Adolescents 2/9/2011. STD Burden CHANGES IN THE 2010 STD TREATMENT GUIDELINES: WHAT ADOLESCENT HEALTH CARE PROVIDERS NEED TO

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1 CHANGES IN THE 2010 STD TREATMENT GUIDELINES: WHAT ADOLESCENT HEALTH CARE PROVIDERS NEED TO KNOW Gale R Burstein, MD, MPH, FAAP, FSAHM Women and Children s Hospital of Buffalo Buffalo, NY STD Burden >19 million STD cases occur in USA each year disproportionately among young people and racial and ethnic minority populations estimated $17 Billion in annual direct medical costs of treating STDs and sequelae STDs can cause serious health problems ectopic pregnancy, infertility, chronic pelvic pain increased risk of HIV infection CDC 2010 STD Treatment Guidelines Update the 2006 Guidelines Advise health-care providers on most effective STD treatment, screening, prevention and vaccination Recommendations developed in consultation with public and private sector professionals knowledgeable in STD management AAP, SAHM, ACOG, AMA, ACPM, ACEP represented CDC revises the Guidelines every ~ 3-4 years, using a scientific, evidence-based process CDC STD treatment guidelines Changes that are important for clinicians who care for adolescents Adolescents Screening Prevention 1

2 Adolescent Screening Annual C. trachomatis screen all sexually active females aged 25 yrs consider screening adolescent/young adult males in clinical settings associated with high chlamydia prevalence (e.g., adolescent clinics, correctional facilities, STD clinics and YMSM). Annual N. gonorrhoeae screen all at risk sexually active females Females aged <25 years are highest risk for gonorrhea infection Discuss HIV screening with all adolescents and encourage testing for those at risk Adolescent Screening Routinely screening asymptomatic adolescents for certain STDs (e.g., syphilis, trichomoniasis, BV, HSV, HPV, HAV, and HBV) is not recommended YMSM and pregnant adolescents might require more thorough evaluation Cervical cancer screening should begin at 21 yrs Adolescent Prevention Encourage immunizations, including HPV, HAV and HBV Provide information on HIV infection, testing, transmission, and implications of infection to all adolescents as part of health care. Integrate sexuality education into clinical practice. USPTFS recommends high-intensity STD prevention behavioral counseling for all sexually active adolescents. Persons in Correctional Facilities New section Chlamydia and gonorrhea screening for all females up to age 35 years Base syphilis screening recommendations on local area and institutional syphilis prevalence Women Who Have Sex with Women Sexual identity, sexual behaviors, sexual practices, and risk behaviors of WSW are diverse. Most self-identified WSW (53%--99%) report having had sex with men. Adolescent WSW and females with both male and female partners might be at increased risk for STDs and HIV. syphilis transmission (likely through oral sex) between female sex partners can occur C. trachomatis among WSW may be more common HPV transmission can occur from skin-to-skin or skinto-mucosa contact during sex Women Who Have Sex with Women Regardless of reported same sex behavior, providers should consider: screening all females for chlamydia and syphilis as per recommendations offering routine cervical cancer screening and HPV vaccine in accordance with current guidelines 2

3 New Chlamydia and Gonorrhea Testing Options Nucleic acid amplification tests (NAATs) most sensitive tests to detect C. trachomatis and CDCrecommended FDA-cleared for testing urine, cervical, and urethral specimens Some FDA-cleared for testing provider- or patientcollected vaginal swabs Rectal or oropharyngeal swab NAAT testing not FDAcleared some labs met requirements for gonorrhea and chlamydia NAATs on rectal swab specimens and gonorrhea NAATs on oral swabs Gonorrhea Treatment Treatment for Uncomplicated Gonorrhea Infection of the Cervix, Urethra or Rectum DUAL THERAPY for gonorrhea treatment Gonococcal antimicrobial resistance remains an issue in U.S. Penicillin, tetracycline or quinolones are no longer gonorrhea treatment options!!! CDC recommends dual therapy for gonoccocal infections at all anatomic sites concerns about possible emergence of cephalosporin-resistant gonorrhea in U.S. Treatment for Uncomplicated Gonorrhea Infection of the Pharynx Gonorrhea Treatment Recommend tx with ceftriaxone IM over cefixime po when possible Limited efficacy of cefixime for pharyngeal infection Consider Rx with Ceftriaxone if pt may also engage in oral sex and oral GC test not done In published clinical trials, ceftriaxone cured 99.2% of uncomplicated urogenital and anorectal and 98.9% of pharyngeal infections 3

