Dr Michelle Hanlon Consultant physician, Genitourinary Medicine Olafiaklinikken, Oslo University Hospital. National Advisory Unit for STIs
Truvada FDA approved PrEP 2012 Initial slow uptake now over 120,000 PREP users
on demand and daily PrEP to those at risk
Daily PrEP: HIV neg MSM n=544 Condomless anal sex in preceeding 3 months Start PrEP immediately n=275 Vs defer PrEP n=269 3 PrEP vs 20 deferred infected Relative reduction: 86% NNT* 13, (90% CI 9-25) (*number needed to treat) Lancet 2016; 387: 53 60
In PrEP group: 3 incident HIV infections 1) reactive HIV test at 4-week visit, infection thought to pre-date start of PrEP 2) reactive HIV test at 61 weeks, not prescribed study drug since enrolment visit. 3) seroconversion illness at 53 weeks; last clinic attendance was 12-week visit (prescribed 90 tablets of study drug. Findings suggest that there were no breakthrough HIV infections in participants who were taking PrEP. Lancet 2016; 387: 53 60
Lancet 2016; 387: 53 60
on demand* and daily PrEP to those at risk * on demand is also known as event driven or event based dosing
On demand PrEP n=400 HIV neg MSM/ trans women, unprotected anal sex x 2 partners in past 6 months 199 TDF/FTC, 201 placebo, f/up median 9.3 months (4.9-20.6) 2 infections TDF/FTC, 14 placebo Relative Reduction 86% N Engl J Med 2015; 373:2237-2246
2 incident HIV-1 infections in TDF/FTC group, both diagnosed at scheduled visit v 1 returned 60/60 tablets v 2 returned 58/60 tablets Study drugs not detected in plasma samples at time of HIV-1 diagnosis. deemed to be nonadherent to preexposure prophylaxis N Engl J Med 2015; 373:2237-2246
on demand and daily PrEP to those at risk HIV-negative MSM and trans who are inconsistent in their use of condoms with casual partners or with HIV-positive partners who are not on treatment. A recent STD or use of post-exposure prophylaxis may be markers of increased risk for HIV acquisition.
May be considered in HIV negative heterosexual women and men who are: v Inconsistent in condom use and v Likely to have HIV positive partner not on ART
2013-2015: PrEP : case by case 2016: full chapter on PrEP (EACS)
Bent Høie (right), Norwegian Minister for Health
Roughly translated and paraphrased: national health service grants financial support to anti-infectious drugs which can prevent general communicable infections in persons considered to be at particularly high risk of being infected in Norway https://lovdata.no/register/forskrifter
https://www.minervanett.no/hiv-medisin-tilfriske-menn-er-feil-prioritering/ In a liberal democracy, decisions regarding the distrubution of public funds cannot be based on which interest organisations are the most adept/ best at promoting their own cause
Checked 28.01.18 2325 NOK = 243
In 2017 : 161 new infection 102 (63%) men 30 (18.6%) MSM
In 2016 : 220 new infections 157 (71%) were men 87 (39.5%) MSM https://www.fhi.no/nyheter/2017/hivtall-fra-2016/ Total 6064 diagnosed with HIV in Norway
Total population ca 5.2 million Population the largest urban settlements Population 2017 Change 2016/ 2017 % change 2016/2017 Oslo 988,873 13,129 1.3 Bergen 254,235 1463 0.6 Stavangar/ Sandnes 220,943 7630 3.6 Trondheim 180,557 2940 1.7 Drammen 116,446 1309 1.1 www.ssb.no
Primarily public healthcare system Pay nominal fee per doctor-visit v 16 general practitioner, 37 specialist Cap 238: frikort Exception v pregnant, children <16yrs old v notifiable infectious disease e.g TB, HIV, Chlamydia
Normally (e.g. HSV treatment): pay 100% cost medicine If chronic condition : pay 39% prescription costs (up to 56 ) EXEMPT: Notifiable infectious disease (paragraph 4) v e.g. HIV, syphilis,chlamydia, shigella) v free of charge
MSM and Trans reporting condomless anal sex with several partners in the past 12 months AND highly likely to continue this behaviour Supporting factors: STI past 12 months Sex under the influence of drugs minority background http://legeforeningen.no/fagmed/norsk-forening-for-infeksjonsmedisin/nyheter/faglige-retningslinjerfor-oppfolging-og-behandling-av-hiv-2018/
Heterosexuals Individual assessment Serodiscordant partner HIV VL>50 (TrASP is preferred) http://legeforeningen.no/fagmed/norsk-forening-for-infeksjonsmedisin/nyheter/faglige-retningslinjer-foroppfolging-og-behandling-av-hiv-2018/
Holistic approach including Advice regarding safer sex Regular testing for HIV and STIs Comorbidities e.g. Substance misuse, mental health should be assessed and referred as appropriate http://legeforeningen.no/fagmed/norsk-forening-for-infeksjonsmedisin/nyheter/faglige-retningslinjerfor-oppfolging-og-behandling-av-hiv-2018/
Seniorrådgiver Øivind Nilsen
Largest STI clinic in Norway v Walk-in clinic v Appointment based v MSM evening clinic v Outreach National Advisory Unit for STIs
Centralise care in greater Oslo area Build up expertise
Effective hiv prevention tool period of your life 2 weeks, 2 months, 2years...
period of your life 2 weeks, 2 months, 2years...
