2014 CDC Treatment Guidelines for STDs What s New, What s Important, What s Essential. STD Treatment Guidelines. How are the guidelines prepared?

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1 2014 CDC Treatment Guidelines for STDs What s New, What s Important, What s Essential Bradley Stoner, MD, PhD Associate Professor, Washington University School of Medicine Medical Director, St. Louis STD/HIV Prevention Training Center St. Louis, MO Disclosure: Bradley Stoner, MD, PhD Dr. Stoner has no relevant financial interests to disclose STD Treatment Guidelines Prepared and published by Centers for Disease Control and Prevention (CDC) Evidence-based recommendations Revised approx. every 4 years NEW guidelines expected (possibly) in late 2014 How are the guidelines prepared?

2 More than just treatment guidelines Clinical diagnosis Laboratory diagnosis Treatment Partner notification Prevention Special populations adolescents, incarcerated, MSM, WSW What s new this time around? Add l recs for screening women and MSM New treatment options for gonorrhea Re-screen recs for men and women New sections on Mycoplasma genitalium and transgender clients Chlamydia Chlamydial cervicitis Nongonococcal urethritis NGU - Gram stain

3 Chlamydia conjunctivitis Chlamydia Incidence estimates: 2.8 million cases in US annually Diagnostic issues: Self collected rectal swabs for MSM efficacious Highly acceptable Pharyngeal screening: The clinical significance of oropharyngeal C. trachomatis infection is unclear (oropharyngeal screening for CT is not recommended) If detected, treat with routine CT tx regimens Hetero male screening: considered in venues with high prevalence (adolescent clinics, corrections, STD clinics) Chlamydia Treatment Adolescents and Adults Recommended regimens (non-pregnant): Azithromycin 1 g orally in a single dose Doxycycline 100 mg orally twice daily for 7 days Recommended regimens (pregnant*): Azithromycin 1 g orally in a single dose * Test of cure at 3-4 weeks only in pregnancy Proposed: 1) Add Doryx (delayed release doxycycline) 200 mg QD x 7 d as alternative 2) Move amoxicillin from recommended list alternative in pregnancy Persistent NGU Treatment Recommended regimens: Metronidazole 2 g orally in a single dose OR Tinidazole 2 g orally in a single dose PLUS Azithromycin 1 g orally in a single dose (if not used for initial episode) Moxifloxacin 400 mg PO x 7d effective for NGU persistence or recurrence (M. genitalium) NGU Persistent and Recurrent NGU: In areas where T vaginalis is prevalent, men who have sex with women should be presumptively treated with a nitroimidazole Proctitis No major changes Presumptive treatment of LGV for MSM with proctitis and anorectal Chlamydia, particularly if patient is HIV-infected or any of the following are present bloody discharge perianal ulcers mucosal ulcers

4 Gonorrhea Gonococcal urethritis Gonorrhea - gram stain of urethral discharge Gonococcal cervicitis Bartholin s abscess GC conjunctivitis

5 Disseminated gonococcal infection Disseminated gonococcal infection Gonorrhea Incidence estimates: 820,000 cases in US annually Diagnostic issues: The sensitivity of NAATs in urogenital and nongenital sites is superior to culture, but varies by NAAT type Self collected vaginal & rectal swabs are acceptable Treatment: changes to treatment recommendations and follow-up TOCs Gonorrhea Treatment Pre-Antibiotics 5 weeks of rest Avoid alcohol Avoid sex Urethral Dilation 2 weeks of urethral irrigation

6 Gonorrhea Treatment Uncomplicated Genital, Rectal, or Pharyngeal Infections Ceftriaxone 250 mg IM in a single dose * Regardless of CT test result Proposed: remove doxycycline from recommended, and make it alternative PLUS* CDC 2014 (draft recommendations) Azithromycin 1 g orally (preferred) or Doxycycline 100 mg BID x 7 days Gonorrhea Treatment Alternatives Anogenital Infections ALTERNATIVE REGIMENS: Cefixime 400 mg orally once PLUS Dual treatment with azithromycin 1 g (preferred), regardless of CT test result OR Gentamicin 240 mg IM +Azithromycin 2 g orally OR Gemifloxacin 320 mg IM + azithromycin 2 g orally CDC 2014 (draft recommendations) Proposed: Limit TOC only to pharyngeal GC treated with alternative regimen, extend interval to 14 days What about PID? NOT! Pelvic inflammatory disease often caused by chlamydia and/or gonorrhea ACE trial (currently under way) will answer question about whether PID should routinely be treated with metronidazole (along with other abx) CT/GC Partner Treatment CT/GC Partner Management Options Patient referral Ask patient to notify partner and ensure treatment Have patient bring partner to clinic for concurrent treatment Internet-based anonymous notification Expedited partner treatment (EPT) Patient-delivered partner treatment (PDPT) Health department field-delivered treatment Pharmacy-based Provider or clinic-based referral Health department referral

7 Partner Management: Key Points Clinical evaluation first-line option Concurrent patient-partner therapy is feasible and effective for many clients EPT is still an option Safe and effective at reducing reinfection for GC Dual therapy (cefixime 400 mg + azithromycin 1 g) is crucial if PDPT is offered Retesting for Repeat Infection Proposed: routinely offer EPT to heterosexual pts with CT/GC if partner cannot be promptly treated Rapid Repeat Chlamydial Infection is Common in Women Repeat Infection is Dangerous Retesting Prevalence Typical Screening Prevalence Repeat CT infection leads to higher risk of complications: PID, ectopic pregnancy, infertility Most infections are asymptomatic Relative Risk Hosenfeld C, et al. Sex Transm Dis Aug;36(8): Hillis SD, et al. (1997). Am J Obstet Gynecol 176(1 Pt 1): Repeat Testing after an STD infection Syphilis - Primary Proposed: Women who test positive for chlamydia, gonorrhea or trichomonas should be rescreened for all three at three months following treatment. Men who test positive for chlamydia or gonorrhea should be retested at three months after adequate therapy. Any patient diagnosed with syphilis should undergo follow up serologic syphilis testing per current recommendations. HIV testing should also be considered in all patients with a prior STD history.