4 Ceftriaxone for GC Rx A 250-mg dose of ceftriaxone is now recommended over a 125-mg dose 1) increasingly wide geographic distribution of isolates demonstrating decreased susceptibility to cephalosporins in vitro, 2) reports of ceftriaxone treatment failures, 3) improved efficacy of ceftriaxone 250 mg in pharyngeal infection (which is often unrecognized), 4) utility of having a simple and consistent recommendation for treatment regardless of anatomic site involved. Gonococcal Isolate Surveillance Project (GISP) Percentage of Neisseria gonorrhoeae Isolates with Resistance or Intermediate Resistance to Ciprofloxacin, Percentage Resistance Intermediate Resistance Year NOTE: Resistant isolates have ciprofloxacin minimum inhibitory concentrations (MICs) >1 µg/ml. Isolates with intermediate resistance have ciprofloxacin MICs of µg/ml. Susceptibility to ciprofloxacin was first measured in GISP in Gonococcal Isolate Surveillance Project (GISP) Penicillin, Tetracycline, and Ciprofloxacin Resistance Among GISP Isolates, % 1.1% 2.2% 5.5% 2.1% 7.9% Susceptible PenR Gonococcal Isolate Surveillance Project (GISP) Distribution of Minimum Inhibitory Concentrations (MICs) to Cefixime Among GISP Isolates, and 2009 Percentage % 3.8% TetR QRNG % PenR/TetR PenR/QRNG TetR/QRNG PenR/TetR/QRNG < MICs (µg/ml) NOTE: PenR = penicillinase producing Neisseria gonorrhoeae and chromosomally mediated penicillinresistant N. gonorrhoeae; TetR = chromosomally and plasmid mediated tetracycline-resistant N. gonorrhoeae; and QRNG = quinolone-resistant N. gonorrhoeae. NOTE: Isolates were not tested for cefixime susceptibility in 2007 and Vaginal infection Diagnosis: vulvovaginal lcandidiasis i (VVC) vs bacterial vaginosis (BV) vs trichominiasis Management: new BV Rx options 4

5 Vaginal Infection: Diagnostic Challenges Vaginitis diagnostic evaluation is challenging BV can be diagnosed by clinical criteria (i.e., Amsel's Diagnostic Criteria) or Gram stain Gram stain, microscopy and ph paper often not available in primary care provider s office Only 60% 70% T. vaginalis sensitivity with microscopic examination of vaginal secretions Source: Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. Available at: Vaginal Infection: Diagnostic Opportunities CLIA - waived, more sensitive, point of care, vaginal tests: OSOM Trichomonas Rapid Test (Genzyme Diagnostics, Cambridge, Massachusetts) immunochromatographic capillary flow dipstick technology OSOM BVBLUE Test (Genzyme Diagnostics, Cambridge, Massachusetts) detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with BV including Gardnerella, Bacteroides, Prevotella and Mobilincus. Both rapid test results available in 10 minutes Vaginal Infection: Diagnostic Opportunities Affirm VP III (Becton Dickenson, San Jose, California) nucleic acid probe test for T. vaginalis, G. vaginalis, and C. albicans CLIA - moderate complexity test results available within 45 minutes FDA-approved T. vaginalis NAAT kit may soon be available and has demonstrated enhanced sensitivity and specificity 5

6 Trichomoniasis Treatment Metronidazole 2 g orally X1 OR Tinidazole 2 g orally x 1 Vaginal Infections: New BV Treatment Two new alternative BV treatment regimens for patients not tolerating metronidazole or have difficulty with compliance Metronidazole shortage nationally due to recall Metronidazole gel is not recommended less efficacious for trichomoniasis treatment (<50%) than oral metronidazol. unlikely to achieve therapeutic levels in the urethra or perivaginal area Tinidazole 2 g orally once daily for 3 days Tinidazole 1 g orally once daily for 5 days are Pelvic Inflammatory Disease (PID) Alternative treatment including azithromycin Azithromycin has demonstated short term effectiveness in one randomized trial in combination with ceftriaxone Ceftriaxone 250 mg IM in a single dose PLUS azithromycin 1 g orally once a week for 2 weeks Consider adding metronidazole to treat anaerobes and will also treat BV Regimens that include a quinolone no longer recommended for PID treatment Emergence of quinolone-resistant N. gonorrhoeae External Genital Warts (HPV) Sinecatechins 15% ointment is new external genital warts patientapplied therapy treatment option green-tea extract with an active product (catechins) Apply 3 times daily (0.5-cm strand of ointment to each wart) using a finger to ensure coverage with a thin layer of ointment until complete clearance of warts for up to 16 weeks Do not wash off after use Sexual (i.e., genital, anal, or oral) contact should be avoided while the ointment is on the skin Most common side effects are erythema, pruritis/burning, pain, ulceration, edema, induration, and vesicular rash Not recommended for HIV-infected persons, immunocompromised persons, or persons with clinical genital herpes because the safety and efficacy not established Unknown safety during pregnancy expensive 6

7 Cost of Topically Administered, Patient-applied Genital Warts Therapies (April 2008 Prices) Drug & Strength Sinecatechins ointment 15% (Veregen TM ) Podofilox 0.5% topical solution Imiquimod 5% topical cream (Aldara TM ) Estimated Cost/ Month Supply ($)* Estimated 1-month supply (1-2 15g tubes): $150-$300 Estimated one-month supply: $24 One-month supply: $95 *Usage dependent on total wart area Scabies Ivermectin (Stromectol) 200ug/kg orally x 1 and repeat in 2 weeks new first line scabies treatment option not recommended for pregnant or lactating patients safety in children wt < 15 kg not determined Adolescent/Adult Sexual Assault Testing Prophylaxis 7

