3/28/2016. Why you should care? Dana W. Dunne, MD, FACP Associate Professor of Medicine Yale University School of Medicine New Haven, Connecticut

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1 Sexually Transmitted Diseases (STDs) and HIV: Top Ten Highlights for Clinicians Dana W. Dunne, MD, FACP Associate Professor of Medicine Yale University School of Medicine New Haven, Connecticut FINAL: New York, New York: March 23, 2016 Financial Relationships With Commercial Entities Dr Dunne has no relevant financial affiliations to disclose. (Updated 03/15/16) This presentation will include discussion of pharmaceuticals or devices that have not been approved by the FDA. Off-label use of extra-genital (rectal and pharyngeal) nucleic acid amplification tests (NAATs) for gonorrhea and chlamydia Thank you to Katherine Hsu, MD (Ratelle STD PTC) and others in NNPTC for slide sharing Slide 1 of 35 Why you should care? 1. HIV incidence rates remain high 2. STI- marker of high risk activity 3. STI- personal and public health concern 4. STI- enhance transmission of HIV Getting to zero = more effective STI screening and treatment in our HIV-infected patients Slide 2 of 35 1

2 Learning Objectives After attending this presentation, participants will be able to: Identify elements and rationale of an effective STI screening approach Recognize current STI epidemiology in HIV clinic and PrEP setting Describe recommended treatment and partner notification approaches for key bacterial STIs Outline- Slide 3 of 35 Let s take a trip to the clinic You are seeing Mr. G.P. for a routine HIV clinic appointment. He has well controlled HIV; self-describes as bisexual currently with a stable female partner. You have clinical questions about the following: 1. Are STI rates really that high in HIV clinic to warrant testing after initial intake? 2. Can you limit STI screening to only sites exposed? 3. Can t you pick up most things just by having him pee in a cup? Slide 4 of 35 STI rates are high in HIV clinics High baseline and incident STIs in HIV clinic US: HIV Primary Care clinic- 4 cities (n=557) 13% prevalent STI, 7% incident STI MSM- accounted for 94 % of infections (if trich excluded); 20% of incident STIs at 6 months most common: rectal CT, pharyngeal GC Risk factors polysubstance abuse ; >4 partners in 6 months Screening rates suboptimal 39% of HIV patients screened for GC/CT (vs 76% lipid screening) 10% Extragenital screening in MSM Mayer K, et al. STD 2012 Berry JAIDS, 2015 Slide 5 of 35 2

3 Women who do not need a pelvic exam as part of their clinic evaluation may be screened for chlamydia and gonorrhea by providing a self-collected vaginal swab. Your healthcare provider should give you instructions and make sure you understand what to do before you start. This page explains the procedure. (Illustrations courtesy of Gen-P robe Incorporated, San Diego CA) NC Sexually Transmitted Diseases Public Health Public Health Program Manual /Laboratory Testing & Standing Orders Self-Collected Swabs April 2011 Page 1 of 1 To collect a vaginal swab for gonorrhea/chlamydia testing: 1. Thoroughly wash your hands before starting. Undress from the waist down. 2. Read the instructions for using the test kit. 3. Open the kit package and set the tube of liquid to the side (do not open tube). 4. Partially peel open the swab package as directed, exposing the stick end of the swab (see picture 1). IMPORTANT: Do not touch the soft tip of the swab or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, ask for a new test kit. 5. Remove the swab from the package carefully; do not lay it down. 6. Hold the swab in the middle of the stick (shaft) with your thumb and forefinger (see picture 2). 7. Carefully insert the soft tip end of the swab into your vagina about 2 inches (5 cm) past the opening of the vagina (see picture 3). Gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. 8. Withdraw the swab without touching your skin. 9. While still holding the swab, carefully unscrew the cap from the tube of liquid. Do not spill the contents of the tube. (See picture 4.) 10. Immediately place the swab into the tube so that the soft tip of the swab is visible below the tube label. (See picture 5.) 11. Carefully break the swab shaft at the scoreline (dented line around middle of stick), being careful not to spill the liquid in the tube (picture 6). Leave the soft end of the swab in the tube and throw away the top portion of the swab shaft (picture 7). Tightly screw the cap onto the tube (picture 8). 12. If the contents of the tube are spilled or the tip of the swab touches anything, ask for a new test kit. 13. Return the tube as instructed by the nurse or doctor. 3/28/2016 Tip #1- Remember routine STI Testing during HIV care Initial care visit Syphilis serology Gonorrhea, chlamydia NAAT (at sites exposed) Women- Trichomonas testing (NAAT, culture) Cervical pap test per existing guidance (HIV OI guidelines) Hepatitis A/B/C testing ##More frequent screening dependent on risk! New sex partner, partner with concurrent partners or more than one partner, or partner with an STI High risk behavior Partner services, prevention counseling CDC 2015 Treatment Guidelines, HIVMA 2014 Slide 6 of 35 Tip # 2: Don t rely on symptoms or self-reported exposure Selective or symptom screening can miss up to half of STIs- (Van Liere 2013) Screening only urine misses majority of STIs in MSM- (Marcus 2011) Proportions of chlamydial and gonococcal infections among asymptomatic men who have sex with men that would be missed by different screening practices San Francisco City Clinic, Slide 7 of 35 Screening- What swab do I use? Genital Testing Men- Urine = urethral swab Women and Chlamydia Urine << Vaginal Swab; cervical Vaginal- provider or patient collected Self-Collected Vaginal Swabs for Gonorrhea Extragenital Testing* *check for lab validation locally Pharyngeal- Like strep throat swab Rectal- Provider or patient collected Slide 8 of 35 3

