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Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
Identification of Perinatal HIV Exposure
(Last updated: March 5, 2015; last reviewed: March 5, 2015)
HIV testing early in pregnancy is recommended as standard of care for all pregnant women in the United States (AII).
Repeat HIV testing in the third trimester, before 36 weeks’ gestation, should be considered for all HIV-seronegative pregnant women and is recommended for pregnant women who are at high risk of HIV infection (AIII).
Rapid or expedited HIV testing at the time of labor or delivery should be performed on women with undocumented HIV status; if results are positive, intrapartum and infant postnatal antiretroviral prophylaxis should be initiated immediately, pending results of the confirmatory HIV antibody test (AII).
Women who have not been tested for HIV before or during labor should undergo rapid or expedited HIV antibody testing during the immediate postpartum period or their newborns should undergo rapid HIV antibody testing. If results in mother or infant are positive, infant antiretroviral prophylaxis should be initiated immediately and the mothers should not breastfeed unless confirmatory HIV antibody testing is negative (AII). In infants with initial positive HIV viral tests (RNA, DNA), prophylaxis should be stopped and antiretroviral treatment initiated.
For HIV-seronegative women in whom acute HIV infection is suspected during pregnancy, intrapartum, or while breastfeeding, a virologic test (e.g., plasma HIV RNA assay, antigen/antibody combination immunoassay) should be performed because serologic testing may be negative at this early stage of infection (AII).
Results of maternal HIV testing should be documented in the newborn’s medical record and communicated to the newborn’s primary care provider (AIII).
Infant HIV antibody testing to determine HIV exposure should be considered for infants in foster care and adoptees for whom maternal HIV infection status is unknown (AIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials in children† with clinical outcomes and/or validated endpoints; I* = One or more randomized trials in adults with clinical outcomes and/or validated laboratory endpoints with accompanying data in children† from one or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; II = One or more well-designed, nonrandomized trials or observational cohort studies in children† with long-term outcomes; II* = One or more well-designed, nonrandomized trials or observational studies in adults with long-term clinical outcomes with accompanying data in children† from one or more similar nonrandomized trials or cohort studies with clinical outcome data; III = Expert opinion
† Studies that include children or children/adolescents, but not studies limited to post-pubertal adolescents
HIV infection should be identified prior to pregnancy or as early in pregnancy as possible. This provides the best opportunity to prevent infant HIV infection and to identify and start therapy as soon as possible in infants who become infected. Universal HIV counseling and voluntary HIV testing are recommended as the standard of care for all pregnant women in the United States by The Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children (the Panel), the U.S. Public Health Service, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the U.S. Preventive Services Task Force.1-6 All HIV testing should be performed in a manner consistent with state and local laws (http://nccc.ucsf.edu/clinical-resources/hiv-aids-resources/state-hiv-testing-laws/). The Centers for Disease Control and Prevention (CDC) recommends the “opt-out” approach, which involves notifying pregnant women that HIV testing will be performed as part of routine care unless they choose not to be tested for HIV. The "opt-in" approach involves obtaining specific consent before testing and has been associated with lower testing rates.7,8 The mandatory newborn HIV testing approach, adopted by several states, involves testing of newborns for perinatal HIV exposure with or without maternal consent, if prenatal or intrapartum maternal testing is not performed.
