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ACTHIV 2021: a State-Of-The-Science Conference for Frontline Health

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ACTHIV 2021: a State-Of-The-Science Conference for Frontline Health ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals What’s New in Sexually Transmitted Infections Julie Dombrowski, MD, MPH Associate Professor of Medicine University of Washington ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Learning Objectives Upon completion of this presentation, learners should be better able to: 1. Describe recent changes in treatment guidelines for gonorrhea and chlamydia 2. Identify why single dose azithromycin is falling out of favor for STI treatment 3. Describe the clinical significance of and appropriate treatment for M. genitalium infection • There will be no off-label/investigational uses discussed in this presentation ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Outline • Treatment changes – Gonorrhea Key Sources – Chlamydia • 2015 CDC STD Guidelines – Urethritis • Updated Guidelines for Gonococcal Infection, 2020 – Trichomoniasis • 2021 STI Treatment Guidelines Update Webinar (Dec 2020) • Advances in prevention – Meningococcal vaccine – Doxycycline prophylaxis ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals St. Cyr et al, MMWR 2020; 69:1911-1916; https://www.cdc.gov/std/training/webinars.htm CDC 2018 STD Surveillance Summary ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals www.cdc.gov/std Audience Response Question • In the 2019 CDC report, Antibiotic Resistance in the United States, N. gonorrhoeae was ranked at which threat level? – Urgent – Serious – Concerning – Watch List ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals • In the 2019 CDC report, Antibiotic Resistance in the United States, N. gonorrhoeae was ranked at which threat level? – Urgent – Serious – Concerning – Watch List ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals CDC, Antibiotic resistance in the United States, 2019 Gonorrhea Treatment 2015 CDC Treatment Guidelines Ceftriaxone 250mg IM x 1 Plus Azithromycin 1g orally x 1 Antimicrobial PK/PD properties of Stewardship ceftriaxone ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Azithromycin Resistance Ceftriaxone Cefixime Azithromycin ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Figure from: St. Cyr, 2020 STD Prevention Conference Pharmacokinetic/pharmacodynamic properties ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Slide credit: Dr. Lindley Barbee & Dr. Sancta St. Cyr Gonorrhea Treatment 2015 CDC Treatment Guidelines Ceftriaxone 250mg IM x 1 Plus Azithromycin 1g orally x 1 2020 Update to Gonococcal Infection Guidelines Ceftriaxone 500mg IM x 1 ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Chlamydia trachomatis & Mycoplasma genitalium ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals From giantmicrobes.com Audience Response Question • 42 yo man with well-controlled HIV (VL undetectable, CD4>500) who completed routine STI screening at his last medical visit, test results shown below. How would you treat him? Site GC CT Pharynx - - – Azithromycin 1g po x 1 Rectum - + – Doxycycline 100mg po BID x 7 days Urethra - - – Doxycycline 100mg po BID x 21 days (urine) – Needs additional assessment before treatment ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Audience Response Question • 42 yo man with well-controlled HIV (VL undetectable, CD4>500) who completed routine STI screening at his last medical visit, test results shown below. How would you treat him? Site GC CT Pharynx - - – Azithromycin 1g po x 1 Rectum - + – Doxycycline 100mg po BID x 7 days Urethra - - – Doxycycline 100mg po BID x 21 days (urine) – Needs additional assessment before treatment ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Chlamydia Treatment 2015 CDC Treatment Guidelines Azithromycin 1g po x 1 Or Doxycycline 100mg po BID x 7 days Doxycycline Azithromycin • May be more effective • Single dose that can be for symptomatic directly observed infections • Evidence of equivalence • More effective for rectal for GU tract infections infections • Safe in pregnancy ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals RCTs of Doxycycline vs. Azithromycin, Urogenital Chlamydia Azithromycin Doxycycline Efficacy Difference 94% Kong meta-analysis, 2014 2.6% (95% CI: 0.5 – 4.7) 97% Symptomatic 7.4% (95% CI: 2.0-12.9) 90% Geisler, overall, 2015 3.2% (95% CI: 0.4-7.4) 97% 90% Geisler, symptomatic, 2015 10%, p-value = 0.17 100% 0% 20% 40% 60% 80% 100% ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Kong FY, CID 2014; Geiser W, NEJM 2015 ARE TREATMENT OUTCOMES DIFFERENT FOR RECTAL CHLAMYDIA? ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Randomized, double-blinded, placebo-controlled trial of AZM vs. DOX for treatment of rectal CT in MSM Enrollment Randomized (n=177) Allocation Doxycycline* (n=88) Azithromycin (n=89) 2 & 4 Week Discontinued treatment (n=7) Discontinued treatment (n=5) Follow-Up Lost to follow-up (n=5) Lost to follow-up (n=5) Early termination (n=2) Early termination (n=2) Analysis Intention to treat (n=88) Intention to treat (n=89) Complete case (n=70) Complete case (n=65) 16 negative baseline CT NAAT 17 negative baseline CT NAAT Per protocol (n=46) Per protocol (n=48) ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Dombrowski JC et al, Clin Infect Dis 2021; online ahead of print Microbiologic Cure at Four Weeks, by Treatment Group 100% DOX AZM 90% 100% 80% 91% Only one participant 70% 74% 71% randomized to 60% doxycycline had a +NAAT, other seven lost 50% n=70/70 n=48/65 n=80/88 n=63/89 to follow-up 40% 30% Absolute Difference Absolute Difference 20% 26% 20% (95% CI: 16-36%) (95% CI: 9-31%) % with Negative NAAT at 4 at weeks NAAT with% Negative 10% p<0.001 p<0.001 0% Complete Case Intention to Treat ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals WHAT ABOUT ADHERENCE TO DOXYCYCLINE? ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Mycoplasma genitalium • Causes urethritis in men • No consensus on causal role in cervicitis, PID • Population prevalence of urethral infection (2001-2002 data): – CT: 4.0% – M. gen: 1.0% – GC: 0.4% • FDA approved test now available • No recommendation for screening (yet?) • Recently updated clinical epidemiology data ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Manhart 2007 Prevalence of Key Pathogens among Men with Urethritis (MAGNUM study) Study Site (n) N. C. M. T. gonorrhoeae trachomatis genitalium vaginalis Birmingham, AL 33% 23% 30% 7% (n=235) Durham, NC (n=93) 42% 32% 25% 8% Greensboro, NC 43% 29% 39% 10% (n=152) New Orleans, LA 37% 25% 29% 2% (n=103) Pittsburgh, PA (n=174) 26% 27% 28% 12% Seattle, WA (n=157) 35% 25% 29% 2% Overall 35% 25% 29% 7% ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Bachmann LH, Clin Infect Dis 2020 Prevalence of Resistance Mutations in M. gen among Men with Urethritis (MAGNUM study) 80% Azithromycin (1) Quinolone (2) 70% 76% 60% 68% 62% 62% 64% 50% 61% 60% 40% 30% 18% 20% 17% 13% 16% 12% 10% 6% 6% 0% Birmingham Durham Greensboro New Orleans Pittsburgh Seattle Overall 1. 23S rRNA mutation, among those with evaluable results 2. parC mutation, among those with evaluable results ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Bachmann LH, CID 2020 Resistance-Guided Treatment Algorithm Melbourne Sexual Health Centre 2020 study Urethritis, cervicitis & proctitis + M. gen (n=388) 2017-2018 Doxycycline x 7 days Combined M.gen diagnostic & resistance assay Doxycycline x 7 days M. gen + M. gen + M. gen + M. gen + AZM susceptible AZM resistant AZM susceptible AZM resistant (n=109) (n=274) AZM 1g x 1 AZM 1g x 1 Sitafloxacin Moxifloxacin + + 100mg/day x 7 400mg/day x 7 500mg/day x 3 500mg/day x 3 Initial report 95.4% cure 92.0% cure 95% and 92% cure (n=104) (n=252) ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Read TRH, Clin Infect Dis, 2018; Durukan D, Clin Infect Dis, 2020 Audience Response Question (Trivia) • This sexually transmitted pathogen is itself frequently infected with a virus: – Chlamydia trachomatis – Neisseria gonorrhoeae – Mycoplasma genitalium – Trichomonas vaginalis – Shigella spp. – Treponema pallidum ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Audience Response Question (Trivia) • This sexually transmitted pathogen is itself frequently infected with a virus: – Chlamydia trachomatis – Neisseria gonorrhoeae – Mycoplasma genitalium – Trichomonas vaginalis – Shigella spp. – Treponema pallidum ACTHIV 2021: A State-of-the-Science Conference for Frontline Health Professionals Graves KJ, Int J of STD & AIDS, 2018; Graves KJ, Clin Infect Dis, 2019 Trichomonas vaginalis Treatment 2015 CDC Treatment Guidelines 2020 ACOG Guidelines Metronidazole 2g orally single dose Metronidazole 500mg BID x 7 days Or Tinidazole 2g orally single dose RCTs show superiority of 7d Disulfuram-like course vs. single dose in both reaction with HIV+ women (92% vs. 83%) alcohol & HIV- women (89% vs. 81%) (let go of this) ACTHIV 2021: A State-of-the-Science
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