US Public Health Service Clinical Practice Guidelines for PrEP

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1 Webcast 1.3 US Public Health Service Clinical Practice Guidelines fr PrEP P R E S ENTED BY: M A R K T H R U N, M D A S S O C I AT E P R O F E S S O R, U N I V E R S I T Y O F C O L O R A D O, D I V I S I O N O F I N F E C T I O U S D I S E A S ES D I R E C TO R, H I V / S T D P R E V E N T I O N A N D C O N T R O L, D E N V E R P U B L I C H E A LT H D I R E C TO R, D E N V E R P R E V E N T I O N T R A I N I N G C E N T E R

2 Federal PrEP Guidelines Released n May 14, 2014 by the US Public Health Service Develped by a federal inter-agency wrking grup led by the Centers fr Disease Cntrl and Preventin (CDC), with input frm prviders, HIV patients, partners, and affected cmmunities Recmmend that PrEP be cnsidered fr peple wh are HIV-negative and at substantial risk fr HIV

3 Federal PrEP Guidelines Prvide clear criteria fr determining a persn s HIV risk and indicatins fr PrEP use. Require that patients receive HIV testing t cnfirm negative status befre starting PrEP. Underscre imprtance f cunseling abut adherence and HIV risk reductin, including encuraging cndm use fr additinal prtectin. Recmmend regular mnitring f HIV infectin status, side effects, adherence, and sexual r injectin risk behavirs. Include a prviders supplement with additinal materials and tls fr use when prescribing PrEP.

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5 Recmmended Ratings Quality f Evidence I. One r mre well executed, randmized cntrlled trials with clinical utcmes, validated labratry endpints r bth Strength f Recmmendatin A. Strng recmmendatin II. One r mre well executed nnrandmized trials r bservatinal chrt studies with clinical utcmes B. Mderate recmmendatin III. Expert pinin C. Optinal recmmendatin

6 Key Messages f the Guidelines

7 Daily ral PrEP is recmmended as ne preventin ptin fr: Sexually active adult men wh have sex with ther men at substantial risk fr HIV. (IA) Adult hetersexually active men and wmen at substantial risk fr HIV. (IA) Adult injectin drug users at substantial risk fr HIV. (IA) And shuld be discussed with hetersexually active partners f persns living with HIV in relatin t cnceptin and pregnancy. (IIB)

8 Indicatins fr PrEP in MSM Adult man: Withut acute r established HIV infectin Any male sex partners in past 6 mnths Nt in a mngamus partnership with a recently tested, HIV-negative man AND at least ne f the fllwing: Any anal sex withut cndms (receptive r insertive) in past 6 mnths Any STI diagnsed r reprted in past 6 mnths Is in an nging sexual relatinship with an HIV-psitive male partner

9 Indicatins fr PrEP in Hetersexual Men and Wmen Adult persn: Withut acute r established HIV infectin Any sex with ppsite sex partners in past 6 mnths Nt in a mngamus partnership with a recently tested, HIV-negative partner AND at least ne f the fllwing: Is a man wh has sex with bth wmen and men (behavirally bisexual) [als evaluate indicatins fr PrEP use by MSM criteria] Infrequently uses cndms during sex with 1 r mre partners f unknwn HIV status wh are knwn t be at substantial risk f HIV infectin (IDU r bisexual male partner) Is in an nging sexual relatinship with an HIV-psitive partner

10 Indicatins fr PrEP in IDU Adult persn: Withut acute r established HIV infectin Any injectin f drugs nt prescribed by a clinician in past 6 mnths AND at least ne f the fllwing: Any sharing f injectin r drug preparatin equipment in past 6 mnths Been in a methadne, buprenrphine, r subxne treatment prgram in past 6 mnths Risk f sexual acquisitin (als evaluate by MSM and Hetersexual criteria)

11 PrEP in Adlescents The data n efficacy and safety in adlescents are insufficient. The risks and benefits f PrEP fr adlescents shuld be weighed carefully in the cntext f lcal laws and regulatins abut autnmy in health care decisin-making by minrs. (IIIB)

