts with male or female hormones fine to continue.

Question 23

what would you say to a patient regarding risks of PrEP?

Answer 23

very safe in majority of patients small risks associated with kidneys and bones. Can affect kidney function but we monitor kidneys - more at risk older you are (>40 years) and those with pre-existing kindey issues or diabetes/hypertension. Studies suggest any kidney damage caused by PrEP is self limiting and resolves on stopping

Bones- PrEP can decrease BMD. again on stopping PrEP has been found to be self-limiting and improve once stopped. increased risk in those with RF for reduced BMD e.g. smoker/ low or high BMI/ alcohol XS/ steroids/ diabetes/ known Osteopenia or OP.

Question 24

in terms of bone health which age group of patients would you need to consider bone health the most? (other than patients with specific co-morbdities)

Answer 24

adolescents (age 15-25 years) as they are yet to reach peak bone mass (TAF has now been approved in the UK and can be used in those < 18 years) - studies suggest that BMD loss in men is reversible, however they do have persistent lower z scores in the spine even after 48 weeks off PrEP, suggesting that use of TDF prep may be a particular risk for adolescents as this is a critical period for attainment of bone mass.

BMDdecrease hip -1.5 and spine -2

Question 25

what is the window period for HIV blood tests

Answer 25

45 days

Question 26

what should you do if someone comes wanting to start PrEP but has had symptoms of seroconversion in last 4 weeks

Answer 26

defer starting PrEP
take HIV ag/antibody test and HIV viral RNA

Question 27

what are the baseline blood tests and STI screen required in all patients starting PrEP?

Answer 27

HIV ag/antibody test
STS
CT/GC screen (tripple site if MSMs)
hepatitis B - check immunity if not known, hep c (if MSMs, high risk groups e.g. PWID)
U&Es - check eGFR,
urine dip - if >=1+ protein send for uPCR
+/- UPT

Question 28

how do you manage Hepatitis B blood tests and vaccination for someone on PrEP and why?

Answer 28

need to check immunity prior to/ at the time of starting PrEP to hep B, if not immune offer hep B vaccine

if Hep SaB > 100 no futher action required, immune to hep B
if HepB SaB 10-100 consider booster, no further action required
if HepB sab< 10, start hep B vaccine and monitor 3 monthly until can check hepB SaB following course completion

worry is that TDF is the treatment for hepatitis B, if patient has hep B and we don’t know or acquires hep b whilst on PrEP and then comes off PrEP can cause hepatitis flare

Question 29

if hepatitis B surface antigen is positive and patient has started PrEP what would you advice?

Answer 29

continue PrEP refer to hepatitis specialist hep b, don’t stop prep as worry could cause acute hepatitis flare need to be taking daily dosing.

Question 30

what should eGFR be inorder to prescribe TD-FTC PrEP

Answer 30

eGFR > 60ml/min

Question 31

how long a course of PrEP can you prescribe

Answer 31

90 days (3 monthly)

Question 32

how often does BASHH recommend a patient attends for PrEP reviews

Answer 32

3 monthly -advised to have full STI screen every 3 months
if starting PrEP BASHH advices check in at 1 month to check adherence/SE (in practice sheffield doesn’t do this anymore)

Question 33

how often should U&Es be checked if on PrEP

Answer 33

if <40 years AND eGFR> 90mls/min = annually (no need for repeat urinalysis as poor PPV)
if >40 years or eGFR< 90 or RF for renal disease = 6 monthly U&E + urinalysis (send uPCR if protein >= 1 +)

note BASHH don’t suggest repeating urinalysis as has low PPV in patients with normal eGFR at baseline and no renal RF. However would recommend it in 6 monthly cohort.

Question 34

in studies how much did BMD reduce by at 48 weeks

Answer 34

1.5-2% reduction in BMD at hip and spine

Question 35

is PrEP safe in BF and pregnancy

Answer 35

yes - guidance suggests to continue PrEP in these situations especially if ongoing HIV risk

Question 36

where should you report use of PrEP during pregnancy

Answer 36

antiretroviral pregnancy registry

Question 37

what is the Ts and Ss rules for taking prep

Answer 37

take one tablet of PrEP on tuesday, thursday, saturday and sunday.
4 tablets per week
only suitable for anal sex.
need to lead in with 7 days before dropping down to 4 tablets per week. A way of structuring on demand prep…we know if taking daily PrEP efficacy is not lost unless you miss more than 4 tablets in a 7 day period.

can’t find in guidelines…