4 Tip #1 and 2- Universal screening every 3-6 months for atrisk patients Regardless of symptoms Regardless of site exposed Pharyngeal GC NAAT** Urine GC/CT NAAT Rectal GC/CT NAAT** Can be pt collected *In HIV-coinfected individuals, screen hep C at least annually **Off-label use - not FDA-approved for testing at extragenital sites, but many reference labs have validated the assay for use Slide 9 of 35 Your patient s STI screen results return. He has pharyngeal gonorrhea but chlamydia testing from all sites (using NAATs) is negative. How to treat? 1. Ceftriaxone 125 mg IM x 1 2. Ciprofloxacin 500 mg po x 1 plus azithromycin 1 gm po x 1 3. Cefixime 400 mg po x 1 4. Ceftriaxone 250 mg IM x 1 5. Ceftriaxone 250 mg IM plus azithromycin 1 gm po x 1 17% 4% 6% 0% Ceftriaxone 125 mg IM x 1 Ciprofloxacin 500 mg po x 1 plu... Cefixime 400 mg po x 1 Ceftriaxone 250 mg IM x 1 Ceftriaxone 250 mg IM plus az... 72% Slide 10 of 35 Tip #3- Use DUAL Treatment for Gonorrhea Gonorrhea- Uncomplicated Genital, Rectal, or Pharyngeal Infections Ceftriaxone 250 mg IM in a single dose* PLUS* Azithromycin 1 g orally * Regardless of CT test result Azithromycin 2 g orally removed as an alternative regimen *If CTX unavailable-cefixime 400 mg orally once (anorectal infection only) CDC 2015 STD Treatment Guidelines Slide 11 of 35 4

5 Tip #4-Rescreen 3-4 months after STI Women with CT, GC or trichomonas should be rescreened at 3 months after treatment. Men with CT or GC should be rescreened at 3 months after treatment. Patients diagnosed with syphilis should undergo follow up serology per current recommendations. Slide 12 of 35 You remember something about partner notification Expedited Partner Therapy (EPT) is legal in my state: 1. Yes 2. No 3. I don t know 64% 32% 4% Yes No I don t know Slide 13 of 35 Tip #5-EPT is effective and now legal in (most) all states Legal Status of EPT as of 2016 PDPT can prevent reinfection of index case and has been associated with a higher likelihood of partner notification Slide 14 of 35 5

