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PRE-EXPOSURE PROPHYLAXIS FOR PRIMARY CARE ERIK WERT, D.O FACOI MEDICAL DIRECTOR INGHAM COMMUNITY HEALTH CENTERS INGHAM COUNTY HEALTH DEPARTMENT Objectives • 1) Know the current guidelines for PrEP • 2) To identify individuals who would benefit from PrEP • 3) Conversion of Post-Exposure Prophylaxis to Pre-Exposure • 3) ICHC partnership between CBO and ICHD to facilitate the program Institute of Medicine Barriers to care: “ironically, it requires greater intimacy to discuss sex, than engage in it” Institute of Medicine (1997) Background • • • • Approximately 50,000 new cases of HIV yearly Prevalence rates have increased since ART Rates are decreasing in heterosexual/IDU Higher rates in MSM MSM of color • Access question • Higher rates in transgender patients • General US population 0.6% of population, transgender is 1.15% Background • Youth – 13y/o to 24 y/o make up approximately 1/5 of new cases • Most individuals did not know their HIV status • Decreasing in all racial groups except African American, and African American MSM highest HIV Testing Universal HIV Screen Early Detection HIV + Early Implementation of ART HIV Negative Risk Behavior/PrEP Reduction of HIV CDC, USPSTF and AAP all recommend screening Opt out, not opt-in Clinical Guidelines • Established by CDC and USPHS • Current indications 1) Recommended for sexual active MSM at substantial risk for HIV (1A) 2) Recommended for heterosexual active males and females at risk for HIV (1A) 3) Recommended option for IDU (1A) 4) Heterosexual active females with males infected with HIV + (Sero-discordant) couples (IIB) Additional • Exclude all possible acute infection or chronic infection • FDA recommends Truvada™ (TDF/FTC) at fixed dose 300mg/200mg daily (IA) • IUD/Heterosexuals – there is possibility of TDF alone, but not in MSM • Information in adolescents is insufficient (IIIB) • Currently studies on adolescent and pregnant women is ongoing Descovy ™ (TAF/FTC) • • • • • Newer formulation of TDF TAF Less toxic to renal system Allowed to CrCl of 30ml/min DO NOT USE FOR PrEP. They are working on new formulations Common Patient Questions • How Does it work? • May prevent the replication of virus • Can I take it as needed? • No, it’s a daily medication • Is your patient going to be compliant • Current CDC recommendation is DAILY • IPERGAY – on demand – worked • Do I have to take it for my lifetime? • No, you take it during periods where risk is highest TDF (Tenofovir) • • • • • NRTI – Nucleotide reverse transcriptase For PrEP – fixed doses 300mg Well tolerated Lactic Acidosis and hepatomegaly and steatosis Monitor for Hep B infection • Check status, vaccinate if needed • Some decline in bone density (approximately 1%) • Renal function – can cause an ARF • Can only be used with GFR > 60ml/min FTC (Emtricetabine) Emtriva ™ • NRTI – Nucleoside Reverse Transcriptase inhibitor • Fixed dose 200mg • Always used in combination • Renal adjustment • Lactic Acidosis and hepatomegaly • Active against Hepatitis B, but not use to treatment – not recommended PrEP Timeline iPrEx (2010) & US MSM August 2012 TDF2 Partners PrEP July 2012 FEM-PrEP January 2011 CDC Interim Guidance: PrEP for MSM May 2014 US Public Health Service Clinical Practice Guideline for PrEP July 2012 FDA Approval TDF/FTC PrEP June 2013 Bangkok TDF Study March 2013 VOICE June 2013 CDC Interim Guidance: PrEP for IDU August 2012 CDC Interim Guidance: PrEP for heterosexuals January 2014 NYS AIDS Institute Guidance for PrEP Studies • iPrEx studied TDF/FTC, MSM and FTM – finding those who took less likely to be infected – when controlled for serum levels significant reduction was noted • THIS LEAD TO THE CDC issuing its interim guidelines in 2011 Studies • US MSM – Randomized, double blinded, placebo study using just TDF and noted decreased bone mineralization of approximately 1% at the femoral neck • THIS IS TEMPORARY resolves after discontinuation Studies • FEM-PrEP – TDF/FTC in females was stopped due to inability to determine effectiveness Reason: ADHERENCE WAS LOW • TDF-2 (Botswana) – This randomized controlled, oral PrEP in males and females – decreased rates Reason ADHERENCE WAS HIGHER Studies • Bangkok TDF Study – IDU using only TDF found lower rates • PROUD STUDY – MSM in UK, placebo arm halted when the divergence happened Assessment of Risk • Risk Behaviors • Do you have sex with men, women, both • How many partners have you had • Do you engage in receptive anal intercourse • Do you consistently use condoms • Were any of your partners HIV + • Have you used methamphetamine Risk • Transgender • Have a 2x the rates of HIV infection • Average US population is 0.6%, transgender is 1.15% • Income disparity • May lead to risky behaviors Risk Screen by anatomy and behavior, never sexual orientation or gender identity After Risks • Discuss behavioral interventions • PrEP has side effects • Consistent use of condoms still required to reduce STI/STD Complicated Cases • If partner is HIV + • Is the partner on therapy? • Are they virally suppressed? • In heterosexual couples if partner is suppressed there is a 96% reduction • No data in MSM • Experience • Many individuals want to go on for their own control of the situation Indications MSM • • • • Adult Male (PrEP indication only >18y/o) R/O acute or established