8 Possible initial examination STD tests C. trachomatis and N. gonorrhoeae NAATs regardless of sites of penetration T. vaginalis test wet mount and culture point-of-care testing of vaginal-swab specimen HIV, HBV and syphilis tests Decisions to perform these tests should be made on individual basis Possible initial examination STD tests Decisions to perform these tests should be made on individual basis If sexually active, positive test may reflect infection acquired prior to assault Risk of poor f/u if wait to treat based on lab test results Cost Should not change management STD Prophylaxis Test of Reinfection Follow up Test of Reinfection Partner Services High C. trachomatis, N. gonorrhoeae and T. vaginalis reinfection rates treated persons resume sex with untreated partners or initiate sex with new partners Retest t and for chlamydia and/or gonorrhea ~3 months after treatment or whenever persons next present for medical care Retest for T. vaginalis at 3 months following initial infection No data support retesting for T. vaginalis Regardless if patients believe sex partners treated 8

9 Treatment of STI-infected persons sex partners Expedited Partner Therapy Treatment of sex partners without a prior health care provider exam or assessment Central component of prevention and control of bacterial STIs in the U.S. for six decades Treatment recommended for all sexually exposed partners within a specified time interval Initially developed for syphilis control Now recommended for gonorrhea, chlamydia, and HIV infection Traditional STI partner management strategies Syphilis Reported Cases by Stage of Infection, United States, Provider Referral: Partners directly contacted by index patient s provider or by a health department disease intervention specialist Patient Referral: Index patient assumes primary responsibility to notify and refer his/her partners at risk Contract referral: Patient referral supplemented by provider referral for partners who do not respond within a specified time Gonorrhea Rates, United States, Chlamydia Rates by Sex, United States, Rate (per 100,000 population) 500 Rate (per 100,000 population) Men Women Total Year Year NOTE: As of January 2000, all 50 states and the District of Columbia had regulations that required chlamydia cases to be reported. 9

10 Reported Communicable Diseases, United States, 2008 Chlamydia 1,108,374 Gonorrhea 355,991 All other 65 diseases 339,719 EPT Methods Patient-Delivered Partner Therapy: Given index case medication intended for the partners OR Prescribe extra doses of medication in the index patients names OR Write partner(s) prescription(s) for medication Partners collect medication at public health clinics or other venues Public health workers deliver medication to partners in non-clinical settings EPT in NY State Eligibility criteria for EPT Officially legal to treat partners of chlamydia-infected patients with EPT on January 23, 2009 as per NYSDOH regulations (PHL 2312) Only for partner(s) of a patient diagnosed with C. trachomatis infection NYSDOH regulations and tools at: Not for any partner(s) of patients who are gonorrhea or syphilis coinfected Educational material requirements Provide informational materials to index case to give to his/her sexual partner(s) Counsel each index case to inform partner(s) of importance to read informational materials prior to taking medication NYSDOH provider, patient and partner informational materials will be available at: EPT Educational Material Messages Encourage partner(s) to seek complete STI evaluation regardless of whether take EPT meds; Disclose risks of potential adverse drug reactions; Inform partner that he/she may be infected with other STIs that may not be treated by EPT meds; Inform partner that if Sx c/w more serious infxn (i.e., abdominal, pelvic, or testicular pain, fever, nausea or vomiting) he/she should seek medical care ASAP; 10

11 EPT Educational Materials Messages Recommend that if partner may be pregnant, should take medications and seek medical evaluation ASAP; Instruct patient and partner to abstain from sex for >7days after both treated to decrease the risk of recurrent tinfection; Inform partner who is high risk of HIV that he/she should consult a health care practitioner for a complete medical evaluation including HIV and STI testing; Inform patient and partner how to prevent repeated chlamydia infection. Prescription format EPT must be written in the body of the Rx form above med name/dosage for all Rx s issued; Ideally, sexual partner s name, address, and DOB should be written in designated area of prescription form; but If sexual partner's name, address, and DOB are not available, written designation EPT shall be sufficient for pharmacist to fill Rx. Separate prescription required for each partner Providers reporting C. trachomatis cases Report C. trachomatis cases who are provided with EPT to local health department Include EPT and # of sexual partners for whom a Rx or meds was provided ECDOH is revising (STD) reporting forms to include EPT ECDOH reporting forms available at: or call Chlamydia Percentage of Reported Cases by Sex and Selected Reporting Sources, United States, 2009 Percentage Men Women *HMO = health maintenance organization; STD = sexually transmitted disease; HD = health department. NOTE: These categories represent 75.2% of cases with a known reporting source. Of all cases, 9.5% had a missing or unknown reporting source. Private Physician/HMO* STD* Clinic Other HD* Clinic Family Planning Clinic Emergency Room What is next? NYSDOH will send out Dear Colleague letters to inform providers & pharmacists about EPT availability AAP NYS District II Planning info dissemination strategy Partner with NYSDOH and other NYS medical professional organizations Questions may be sent to: ept@health.state.ny.us Thank you!! Questions??? 11