6 EPT local details STATE Contact to CT Contact to GC Notes NY Azithromycin 1 gm Not sanctioned heterosexual NJ Azithromycin 1 gm CT Azithromycin 1 gm Cefixime 400 mg +AZ Cefixime 400 mg +AZ heterosexual ( MSM w caution ) heterosexual Slide 15 of 35 Your patient tells his female partner about EPT but she prefers to come to the clinic. She is known to be HIV+. You commence routine STI screening and treat her as a contact to GC. Her Trichomonas antigen test returns positive. Which of the following is recommended for treatment? 1. Metronidazole gel 2% intravaginally q hs 5 nights 2. Metronidazole 2 gm orally x 1 dose 3. Metronidazole 500 mg orally BID x 7 days 4. No treatment necessary as she is asymptomatic and not pregnant Metronidazole gel 2% intravagi... 8% Metronidazole 2 gm orally x % 45% Metronidazole 500 mg orally B.. 1% No treatment necessary as she.. Slide 16 of 35 Trichomonas treatment HIV+ women Recommended Regimen for Women with HIV Infection Metronidazole 500 mg orally twice daily x 7 days Rescreen in 3 months (ideally with NAAT) Slide 17 of 35 6

7 Tip #6- Employ Newer Testing Options for Trich Microscopy is inferior to new options, including Rapid antigen testing (OSOM) Nucleic acid amplification testing APTIMA TMA Trichomonas vaginalis assay May use same specimen types as used with gc/chl NAATs (i.e. vaginal swab, endocervical swab, urine) Huppert CID 2007 Test Sens Spec APTIMA TMA 98% 98% OSOM 90% 100% Culture 83% 100% Wet prep 56% 100% Slide adapted from Marrazzo, IDSA 2011 Slide 18 of 35 Mr G.P. lets one of his male partners know about the STD contact. Mr. O.S. comes to your clinic for GC screening and treatment. What else can you offer? 1. GC pharyngeal NAAT; GC/CT urine and rectal NAAT 2. Syphilis serology 3. Hepatitis B/C 4. HIV testing 5. Vaccination (Hep A/B, HPV) 6. PrEP GC pharyngeal NAAT; GC/CT ur... Syphilis serology 100% 0% 0% 0% 0% 0% Hepatitis B/C HIV testing Vaccination (Hep A/B, HPV) PrEP Slide 19 of 35 High burden of bacterial STIs /PrEP settings STUDY Baseline STI % Incident STI% PROUD 63% 51-57% IPERGAY 25-31% 20% Partners PrEP 10-15% McCormack Lancet 2016 Molina NEJM 2015 Baeten NEJM 2012 Slide 20 of 35 7

8 Tip #7- Screen for bacterial STI in PrEP clinic! Slide 21 of 35 Rethink CDC PrEP STI q 6 month screening guidelines? 21% incident STI in 6 months prior to PrEP start Relying on symptoms would miss -77% of STI at 3 months -68% of STI at 9 months Repeat patients responsible for bulk of incident infections Golub, S, et al, Abstract #869 CROI, 2016 Slide 22 of 35 Case continues Mr. O.S. has full STI screen and baseline HIV test, gets GC exposure treatment and starts daily tenofovir/emtricitabine. 3 months later he returns for an evaluation and STI screen is repeated. He reports he can barely read the instructions in the bathroom about selfobtaining rectal swab due to a recent blurriness in his L eye. 2 days later his Syphilis EIA returns POSITIVE with reflex RPR of 1:256. He admits to a suspicious rash two weeks ago which has now resolved. His rectal CT NAAT is positive. Management?? Slide 23 of 35 8

9 Rates of infectious syphilis rising in MSM especially HIV % HIV coinfected Prevalence (2011) 2.6% in HIV-negative MSM 10.1% in HIV-positive MSM 75% of all P & S syphilis in MSM Core group of HIV+ MSM disproportionately contribute Slide 24 of 35 Tip #8- Neurologic complaints should prompt consideration of neurosyphilis Symptoms Visual changes, hearing loss, facial weakness, stuttering stroke symptoms Entities- Symptomatic early neurosyphilis (SENS) Ocular- uveitis, chorioretinitis most common Otic- tinnitus, SNHL Cranial Nerve involvement Aseptic meningitis Meningovascular Slide 25 of 35 Syphilis- When to do an LP? 1. Signs or symptoms of neurosyphilis 2. Diagnosis of Tertiary syphilis 3. May benefit? -Not serologically responding to treatment (eg-4-fold drop 6-12 months in early syphilis) Interpretation: Si/sx and Pos CSF-VDRL= diagnostic of neurosyphilis Si/sx with abn CSF (prot >40, WBC >5) with NEG CSF- VDRL = consider neurosyphilis. Negative CSF-TPPA virtually excludes neurosyphilis CDC STD Tx Guidelines 2015 Slide 26 of 35 9

