STI UPDATE: Clinical Challenges Emerging Issues Hot Topics. Objectives WE 273 ACHA 2012 ANNUAL MEETING CHICAGO MAY 30, 2012

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1 STI UPDATE: Clinical Challenges Emerging Issues Hot Topics Craig Roberts, PA C, MS P. Davis Smith, MD WE 273 ACHA 2012 ANNUAL MEETING CHICAGO MAY 30, 2012 Objectives 2 List five new or emerging issues in the management of STIs Recite current treatment recommendations for gonorrhea and chlamydia Describe surveillance systems for monitoring antibiotic resistance in STIs Discuss innovations in diagnostic tests used for STIs A presentation handout will be provided on the ACHA web site 5/30/2012 1

2 Topics Emerging Issues & Challenges 3 Gonorrhea treatment and antibiotic resistance Azithromycin for chlamydia treatment failures? Managing idiopathic urethritis Missed opportunities in chlamydia screening Use of newer assays for diagnosis and screening Recognizing acute HIV infection Anal cytology yay or nay? Disclosures 4 Craig Roberts is a speaker for Merck. No financial support was received for this program. Davis Smith is a consultant, medical director and author for Student Health 101, a health communications company. No financial support was received for this program. 5/30/2012 2

3 Case Presentations 5 These cases are designed to illustrate some issues in the management of selected STIs We ll also cover areas of uncertainty and controversy in testing or treating STIs These are actual cases representing real patients seen in college health centers. Names have been changed and other information may have been modified to protect their identity. CDC STD Treatment Guidelines 6 Authoritative source of STD treatment and management Screening, prevention and vaccination strategies, plus treatment regimens Updated every 4 5 years Pocket guides, wall charts, slide set, PDA versions available Download or order at 5/30/2012 3

4 2010 STD Treatment Guidelines 7 New in this version: Revised gonorrhea treatment regimens Updated evaluation and management of syphilis Expanded prevention guidance, incl. HPV vaccine for men Expanded guidance on screening in special populations Trich rescreen infected women 3 mo after treatment Chlamydia & GC rescreen infected men 3 mo after treatment Bacterial vaginosis added alternative treatment regimens New HPV screening, genital wart treatment options Case Dysuria in a Young Woman 8 Sheila, 19, has had urinary symptoms X 1 week HPI from visit on 2/13/12: Dx with UTI 2/1/12. See note. Completed 7 day course of Nitrofurantin. Frequency, suprapubic pain resolved, but external stinging and mild urgency persist. Denies risk for STI. New partner 4 mo ago with 100% condom use. How would you manage this patient today? What lab tests would you do now? What would you treat with, if anything? 5/30/2012 4

5 Case Dysuria in a Young Woman 9 Urinalysis: 2 5 WBC, no bacteria, no blood clinician elected to wait for final results before treating Urine culture grew <10 4 mixed flora Her urine chlamydia test was positive she was treated with azithromycin, and her sx resolved This was the first time this patient had been tested for chlamydia despite multiple visits in the prior year Discussion Chlamydia Screening 10 CDC and USPSTF recommend: Screen all sexually active women under age 25 for CT every year regardless of perceived risk Dysuria is a common presenting symptom of chlamydia in women You can easily test for chlamydia using a first void urine specimen; a pelvic exam is not required Discuss: should you test for chlamydia in every young woman with UTI symptoms? 5/30/2012 5

6 11 STD Diagnostics Nucleic Acid Amplification Tests (NAATs) NAATs for chlamydia and GC are standard urine, self collected vaginal swab, or cervical swab NAATs are available for trich and herpes (i.e. PCR) Real world sensitivity and specificity is usually >99% NAATs can be used for nongenital sites (rectal and pharynx) but are not FDA cleared; lab must validate Limitation: can t monitor for drug resistance (yet) Screening Guidelines for Women 12 Begin screening at age 21 Screen every 3 years to age 29 Screen every 3 5 years age 30+ Cervical Cancer Screening new Screen regardless of sexual activity Pelvic exam needed Chlamydia Screening Begin screening at age 15 Screen annually to age 25 Screen age 25+ only if at risk Screen only if sexually active Pelvic exam not needed A pelvic exam before age 21 is not needed unless medically indicated A pelvic exam is not required to prescribe contraception A pelvic exam is not needed to screen for STIs ACOG 2011, Committee Opinion 483 ACOG 2009, Practice Bulletin 109 USPSTF 2012, Cervical Cancer Screening USPSTF 2008, Recommendations for STI Screening 5/30/2012 6

