The (likely) New 2010 CDC STD Treatment Guidelines http://www.cdc.gov/std/treatment Deborah Cohan, MD, MPH University of California, San Francisco San Francisco General Hospital cohand@obgyn.ucsf.edu I have no financial conflicts of interest to disclose. Overview Screening recommendations Chlamydia Gonorrhea Pelvic Inflammatory Disease Mycoplasma genitalium Syphilis Herpes Simplex Virus Trichomonas Bacterial vaginosis Guideline Development Process Based on 4 outcomes Microbiologic cure Clinical cure Prevention of sequelae Prevention of Transmission Alphabetized unless prioritized Expert Panel 2009 Final GL available Fall 2010? Winter? **Final document may differ from my slides** 1
2010 Guidelines: Prevention Pregnancy: Emergency contraception: Plan B and OCP HIV: Male circumcision as prevention Post-exposure prophylaxis (PEP) Sexual assault section Pre-Exposure Prophylaxis (PrEP) On-going research 2010 Guidelines: Screening Sexual history with 5 P s Partners, Pregnancy Prevention, Protection from STDs, Practices, Past hx of STDs Added question about partner s concurrent partners Special populations: Pregnant women: no screening for BV, trich or HSV-2 serology Adolescents: confidentiality section expanded WSW: BV discussed but screening not recommended Correctional settings: added section on women Informing patients which STDs they are (and are NOT) getting tested for Case 1. I m here for my pap. A 20 year old female presents to your gynecology clinic saying, I m here for my pap. She has been sexually active for 4 years. She has had 1 male partner for the past 3 months and 5 lifetime partners. What screening do you (and CDC) recommend? Pap smear Gonorrhea Chlamydia HIV 1. Pap smear 2. GC, CT 3. GC, CT, HIV 4. All of the above 1% 33% 43% 23% Pap smear GC, CT GC, CT, HIV All of the abo... 2
STD Screening Pregnant HIV Syphilis HBsAg CT GC (if <25 or risk factors) Pap (if 21+ yo and sexually active x 3+ yr) HCV (if risk factors) Adolescents/< 25 yr old HIV (if sexually active/idu) CT and GC (annual) (<24 for USPSTF) Pap (21 yo and sexually active x 3yrs) Other STDs (if risk factors) Case 1 continued Your lab conducts NAAT testing for CT and GC. What type of specimen do you send on this woman? What type of specimen do you send on this woman? CT and GC NAAT: Specimen Types 1. Endocervical swab 2. First-void urine (aka dirty catch ) 3. Vaginal swab (clinician or patientcollected) 4. Liquid-based cytology specimen 66% 19% 9% 5% Vaginal swabs Self-collection associated with 96-98% sensitivity (equivalent to provider-collected) Sensitivity equivalent or better vs. cervical swabs and first-void urine Cervical swab=ok if doing a speculum anyway Liquid cytology media=ok Some concern about liquid media inhibiting amplification, screening low-risk populations Endocervical s... First-void uri... Vaginal swab (... Liquid-based c... Schacter STD 2005; Chernesky STD 2005; APHL/CDC Expert Consultation Meeting Summary Report 2009 3
Case 1 continued Your patient s CT screen was positive. How do you manage this patient? Recommended Regimens: Azithromycin 1gm PO x 1 (directly observed) Amoxicillin 500mg PO TID x 7d (pregnancy) Doxycycline 100mg PO BID x 7d (not in pregnancy) Alternative Regimens: Ofloxacin 300mg BID or Levofloxacin 500mg PO daily x 7d (not in pregnancy) Erythromycin base 500mg PO QID x7d (pregnancy) Chlamydia Management: Not just a dose of antibiotics Treat all partners! Expedited Partner Therapy (to be emphasized in 2010) Currently illegal in 8 states (AK, FL, KY, MI, OH, OK, SC, WV) www.cdc.gov/std/ept/legal