The New 2010 CDC STD Treatment Guidelines I have no financial conflicts of interest to disclose.

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1 The New 2010 CDC STD Treatment Guidelines Jody Steinauer, MD, MAS University of California, San Francisco San Francisco General Hospital I have no financial conflicts of interest to disclose. Overview General screening & prevention Pap smear Screening & treatment Chlamydia, Gonorrhea Pelvic Inflammatory Disease Discharge Trichomonas, BV Blisters HSV Lab results Syphilis Discharge Urethritis/STDS in men 1

2 2010 Guidelines: Prevention Abstinence/fewer partners Male condoms (and female condoms) Pre-exposure vaccination HPV, HBV HIV: Male circumcision as prevention Microbicides R&D Post-exposure prophylaxis (PEP) Sexual assault section Pre-Exposure Prophylaxis (PrEP) On-going research 2010 Guidelines: Screening Special populations: Pregnancy: updates Adolescents: confidentiality section expanded MSM: new screening guidelines WSW: new screening guidelines Correctional settings: added section on women Patient education which STDS being (not) tested Sexual history with 5 P s Partners, Pregnancy Prevention, Protection from STDs, Practices, Past hx of STDs Added question about partner s concurrent partners Taking a Sexual History 1. Partners number in recent time frame Do you have sex with men, women, or both? In the past 2 months, how many partners have you had sex with? In the past 12 months, how many partners have you had sex with? Is it possible that any of your sex partners in the past 12 months had sex with someone else while they were still in a sexual relationship with you? 2. Pregnancy intentions prevention v. planning What are you doing to prevent pregnancy? What are you doing to prepare for pregnancy? 3. Protection from STDs What do you do to protect yourself from STDs and HIV? 2

3 4. Practices details! Taking a Sexual History To understand your risks for STDs, I need to understand the kind of sex you have had recently. Have you had vaginal sex, meaning penis in vagina sex? If yes, Do you use condoms: never, sometimes, or always? Have you had anal sex, meaning penis in rectum/anus sex? If yes, Do you use condoms: never, sometimes, or always? Have you had oral sex, meaning mouth on penis/vagina? For condom answers: If never: Why don t you use condoms? If sometimes: In what situations (or with whom) do you not use condoms? 5. Past history of STDs Have you ever had an STD? Have any of your partners had an STD? History and Counseling Open-ended questions, understandable and normalizing language High-intensity behavioral counseling Additional questions to identify HIV and viral hepatitis risk: Have you or any of your partners ever injected drugs? Have any of your partners exchanged money or drugs for sex? Is there anything else that I need to know about? Case 1. I m here for my pap. A 20 year old female presents to your clinic: 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. 3

4 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 Indications for screening Pregnant HIV CT (twice if 25) GC (if risk factors or local epidemiology warrants)* Pap (if 21+ yo and sexually active x 3+ yr) HCV (if risk factors) Syphilis HBsAg Adolescents/ 25 yr old HIV CT (annual) ( 24 for USPSTF) GC (if risk factors or local epidemiology warrants)* Pap (21 yo and sexually active x 3yrs) HCV (if risk factors) *Consult your health department! Screening: CDC Based on individual risk and population risk GC and CT screening Age guidelines (CT only) History of GC, chlamydia, or PID in the past 2 years More than 1 sexual partner in the past year New sexual partner within 90 days Reason to believe that a sex partner has had other partners in the past year Syphilis, HIV screening HIV screening of everyone once sexually active Sexual history, partner behaviors, local prevalence 4

5 Screening: USPSTF High-risk: New partner, multiple partners, inconsistent condoms, sex in exchange for drugs or money, high community prevalence, age <25 for women GC/CT Non-pregnant women: GC, CT, Syph, HIV Pregnant women: above plus Hep B Men: Syphilis and HIV Low-risk: NO SCREENING Except pregnant women: Syph, HIV & Hep B Testing for STI Co-Infection If positive for Test for Chlamydia GC, syphilis, HIV GC Chlamydia, syphilis, HIV Syphilis Chlamydia, GC, HIV Primary herpes Chlamydia, GC, syphilis, HIV Recurrent herpes (?) may be long standing Trichomoniasis(?) may be long standing Ext genital warts (?) may be long standing BV, candida Not STIs, therefore don t screen Case 1. Continued Your lab conducts NAAT testing for CT and GC. What type of specimen do you send on this woman? 5