7 Which type of school are you? 13 Old school Chlamydia tests are only done at an annual gyn visit Chlamydia tests are only collected from the cervix Chlamydia tests are only done for women thought to be at risk Cool School Chlamydia tests are done at any type of visit Testing is done with urine or vaginal swab Annual screening is promoted to all women under 25 Chlamydia Screening Opportunities 14 Add chlamydia testing when you collect a urine for: Pregnancy test requests UTI symptoms or evaluation Routine medical exam Sports physicals Promote a culture of screening in your SHS Offer walk in or express visits; make it easy and fast No exam needed use urine or self collected swab Nurse visits, health educators, etc. can all initiate testing 5/30/2012 7

8 Case Urethral Discharge y.o male, MSM, with 3 day history of acute dysuria and urethral discharge Exam: purulent urethral discharge Lab: Gram stain done in clinic shows full field PMNs, with Gram negative intracellular diplococci What s the diagnosis? Presumptive gonococcal urethritis CDC Discussion Gonorrhea 16 Management Questions What other STI tests are needed? Which drug(s) should be used for treatment? 5/30/2012 8

9 Routine STI Screening for MSM 17 GC and CT urine using a nucleic acid amplification test (NAAT) GC tests of other exposed sites (pharynx and/or rectal) NAAT preferred if available. RPR or VDRL for syphilis HIV antibody HBsAg if not immunized prior to sexual debut CDC 2010 STD Treatment Guidelines USPSTF 2008, Recommendations for STI Screening Gonorrhea Treatment Overview 18 Quinolone resistance is now widespread Do not use single dose cipro to treat GC. Ever. 3 rd gen cephalosporins the only real choice Few alternatives in the pipeline Penicillin allergy is not a contraindication to using cephalosporins If cephalosporin allergy give azithromycin 2g single dose new 5/30/2012 9

10 19 Gonorrhea Treatment Important changes in 2010 guidelines Preferred Ceftriaxone 250mg IM single dose, plus Azithromycin 1g single dose, or doxycycline 100mg BID X 7 days Alternative Cefixime* 400mg PO single dose, plus Azithromycin 1g single dose, or doxycycline 100mg BID X 7 days Other 3 rd gen cephalosporins are either more expensive or less efficacious and are not recommended for routine use. Azithromycin alone as 2g single dose is not recommended due to GI distress and emergence of resistance. Use only for patients with cephalosporin allergy. *Cefixime is not effective for pharyngeal infection Are Cephalosporins Next? 20 Decreased susceptibility to cephalosporins now being reported worldwide: MMWR 2011;60(26) Resistance to cefixime will probably emerge first, thus new guidelines favor treatment with IM ceftriaxone Expanded surveillance important, report suspect treatment failures to your local health department Consider test of cure, esp for asx infections/msm Important editorial by Gail Bolan: NEJM 2012 Feb 9 Note: Dr. Bolan will discuss this topic at 1:45 PM today in the Clinical Medicine Hot Topics session WE 347 5/30/

11 Gonococcal Isolate Surveillance Project (GISP) Location of Participating Sentinel Sites and Regional Laboratories, United States, 2010 GISP data including drug MICs is available at cdc.gov/std/gisp Gonococcal Isolate Surveillance Project (GISP) Distribution of Minimum Inhibitory Concentrations (MICs) to Cefixime Among GISP Isolates, 2006 and Percentage < MICs (µg/ml) NOTE: Isolates were not tested for cefixime susceptibility in 2007 and /30/

12 Case Recurrent Dysuria 23 Jonas, age 22, had chlamydial urethritis 4 weeks ago. His symptoms resolved after taking azithromycin. His partner was treated. Now notes mild dysuria for 3 days, but not as bad as last time. What other history is important to obtain? He reports no sexual activity since treatment On physical exam, there is a small amount of mucopurulent urethral discharge. There are no lesions or rash. No other pertinent findings. Discussion Recurrent Dysuria 24 How would you manage this patient? What lab tests you would order, if any? Should you repeat his chlamydia test? Would you treat empirically? Which drug? UA shows WBCs/hpf, no bacteria Rx provided for doxycycline 100mg BID X 7 days The next day, the urine chlamydia test is positive Would this change your therapy? 5/30/

