29/09/2017. STI treatment guidelines. Rationale. WHO STI Guidelines. STI Treatment 2016 Guidelines. STI guidelines: Prevention, Management and Control

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1 29/09/ t h ESC Se min ar, Sain t-p e te rsb u rg, 1 3 Se p temb e r Declaration of interest STI Treatment 2016 Guidelines Conflict of interest We declare that I have no commercial or financial interests pertaining to the subject of this presentation or its content. Natalia Bakunina on behalf of Department of Reproductive Health and Research HRPres earch W HO pr ior it ies in inf er t ilt y 1 2 STI treatment guidelines 3 Rationale Neisseria gonorrhoeae Chlamydia trachomatis Genital herpes simplex Treponema pallidum (syphilis) Syphilis screen and treat for pregnant women 4 STI guidelines: Prevention, Management and Control Phases Topics Phase 1 Treatment of specific STIs: Chlamydia trachomatis (chlamydia), Neisseria gonorrhoeae (gonorrhoea), HSV-2 (genital herpes) and Treponema pallidum (syphilis) Syphilis screening and treatment of pregnant women STI syndromic approach Phase 3 Phase 4 5 STI guidelines last updated in 2003 Concerns about STI syndromic case management Treatment issues related to antimicrobial resistance in N. gonorrhoeae Scaling up syphilis screening increasing availability of rapid syphilis test, testing flowcharts 4 WHO STI Guidelines Non-infected: Primary prevention Timeframe November 2013 December 2016 Infected May 2016 December 2017 Syphilis screening Asymptomatic Clinical management package Phase 2 Symptomatic STI prevention: condoms, behaviour change communication, biomedical interventions and vaccines Treatment of specific STIs and reproductive tract infections (RTIs) not addressed in Phase 1: Trichomonas vaginalis (trichomoniasis), bacterial vaginosis, Candida albicans (candidiasis), Hemophilus ducreyi (chancroid), Klebsiella granulomatis (donovanosis), human papillomavirus (HPV; genital warts/cervical cancer), Sarcoptes scabiei (scabies) and Phthiruspubis (pubic lice) STI laboratory diagnosis and screening Operational issues Screening Presumptive treatment Syndromic management Laboratory diagnosis Partner management Effective treatment 6 6 1

2 Objective of the guidelines Target audience Provide evidence-based guidance on treatment of specific STI N. gonorrhoeae, Chlamydia trachomatis and Treponema pallidum and syphilis screening and treatment for pregnant women Support countries to update their national guidelines Health-care providers at all levels (primary, secondary and tertiary) of the health-care system Individuals working in sexual and reproductive health programmes, such as HIV/AIDS, family planning, maternal and child health and adolescent health Policy-makers, managers, programme officers and other professionals implementing STI management interventions at regional, national and subnational levels Guideline Development Group WHO Steering Committee from different WHO departments and representation from regions Inventory of existing guidelines Determine the need for an updated guideline Draft initial PICO STI guideline development group 33 STI experts with different expertise 4 subgroups to focus on specific STIs Finalize the scoping document PICO methods Involve in the entire process of guideline development STI external development group STI experts Reviewed the final document 10 Review of evidence PICO uestion and components - benefits, harms, patient values, acceptability, feasibility, euity and costs Search terms and search strategies developed Pre-existing evidence Previously published guidelines that included systematic reviews of the literature Existing systematic reviews Cochrane Library s uite of databas es (Cochrane Databas e of Systematic Reviews [CDSR], Database of Abstracts of Reviews of Effects [DARE], Health Technology As s es s ment [HTA] database and the American College of Phys icians [ACP] Journal Club) New systematic review of randomized controlled trials (RCTs) and nonrandomized studies GRADE Evidence Profile Evidence to decision framework Making recommendations STI GDG group Follow-up teleconferences Assessment of uality/certainty of the evidence at four levels High We are very confident that the true effect lies close to that of the estimate of the effect. Moderate We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect

