Disclosures Management of STIs: Challenges in Practice I have no disclosures or conflicts of interest to report. Alison O. Marshall, MSN, FNP-C Associate Professor of Practice & Director of the Family Nurse Practitioner Program Simmons College of Nursing and Health Sciences Faculty, Sylvie Ratelle STD/HIV Prevention Center of New England Slides provided by the National Network of STD/HIV Prevention Centers Development of CDC STD Treatment Guidelines CDC STD Treatment Guidelines Development Key Questions Enlistment of Subject Matter Experts Systematic Review of Evidence Background papers Tables of evidence Guidelines Meeting, April 2013 Online: www.cdc.gov/std/treatment Answer the Key Questions Rate the quality of the evidence Identify critical gaps in knowledge (research agenda) Write the Guidelines document Recommended regimens ( in the box ) preferred over alternative regimens Treatments are typically alphabetized unless there is a preferred choice Language in yellow highlighted boxes reflects changes discussed at consultation meeting, actual language may differ STD Screening for Women Sexually Active adolescents & up to age 25 Routine chlamydia and gonorrhea screening Others STDs and HIV based on risk Women over 25 years of age STD/HIV testing based on risk Pregnant women Chlamydia ( 25 years of age or at-risk) HIV Syphilis serology HepB sag Hep C (if high risk) CDC 2010 STD Tx Guidelines www.cdc.gov/std/treatment Chlamydia & 1
Chlamydia New incidence estimates: 2.8 million cases in US annually Diagnostic issues: Self collected rectal swabs for MSM appear as sensitive as clinician collected swabs Highly acceptable to patients Pharyngeal screening: Still not routinely recommended, but can be sexually transmitted If detected, treat with routine CT tx regimens Hetero male screening: Consider in certain venues only (corrections, STD clinics, etc) Addition of a new treatment regimen Satterwhite et al. STD 2013 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) May add Doryx (Delayed release doxycycline) 200 mg QD x 7 d an additional regimen 2) Amoxicillin as an alternative for pregnant women with CT PID: Oral/IM Treatment Oral/IM regimens: Ceftriaxone 250 mg IM (or other parenteral 3rd generation cephalosporin) x 1 or Cefoxitin 2 g IM with probenecid 1 g orally once PLUS Doxycycline 100 mg orally twice daily for 14 days WITH OR WITHOUT Metronidazole 500 mg orally twice daily for 14 days Azithromycin and risk of cardiac death CDC notes that only 5 day regimen was studied- no change in treatment for STIs. http://www.cdc.gov/std/treatment/azithromyc in.html CDC 2010 STD Tx Guidelines www.cdc.gov/std/treatment New incidence estimates: 820,000 cases in US annually Diagnostic issues: Self collected pharyngeal swabs: data look favorable but not enough data to recommend (less data than rectal) Self collected rectal swabs (language similar to CT) Satterwhite et al. STD 2013 2
Treatment 2006 n Ceftriaxone 125 mg IM x 1 n Cefixime 400 mg PO x 1 Treatment, 2007 n Ceftriaxone 125 mg IM x 1 n Cefixime 400 mg PO x 1 Treatment, 2010 n Ceftriaxone 250 mg IM x 1 n Cefixime 400 mg PO x 1 Co-treat w/ azithromycin 1 g PO or doxycycline 100 mg PO bid x 7 days Treatment, 2012 n Ceftriaxone 250 mg IM x 1 Cefixime 400 mg PO x 1 Co-treat w/ azithromycin 1 g PO or doxycycline 100 mg PO bid x 7 days Treatment Uncomplicated Genital, Rectal, or Pharyngeal Infections Ceftriaxone 250 mg IM in a single dose * Regardless of CT test result CDC 2010 STD Treatment Guidelines www.cdc.gov/std/treatment PLUS* Proposed: Doxycycline may be removed from recommended to alternative Azithromycin 1 g orally (preferred) or Doxycycline 100 mg BID x 7 days* Treatment Alternatives Anogenital Infections ALTERNATIVE CEPHALOSPORINS: Cefixime 400 mg orally once PLUS Dual treatment with azithromycin 1 g (preferred) or doxycycline 100 mg BID x 7 days, regardless of CT test result IN CASE OF SEVERE ALLERGY: Azithromycin 2 g orally once (Caution: GI intolerance, emerging resistance) Prior TOC recommendation: Test of cure in 1 week for anyone treated w/ alternative regimens Proposed: Limit TOC only to pharyngeal GC treated with alternative regimen, may extend interval to 14 days MMWR 2012 / 61(31);590-594 3
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 Concurrent patient and partner treatment (CPPT) EPT- as of 2/1/2014 N=241 pregnant women with CT or GC 45 received CPPT 196 standard patient referral CPPT recipients less likely to have a positive TOC (OR =0, p<0.001)or repeat infection (OR=0, p <0.12) CPPT shortened the time to treatment versus standard referral by 5 days No repeat infections among CPPT compared to 19 infections in standard referral group Mmeje et al. STD 2012 http://www.cdc.gov/std/ept/legal/default.htm Partner Management: Key Points Clinical evaluation first line option Concurrent patient partner therapy is feasible and effective for many clients PDPT is still a second line 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: CPPT may be added as recommended strategy Offer PDPT routinely to heterosexual patients with CT/GC if partner cannot be promptly treated 4
