2015 CDC STD GUIDELINES: NEW TESTING, TREATMENT AND DISEASE
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1 2015 CDC STD GUIDELINES: NEW TESTING, TREATMENT AND DISEASE Gale R. Burstein, MD, MPH, FAAP, FSAHM Commissioner, Erie County Department of Health, Clinical Professor of Pediatrics, SUNY at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY Faculty, NYC STD/HIV Prevention Training Center
2 Disclosures Dr. Gale Burstein has no financial relationships to disclose or Conflicts of Interest to resolve. Commercial support: There is no outside funding for this activity.
3 Learning Objectives Examine STD epidemiology Review significant 2015 CDC STD Treatment Guidelines changes Review recommended adolescent STI screening and available tests Provide opportunity for Q & A
4 STD EPIDEMIOLOGY
5
6 Chlamydia 6 39% There were 28,739 cases of chlamydia diagnosed in Louisiana in 2013, a rate of cases per 100,000. This represents a 4.5% rate increase from 2012 to 2013.
7 Highest number of chlamydia diagnoses occur in persons aged and yrs, making up 71% of Louisiana diagnoses.
8 2014 Cases Percent Rate
9
10 Gonorrhea There were 8,669 cases of gonorrhea diagnosed in Louisiana in 2013, a rate of cases per 100,000. This represents a 3% rate decrease from 2012 to %
11 66% of Louisiana s GC diagnoses occur in persons aged yrs
12 2014 Cases Percent Rate
13
14 Primary and Secondary Syphilis 65% There were 423 cases of P&S syphilis diagnosed in Louisiana in 2013, a rate of 9.1 cases per 100,000. This represents a 23% rate increase from 2012 to 2013.
15 The 2014 P&S syphilis diagnosis rate of 19.5/100,000 was 3.5 times greater than rate of 5.6/100,000 In USA, : P&S syphilis = 10.6 In 2014, 77% of P&S syphilis diagnoses were
16 2014 rate of new P&S syphilis diagnoses among blacks = 29.0/100,000 ~6.5 times higher than whites at 4.5/100,000 The P&S syphilis rate for blacks 48% from 2012 to 2014
17
18 Congenital Syphilis Rates Louisiana and the United States Louisiana Department of Health & Hospitals Office of Public Health STD/HIV Program
19 Female P&S Syphilis Rates Louisiana and the United States Louisiana Department of Health & Hospitals, Office of Public Health, STD/HIV Program
20 53 cases in 2015
21
22 Louisiana Congenital Syphilis, 2014 N=46 cases Race of mothers: o 85% black o 15% white ~85% of mothers <30 yr old when delivered 7 out of 9 of LA s public health regions had >1 congenital syphilis case o Shreveport region: 35% of cases o New Orleans and Monroe regions: 15% of cases
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25 Adolescent STD screening Routine annual chlamydia and gonorrhea screening for sexually active <25 yrs Considered chlamydia screening sexually active, heterosexual, young in clinical settings with chlamydia prevalence oadolescent clinics, correctional facilities, STD clinics
26 Adolescent STD screening Discuss and offer HIV screening to all youth orapid tests ideal Routine screening of Asx adolescents for certain STDs (e.g., syphilis, trichomoniasis, BV, HSV, HPV, HAV, and HBV) not generally recommended YMSM and pregnant adolescents should be screened for syphilis
27 Screening tests for sexually active MSM HIV serology Syphilis serology Urine, pharyngeal, rectal gonorrhea NAAT Urine, rectal chlamydia NAAT Test at least once per year HCV screening for HIV+ MSM annually
28 Pre-exposure prophylaxis (or PrEP) PrEP used to HIV infection risk for people at risk HIV risk from sex by > 90% HIV risk from injection drug use by > 70%. Daily Truvada (tenofovir and emtricitabine) Indicated to prevent HIV infection for at risk or