3 Implication of strong and conditional recommendations using the GRADE approach Implications Strong recommendation Conditional recommendation The WHO STI guideline recommends The WHO STI guideline suggests For patients Mos t individuals in this s ituation would The majority of individuals in this situation want the recommended course of would want the suggested course of action, but action, and only a small proportion many would not. would not. 13 For clinicians For policy- makers Formal decision aids are not likely to be needed to help individuals make decisions consistent with their values and preferences. Mos t individuals s hould rec eive the rec ommended c ours e of ac tion. Adherence to this recommendation according to the guidelines could be used as a uality criterion or performance indicator. The recommendation can be adopted as policy in most situations. Clinicians s hould recognize that different choices will be appropriate for each individual and that clinicians must help each individual arrive at a management decision consistent with the individual s values and preferences. Dec is ion aids may be us eful to help individuals make decis ions cons is tent with their values and preferences. Policy-making will reuire s ubs tantial debate and involvement of various stakeholders. 14 NEISSERIA GONORRHOEA Key Messages : N. gonorrhoea Local resistance data to determine the choice of therapy (both for dual therapy and single therapy). Use of dual therapy over single therapy Ceftriaxone 250 mg or Cefixime 400 mg plus Azithromycin 1 gram Quinolones are no longer recommended Oropharyngeal infection Treatment Failure: increase dose Ceftriaxone 500 mg plus Azithormycin 2 grams Gentamicin or Spectinomycin plus Azithromycin 2 grams For all neonates, topical ocular prophylaxis for the prevention of gonococcal and chlamydial ophthalmia neonatorum. rrhoeatreatment-guidelines/en/ Chlamydia trachomatis Key Messages : C. trachomatis and LGV C. trachomatis Azithromycin or Doxycyline remain to be treatment of choice Ano-rectal infection: Doxycline over Azithromycin Lymphogranuloma venereum doxycycline 100 mg orally twice daily for 21 over azithromycin 1 g orally, weekly for 21 ilistreatment-guidelines/en/ Treponema pallidum (syphilis)

4 19 Key Message: Early syphilis ( primary, secondary, early latent < 2 years ) Drug of Choice Adults and Adolescents Benzathine penicillin G 2.4 million units IM QD x 1 Pregnant Women Benzathine penicillin G 2.4 million units IM QD x 1 Alternative Procaine penicillin G 1.2 Procaine penicillin G 1.2 million units IM QD x million units IM QD x Penicillin allergy or stock out Doxycycline 100 mg BID x 14 or Ceftriaxone 1 g IM, QD x or in special circumstances Azithromycin 2 g QD x 1 Erythromycin 500 mg QID x 14 * or Ceftriaxone 1 g IM, QD x * or in special circumstances Azithromycin 2 g QD x 1* *with caution Key Message: LATE SYPHILIS (infection of more than two years duration without evidence of treponemal infection) 20 Adults and Adolescents Pregnant Women Drug of Choice Benzathine penicillin G Benzathine penicillin G 2.4 million units IM QD x 2.4 million units IM QD 3 consecutive weeks 3 consecutive weeks Alternative Procaine penicillin G 1.2 Procaine penicillin G million units IM QD x million units IM QD 20 x 20 Penicillin allergy or stock out Doxycycline 100 mg BID x 30 Erythromycin 500 mg QID x 30 (with caution) Because syphilis during pregnancy can lead to severe adverse complications to the fetus or newborn, stock-outs of benzathine penicillin for use in antenatal care should be avoided. Key Message: Congenital syphilis In infants with confirmed congenital syphilis or infants who are clinically normal, but mother with syphilis was not treated, inadeuately treated (including treated within 30 of delivery) or treated with non-penicillin regimen: Aueous benzyl penicillin 100, ,000 U/kg/day intravenously for Procaine penicillin 50,000 U/kg/day single dose intramuscularly for In infants who are clinically normal and the mother had syphilis and was adeuately treated with no signs of reinfection: closely monitor the infants over treatment Benzathine penicillin G 50,000 U/kg/day single dose intramuscularly ications /rti s/gen ital-hsvtreatment-guidelines/en/ Genital herpes simplex virus Key Messages: Genital Herpes Simplex Virus Primary Episodic Suppressive Acyclovir 400 mg TID x 10 Acyclovir 200 mg 5 x day x 10 Valacyclovir 500 mg BID x 10 Famciclovir250 mg TID x 7-10 Acyclovir 400 mg TID x 5 Acyclovir 800 mg BID x 3 day Acyclovir 800 mg TID x 2 Valacyclovir 500 mg BID x 3 Famciclovir250 mg TID x 5 Acyclovir 400 mg BID Valacyclovir 500 mg OD Famciclovir250 mg BID Key Messages: Genital Herpes Simplex Virus HIV positve and immunocompromis Primary Episodic Suppressive Acyclovir 400 mg TID x 10 Acyclovir 200 mg 5 x day x 10 Valacyclovir 500 mg BID x 10 Famciclovir250 mg TID x 10 Acyclovir 400 mg TID x 5 Valacyclovir 500 mg BID x 5 Famciclovir250 mg TID x 5 Acyclovir 400 mg BID Valacyclovir 500 mg BID Famciclovir500 mg BID Suppressive therapy: Individuals who have freuent recurrences (such as four to six times per year or more), severe symptoms or episodes which cause distress will likely choose suppressive therapy over episodic therapy. PLHIV: increase dosages for episodic and suppressive therapy 23 Suppressive therapy: Individuals who have freuent recurrences (such as four to six times per year or more), severe symptoms or episodes which cause distress will likely choose suppressive therapy over episodic therapy. PLHIV: increase dosages for episodic and suppressive therapy 24 4