13 25 Chlamydia Treatment 2010 CDC Treatment Guidelines Azithromycin 1 gm single dose or Doxycycline 100 mg BID x 7 days Effectiveness is equivalent in most studies BUT Is Azithromycin Always Best? 26 Some evidence of treatment failures Schwebke et al Clin Infect Dis 2011;52:163 Only 77% efficacy in eradicating chlamydia in men with NGU May be related to organism burden, or unknown factors But other studies strongly favor azithromycin Emerging issue and concern; stay tuned Interim guidance: Use doxycycline for persisting sx or recurrent infection Consider test of cure 4 6 weeks post treatment Important to rescreen all positive patients at 3 months 5/30/

14 Case: Persistent Dysuria 27 Suppose this patient had the same presentation of urethritis, but was originally negative for chlamydia and gonorrhea, and his symptoms never really resolved. How would you manage his symptoms now? Retreat? with which medication? Repeat labs? Treat the partner(s)? Nonspecific Urethritis in Men 28 Continuum of symptoms: mild urethral irritation doesn t feel right, to frank dysuria and discharge Standard dx criteria is 5 WBC/hpf on Gram stain or 10 WBC/hpf on initial void urinalysis Pearl: dysuria in young men is usually an STI Initial treatment: azithromycin or doxycycline For recurrent or persistent symptoms, cover both trich and M. genitalium (azith + metro) 5/30/

15 Idiopathic Urethritis (non GC, non CT) 29 >50% of NGU is idiopathic (no pathogen identified) Mycoplasma genitalium an emerging STI Causes 5 25% of NGU; maybe cervicitis, PID diagnostic tests not widely available azithromycin is more effective than doxycycline Adenovirus, HSV, trich, anaerobes, and enteric bacteria are other common causes Non infectious causes should be considered, especially when pyuria is absent see Horner and Wetmore STD 2011;38(3) Recurrent Urethritis My Approach 30 Repeat urinalysis (initial void), confirm pyuria Rule out reinfection Re exposed? re treat with same medication No sexual contact? re treat with alternate (e.g. doxy) Consider trich, and test or treat as appropriate Treat partner if ongoing relationship Condom use to prevent re exposures in short term NSAID and watchful waiting if no pyuria HSV serology if primary symptom is dysuria alone 5/30/

16 Case Positive Syphilis Test y.o. female graduate student, requests treatment for syphilis Recently went to donate eggs at a fertility clinic, screening test there was positive for syphilis Unsure if ever tested for syphilis in the past Sexual history: 5 lifetime partners, all male With current partner for over two years, he is asx Copy of lab results obtained from other clinic 32 5/30/

17 Reverse Sequence Syphilis Screening 33 Case discussed with health department This was a new EIA treponemal test Follow up tests needed RPR or VDRL FTA (regardless of RPR) See MMWR 2011;60(5) Discussion: Case Follow Up 34 RPR was non reactive, FTA was reactive Pt treated with bicillin X3 for latent syphilis 6 months later, follow up visit: Repeat FTA test done elsewhere was negative Partner tested negative Repeat RPR negative. Discussed with DPH who advises Treponemal tests (FTA, EIA) are not useful for her Non treponemal tests (RPR, VDRL) should only be used if she has symptoms or history of exposure Lesson: newer tests are not always better tests 5/30/

18 Case Rash on Palms & Soles 35 Secondary syphilis there s nothing else like it! Toby, age 25 rash X 1 week MSM PMHx: HIV infection Syphilis Epidemiology 36 Low incidence; most infections now occur in MSM incidence in MSM is 61X incidence in MSW in ACHA Pap STI Survey, 73% of cases were MSM screening MSM for syphilis is important HIV co infection is common (~50%) Routine screening of low risk patients is not recommended by CDC or USPSTF Nilay Patel will discuss this topic in session WE 180 today at 10:00 am: HIV & Syphilis among MSM at New England Colleges and Universities 5/30/

19 Syphilis Treatment 37 Standard treatment unchanged Penicillin G benzathine, 2.4 million units IM single dose (Bicillin L A ) weekly X3 if duration is unknown or > 1 year Doxycycline x14 days if PCN allergy Same tx regimen if HIV+, but monitor with serologic follow up more frequently (q 3 months) Azithromycin as alternative drug discouraged documented resistance and treatment failures New Diagnostic Tests 38 Syphilis Rapid/point of care tests (pending FDA clearance) EIA tests Fast, easy, cheap Popular with labs More false positives, so must confirm with second treponemal test. eg TP PA, using CDC algorithm HIV Combo antigenantibody tests Adds p24 antigen Reactive at ~3 weeks Does not distinguish acute vs. prior infection Screening test of choice; improved sensitivity 5/30/