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. 2009 Aug;36(8):478-89 Hillis SD, et al. (1997). Am J Obstet Gynecol 176(1 Pt 1): 103-7. Current Retesting Recommendations All women and men with CT or GC should be retested ~ 3 months after initial treatment Retesting should occur whenever patient returns to clinic (regardless of reason for visit), anytime within 1-12 months post treatment Test of cure is not recommended, except in pregnancy (for CT only) Repeat Screening after an STD infection Proposed: Women with CT, GC or trich should be rescreened at 3 months after treatment. Men with CT or GC should be rescreened at 3 months after treatment. Patients diagnosed with syphilis should undergo follow up serologic serololgy per current recommendations. HIV testing should also be considered in all patients with a prior STD history CDC 2010 STD Tx Guidelines, www.cdc.gov/std/treatment Genital Herpes Incidence estimates: 776,000 new infections per year Prevalence estimates: 48.5 million persons infected Diagnosis: Currently culture and serology Proposed: NAATS are most sensitive and increasingly available Treatment: No changes proposed Type-Specific gg-based HSV Serology: Commercial Kits 2010 Sensitivity Specificity HerpeSelect 2 ELISA (Focus) 96 100* 97 100 HerpeSelect Immunoblot (Focus) 97 100 98 HerpeSelect Express (Focus) 86 100 97 100 biokit HSV 2 (biokitusa ) 93 100 94 97 Cobas HSV 2 (Roche) 93 98 Captia Select HSV 2 (Trinity) 90 92 91 99 Cost varies; $20-$140 Western blot assay, considered gold standard, available through University of Washington 5
Interpreting Serology- The Math 100,000 people = at 10% prevalence 10,000 reacted to the test Using Herpes Select s lowest sensitivity of 96%, sensitivity of 97% Pt. + Pt. - Test + 9600 2700 PPV = 9600/12300 =.78 or 78% **Essential problem using this test for screening** More Genital Herpes Prevention: suppressive anti HSV therapy in HIV/HSV-2 co-infected patients does not reduce risk of HIV transmission Discussion regarding counseling of HSV-1 genital infection Test - 400 87300 NPV = 87300/87700 =.99 or 99% Sensitivity 10,000 Specificity 90,000 HSV NAATs BD ProbeTec HSV 1 & 2 Q x Assay anogenital lesions in females and males >16 EraGen Multicode-RTx HSV 1 & 2 anogenital lesions in females >17 BioHelix HSV Assay Oral/anogenital lesions females and males Indicates presence of HSV 1 or 2 Not type specific Syphilis Incidence estimates: 55,000 new cases per year Diagnostic issues: More labs using treponemal EIA (reverse sequence screening) CDC continues to recommend traditional algorithm Treatment: No changes proposed LP for neurosyphilis: No changes proposed Proposed: If a treponemal EIA is used in pregnancy and results are: EIA+, RPR-, TPPA-, repeat in 2 weeks if high risk for syphilis Discussed: 21% of patients w/ early syphilis do not have 2-dilution decline in titer in 6-12 mos, optimal management of these patients is 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 18-24 million units IV daily administered as 3-4 million IV q 4 hr for 10-14 d Only one dose of PCN Is recommended for early syphilis in HIV-infected 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 10-14 d If penicillin or doxycycline not feasible, consider: Azithromycin 2 g po in a single dose* * Do NOT use azithromycin in MSM or pregnant women In pregnancy, benzathine penicillin is the only recommended therapy. No alternatives 6
What is the maximum time allowed between Bicillin doses? Clinical experience suggests 10-14 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 Trichomonas Incidence estimates: 1 million new infections Prevalence: 3% nationwide, 10% Af American women, 20-30% among incarcerated women Annual screening recommended for HIV+ women new or multiple partners, history of STDs Proposed: Retesting recommended 3 months after treatment Consider screening those at high risk for infection or negative sequelae (receiving care in corrections or STD clinic settings) Trichomoniasis Treatment Recommended regimen: Metronidazole 2 g PO x 1 Tinidazole 2 g po x 1 HIV-infected women: Metronidazole 500 mg PO BID x 7d (consider) Alternative regimen: Metronidazole 500 mg PO BID x 7d Recommended regimen in pregnancy: Metronidazole 2 g PO x 1 Want to know more about STDs? There s an app for that. CDC Treatment Guidelines App for Apple and Android Available now, FREE! (accept no competitors) Note: Vaginal therapy is ineffective Tinidazole is a Category C drug in pregnancy Download the app now 7