HIV infection Any male partner in last 6 months In a non-monogamous relations And one of the following • Any anal intercourse in last 6 months • Any STI in last 6 Months • In an ongoing relationship with HIV + partner PrEP Heterosexual males/female • • • • Adult: > 18 y/o No acute or established HIV Any sex with opposite partner Non-monogamous relationship with recently tested HIV – At least one of the following 1. Male who is msmw 2. Partner who is HIV + 3. Infrequent use of condoms with individual who has unknown HIV status and at high risk IUD • • • Have you ever injected drugs not prescribed In past 6 months have you injected using needles, syringes used by another person In past 6 months have you been on medications for treatment RECOMMENDATION INDICATIONS 1. Adult > 18 y/o 2. No active HIV infection 3. Any injection in last 6 months 3. At least one of following 1. Shared of injection or prep material 2. Been in treatment in last 6 months Risk of HIV as noted in the MSM or Heterosexual PEP to PrEP • Individuals who have high risk exposure who are placed on PostExposure Prophylaxis • CDC Guidelines • Truvada + Raltegravir (isentress) 400mg BID • NEW: Truvada + Dolutegravir (Tivicay) 50mg qd • Discussion conversion to PrEP PEPPrEP • This discussion should occur early • If the individual is interested obtain the baseline lab work LAB TESTING • CDC • Hepatitis B/C • Creatinine Clearance - CMP • RPR • Urine Gonorrhea and Chlamydia • Urine Pregnancy Test • ICHC/ICHD • HSV ½ • Hepatitis A • +/- Anal Pap Smear – No consensus • Oral and Anal • Can be self collected • Check with Lab what tubes and media to use Hepatitis Panel • Hepatitis A IgG • Acutely IgM • Hepatitis B surface Ag • Hepatitis B surface Ab • Hepatitis B Core Total Antibody • Acutely IgM • Hepatitis C Antibodies Hepatitis B serology Testing Immunization • The reason we prefer the panel is to dictate vaccination • Consider the Hepatitis A vaccine in all MSM if not always ready immunized • HPV vaccination per the guidelines Providing PrEP • Scripts are 3 months supplies only • Have to come in for evaluation • Medication adherence • Re-enforcement of behavioral • Re-assess the need for PrEP Complaints • Most common is nausea, headache, abdominal pain, flatulence • Start up syndrome – resolves in about 1-2 weeks in most patients Interactions • No issues with Oral Contraceptives • No interaction with hormone replacement for transgender patients • No effects of methadone or buprenorphine • Medication that can effect renal function care a concern – Aminoglycosides, NSAIDs, anti-herpetic drugs • Remember CrCl > 60 – so if borderline order BMP more frequently Monitoring • Prescribed in three month intervals • Every three months (CDC) • Pregnancy Tests • HIV test – Rapid or blood draw • Discussion of psycho social ICHC/ICHD Variation 1. BMP, RPR, Hep C 2. Screening oral/anal/urine of GC/Chlamydia Monitoring • Every 6 Months (CDC) • • • • • CMP STI Testing RPR HIV Pregnancy testing Monitoring • At every evaluation consider 1. 2. 3. 4. Does the patient still needed it Has there been social changes Where are they in the social changes Consider the duration of the relationships Consideration • Information if patient discontinues • Check the HIV status • Documents why the medication is discontinued • Recent medication changes Special Consideration • Pregnancy • FDA and perinatal antiretroviral usage • Limited safety data • Patient with chronic hepatitis B • Both TDF/FTC are active against Hepatitis B • Only TDF is indicated for Hepatitis B • Would recommend ID to deal with this issue PrEP FAILURE • To date only 1 case of failure • Back story: MSM, consistent with Truvada ™ seroconverted to HIV + • Had Stopped using barrier prophylaxis • Multiple sexual receptive anal encounter 45 days preceding • VIRAL PATTERN: Resistant to TDF and FTC • This mutation is very uncommon less then 1% • Also resistant to INSTI This resistance pattern shows more transmitted rather then acquired Intersection Interactions • ICHC is a division of the ICHD • Connection to the STI/STD department • Allows for smooth transitions • CBO – Local non-profits – HIV organization provides PEP/PrEP referrals • Private offices outreach to offices who would like patients put on it an monitored • Send letters to PCP • Discuss findings Cases • 24 year old MSM presents with request for PrEP • Questions? Question • When was his last sexual interaction • Does he engage in oral or anal • Does he engage in receptive or insertive sex • Does he know the status of his partner • ANSWER: Anal receptive, partner unknown Question • IS HE A CANDIDATE for PrEP? LABS • Check • What if the patient is having any symptoms (prodromal) in last 4 weeks? • What do you do? Answer 1. You can defer and recheck a HIV antibody test 2. Check an HIV antigen/Antibody test (4th generation) 3. Check a HIV viral load Question • Answer: NO, He is more a candidate for PEP with possible conversion to PrEP in the future • So TDF/FTC + Raltegravir or Dolutegravir Follow UP • Patient returns after completing 28 Days of PEP, what can you do? References • http://www.cdc.gov/hiv/prevention/researc h/prep/ • http://www.cdc.gov/hiv/pdf/PrEPguidelines 2014.pdf • http://www.inpractice.com/Textbooks/HIV/ Antiretroviral_Therapy/ch10_pt1_Overview .aspx • NYSDOH AI: http://www.hivguidelines.org/