NZ PrEP Study: Clinical Data

Sunita Azariah, Renee Jenkins, Peter

Saxton

Auckland Regional Sexual Health Service

NZ PrEP: Disclosures

• Gilead Sciences funded the study medications,

research associated laboratory costs and a

research nurse

• NZAF and PHARMAC provided funding to set

up and analyse the on-line behavioural survey

NZ PrEP Protocol

• Based on NSW Prelude

– Open-label single-arm treatment evaluation study

• Duration 24 months

• Sample limited to 150 due to ARSHS operational

requirements

• Equity quotas-50% had to be non-European

• Ethics approval granted by HDEC 15/09/2016

16NTA112

Aims

• To implement fully-funded PrEP in a sexual health clinic

setting to:

• Assess feasibility, retention and duration of use

• Refine clinical protocols to optimise service delivery

• Assess risk behaviours on PrEP including sexual

partnering; condom use; STI and HIV incidence

• Analysis of factors (socio-demographic and attitudes)

associated with PrEP acceptability, retention and

sexual behaviours

Inclusion Criteria

• HIV negative GBM or Trans people were

eligible if:

• Aged 18 or over and eligible for funded care in

NZ and resident in Auckland during duration of

study

• No medical contraindications to taking

tenofovir/emtrictabine

• Plus specific behavioural risk criteria

Inclusion Criteria (2)

• Likely to have multiple events of CLAI in the next 3 months AND any of the

following:

• At least 1 episode of receptive CLAI with any CMP with HIV infection who

was not on ART or with a male partner of unknown HIV test status in the

previous 3 months OR

• A diagnosis of rectal gonorrhoea or rectal chlamydia during the previous 3

months OR

• Other high-risk behaviour such as a history of methamphetamine use in

the previous 3 months

• A regular sexual partner of an HIV-infected man who was not on ART or

has detectable viral load with whom CLAI has occurred in the previous 3

months

Protocol

• Participants were tested at enrolment for STI’s,

HIV, viral hepatitis and renal and liver function

• They were re-tested at 1 month and then were

required to attend 3-monthly follow-up for STI

testing, repeat serology for HIV and syphilis, renal

and liver function testing

• At enrolment participants were required to

complete an on-line baseline behavioural survey

and after each subsequent 3-monthly visit

(modified from VicPrEP)

• Truvada was dispensed at community pharmacies

Enrolment and Retention

• Participants enrolment began in February 2017

• Enrolment was completed in December 2017

– 152 had baseline screening but 2 never attended any

further visits

• The last participant study visit was completed

of February 2019.

• 41(27%) exited or were lost to follow-up by 24

months

• By week 96 only 11 participants remained

• PrEP was publically funded 1

March 2018

Retention

Baseline W 4 W 12 W 24 W 36 W 48 W 60 W 72 W 84 W 96

100

120

140

160

Baseline Characteristics n=150

n %

<30

43.3 Range=18-55, median=31

30+ 81 56.6

European only 72 48.0

Maori 32 21.3

Pacific 13 8.7 52%

Asian 29 19.3 Non-European

MELAA 10 6.7 (total response method)

Central Auckland 88 58.7

Rest of Auckland 62 41.3

Less than tertiary

degree

67 44.7

Tertiary degree 83 55.3

Gay 138 92.0

Bisexual or other 12 8.0

STI Prevalence and Incidence

• Baseline prevalence defined as STI diagnosis at

Visit 0(pre-enrolment)

• Incident STI was defined as a new STI

diagnosis at a subsequent visit

• If a participant was diagnosed with an STI

between scheduled visits this was counted in

the following scheduled visit

• STI Results presented are up to week 72

Clinical Issues

• None of the participants acquired HIV

infection during the study period

• There were no serious adverse events

• 3 participants were advised to stop PrEP on

medical grounds

– 2 had elevated liver transaminases that got worse

on PrEP

– 1 had renal issues- eGFR declined to 54 ml/min

STI Diagnoses by Study Visit

Diagnosis Baseline

N=152

Visit2

(W4)

