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STI Update. Peter A. Leone,MD Associate Professor of Medicine University of North Carolina Medical Director North Carolina HIV/STD Prevention and Care Branch. North Carolina HIV Disease Reports. North Carolina HIV. ~32,000 living with HIV ~ 18,000 aware of HIV infection
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STI Update Peter A. Leone,MD Associate Professor of Medicine University of North Carolina Medical Director North Carolina HIV/STD Prevention and Care Branch
North Carolina HIV • ~32,000 living with HIV • ~ 18,000 aware of HIV infection • ~12,000-13,000 in care • ~30-40% unaware of HIV status
Awareness of Serostatus Among People with HIV and Estimates of Transmission ~25% unaware of infection ~55% of new infections ~75% aware of infection ~45% of new infections PLWHA New infections each year
Identification of HIV Status to Reduce Transmission • Goal of new CDC recommendations to increase number who know HIV+ status • People do not perceive risk • Clinicians do not offer test • Stigma of identified risk and of testing • Knowing HIV+ status can reduce transmission by: - Behavior change - HAART reducing viral load MMWR 55:1-7, 2006 Inungu J. AIDS atient Care STDs 16:293, 2002
Knowledge of HIV Infection and Behaviour Reduction in unprotected anal or vaginal intercourse with HIV Negative partners - HIV positive aware vs HIV positive unaware: 68% (95% CI: 59%–76%) Source: Marks G, et al. Meta-analysis of high risk sexual behavior, aware vs unaware. JAIDS. 2005
Source of HIV tests and Positive Tests • 38-44% of adults 18-64 yrs. have been tested • 16-22 million aged 18-64 yrs. tested/yr in U.S. HIV Tests HIV+ Tests • Private MD/HMO 44% 17% • Hospital/ED/Outpt. 22% 27% • Public clinics 9% 21% • HIV C&T 5% 9% • Drug treatment 0.7% 2% • Correctional facility 0.6% 5% • STD clinics 0.1% 6% National Health Interview Survey,2002; Suppl; to HIV/AIDS surveillance,2000-2003
New CDC Recommendations forScreening for HIV infection: • In all health care settings, screening for HIV infection should be routinely performed for all patients age 13-64 • Providers should initiate screening unless HIV prevalence has been documented to be <0.1%. • All patients initiating treatment for TB should be routinely screened for HIV infection • All patients seeking treatment for STDs, including all patients attending STD clinics, should be routinely screened for HIV during each visit for a new complaint, regardless of patient specific behavioral risks for HIV infection.
Further Modification to “Routinize” HIV testing in Medical Care Settings "Testing for HIV may be offered as part of routine laboratory testing panels using a general consent which is obtained from the patient for treatment and routine laboratory testing,so long as the patient is notified that they are being tested for HIV and given the opportunity to refuse testing."
Changes to NC Administrative CodeNov. 1, 2007 • Providers and Laboratories to report HIV/AIDS from 7 days to 24 hrs • HIV testing can be a part of a panel of tests without a standalone written consent just for HIV testing as long as the consent for testing specifies that HIV testing is included.
Changes to NC Administrative CodeNov. 1, 2007 • Opt-out HIV screening in medical settings and for prenatal and STD visits • Pretest counseling not required • Post-test counseling required only for positives • HIV tests at first prenatal visit and 3rd trimester • Mandatory HIV test at L&D for all women for whom HIV status is unknown and in infant if test not obtained from mother
General Consent Form I hereby voluntarily consent to medical and/or dental examinations, treatments and procedures which are deemed necessary in the opinion of my physician and health care providers, including HIV tests, laboratory tests and x-rays. I understand that my medical information is strictly confidential and is protected by North Carolina General Statute 130A-143 and no guarantees or warrantees have been made to me concerning the results of the examinations, treatments or procedures. My signature acknowledges that I have been given the opportunity to ask questions about this consent form and the opportunity to refuse services. Client Signature _____________ Date_____________
HIV Required Reporting in NC Confirmed HIV infection is defined as: - a positive virus culture - repeatedly reactive EIA antibody test confirmed by WB or indirect immunofluorescent antibody test; - positive polymerase chain reaction(PCR)test; or other confirmed testing method approved by the Director of the State Public Health Laboratory
HIV/STD Rule Changes (STD) http://www.epi.state.nc.us/epi/hiv/ Branch Overview Current Initiatives
UNC Hospitals Rules Changes • UNC Health Care System has required a written consent from patients for HIV tests. The HIV testing rules have been revised and, as a result, after January 1, 2008, a separate written consent for HIV testing will not be required. Our General Consent for Treatment contains a consent for routine laboratory testing that encompasses HIV testing.