Inform Health Department (SF: 415-487-5555) Test of cure Only if pregnant, non-compliant, persistent symptoms after Rx, suspect early reinfection after Rx At least 3 wks after treatment Re-testing (not a test of cure) 3 months for all men/women with + CT (to be emphasized in 2010) Gonorrhea (Likely) 2010 Treatment Recommendations Recommended: Ceftriaxone 250mg IM x 1 plus Azithro 1 gm PO x 1 Alternative: Cefixime 400mg PO x 1 plus Azithro 1 gm PO x 1 Alternative if Cephalosporin allergy: Azithromycin 2 gm PO x 1? Pharyngeal: Ceftriaxone 250mg IM x 1 plus Azithro 1 gm PO x 1 Treat partners! Inform Health Department Test of cure Same indications as CT Re-testing in 3 months Pelvic Inflammatory Disease Diagnosis: no change in criteria CMT or adnexal tenderness or uterine tenderness Treatment: No change anticipated (14 day regimens) Azithromycin mentioned but not recommended OUT Ofloxacin* 400mg BID or Levoflox* 500mg QD with/without Metronidazole 500mg BID IN Ceftriaxone 250mg IM x1 (or other 3 rd gen Ceph) PLUS Doxycycline 100 mg PO BID with/without Metronidazole Cefoxitin 2g IV Q6hr plus Doxycycline 100mg PO/IV Q12hr Clindamycin 900 mg IV Q8 hr PLUS Gentamicin 2 mg/kg IV, then 1.5 mg/kg Q8 hr Ampicillin/Sulbactam 3g IV Q6 hr PLUS Doxycycline 100 mg PO/IV Q12 hr * FQ only if Cephalosporin contraindicated, low risk of GC, and good follow-up 4
Mycoplasma genitalium New section in 2010 guidelines Associated with urethritis, endometritis, PID Associated with poor reproductive health outcomes? No FDA-approved screening test Treatment unclear Azithromycin ~85% effective for male NGU Case 2. The lab memo You got a memo from your lab last month that the syphilis assay has changed. 28 yr old G1P0 at 8 weeks initiating prenatal care at your clinic. Your patient s routine prenatal lab results: EIA positive, RPR negative Why did the lab change protocols? What do these results mean? Syphilis Screening Traditional protocol Quantitative, non-specific, non-treponemal assay (RPR, VDRL) Confirmatory qualitative treponemal test (TPPA) New protocol New treponemal tests EIA/CLIA Non-treponemal test (RPR, VDRL) 2 nd treponemal test (TPPA) if EIA+/RPR- Advantages Cheaper, automated, no pipetting, no prozone effect Disadvantages Will confuse us! Not useful if prior treated syphilis or for neonatal eval Unclear significance of EIA+/RPR- (especially HIV+) Early syphilis? False positive EIA? Old untreated or treated? Primary and Secondary Syphilis 5
Syphilis - Treatment Genital Herpes Simplex Virus (HSV) Primary Secondary Early Latent Late Latent (>1 yr) Latent Unknown Duration Tertiary Neurosyphilis Treatment Benzathine PCN G 2.4 million Units IM Benzathine PCN G 2.4 million Units IM qweek x 3 weeks Aqueous Crystalline PCN G 18-24 mill units/day IV x 10-14 days PCN Allergic Doxycycline 100mg BID x2wks Tetracycline 500mg QID x2wks (Except pregnancy) Doxycycline 100mg BID x4wks Tetracycline 500mg QID x4wks (Except pregnancy) Desensitize and treat with PCN HSV is a recurrent, incurable infection. Very common (seroprevalence 5-30%+) Most people with genital HSV go undiagnosed. Both HSV-1/HSV-2 can cause genital herpes. Transmission with/without symptoms. Asymptomatic shedding more common in 1 st 2 yrs (5-10% of days vs. 2% of days) Discordant partners: 12% transmission/year 17% male to female vs. 4% female to male Genital Herpes Testing Indications for HSV-2 serology: HIV-infected, multiple partners, (MSM at risk for HIV) Comprehensive STD evaluation Other potential indications for HSV-2 serology: Recurrent/atypical symptoms with negative culture Patients with a partner with genital HSV Clinical diagnosis without lab confirmation Universal screening: NOT recommended False negative serologic test Primary infection (2 weeks 3 month for antibody production) 6