N=148

Visit3

(W12)

N=142

Visit4

(W24)

N=134

Visit5

(W36)

N=129

Visit6

(W48)

N=121

Visit7

(W60)

N=98

Visit8

(W72)

N=78

Gonorrhoea 20 (13%) 10 (7%) 13 (9%) 18(13%) 17 (13%) 13(10%) 4(4%) 10(12%)

Chlamydia



23 (15%) 10(7%) 26(18%) 24(22%) 28(22%) 14(12%) 12(12%) 12(15%)

Syphilis



4 (3%) 3 (2%) 1 (0.7%) 9(2%) 3(2%) 2(2%) 1(1%) 5(6%)

RectalSTI



31 (20%) 12(8%) 25(17%) 22(23%) 30(23%) 17(14%) 11(11%) 16(20%)

Other



5 (3%) 3(2%) 2 (1%) 0(1%) 11%) 4 (3%) 1(1%) 0(0%)

AnySTI 42 (28%) 17 (11%) 34(24%) 43(32%) 41(32%) 26(21%) 17(17%) 20(26%)

No

Diagnosis

110 (72%) 121 (82%) 112

(79%)

93(70%) 95(74%) 98(79%) 81(82%) 64(82%)

STI Incidence

• Averaged 26% across visits

• Overall incidence of any STI at 6 months was

significantly higher among participants who at

baseline reported in the previous 3 months:

• More than 10 male partners (61.9%, p<0.05)

• Group sex (67.7%, p<0.01)

• And chemsex (81.8%, p<0.01)

• But was not associated with ethnicity or age.

Baseline Prevalence of STI’s in other

Demonstration Projects

Baseline NZPrEP PROUD PRELUDE

Any STI 28% 17% 17%

Rectal

gonorrhoea

10.6% 5.0% 2.6%

Rectal

chlamydia

12.6% 4.0% 7.8%

Syphilis 2.7% 5.0 % 1.1%

Funded PrEP

• 91 NZ PrEP participants transitioned onto funded

PrEP

– 10 exited then accessed funded PrEP

– 81 completed study before accessing funded PrEP

• Where did they access funded PrEP?

– 81 attended sexual health

– 10 attended GP

• Since PrEP was funded we have had 2225 visits to

the service for PrEP

• 912 of these were for initiation of PrEP

Ethnicity Funded PrEP

Maori European Pacific Asian MELA/Other

10%

20%

30%

40%

50%

60%

70%

NZ PrEP

Funded PrEP

2013 Census

Summary

• Incident STIs are high in this sample

– Behavioural risk factors

– Regular STI testing

• Reinforces importance of regular STI testing for people

on PrEP

• PrEP provision has increased clinic workload

• Costly in terms of clinician time, laboratory testing etc

• Sexual health services will need adequate resourcing to

manage demand

• Ethnicity quotas have shown the importance of

improving equity and access

NAAT Testing

Total Urine Vaginal Rectal Pharyngeal

1000

2000

3000

4000

5000

6000

7000

8000

Q1 2017

Q4 2017

Q1 2019

Acknowledgements

We would like to thank

• The men participating in the study

• The staff at Auckland Sexual Health Service for

administering study procedures

• Community pharmacists Eric Ho and Tony Sie for their

valuable support

• Ron Graham for setting up the database

• Dr Dean Murphy, Prof Martin Holt and Associate Prof

Iryna Zablotska at the University of NSW, Sydney,

Australia for their advice and support.

• Gilead Sciences and NZAF for financial support

Steering Group

• Auckland Sexual Health Regional Service

– Sunita Azariah, Suzanne Werder, Renee Jenkins,

Rose Forster, Rick Franklin

• University of Auckland

– Peter Saxton

• Body Positive

– Mark Fisher, Ron Graham

• NZAF

– Whati Te Waake-(Kaiarahi), Jason Myers, Joe Rich