Early identification of HIV-infected women is crucial for their health and for the care of their children, whether the children are infected or not. Knowledge of antenatal maternal HIV infection enables:
HIV-infected women to receive appropriate combination antiretroviral therapy (cART) and prophylaxis against opportunistic infections for their own health, which may also decrease risk of transmission to their partners.2,9,10
Provision of cART to the mother during pregnancy and labor, and antiretroviral (ARV) prophylaxis to the newborn to reduce the risk of perinatal transmission of HIV transmission;4
Counseling of HIV-infected women about the indications for (and potential benefits of) scheduled elective cesarean delivery to reduce perinatal transmission of HIV;4,11-13
Counseling of HIV-infected women about the risks of HIV transmission through breast milk (breastfeeding is not recommended for HIV-infected women living in the United States and other countries where safe alternatives to breast milk are available);14
Initiation of prophylaxis against Pneumocystis jirovecii pneumonia beginning at age 4 to 6 weeks in all HIV-infected infants and in those HIV-exposed infants whose HIV infection status remains indeterminate;15 and
Early diagnostic evaluation of HIV-exposed infants, as well as testing of partners and other children, to permit prompt initiation of cART in infected individuals.1,16
Repeat HIV Testing in the Third Trimester
Repeat HIV testing should be considered for all HIV-seronegative pregnant women. A second HIV test during the third trimester, before 36 weeks’ gestation, is recommended4,17 for women who:
Are receiving health care in a jurisdiction that has a high incidence of HIV or AIDS in women between ages 15 and 45, or are receiving health care in facilities in which prenatal screening identifies at least 1 HIV-infected pregnant woman per 1,000 women screened (a list of areas where such screening is recommended is found in the 2006 CDC recommendations);
Are known to be at high risk of acquiring HIV (e.g., those who are injection drug users or partners of injection drug users, exchange sex for money or drugs, are sex partners of HIV-infected individuals, have had a new or more than one sex partner during current pregnancy, or have been diagnosed with a new sexually transmitted disease during pregnancy); or
Have signs or symptoms of acute HIV infection.2,3,18,19
Women who decline testing earlier in pregnancy should be offered testing again during the third trimester. If acute HIV infection is a possibility, virologic testing with a plasma HIV RNA assay or, if unavailable, an antigen/antibody combination immunoassay, should be performed because serologic testing may be negative at this early stage of infection.20
Rapid HIV Testing During Labor in Women with Unknown HIV Status
Use of rapid test kits or an expedited immunoassay to detect HIV infection is recommended to screen women in labor whose HIV status is undocumented and to identify HIV exposure in their infants.1-3,5,16 Any hospital offering intrapartum care should have rapid or expedited HIV testing available and should have policies and procedures in place to ensure that staff are prepared to provide patient education about rapid or expedited HIV testing, that results are available ideally within 1 hour, that appropriate ARV medications are available whenever needed, and that follow-up procedures are in place for women found to be HIV-infected and their infants. Rapid tests have been found to be feasible, accurate, timely, and useful both in ensuring prompt initiation of intrapartum and neonatal ARV prophylaxis and in reducing perinatal transmission of HIV.21 Results of rapid tests can be obtained within minutes to a few hours with accuracy comparable to standard enzyme-linked immunosorbent assays (EIA).5,22,23 A single negative rapid test does not need confirmation unless acute HIV infection is a possibility, in which case, a virologic test is necessary.20 A positive rapid HIV test result must be followed by a supplemental test to confirm the presence of HIV infection.23 However, immediate initiation of ARV prophylaxis for prevention of perinatal transmission of HIV is strongly recommended pending confirmation of an initial positive rapid HIV test.1,4,6,16
HIV Counseling and Testing During the Postnatal Period
Women who have not been tested for HIV before or during labor should be offered rapid or expedited testing during the immediate postpartum period or their newborns should undergo rapid or expedited HIV testing with maternal consent (unless state law allows testing without consent).1,3,4,16 Use of rapid or expedited HIV assays or expedited EIA for prompt identification of HIV-exposed infants is essential because neonatal ARV prophylaxis should be initiated as soon as possible after birth—ideally no more than 6 to 12 hours after birth—to be effective for the prevention of perinatal transmission. When an initial HIV test is positive in mother or infant, initiation of infant ARV prophylaxis and counseling against initiation of breastfeeding is strongly recommended pending results of confirmatory HIV tests.4 If confirmatory tests are negative and acute HIV infection is excluded, infant ARV prophylaxis can be discontinued. In the absence of ongoing maternal HIV exposure, breastfeeding can be initiated. Mechanisms should be developed to facilitate HIV screening for infants who have been abandoned and are in the custody of the state.