Genital HSV Treatment Primary: Acyclovir (ACV) 400mg TID x 7d Valacylovir (V-ACV) 1gm BID x 7d Famciclovir (FAM) 250mg TID x 7d Recurrent: ACV 400mg TID x 5d (HIV: 7-10d) ACV 800mg BID x 5d or 800mg TID x 2d V-ACV 500mg BID x 3-5d V-ACV 1gm qday x 5d (HIV: 1gm BID x 5-10d) FAM 125mg BID x5d (HIV: 500mg po BID x 5-10d) FAM 500mg x1, then 250mg BID x2d (new in 2010) FAM 1000mg po qday x 1d Suppression: ACV 400mg BID (pregnancy: 400mg TID; HIV: 400-800mg BID-TID) V-ACV 500mg po QD or 1gm po QD (HIV: 500mg po BID) FAM 250mg po BID (HIV: 500mg po BID) FAM less effective at suppressing viral shedding Impact of suppression in late pregnancy on risk of neonatal HSV? Trichomoniasis Screening Screening indications: HIV+ Consider if at risk : new/multiple sex partners, Hx STD, inconsistent condoms, sex work, IDU New assays: Rapid antigen test (OSOM; Genzyme) sens/spec vs. wet mount APTIMA TMA Trichomonas Vaginalis Analyte Specific Reagent (ASR; Gen-Probe) NAAT Can use same specimen as for APTIMA Combo 2 (for CT/GC) Other testing situations: Suspect trich but wet mount negative culture or newer assays Pap with trich confirm if low risk Trichomoniasis Treatment Recommended: Metronidazole 2gm po x 1 (pregnancy) Tinidazole 2gm po x 1 (no longer just alternative in 2010) Better GI tolerability Effective against Metronidazole-resistant trich Alternative: Metronidazole 500mg PO BID x 7d Metronidazole safe at all gestational ages Treatment failures: Metronidazole 500mg po BID x 7d or Tinidazole 2gm po x 1 If repeat failure: Metronidazole or Tinidazole 2gm po x 5d Susceptibility testing at CDC (707-488-4115) Treat partner and screen for other STIs Consider retesting in 3 months 7
Bacterial Vaginosis Prevention: condoms and no douching Screening NO longer recommended: Asx c high-risk pregnant women Pre-surgical Avoid expensive testing (PCR, culture) Treatment: Symptomatic BV emphasized No evidence yet for probiotics Metronidazole 2gm deleted Clindamycin cream may be less effective BV: Treatment Recommended Metronidazole (MTZ) 500mg BID x 7d (pregnancy) MTZ gel 0.75% intravaginal QHS x 5d Clindamycin cream 2% intravaginal QHS x 7d (not in pregnancy, assoc with LBW) Alternatives Clindamycin 300mg BID x7d (pregnancy) Clindamycin ovules 100mg intravaginal QHS x3d Metronidazole 250mg TID x7d (pregnancy only) Tinidazole 2gm QD x 3d (new) Tinidazole 1gm QD x 5d (new) Take It Home Screen appropriately Don t forget to screen for CT/GC if <25 CT screening in pregnancy, but otherwise avoid in older women unless indicated Vaginal swab often best method for CT/GC Test of cure for CT/GC: pregnancy Retesting in 3 months (to detect reinfection) Treat partners (know your state law) Report STI treatment to Health Department Take It Home If she has one STD, screen for other STDs including HIV. Page the RID fellow (415) 443-8726 with any questions or consults. Available 24/7 8
References and Resources CDC STD Treatment Guidelines www.cdc.gov/std/treatment City Clinic/SF Dept of Public Health Excellent resources for patients and providers www.sfcityclinic.org/providers/ Handheld resources Johns Hopkins antibiotic guide http://www.hopkins-abxguide.org/ You! Meg Autry, MD UCSF CME office Gail Bolan, MD Thank You Jeanne Marrazzo, MD Susan Philip, MD 9