Rules Changes • NOTE: Patients must still be notified in advance that the test will be performed and, with exceptions below, patients must still consent to the testing. This notification and consent may be done orally, but the physician must document in the patient’s medical record. • Pre-test counseling is no longer required for HIV testing.
Window Periods for HIV Tests Stekler J. et al CID 2007
0 10 20 30 40 50 60 70 80 90 100 HIV viremia during early infection Peak viremia: 106-108 gEq/mL HIV RNA (plasma) Ramp-up viremia DT = 21.5 hrs HIV Antibody HIV p24 Ag p24 Ag EIA - Viral set-point: 102 -105 gEq/mL HIV MP-NAT - 1st gen 2nd gen HIV ID-NAT - 4th gen 3rd gen “blip” viremia 11 16 22
3rd Generation HIV assays • Moving the window to the “left” • Increase in ELISA + and WB – or WB+/- • Think AHI but recognize may have false positive
Fever Rash Oral ulcer Weight loss Loss of appetite Headache Fatigue Adenopathy Sore throat/ pharyngitis Muscle and/or joint pain Diarrhea GI upset/nausea/ vomiting Non-specific Mononucleosis-like Signs and Symptoms
Common Signs & Symptoms Study of 160 patients with primary HIV infection in 3 countries % of patients Vanhems P et al. AIDS 2000; 14:0375-0381.
Role of Rapid Antibody Testing • Makes testing feasible in non-traditional settings • Highly effective for outreach situations (needle exchange, bathhouse testing, “street-corner” outreach) • Increases receipt of positive HIV test results • Where HIV results notification (PCRS) not in place • Might increase requests for HIV testing • Is not preferred in many established testing settings • Cost 2-3x ELISA Ab tests • May defer resource allocation to HIV negatives • May miss AHI
PCR Testing of Pooled Sera to Identify Acute HIV Infection (seronegative, PCR positive) Source: ISSTDR, 2007
Typical Course of Primary HIV 1 mil 100,000 + _ 10,000 1,000 100 HIV RNA HIV RNA HIV-1 Antibodies Ab P24 + Exposure Symptoms 10 0 3 14 21 28 35 Days Source: Hecht. Primary HIV.
ACUTE HIV SYNDROME If you have an STD, Get Tested for HIV. Early Detection is Best! Learn to Recognize IT. Tell a Friend. Acute HIV is Easily Misdiagnosed. IT CAN BE MISTAKEN FOR COMMON ILLNESSES Common Symptoms of Acute HIV: High Fever Rash Fatigue Swollen Glands Sore Throat Nausea/Vomiting Night Sweats Symptoms usually appear about 2 weeks after exposure What Puts You At Risk? Unprotected Sex Sharing Needles The Acute HIV Program 919-966-8533 • If you suspect you may have Acute HIV, get tested at your Local Health Department or at your doctor’s office. • FREE Screening for acute HIV is done on all HIV tests done through the NC Health Departments • Screening for acute HIV can be done at your doctor’s office – ask for an HIV RNA test in addition to the standard HIV antibody test. SPREAD THE WORD - NOT HIV
Discordant results • 167,371 rapid HIV ELISA • 2589 (1.6%) HIV + • 2417 (93%) WB/IFA + • 172 (7%) WB/IFA - or +/- • 89/182 (52%) repeat confirmatory test • 17 (19%) were HIV+ (3 WB +/- and NAAT+) • 72/89 (81%) were uninfected (12 repeat WB +/-) Discordants: ~50% repeat + for which 20% were HIV+ (3 AHI) Wesolowski et al, PLoS 2008
Discordant results • EIA / ELISA + require confirmatory test WB + WB – WB or +/- NAAT ++ NAAT + NAAT - NAAT+/- AHI Repeat test Probable - HIV+ AHI HIV-
HIV Testing Goals • Universal testing of individuals 13-64 yr • Opt-out testing in STD/ Prenatal/Prison settings • Allow uncoupling of pre- and post-test counseling from HIV testing itself • Think and test for AHI ( RNA) with “mono-like” illness in sexually active adult……. Fast Track
Gonococcal Isolate Surveillance Project (GISP) — Percent of Neisseria gonorrhoeae isolates with resistance or intermediate resistance to ciprofloxacin, 1990–2004 Note: Resistant isolates have ciprofloxacin MICs ≥ 1 µg/ml. Isolates with intermediate resistance have ciprofloxacin MICs of 0.125 - 0.5 µg/ml. Susceptibility to ciprofloxacin was first measured in GISP in 1990.