8 Syphilis - Primary Syphilis - Secondary Syphilis Incidence estimates: 55,000 new cases per year Diagnostic issues: More labs using treponemal EIA (reverse sequence screening) If a treponemal EIA is used and results are: EIA+, RPR-, TPPA-, repeat in 2 weeks Treatment: No changes LP for neurosyphilis: No changes Follow-up: 21% of patients w/ early syphilis do not have 2- dilution decline in titer in 6-12 mos, optimal mgmt unclear Syphilis Treatment Primary, Secondary & Early Latent: Benzathine penicillin G 2.4 million units IM in a single dose Late Latent and Unknown Duration: Benzathine Penicillin G 7.2 million units total, given as 3 doses of 2.4 million units each at 1 week intervals Neurosyphilis: Aqueous Crystalline Penicillin G million units IV daily administered as 3-4 million IV q 4 hr for d Only one dose of PCN is recommended for early syphilis in HIV+ persons, extra doses not needed Syphilis Treatment Primary, Secondary & Early Latent Alternatives (non-pregnant penicillin-allergic adults): Doxycycline 100 mg po bid x 2 weeks Tetracycline 500 mg po qid x 2 weeks Ceftriaxone 1 g IV (or IM) qd x d Azithromycin 2 g po in a single dose* * Do NOT use azithromycin in MSM or pregnant women In pregnancy, benzathine penicillin is the only acceptable therapy. No alternatives What is the maximum time allowed between Bicillin doses? Clinical experience suggests10-14 days ok for nonpregnant adults <9 days is best based on limited pharmacologic data In pregnancy, must adhere to strict 7 days between doses 40% of pregnant women are below treponemicidal levels after 9 days If a dose is missed, the entire series must be restarted

9 Human Papillomavirus HPV and Cervical Cancer in the U.S. HPV infection ubiquitous:» 79 million people currently infected» 14 million new infections annually» 80% of people acquire HPV at some point Cervical cancer still a problem:» 12,170 new cases and 4,220 deaths (2012)» Significant racial and ethnic disparities: highest rates among Black & Hispanic Satterwhite STD 2013; Source: ACS HPV Vaccine Recommendations Population Recommendation Gender Age All Females 9-26 Routine vaccination with either HPV4 (Gardasil) or HPV2 (Cervarix) All Males 9-21 Routine vaccination with HPV4 MSM and HIV+ Males Permissive recommendation HPV Routine vaccination with HPV 4 More HPV recs New tx for genital warts: Imiquimod 3.75% cream, apply daily Move podophyllin out of the box of recommended therapy to alternative (due to reports of severe toxicity) * Irrespective of history of abnormal Pap, HPV, genital warts MMWR, 2014; Aug 29 (RR05) Genital herpes Genital herpes

10 Genital Herpes Incidence estimates: 776,000 new infections per year Prevalence estimates: 48.5 million persons infected Diagnosis: Currently culture and serology» Proposed: NAAT (PCR) or viral culture should be used for diagnosis of HSV (not serology) Treatment: No changes proposed Trichomonas Incidence estimates: 1 million new infections Screening recommended for HIV+ women (proposed interval: at least annually) Consider screening in those receiving care in high prevalence settings (STD clinics, corrections) or at high risk of infection new or multiple partners, history of STDs exchange sex for payment, use injection drugs Retesting recommended 3 months after treatment Trichomoniasis Treatment Recommended regimen: Metronidazole 2 g PO x 1 Tinidazole 2 g po x 1 Women with HIV infection: Metronidazole 500 mg PO BID x 7d Alternative regimen: Metronidazole 500 mg PO BID x 7d Recommended regimen in pregnancy: Metronidazole 2 g PO x 1 Bacterial Vaginosis Screening: No changes to recs for screening in pregnancy (still not routinely recommended) Treatment of non-pregnant women: no changes Proposed BV in pregnancy: symptomatic pregnant women can be treated with any of the oral or vaginal regimens recommended in nonpregnant women Note: Vaginal therapy is ineffective Tinidazole is a Category C drug in pregnancy

11 Hepatitis A and B Hep A Proposal to add statement that persons who have a documented history of 2 dose hepatitis A vaccination in the past do not need further vaccination or serologic testing Hep B No major changes Hepatitis Hep C Current language: Routine HCV-testing of HIV-infected MSM should be considered Proposed : HCV antibody tests should be serially monitored, at least yearly and more frequently depending on local circumstances (HCV prevalence, incidence, resources, and other factors), to detect conversion from HCV-antibodynegative to positive. [In HIV-infected MSM] Miscellaneous New sections on Special populations: Transgender men/women Mycoplasma genitalium And don t forget the triple dip Syphilis serology Pharyngeal GC Urine GC/CT Rectal GC/CT THANK YOU! Acknowledgements to Ina Park, MD, MS and Kimberly Workowski MD FACP for assistance with this presentation