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2/20/2017 PERINATAL HIV UPDATE STEPHEN A THACKER, MD, FAAP PEDIATRIC INFECTIOUS DISEASE CHILDREN’S HOSPITAL OF SAVANNAH PERINATAL UPDATE OBJECTIVES 1. Update on HIV Epidemiology 2. Trends in vertical HIV transmission 3. Discussion of Georgia Laws on RPR and HIV screening 4. Perinatal HIV Screening/Testing 5. Prophylaxis against vertical transmission MARCH 10 TH 2017 Vertical Transmission Rates of > 20% BASELINE FACTS • CDC estimates that nearly 50,000 individuals become infected with HIV annually in the United States. • From 2009 through 2015, rate of diagnoses remained relatively stable • Antiretroviral medications given to women with HIV during pregnancy and delivery and to their newborns in the first weeks of life reduce the vertical transmission rate from 25% to 2% or less. • Even instituting maternal prophylaxis during labor and delivery, neonatal prophylaxis within 24–48 hours of delivery, or both, can substantially decrease rates of infection in infants 1 2/20/2017 DIAGNOSES OF HIV INFECTION AMONG FEMALE ADULTS AND ADOLESCENTS, BY RACE/ETHNICITY, 2010–2014—UNITED STATES AND 6 DEPENDENT AREAS Only 81% of people aware of their HIV Dx in GA Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. a Hispanics/Latinos can be of any race. RATES OF NEW DIAGNOSES OF HIV INFECTION AMONG FEMALE ADULTS AND ADOLESCENTS 2015—UNITED STATES AND 6 DEPENDENT AREAS N = 7,498 TOTAL RATE = 5.4 Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. Data for the year 2015 are preliminary and based on 6 months reporting delay. Georgia is #5 in the nation RATES OF FEMALE ADULTS AND ADOLESCENTS LIVING WITH DIAGNOSED HIV INFECTION YEAR-END 2014—UNITED STATES AND 6 DEPENDENT AREAS N = 235,813 TOTAL RATE = 171.0 Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. Data are based on address of residence as of December 31, 2014 (i.e., most recent known address). Georgia is #7 in the nation 2 2/20/2017 DIAGNOSES OF HIV INFECTION AND POPULATION AMONG FEMALE ADULTS AND ADOLESCENTS, BY RACE/ETHNICITY, 2015—U.S. Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. Data for the year 2015 are preliminary and based on 6 months reporting delay. a Hispanics/Latinos can be of any race. DIAGNOSES OF HIV INFECTION AMONG FEMALE ADULTS AND ADOLESCENTS BY REGION AND RACE/ETHNICITY, 2015—UNITED STATES Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. Data for the year 2015 are preliminary and based on 6 months reporting delay. a Hispanics/Latinos can be of any race. DIAGNOSES OF HIV INFECTION AMONG FEMALE ADULTS AND ADOLESCENTS BY RACE/ETHNICITY, 2015—UNITED STATES Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. Data for the year 2015 are preliminary and based on 6 months reporting delay. Rates are per 100,000 population. a Hispanics/Latinos can be of any race. DIAGNOSES OF HIV INFECTION AMONG FEMALE ADULTS AND ADOLESCENTS, BY RACE/ETHNICITY AND TRANSMISSION CATEGORY, 2015—UNITED STATES AND 6 DEPENDENT AREAS Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. Data for the year 2015 are preliminary and based on 6 months reporting delay. Data have been statistically adjusted to account for missing transmission category. a Hispanics/Latinos can be of any race. b Heterosexual contact with a person known to have, or to be at high risk for, HIV infection. c Includes blood transfusion, perinatal exposure, and risk factor not reported or not identified. 3 2/20/2017 Chatham Co. 707 out of every 100,000 living with HIV Last Published: In 2014 Chatham County had 76 new diagnoses (likely underrepresents true value) Ref: AIDSVu https://aidsvu.org/map/?state=GA VERTICAL (MTCT) TRANSMISSION • 2012: there were 120 (reported) cases of perinatal acquired HIV infections in the U.S. VERTICAL TRANSMISSION • Any MTCT event should be considered a sentinel event for the healthcare community • Currently, unacceptable annual rate of newly diagnosed HIV-1 infections among infants in parts of the U.S. • Marked racial disparity • Most recent MTCT rate of 12.3/100 000 among African– Americans versus 0.5/100 000 in Caucasians in Georgia • GA MTCT rate is above the national average • Enhanced Perinatal HIV Surveillance (EPS) program in Georgia stated that the rate of perinatal HIV transmission in the state between 2005 and 2010 was 2.5% compared with 2% nationally AIDS 2015, Vol 29 No 12 4 2/20/2017 DIAGNOSES OF HIV INFECTION AND POPULATION IN CHILDREN AGED <13 YEARS, BY RACE/ETHNICITY, 2014—UNITED STATES Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. bHispanics/Latinos can be of any race DIAGNOSES OF PERINATALLY ACQUIRED HIV INFECTION AMONG CHILDREN BORN DURING 2012— UNITED STATES AND 6 DEPENDENT AREAS N = 120 RATES OF FEMALES AGED 15 44 YEARS LIVING WITH HIV INFECTION, BY AREA OF RESIDENCE, 2013 UNITED STATES AND PUERTO RICO Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. DIAGNOSES OF PERINATALLY ACQUIRED HIV INFECTION AMONG CHILDREN BORN IN THE UNITED STATES AND PUERTO RICO DURING 2008-2012, BY AREA OF RESIDENCE, UNITED STATES AND PUERTO RICO N=672 Georgia was #1 in the nation Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. 5 2/20/2017 TIME OF MATERNAL HIV TESTING AMONG CHILDREN WITH DIAGNOSED PERINATALLY ACQUIRED HIV INFECTION AND CHILDREN EXPOSED TO HIV, BIRTH YEARS 2008-2012— UNITED STATES AND PUERTO RICO TIME OF ANTIRETROVIRAL (ARV) ADMINISTRATION AMONG PREGNANT WOMEN WITH HIV OR PERINATALLY EXPOSED INFANTS BIRTH YEARS 2008–2012—UNITED STATES AND PUERTO RICO Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have not been statistically adjusted. Exposure data from 47 areas. HIV SCREENING OF PREGNANT MOTHERS ACOG RECS AND GA STATE LAW 6 2/20/2017 ACOG: COMMITTEE OPINION RECOMMENDATIONS REPEAT HIV TESTING IN THE 3RD TRIMESTER • All pregnant women should be screened for HIV infection as early as possible during each pregnancy • Recommended for women in areas with high HIV incidence or prevalence and women known to be at high risk of acquiring HIV infection. • Repeat HIV testing in the 3rd trimester for: • women in areas with high HIV incidence or prevalence • women known to be at risk of acquiring HIV infection. • Women who were not tested earlier in pregnancy or whose HIV status is otherwise undocumented should be offered rapid screening on labor and delivery • If a rapid HIV test result in labor is reactive, antiretroviral prophylaxis should be immediately initiated while waiting for supplemental test results ACOG: COMMITTEE OPINION Number 635 • June 2015 • health care facilities in which prenatal screening identifies at least one pregnant woman infected with HIV per 1,000 women screened • Repeat testing in the third trimester, preferably before 36 weeks of gestation ACOG: COMMITTEE OPINION Number 635 • June 2015 REPEAT HIV TESTING IN THE 3RD TRIMESTER Pregnant women at high risk of acquiring HIV: 1. diagnosed with another STD in the past year. 2. those who are injection drug users or whose sex partners are injection drug users 3. those who exchange sex for money or drugs 4. those women with a new sex partner, more than one sex partner during this pregnancy, or sex partners known to be infected with HIV or at high risk of HIV http://www.legis.ga.gov/Legislation/en-US/display/20152016/HB/436 7 2/20/2017 GEORGIA HIV/SYPHILIS PREGNANCY SCREENING ACT OF 2015: EFFECTIVE JULY O.C.G.A. § 31-17-4.2 (2015) § 31-17-4.2. HIV and Syphilis Pregnancy Screening (a) This Code section shall be known and may be cited as the "Georgia HIV/Syphilis Pregnancy Screening Act of 2015." (b) Every physician and health care provider who assumes responsibility for the prenatal care of a pregnant woman during gestation and at delivery shall be required to test such pregnant woman for HIV and syphilis except in cases where the woman refuses the testing. Additionally, every physician and health care provider who provides prenatal care of a pregnant woman during the third trimester of gestation shall offer to test such pregnant woman for HIV and syphilis at the time of first examination during that trimester or as soon as possible thereafter, regardless of whether such testing was performed during the first two trimesters of her pregnancy. Vote Calls: Our Representatives at Work Apr/02/2015 - House Vote #428 Yea(156) Nay(10) NV(6) Exc(8) (c) If at the time of delivery there is no written evidence that an HIV test or a syphilis