6 What Type of Specimen Do You Send on this Woman? 1. Endocervical swab 2. First-void urine (aka dirty catch ) 3. Vaginal swab (clinician or patient-collected) 4. Liquid-based cytology specimen 5. It depends What else are you doing? CT and GC NAAT: Specimen Types Cervical swab-ok if doing a speculum anyway First-void urine = dirty catch - no urine x 1 hour Very sensitive Vaginal swabs Self-collection associated with 96-98% sensitivity (=provider) Sensitivity = or better vs. cervical swabs and first-void urine Anyone can do it! Liquid cytology media=ok Concern about inhibiting amplification, screening low-risk pop. Schacter STD 2005; Chernesky STD 2005; APHL/CDC Expert Consultation Meeting Summary Report 2009 Case 1. Continued Your patient s CT screen was positive. How do you manage this patient? Recommended Regimens: Azithromycin 1gm PO x 1 (also in pregnancy) Direct Observed Therapy 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 (pregnancy) 6

7 Chlamydia Management: Not Just a Dose of Antibiotics Treat all partners! Expedited Partner Therapy Screen for other infections Inform Health Department Test of cure Only if pregnant, non-compliant, persistent symptoms after Rx, suspect early reinfection after Rx >3 wks after treatment Re-testing (not a test of cure) 3 months for all men/women with + CT Also recommended for GC, trichomonas Expedited Partner Treatment (EPT) Bring Your Own Partner ( BYOP ) Bring her partner(s) to the clinic at the time of her treatment so that both client and partner(s) can be counseled and treated at the same visit Patient-delivered partner therapy ( PDPT ) Provide patient with drugs intended for partners Prescribe extra doses of medication in the index patients name Write prescriptions in the partners names Illegal in 8 states (AK, FL, KY, MI, OH, OK, SC, WV) Gonorrhea 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 Quinolone resistance! Same indications as CT Re-testing in 3 months 7

8 Pelvic Inflammatory Disease Diagnosis: no change in criteria CMT or adnexal tenderness or uterine tenderness Treatment: No more quinolones! Azithromycin mentioned but not recommended OUT Ceftriaxone 250mg IM x1 (or other 3 rd gen Ceph) PLUS Doxycycline 100 mg PO BID with/without Metronidazole (alt) ONLY IF NO CEPHALOSPORIN! Ofloxacin* 400mg BID or Levoflox* 500mg QD +/- Metronidazole 500mg BID (not GC!) IN Cefoxitin 2g IV Q6hr or Cefotetan 2 g IV Q12 hr plus Doxycycline 100mg PO/IV Q12hr Clindamycin 900 mg IV Q8 hr PLUS Gentamicin 2 mg/kg IV, mg/kg Q8 hr or single-dose Ampicillin/Sulbactam 3g IV Q6 hr PLUS Doxycycline 100 mg PO/IV Q12 hr Mycoplasma Genitalium Mentioned 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: Discharge A 28 year-old woman comes to your clinic complaining of new discharge. She has a new partner and is suspicious she may have an infection. When you examine her you see this. 8

9 On wet mount you see protozoa. 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 Recommended for partner treatment. 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 ( ) Treat partner and screen for other STIs Consider retesting in 3 months Trichomoniasis Screening Screening indications: HIV+ Consider if at risk : new/multiple sex partners, Hx STD, inconsistent condoms, sex work, IDU Screening methods: Wet mount 60-70% sensitive Rapid antigen test (OSOM 10 min; Affirm VP3 45 min) sens (83%)/spec (97%)vs. wet mount NAAT APTIMA TMA T. Vag Analyte Specific Reagent (ASR; Gen-Probe) Sensitivity 75-98% / Spec 87-98% 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 9

10 Bacterial Vaginosis Prevention: condoms and no douching Screening NO longer recommended: Asymptomatic 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) Case 3: Blisters 10