29 Transgender Men and Women Assess STD- and HIV-related risks based on current anatomy and sexual behaviors odiversity of transgender persons regarding surgical affirming procedures, hormone use, and their patterns of sexual behavior oproviders must remain aware of common STD Sx and screen for STDs on basis of behavior and sexual practices
30
31 Reported cases/100,000 population yrs yrs yrs yrs yrs > 60 yrs Source: National Notifiable Diseases Surveillance System (NNDSS) Year
32
33 Mycoplasma genitalium First isolated in 1981 Genital and reproductive tract disease Frequency omore common than N. gonorrhoeae but less common than C. trachomatis
34 M. genitalium: More common than you think Young adults yrs 1,2 STD Clinic/ED Attendees % 3.8% 19.2% 19.2% Prevalence 1.0% 0.6% 2.1% 13.4% 7.0% 12.1% 15.2% MG CT GC TV Seattle New Orleans Cincinnati Baltimore Durham Men Women 1 Miller 2004; 2 Manhart Totten 2001; 4 Mena 2002 ; 5 Manhart 2003; 6 Huppert 2008; 7-8 Gaydos 2009a & 2009b; 9 Mobley 2012
35 M. Genitalium in males Cause of male urethritis o~15% 20% of nongonococcal urethritis (NGU) cases o 20% 25% of nonchlamydial NGU o 30% persistent or recurrent urethritis Unknown if causes male infertility or other male anogenital tract disease ofound in the rectum in Asx males
36 M. Genitalium in females M. genitalium s pathogenic role less definitive in females vs males ocan be found in vagina, cervix, and endometrium M. genitalium in females commonly Asx Detected in clinical cervicitis and PID cases oevidence suggests that M. genitalium can cause PID, but less frequently than C. trachomatis
37 M. genitalium Detection No FDA-approved diagnostic test BUT.. Commercial Laboratories PCR tests o CLIA certified Hologic Gen-Probe TMA assay (APTIMA Platform) ocommercially available as analyte-specific reagent (ASR) platform Labs need to get CLIA approval Information on web site or call customer service at or at molecularsupport@hologic.com
38 M. genitalium treatment M. genitalium lacks cell wall oantibiotics that target cell-wall biosynthesis are ineffective beta-lactams including penicillins and cephalosporins Given diagnostic challenges, most M. genitalium treatment will occur in context of management for STD syndromes
39 Treatment of M. genitalium Randomized Controlled Trials Doxycycline (100mg bid x 7d) vs. Azithromycin (1g) 87% Microbiologic Cure (%) 45% 67% 31% 30% 40% Doxycycline Azithromycin Mena 2009 Schwebke 2011 Manhart 2013
40 M genitalium and urethritis and cervicitis Consider M gent Rx in persistent /recurrent urethritis and in persistent cervicitis and PID Azithromycin 1 gm more effective odoxy ineffective oaz Resistance emerging For Rx failures with azithro1 gm, Moxifloxacin (400 mg daily x 7-14 days)
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42 Chlamydia Treatment Azithromycin 1g Orally Single Dose O R Doxycycline 100mg orally Twice a day x 7 days Alternatives: Erythromycin or Levofloxacin or Ofloxacin Pregnancy Alternative Regimens: Amoxicillin Erythromycins
43 Azithro vs Doxy for urogenital CT 567 youth detention (12-21 yo & ) participants receiving directly observed therapy Doxy group: no treatment failures Azithro group: 5 (3.2%) failures Overall efficacy: odoxycycline 100% oazithromycin 97% Did not establish non-inferiority of azithro Geisler, et al. NEJM. 2015; 373:
44 Chlamydia treatment Doxycycline delayed release 200 mg tabs (Doryx) o GI upset oqday x 7 days o $
45 Oropharyngeal Chlamydia Clinical significance unclear Routine oropharyngeal CT screening not recommended Can be sexually transmitted to genital sites Treat oropharyngeal chlamydia with azithro or doxy
46 Antibiotic-Resistant Gonorrhea