test has been performed, the physician or other health Apr/02/2015 Senate Vote care provider in attendance at-the delivery shall order that a #330 test for HIV, Yea(47) syphilis, or both beNay(0) administered atNV(8) the time of theExc(1) delivery except in cases where the woman refuses the testing; provided, however, that if available documentation indicates that a test for HIV and syphilis was already performed during the third trimester of her pregnancy in accordance with subsection (b) of this Code section, and the woman does Mar/13/2015 House Vote Yea(161) Nay(7) NV(5) not disclose when questioned-any activities posing a risk for#221 infection with HIV or syphilis occurring more recently than wouldExc(7) have been detected by such test, the physician or health care provider in attendance at the delivery is not required to order such additional test. (d) The woman shall be informed of the test to be conducted and her right to refuse. A pregnant woman shall submit to an HIV test and a syphilis test pursuant to this Code section unless she specifically declines. If the woman tests positive for HIV or syphilis, counseling services provided by the Department of Public Health shall be made available to her and she shall be referred to appropriate medical care providers for herself and her child. (e) If for any reason the pregnant woman is not tested for HIV and syphilis, that fact shall be recorded in the patient's records, which, if based upon the refusal of the patient, shall relieve the physician or other health care provider of any other responsibility under this Code section. (f) The Department of Public Health shall be authorized to promulgate rules and regulations for the purpose of administering the requirements under this Code section. HISTORY: Code 1981, § 31-17-4.2, enacted by Ga. L. 2007, p. 173, § 1/HB 429; Ga. L. 2009, p. 453, § 1-4/HB 228; Ga. L. 2011, p. 705, § 63/HB 214; Ga. L. 2015, p. 1346, § 1/HB 436. http://www.legis.ga.gov/Legislation/en-US/display/20152016/HB/436 GEORGIA HIV/SYPHILIS PREGNANCY SCREENING ACT OF 2015 “(c) If at the time of delivery there is no written evidence that an HIV test or a syphilis test has been performed, the physician or other health care provider in attendance at the delivery shall order that a test for HIV, syphilis, or both be administered at the time of the delivery except in cases where the woman refuses the testing; provided, however, that if available documentation indicates that a test for HIV and syphilis was already performed during the third trimester of her pregnancy in accordance with subsection (b) of this Code section, and the woman does not disclose when questioned any activities posing a risk for infection with HIV or syphilis occurring more recently than would have been detected by such test, the physician or health care provider in attendance at the delivery is not required to order such additional test.” GEORGIA HIV/SYPHILIS PREGNANCY SCREENING ACT OF 2015 “(b) Every physician and health care provider who assumes responsibility for the prenatal care of a pregnant woman during gestation and at delivery shall be required to test such pregnant woman for HIV and syphilis except in cases where the woman refuses the testing. Additionally, every physician and health care provider who provides prenatal care of a pregnant woman during the third trimester of gestation shall offer to test such pregnant woman for HIV and syphilis at the time of first examination during that trimester or as soon as possible thereafter, regardless of whether such testing was performed during the first two trimesters of her pregnancy.” Ref: http://www.lexisnexis.com/hottopics/gacode/Default.asp A SUCCESS STORY: PERINATAL HIV PROPHYLAXIS Ref: http://www.lexisnexis.com/hottopics/gacode/Default.asp 8 2/20/2017 STAGE 3 (AIDS) CLASSIFICATIONS AMONG PERSONS WITH PERINATALLY ACQUIRED HIV INFECTION,1985– 2014—UNITED STATES AND 6 DEPENDENT AREAS PERINATAL HIV EXPOSURE TREATMENT • HIV (+) women should receive ART during pregnancy with a goal of undetectable viral load. • The following should generally be avoided because of a potential increased risk of transmission, unless there are clear obstetric indications: • Artificial ROM in the setting of viremia • Routine use of fetal scalp electrodes for fetal monitoring • Operative delivery with forceps or a vacuum extractor • Episiotomy • Scheduled cesarean delivery is recommended for HIV – infected pregnant women who have HIV RNA levels >1,000 copies/mL near the time of delivery at 38+ weeks. Note. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. Ref: http://aidsinfo.nih.gov/guidelines Last updated October 26, 2016 PERINATAL HIV EXPOSURE TREATMENT PERINATAL HIV EXPOSURE TREATMENT • Intravenous zidovudine/AZT should be administered to HIV-infected women with HIV RNA >1,000 copies/mL (or unknown viral load) near delivery • All HIV-exposed infants should receive postpartum antiretroviral drugs to reduce the risk of perinatal transmission of HIV. • Not required for HIV-infected women receiving ART regimens who have HIV RNA ≤1,000 copies/mL during late pregnancy and near delivery and no concerns regarding adherence ART Ref: http://aidsinfo.nih.gov/guidelines Last updated October 26, 2016 • Goal is within 6-12 hrs of delivery • A 4-week neonatal zidovudine prophylaxis regimen can be used for full-term infants when the mother has received standard ART during pregnancy with sustained viral suppression and there are no concerns related to maternal adherence. • Otherwise, a 6-week course as part of a combination infant prophylaxis regimen is recommended. Ref: http://aidsinfo.nih.gov/guidelines Last updated October 26, 2016 9 2/20/2017 PERINATAL HIV EXPOSURE TREATMENT PERINATAL HIV PROPHYLAXIS REGIMENS • Zidovudine given for 4-6 weeks A combination infant prophylaxis regimen is recommended in infants at higher risk of HIV acquisition, including those born to HIV-infected women who: • Have not received antepartum or intrapartum ARV drugs • Have received only intrapartum ARV drugs • Have received antepartum ARV drugs but do not have viral suppression near delivery • For infants born to mothers with unknown HIV status, expedited HIV testing of mothers and/or infants is recommended as soon as possible, either during labor or after birth, with immediate initiation of infant ARV prophylaxis if the initial expedited test is positive. Oral: • GA <30 weeks: 2 mg/kg/dose every 12 hours; at 4 weeks of age, increase dose to 3 mg/kg/dose every 12 hours • GA ≥30 weeks and <35 weeks: 2 mg/kg/dose every 12 hours; at PNA 15 days, increase dose to 3 mg/kg/dose every 12 hours • GA ≥35 weeks: 4 mg/kg/dose every 12 hours If unable to tolerate enteral, use IV route: • GA <30 weeks: 1.5 mg/kg/dose every 12 hours; at 4 weeks of age, increase dose to 2.3 mg/kg/dose every 12 hours • GA ≥30 weeks and <35 weeks: 1.5 mg/kg/dose every 12 hours; at PNA 15 days, increase dose to 2.3 mg/kg/dose every 12 hours • GA ≥35 weeks: 3 mg/kg/dose every 12 hours Nevirapine at birth, 48 hours later, and 96 hours after the second dose Ref: http://aidsinfo.nih.gov/guidelines Last updated October 26, 2016 PERINATAL HIV TESTING • HIV testing under 15-18 months of age should generally be done via HIV qualitative RNA or DNA PCR. • Testing at time of birth has limited sensitivity (~50%) • Testing Recommendations: • HIV Qualitative PCR • 2 weeks of life • 6 weeks of life • 4-6 months of life • HIV Antibody Screen • Some experts recommend proof of maternal antibody clearance at 15-18 months as a final assessment Dose: Fixed dose: if Birthweight 1.5 to 2 kg: 8 mg; if Birthweight >2 kg: 12 mg TAKE HOMES 1. HIV disproportionately affects African American Women in the South. 2. Early and 3rd trimester HIV screening is mandated by GA State Law 3. ACOG recommends re-screening mothers with continued risk for HIV acquisition. 4. Chatham Co and many counties in Georgia have some of the highest incidence and prevalence of women with HIV in the US per capita. 5. Vertical HIV transmission can nearly always be prevented with identification and intervention. 6. Vertical Transmission of HIV is a sentinel event for a healthcare community. 10 2/20/2017 THANK YOU! Key References: 1. http://aidsinfo.gov 2. http://www.cdc.gov/hiv/statistics 3. http://aidsvu.org Contact Information for any questions: • [email protected] 11