11 Genital Herpes Simplex Virus (HSV) 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. HSV-2 worse prognosis -PCR and type-specific serology 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 Screening 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 Pregnant women with a partner with genital HSV Clinical diagnosis without lab confirmation Universal screening: NOT recommended USPSTF D False negative serologic test Primary infection (2 weeks 3 month for antibody production) Genital Herpes Simplex Virus (HSV) Shortened treatment regimens: 1-day famciclovir and 2-day acyclovir Consider suppression for frequent and infrequent recurrences Reduces frequency by 70% 11

12 Prevention of Genital Herpes Avoid touching lesions during outbreak Condoms will provide some degree of protection Patient treatment during outbreak (or long-term suppression) reduces shedding Suppression with valacyclovir decreases HSV-2 transmission in discordant couples Daily prophylactic treatment reduces shedding Incident HSV infection reduced by 1.7% over 1 year 3.6% seroconvert in absence of treatment 1.9% seroconvert with treatment NNT: 59 people to prevent one case/ year Corey, NEJM, Primary (7-10 days) Recurrent Genital HSV Treatment Acyclovir Famciclovir Valacyclovir 400 mg TID 200 mg 5 times/d 800 mg TID x2d 800 mg BID x5d 400 mg TID x5d 250 mg TID 1 gram BID 1 gm BID x1d 500mg BID x3d 125mg BID x5d 1 gm QD x5d 500 mg x mg BID x 2d Suppression 400 mg BID 250 mg BID gm QD Prophylaxis 400 mg BID** 500 mg QD Case 4. The Lab Memo You received 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? 12

13 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? Case 4. What is your next step? 1. Take a sexual history, including prior syphilis diagnosis and treatment 2. Examine woman 3. Ask your health department to investigate whether she has had prior syphilis results/treatment 4. Order a 2 nd treponemal test (e.g. TPPA) 5. All of the above Syphilis Staging Step #1: Determine if active vs. latent History: symptoms, prior syphilis diagnosis/treatment Exam: mouth, skin (trunk, back, hands, feet), external genitalia If no signs of syphilis on exam LATENT Step #2: Determine timing if latent Early = documented negative RPR/VDRL and/or clear primary/secondary sxs <1 year ago Late = documented negative RPR/VDRL and/or clear primary/secondary sxs > 1 year ago Unclear duration = no documentation/symptoms to time infection If unclear history health dept can help 13

14 PRIMARY SECONDARY Syphilis - Treatment Treatment PCN Allergic Primary Secondary Early Latent Benzathine PCN G 2.4 million Units IM Doxycycline 100mg BID x2wks Tetracycline 500mg QID x2wks (Except pregnancy) Late Latent (>1 yr) Latent Unknown Duration Tertiary Benzathine PCN G 2.4 million Units IM qweek x 3 weeks Doxycycline 100mg BID x4wks Tetracycline 500mg QID x4wks (Except pregnancy) Neurosyphilis Aqueous Crystalline PCN G mill units/day IV x days Desensitize and treat with PCN Make sure correct PCN preparation and use PCN if possible! Case 5: Urethral Discharge You are seeing a 22 year-old man who complains of urethral discharge and burning with urination. 14

15 Urethritis Test for GC and CT Most cases of non-ct/gc - mycoplasma Treatment no change in guidelines Azithromycin 1 g po x 1 Doxycycline 100 mg po BID x 7 d Alternatives: Erythro, levo/oflox (not in GC!) Abstain x 7 days Screen for other STDs Take comprehensive sexual history Screening in Men HIV (CDC); HIV/syph only high-risk (USPSTF) MSM at least annual screening: HIV, syphilis serology Insertive intercourse: GC/CT urine Receptive anal intercourse: GC/CT rectal swab Receptive oral intercourse: GC phar. swab HSV-2 serology if unknown HBsAg More frequent if many partners Take It Home Take a sexual history Provide effective counseling Screen appropriately: CT/GC Don t forget to screen for CT/GC if <=25yrs in 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 dx & treatment to Health Department 15

16 Take It Home If your patient has one STD, screen for other STDs including HIV. You can always call the UCSF Reproductive Infectious Disease fellow (415) with any questions or consults. Available 24/7 References and Resources CDC STD Treatment Guidelines USPSTF City Clinic/SF Dept of Public Health Provider & patient resources Handheld resources Johns Hopkins antibiotic guide Why do I need to take this medicine? Your sex partner has recently been treated for Chlamydia. Thank You You! Deb Cohan, MD, MPH 16