5 BSC - Methodology and main results BSC is effective for the prevention of STIs/HIV in different populations and can be used in conjunction with: ü sex/sexuality education; ü community based behavioural interventions; ü social marketing of condoms; ü multipurpose prevention technologies; ü vaccines; ü circumcision Brief BSC - Methodology sexuality-related and main results communication (BSC) "Brief Sexuality-related Communication (BSC) takes into account the psychological and social dimensions of sexual health and wellbeing in addition to the biological ones" Most interventions could feasibly occur at the primary health care level Particular focus on prevention of STIs/HIV and unintended pregnancy Interventions were effective at changing intermediary behaviours: Ø Decreasing episodes of unprotected sex; Ø Increasing condom use; Ø Decreasing number of sexual partners; Ø Overall impact on STI/HIV incidence and prevalence Low screening coverage Syphilis screening in pregnant women In settings with low screening coverage and treatment of pregnant women for syphilis, high loss to follow-up of pregnant women, or limited laboratory capacity, the WHO STI guideline suggests on-site tests rather than offsite laboratory-based screen and treat strategies Conditional recommendation, low uality evidence The WHO STI guideline recommends screening all pregnant women for syphilis during the first antenatal visit. Strong recommendation, moderate uality evidence Remarks: This recommendation applies to all settings including settings with high or low prevalence of syphilis High prevalence of syphilis ( 5%) Low prevalence of syphilis (<5%) In settings with a high prevalence of syphilis (5% or greater), the WHO STI guideline suggests an onsite rapid treponemal syphilis test and if positive, provide a first dose of treatment and a rapid plasma reagin (RPR) test and then if positive, treat according to duration of syphilis. The WHO STI guideline suggests this seuence of tests rather than a single on-site rapid syphilis treponemal test or on-site rapid plasma reagin (RPR) test strategies Conditional recommendation, low uality evidence In settings with a low prevalence of syphilis (below 5%), the WHO STI guideline suggests a single on-site rapid syphilis treponemal test be used to screen pregnant women rather than on-site rapid plasma reagin (RPR) test strategies. Conditional recommendation, low uality evidence

6 Acknowledgements: Teodora Wi, Mario Festin, Igor Toskin