Infant HIV Testing when Maternal HIV Test Results Are Unavailable
When maternal HIV test results are unavailable (e.g., for infants who are in foster care) or their accuracy cannot be evaluated (e.g., for infants adopted from a country where results are not reported in English), HIV antibody testing is indicated to identify HIV exposure in those infants.1 If antibody testing is positive, further testing is needed to diagnose HIV infection, or in the case of infants older than 18 months, to confirm HIV infection (see Diagnosis of HIV Infection in Infants).
Acute Maternal HIV Infection During Pregnancy or Breastfeeding
The risk of perinatal transmission of HIV is increased in infants born to women who have acute HIV infection during pregnancy or lactation.17,24-27 When acute retroviral syndrome is a possibility in pregnancy or during breastfeeding, maternal testing should include a combination antigen/antibody immunoassay or plasma HIV RNA test, because HIV antibody testing may be negative in early maternal infection. Women with possible acute HIV infection who are breastfeeding should stop breastfeeding immediately until HIV infection is confirmed or excluded.14 Pumping and temporarily discarding breast milk can be recommended and (if HIV infection is excluded), in the absence of ongoing maternal exposure to HIV, breastfeeding can resume. Care of pregnant or breastfeeding women identified with acute or early HIV infection, and their infants, should follow the recommendations in the Perinatal Guidelines.4
Surveillance Reporting of HIV-Exposed Infants to Local and State Health Departments
Clinicians should be aware of public health surveillance systems and exposed-infant reporting regulations that may exist in their jurisdictions; this is in addition to mandatory reporting of HIV-infected persons, including infants. Reporting cases allows for appropriate public health functions to be accomplished.
American Academy of Pediatrics Committee on Pediatric AIDS. HIV testing and prophylaxis to prevent mother-to-child transmission in the United States. Pediatrics. 2008;122(5):1127-1134. Available at http://www.ncbi.nlm.nih.gov/pubmed/18977995.
Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17; quiz CE11-14. Available at http://www.ncbi.nlm.nih.gov/pubmed/16988643.
American College of Obstetrics: Gynecology Committee on Obstetric Practice. ACOG Committee Opinion No. 418: Prenatal and perinatal human immunodeficiency virus testing: expanded recommendations. Obstet Gynecol. 2008;112(3):739-742. Available at http://www.ncbi.nlm.nih.gov/pubmed/18757690.
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf. Accessed on November 25, 2014.
Chou R, Cantor AG, Zakher B, Bougatsos C. Screening for HIV in pregnant women: systematic review to update the 2005 U.S. Preventive Services Task Force recommendation. Ann Intern Med. 2012;157(10):719-728. Available at http://www.ncbi.nlm.nih.gov/pubmed/23165663.
U.S. Preventive Services Task Force. Screening for HIV: recommendation statement. U.S. Preventive Services Taskforce. April 2013. Available at http://www.uspreventiveservicestaskforce.org/uspstf/uspshivi.htm. Accessed December 1, 2014.
Boer K, Smit C, van der Flier M, de Wolf F, with the ATHENA cohort study group. The comparison of the performance of two screening strategies identifying newly-diagnosed HIV during pregnancy. Eur J Public Health. 2011;21(5):632-637. Available at http://www.ncbi.nlm.nih.gov/pubmed/21051473.
Yudin MH, Moravac C, Shah RR. Influence of an "opt-out" test strategy and patient factors on human immunodeficiency virus screening in pregnancy. Obstet Gynecol. 2007;110(1):81-86. Available at http://www.ncbi.nlm.nih.gov/pubmed/17601900.
Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493-505. Available at http://www.ncbi.nlm.nih.gov/pubmed/21767103.
Baggaley RF, White RG, Hollingsworth TD, Boily MC. Heterosexual HIV-1 infectiousness and antiretroviral use: systematic review of prospective studies of discordant couples. Epidemiology. 2013;24(1):110-121. Available at http://www.ncbi.nlm.nih.gov/pubmed/23222513.