47 Gonorrhea Dual Therapy: Uncomplicated Genital, Rectal, or Pharyngeal Infections Ceftriaxone 250 mg IM in a single dose PLUS Azithromycin 1 g orally Doxy no longer recommended as 2 nd antimicrobial for GC Rx o substantially prevalence of GC resistance to tetracycline vs azithromycin
48 What does dual therapy mean? Ceftriaxone and azithromycin administered on same day opreferably simultaneously and under direct observation ochallenge if ceftriaxone IM in office and Rx for azithro to fill in pharmacy must be given within 24 hr time period for adequate treatment
49 Gonorrhea Treatment Alternatives 2015 Anogenital Infections ALTERNATIVE CEPHALOSPORINS: Cefixime 400 mg orally once PLUS Dual treatment with azithromycin 1 g OR doxycycline 100 mg BID x 7 days Doxy removed as cotreatment
50 Gonorrhea Treatment Alternatives Anogenital Infections IN CASE OF SEVERE ALLERGY: X Azithromycin 2 g orally once (Caution: GI intolerance, emerging resistance) Gentamicin 240 mg IM + azithromycin 2 g PO OR Gemifloxacin 320 mg orally + azithromycin 2 g PO
51 Alternative Urogenital GC Regimens Non-comparative randomized trial in adults with urethral or cervical gonorrhea 1. Gentamicin 240 mg IM + azithromycin 2 g PO, or 2. Gemifloxacin 320 mg PO + azithromycin 2 g PO Rationale for regimens Additive effect between gentamicin and azithromycin (in vitro) Gemifloxacin more active against GC with known ciprofloxacin resistance Kirkcaldy, CID 2014
52 New regimen challenges Nausea common o 27% for gentamicin + AZ o 37% for gemifloxacin + AZ o 3% and 7% in each group vomited <1hr after administration Gemiflox no longer available FDA approved (6/15/2015) generic Updates on the availability can be found at:
53 GC Test of Cure Patients with pharyngeal GC treated with an alternative regimen oobtain test of cure 14 days after treatment, using either culture or NAAT Cases of suspected treatment failure oculture and simultaneous NAAT ocall LA Health Dept!!!!
54 Cephalosporin treatment failures Oral cephalosporin treatment failures reported worldwide ojapan, Hong Kong, England, Austria, Norway, France, South Africa, and Canada Ceftriaxone treatment failures in pharyngeal gonorrhea and a few isolates with high-level ceftriaxone resistance reported Unemo Eurosurveillance 2011 Tapsall J Med Microbiol 2009 Ohnishi EID 2011 Allen JAMA 2012
55
56 Azithro susceptibility (4X) o 0.6% in 2013 to 2.5% in
57 Cefixime susceptibility (2x) o 0.4% in 2013 to 0.8% in
58 Ceftriaxone susceptibility (no change) o 0.1% in 2013 and
59 Suspected GC Treatment Failure After Recommended Dual Therapy: What do I do? REPORT: DOH STD program ASAP (within 24 hours) CULTURE: if GC culture not available, call ECDOH REPEAT TREATMENT: Gemifloxacin 320 mg + AZ 2g OR gentamicin 240 mg IM + AZ 2g TREAT PARTNERS: Within 60 days with same regimen as patient receives TEST OF CURE (TOC): Patient returns in 7-14 days for TOC culture and NAAT * If reinfection suspected instead of treatment failure, repeat Tx with CTX 250mg + AZ 1g
60 Expedited partner therapy Should be considered as part of STD management
61 EPT in LA EPT is permissible for chlamydia and gonorrhea EPT is not recommended for the following partners, but full medical evaluation from a health care provider should be sought: opregnant, oat risk for severe medication allergies omsm oco-infected with STDs not covered by EPT oif patient s safety is in doubt.
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63 Want to know more about STDs? There s an app for that. CDC Treatment Guidelines App for Apple and Android
64 Wall chart
65 2010/pdf/2011-Booklet- Whole-Press.pdf Pocket Guide
66 STD CLINICAL QUESTIONS Plan A: call health department
67 STD Clinical Consultation Network (STDCCN) 8 Regional PTCs 76
68
69 Questions???
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