10 Case continued- Mr OS has LP, posterior uveitis confirmed by ophthalmologic exam, high dose IV penicillin started for ocular syphilis/neurosyphilis. Key points- Serologic follow 3,6,9,12,24 months Counsel about Jarisch-Herxheimer reaction Report to local Health Department within 24 hours of diagnosis (CDC Advisory Feb 8, 2016) Pre-antibiotic samples (whole blood, primary lesions, CSF or ocular fluid) saved and stored at -80 immediately on collection (for assistance contact Dr Allan Pillay at or ajp7@cdc.gov) Slide 27 of 35 Tip #9- Treatment regimen for rectal CT depends upon symptoms Scenario A: Rectal CT NAAT positive- asymptomatic pt Treat for uncomplicated CT Azithromycin 1 gm po x 1 or Doxycycline 100 mg po bid x 7 days* Scenario B: Rectal CT NAAT positive- symptoms of proctitis Treat for presumed LGV strain Doxycycline 100 mg po bid x 21 days Further testing to confirm?- LGV strain PCR not commercially available. NYC diagnostic LGV conundrums contact Dr Julie Schillinger (jschilli@health.nyc.gov) *may be superior in rectal CT infections?? RCT needed Slide 28 of 35 Tip #10! Want to know more about STDs? There s an app for that. CDC STD Treatment Guidelines App for Apple and Android Available now, FREE! (accept no competitors) Search STD Treatment in App store Download now! Slide 29 of 35 10

11 National- STD Clinical Consultation Network (STDCCN) NEW!!!!! Provides STD clinical consultation services within 1-5 business days, depending on urgency, to healthcare providers nationally Your consultation request is linked to your regional PTC s STD faculty Just a click away! Slide 30 of 35 Top Ten Tips to Take To Work 1. Remember to screen patients for STIs in your HIV clinic 2. Screen MSM and at risk heterosexuals in all sites, frequently 3. Employ dual treatment for Gonorrhea 4. Rescreen for bacterial STI in 3-4 months THANK YOU! 5. EPT is effective and legal in your state 6. Trichomonas diagnostics have improved- access them 7. PrEP setting STI rate high- screen often 8. Syphilis rates remain high; ask about neurologic symptoms 9. Symptoms drive treatment regimen of rectal CT infection in MSM 10. Fast resources available- Download the App Slide 31 of 35 EPT information National- New York - lth-topics/expedited-partner-therapy.page New Jerseyhttp:// /ept_facts.pdf Connecticuthttp:// _diseases/std/ept_clinical_advisory.pdf Slide 32 of 35 11

12 EPT- Practical Considerations in NYS Write EPT in body of script Can leave patient name, DOB, address blank and pharmacists can fill it DO NOT use for partners of patients w GC, syphilis Provider must 1. provide index patient w/ written materials 2. Counsel index patient to tell partner to read material 3. More info on website Fully electronic prescribing- end of March- stay tuned for EPT exception Slide 33 of 35 Back-Pocket GC Treatment Regimens: Alternatives for cephalosporin-allergic patients Trial conducted in Baltimore, Birmingham, Pittsburgh, San Francisco 401 men and women yrs 202 received gent 240 mg IM + azithro 2 g PO: 100% effective 199 received gemiflox 320 mg PO + azithro2 g PO: 99.5% effective Bottom line Probably fine for urogenital gonorrhea, but trial not powered for extra genital gonorrhea (though it worked in the few cases enrolled) Efficacy limited by tolerance: 8% vomited in the gemiflox + azithro group and needed re-treatment with standard cftx + azithro Kirkcaldy RD et al. CID 2014 Slide 34 of 35 12