Jamieson DJ, Read JS, Kourtis AP, Durant TM, Lampe MA, Dominguez KL. Cesarean delivery for HIV-infected women: recommendations and controversies. Am J Obstet Gynecol. 2007;197(3 Suppl):S96-100. Available at http://www.ncbi.nlm.nih.gov/pubmed/17825656.
Tubiana R, Le Chenadec J, Rouzioux C, et al. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load <500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010;50(4):585-596. Available at http://www.ncbi.nlm.nih.gov/pubmed/20070234.
Townsend CL, Cortina-Borja M, Peckham CS, de Ruiter A, Lyall H, Tookey PA. Low rates of mother-to-child transmission of HIV following effective pregnancy interventions in the United Kingdom and Ireland, 2000-2006. AIDS. 2008;22(8):973-981. Available at http://www.ncbi.nlm.nih.gov/pubmed/18453857.
Committee On Pediatric AIDS. Infant feeding and transmission of human immunodeficiency virus in the United States. Pediatrics. 2013;131(2):391-396. Available at http://www.ncbi.nlm.nih.gov/pubmed/23359577.
Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf. Accessed on December 1, 2014.
Havens PL, Mofenson LM, American Academy of Pediatrics Committee on Pediatric A. Evaluation and management of the infant exposed to HIV-1 in the United States. Pediatrics. 2009;123(1):175-187. Available at http://www.ncbi.nlm.nih.gov/pubmed/19117880.
Birkhead GS, Pulver WP, Warren BL, Hackel S, Rodriguez D, Smith L. Acquiring human immunodeficiency virus during pregnancy and mother-to-child transmission in New York: 2002-2006. Obstet Gynecol. 2010;115(6):1247-1255. Available at http://www.ncbi.nlm.nih.gov/pubmed/20502297.
Sansom SL, Jamieson DJ, Farnham PG, Bulterys M, Fowler MG. Human immunodeficiency virus retesting during pregnancy: costs and effectiveness in preventing perinatal transmission. Obstet Gynecol. 2003;102(4):782-790. Available at http://www.ncbi.nlm.nih.gov/pubmed/14551009.
Richey LE, Halperin J. Acute human immunodeficiency virus infection. The American Journal of the Medical Sciences. 2013;345(2):136-142. Available at http://www.ncbi.nlm.nih.gov/pubmed/23095473.
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed on November 25, 2014.
Bulterys M, Jamieson DJ, O'Sullivan MJ, et al. Rapid HIV-1 testing during labor: a multicenter study. JAMA. 2004;292(2):219-223. Available at http://www.ncbi.nlm.nih.gov/pubmed/15249571.
Centers for Disease Control and Prevention. Rapid HIV-1 antibody testing during labor and delivery for women of unknown HIV status: A practical guide and model protocol 2004. Available at http://www.cdc.gov/hiv/topics/testing/resources/guidelines/rt-labor&delivery.htm. Accessed December 1, 2014.
Centers for Disease Control and Prevention. Protocols for confirmation of reactive rapid hiv tests. MMWR. 2004;53(10):221-222. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5310a7.htm.
Lockman S, Creek T. Acute maternal HIV infection during pregnancy and breast-feeding: substantial risk to infants. J Infect Dis. 2009;200(5):667-669. Available at http://www.ncbi.nlm.nih.gov/pubmed/19627246.
Taha TE, James MM, Hoover DR, et al. Association of recent HIV infection and in-utero HIV-1 transmission. AIDS. 2011;25(11):1357-1364. Available at http://www.ncbi.nlm.nih.gov/pubmed/21572305.
Humphrey JH, Marinda E, Mutasa K, et al. Mother to child transmission of HIV among Zimbabwean women who seroconverted postnatally: prospective cohort study. BMJ. 2010;341:c6580. Available at http://www.ncbi.nlm.nih.gov/pubmed/21177735.
Drake AL, Wagner A, Richardson B, John-Stewart G. Incident HIV during pregnancy and postpartum and risk of mother-to-child HIV transmission: a systematic review and meta-analysis. PLoS Med. 2014;11(2):e1001608. Available at http://www.ncbi.nlm.nih.gov/pubmed/24586123.