Gonococcal Isolate Surveillance Project (GISP) — Percent of Neisseria gonorrhoeae isolates with resistance to ciprofloxacin by sexual behavior, 2001–2004
Gonorrhea • Do not use quinolones (cipro, oflox, levo) http://www.cdc.gov/std/gisp
Previous Recommendations2006 NC STD Treatment GuidelinesUncomplicated Gonorrhea Cefpodoxime 400 mg PO x 1 or Ceftriaxone 125mg IM Alternatives: Gentimicin 240 mg IM ( not for oral pharyngeal)- do test of cure Quinolones: Do test of cure Ciprofloxacin 500mg PO or Ofloxacin 400mg PO or Levofloxacin 250mg PO Azithromycin 2.0 g PO ( expensive, nausea and vomiting) Add co-treatment for Ct if not treating with Azithromycin Plus, Azithromycin 1g PO or Doxycycline 100mg po BID x 7d
2008 NC STD Treatment GuidelinesUncomplicated Gonorrhea Cefixime 400 mg PO x 1 or Ceftriaxone 125mg IM Alternatives: Gentimicin 240 mg IM ( not for oral pharyngeal)- do test of cure Quinolones: Do test of cure Ciprofloxacin 500mg PO or Ofloxacin 400mg PO or Levofloxacin 250mg PO Azithromycin 2.0 g PO ( expensive, nausea and vomiting) Add co-treatment for Ct if not treating with Azithromycin Plus, Azithromycin 1g PO or Doxycycline 100mg po BID x 7d
2006 CDC STD Treatment GuidelinesUncomplicated Gonorrhea Alternatives: • Spectinomycin 2g IM Oral Alternatives: • Cefpodoxime (Vantin®) 400mg PO single dose OR • Cefuroxime (Ceftin®) 500mg PO single dose
Urethritis Management • 2006 CDC STD Guidelines: If Chlamydia or Gonorrhea positive, some experts suggest repeat Chlamydia or Gonorrhea Testing in About 3 Months
The Course of Untreated Syphilis 6 weeks to 6 months Approx. 18 months Many years to a lifetime Infection Primary (Chancre) Secondary (Rash) Latent Syphilis (No signs of disease) Tertiary Benign gummatous Cardio-vascular syphilis Neurosyphilis Incubation period 9 – 90 days Many years to a lifetime Late Syphilis 1-2 years Early Syphilis
Diagnosis of Syphilis • Darkfield microscopy • Direct immunofluorescence • Polymerase chain reaction (PCR) • Serology • Nonspecific (Cardiolipin-based) • Specific (Treponemal)
Serological Tests for Syphilis Non-treponemal (reagin) tests Complement Fixation Test Wasserman reaction Flocculation Reactions Rapid plasma reagin (RPR) test VDRL TRUST Treponemal (specific) tests TPI FTA-ABS TPHA TPPA ELISA (EIA) Automated chemiluminescence platforms Current Chromatographic (POC) Tests
Principle of the Rapid Plasma Reagin Test
Quantitative RPR Test End-Point Titer (1:64)