12 Prescribing PrEP Rule ut chrnic and acute HIV infectin Query patient abut recent expsure Ask abut symptms f acute r primary HIV infectin Perfrm HIV screening test If acute infectin is pssible: Screen using a highly sensitive test: 4th generatin r viral lad test Or pstpne PrEP until repeat HIV screening cmpleted in ne mnth

13 Prescribing PrEP Other labratry tests Renal functin: PrEP shuld nt be prescribed t persns with a creatinine clearance f < 60 ml/min Hepatitis B and C As PrEP may have partial efficacy against hepatitis, it is imprtant t dcument infectin Vaccinatin fr hepatitis A and B is recmmended fr MSM STI screening in all apprpriate anatmic sites: gnrrhea, chlamydia, syphilis

14 Prescribing PrEP Prescribe up t 3 mnths wrth f PrEP The nly regimen apprved by the FDA and recmmended fr PrEP with all ppulatins specified in the guideline is the c-frmulated tenfvir 300 mg/entircitibine 200 mg (Truvada). (IA) Tenfvir alne has shwn efficacy and safety in hetersexuals and IDU (but nt MSM) and can be cnsidered fr these ppulatins. (IC) The use f ther medicatins in place r in additin t TDF/FTC r TDF alne is nt recmmended. (IIIA) Prescribing PrEP fr citally-timed r ther nncntinuus daily use is nt recmmended. (IIIA)

15 Reinfrcing Adherence Adherence cunseling Establish trust and bidirectinal cmmunicatin Prvide simple explanatins and educatin Dse and side effects Imprtance f adherence Symptms f acute infectin

16 Reinfrcing Adherence Adherence cunseling (cnt d) Supprt adherence Dsing schedule tailred t daily rutine Reminders Identify barriers t adherence Mnitr medicatin adherence in a nnjudgmental manner Reinfrce success Identify and manage side effects

17 Reinfrcing Safe Behavirs Behaviral risk-reductin cunseling Establish trust and bidirectinal cmmunicatin Prvide feedback n HIV risk factrs identified during sexual and substance use histry taking Barriers t and facilitatrs f cnsistent cndm use Barriers t and facilitatrs f reducing substance use

18 Reinfrcing Safe Behavirs Behaviral risk-reductin cunseling (cnt d) Supprt risk reductin effrts Identify acceptable incremental steps t risk reductin Identify and address barriers t risk reductin plans Mnitr behaviral adherence in a nnjudgmental manner Reinfrce success If nt successful, assist in mdifying risk reductin plans

19 Fllw-up Visits Every 3 mnths Repeat HIV testing and assess fr signs/symptms f acute infectin t dcument that patients are still HIV-negative. (IA) Repeat pregnancy testing fr wmen wh may becme pregnant. Prvide a prescriptin r refill authrizatin f daily TDF/FTC fr n mre than 90 days (until the next HIV test). Assess side effects, adherence, and HIV risk behavirs. Prvide supprt fr medicatin adherence and risk-reductin behavirs. Respnd t new questins and prvide any new infrmatin abut PrEP use.

20 Fllw-up Visits Every 6 mnths Mnitr creatinine clearance. (IIIA) Cnduct STI testing recmmended fr sexually active adlescents and adults (i.e. syphilis, gnrrhea, chlamydia).

21 Fllw-up Visits Discntinuing PrEP Dcument HIV status Understand reasn fr discntinuing PrEP Cunsel based n recent adherence and risk behavirs

22 Clinical Prvider s Supplement

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24 NACCHO s Webcast Series n PrEP and Lcal Health Departments Mdule 1 PrEP fr HIV Preventin: An Intrductin Beynd the Basics: The Science f PrEP US Public Health Service Clinical Practice Guidelines fr PrEP Mdule 2 Wh Might Benefit frm PrEP: Ppulatin-level Risk Assessments Wh Might Benefit frm PrEP: Individual-level Risk Assessments Mdule 3 Increasing PrEP Awareness and Knwledge in Yur Jurisdictin Incrprating PrEP int Cmprehensive HIV Preventin Prgrams NACCHO s educatinal series abut PrEP was supprted by funding frm Gilead Sciences, Inc.

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