20 Chembio Syphilis Rapid Test 39 This product is not yet approved for use in the United States Case Acute Febrile Illness 40 Shawn, age 22, c/o fatigue, trouble sleeping and intermittent fevers x 2 weeks. Wants mono test. Also recent cough, sore throat, positive rapid strep (treated), 5 lb weight loss Exam normal except for pharyngeal erythema Has male and female sexual partners, and reports unprotected receptive anal intercourse one month ago. HIV ab positive (rapid test), HIV pdna positive 5/30/

21 Discussion Acute HIV Infection 41 When is it prudent to consider acute HIV infection in the differential of febrile illness? Should you take a sexual history in every patient with a mono like illness? Should MSM patients get tested for HIV RNA every time they have a febrile illness? Case Anal Cytology 42 Enrique is a 29 y.o. grad student. He is sexually active with men and comes to the clinic for routine STI screening. He is asymptomatic. His past medical history includes perianal warts 8 years ago, which resolved with treatment. He has heard that gay men have an increased risk of anal cancer and requests that you do an anal Pap smear. Would you do an anal Pap smear? Refer him elsewhere? What other advice would you provide re his concern? 5/30/

22 Discussion Anal Cytology 43 No national guidelines or standards for screening No consensus recommendations for management Minimal data exists to guide screening or follow up Currently not recommended for routine use Most experts advise Paps only for HIV+ patients very high prevalence of anal HPV 16 if HIV+ increased risk of progression to cancer if HIV+ Note: Kristen Keglovitch Baker will discuss this topic in depth at 10:00am Thursday in session TH 338: Anal Paps, HPV and Anal Cancer Screening What have we learned? 44 Chlamydia: test early, test often, esp in women Azithromycin is not a cure all for chlamydia, and probably less so in men with acute urethritis Gonorrhea continues to develop resistance to most drugs we use and there are few options Use nucleic acid tests (for CT, GC and HSV) when available, rather than older technologies Screen MSM for both HIV and syphilis 5/30/

23 Other Questions? 46 Craig Roberts University of Wisconsin Madison Davis Smith Wesleyan University 5/30/

24 Key Resources and References List ACHA 2012 Meeting Session WE-273 STI Update: Clinical Challenges, Emerging Issues and Hot Topics Sexually Transmitted Diseases Treatment Guidelines, Standard reference guide for STD treatment from the Centers for Disease Control and Prevention National Center for HIV/STD/TB Prevention, Division of STD Prevention Primary CDC portal site for STD information, for providers and patients Recommendations of the U.S. Preventive Services Task Force. Guide to Clinical Preventive Services, Agency for Healthcare Research and Quality, Rockville, MD. National Chlamydia Coalition CDC-sponsored coalition of non-profit organizations, professional associations, advocacy groups, and government representatives dedicated to elevating the importance of chlamydia screening and treatment. Website includes screening toolkit, policy guidelines, patient and provider resources. STD Checkup Screen, Diagnose, Treat, & Prevent: A Clinician s Resource for STDs in Gay Men and Other MSM California Dept of Public Health site with recommendations, protocols, guidelines, patient materials. Handsfield H. Questioning Azithromycin for Chlamydial Infection (Commentary). Sex Trans Dis 2011;38:1-2. Schwebke JR et al. Re-evaluating the Treatment of Nongonococcal Urethritis: Emphasizing Emerging Pathogens A Randomized Clinical Trial. Clin Infect Dis 2011;52: Horner P. The Etiology of Acute Nongonococcal Urethritis The Enigma of Idiopathic Urethritis? Sex Trans Dis 2011;38: Wetmore CM et al. Demographic, Behavioral, and Clinical Characteristics of Men With Nongonococcal Urethritis Differ by Etiology: A Case-Comparison Study. Sex Trans Dis 2011;38: CDC. Cephalosporin Susceptibility Among Neisseria gonorrhoeae Isolates United States, MMWR 2011;60: Ohnishi M et al. Ceftriaxone Resistant Neisseria gonorrhoeae, Japan (letter). Emerg Infect Dis 2011;17: Bolan G, Sparling F, Wasserheit J. The Emerging Threat of Untreatable Gonococcal Infection. N Eng J Med 2012;366: Craig Roberts PA-C, University of Wisconsin-Madison cmroberts@uhs.wisc.edu P. Davis Smith MD, Wesleyan University pdsmith@wesleyan.edu