MSM? condomless sex? condomless sex again? Blood test: HIV negative
Self refer or provider referral (waiting list) Recieve appointment for PrEP assessment Baseline bloods taken in advance of consultation First consultation: Nurse first, then Dr
Nurse 30 min Indication?
Nurse 30 min Indication Knowledge of PrEP Condom use Alcohol, partydrugs, chemsex, Addiciton sex, substance
Doctor: Contraindication? Complicating factors? Daily Vs on demand
Vaccinate HBV, HAV* Prescribe appropriate PrEP regime Run through adherance Tests: v Infection screen : HIV, HCV, syphilis, STI screening every visit v Safety screen : biochemistry, urinalysis** *outbreak hepatitis A in Oslo since October 2017 **2017 HIV Norwegian guidelines
Standard follow up post PrEP initiation 1 month: Dr 3 months: Nurse 6 months: Nurse 9 months: Nurse 12 months: Dr
Co morbidities Erectile dysfunction Psychological health Substance misuse Proteinuria, DM, reduced egfr, (creatin) Osteopenia, concommitant steroid use ( anabolic or otherwise)
05.01.17 to 31.12.17 New assessment n= 346 Transfer from other practitioner n=68 (family doctor or infectious diseases specialist) Unpublished feb 2018 : Olafiaklinikken
New assessment n= 346 New patients 6% 3% Daily PrEP 28% 63% EBD PrEP Not indicated did not want EBD: Event based dosing or on demand
First visit: n=168 MSM n= 161 (96%) MSW/M/T n= 7 (4%) Median age 35, (range19-69 yrs) 64% single 90% of those in a relationship open Hanlon, Oral presentation IUSTI 2017, Helsinki
Sex partner past 4 weeks v Median 3, range (0-20) v Mean 4.8 partners Attend sex clubs or sauna 48% Hanlon, Oral presentation IUSTI 2017, Helsinki
Condom use On average ca 42% 17.9% never use condoms Previous PEP use: 19% (32/168) previous PEP, (current- 5 yrs) 5/168 PEP >2 Hanlon, Oral presentation IUSTI 2017, Helsinki
STI testing last 12 months average testing 2.2 per 12 months 43 (16%) no record of STI testing Hanlon, Oral presentation IUSTI 2017, Helsinki
NG CT MG Total Anus 35 35 (LGVx1) 6 76 Pharynx 40 40 Urethra 11 7 18 Early syphilis PrEP naive: N=168 men Hep C 1 6 Hanlon, Oral presentation IUSTI 2017, Helsinki
PrEP naive: : N=168 men: 6-12 months follow up NG CT MG Total Anus 34 41 (LGVx2) 8 83 Pharynx 26 8 34 Urine 7 4 2 13 Early syphilis Hep C 0 6 Unpublished feb 2018: Olafiaklinikken
N=168 PrEP Naive 4% 2% patients 7% 29% 58% none 1 episode 2 episode 3 episode >3 episode Unpublished feb 2018: Olafiaklinikken
16/168 (9.5%) users discontinued PreP Reason for discontinuing Prep Number of PrEP users % of PREP users Medical 4 2.4% Moved country 2 1.2% Change in risk 5 3% Unknown 5 3% Unpublished feb 2018: Olafiaklinikken
26% PrEP naive had a mental health diagnosis recorded at first visit Diagnosis Number Medicated Attending Psychologist Depression 26 14 (54%) 1 Bipolar 3 3 ADHD 6 6 Anxeity 6 0 5 Other 3 0 1 Hanlon, Oral presentation IUSTI 2017, Helsinki
Who should do PrEP?
Potential Prescribers Infectious diseases? Dermatovenerology? General practitioner?
Tromsø: Infectious diseases (ID) Trondheim: Dermatovenerology (DV) Olafiaklinikkken: DV Ahus : ID Kristiansand ID Stavangar ID& DV Bergen ID & DV General practitioners interested and engaged throughout the country
Multicentre Evaluation Study Electronic database: v Pas answer electronic questionnaire v Provider fills in STI, HIV results, other important event App in progress
PrEP has been available for 1 year now Completely free of charge to those who need it Inclusion/ Exclusion Criteria Logistical challenges v Waiting time for assessment appointment (Olafiaklinikken) v Service provision outside larger cities Recent kick off mulitcentre evaluation study
Olafiaklinikken high risk MSM Motivation for PrEP: avoid HIV infection Co-morbidity: mental health,recreational drugs Self reported high adherance, good tolerability No incident HIV infection in our PrEP users to date
Frank Pettersen, ID consultant OUS Bente Magny Bergersen ID consultant OUS Erik Pettersen ID consultant A-hus Alexander Leiva ID consultant Bergen