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• W2022782014 abstract "In the United States, current human immunodeficiency virus (HIV) testing guidelines recommend an opt-out approach for pregnant women, whereby HIV testing is incorporated routinely into the standard panel of prenatal tests with the option to decline. Current recommendations for the initiation of treatment of HIV infection in pregnant women are the same as those for nonpregnant women. However, the special circumstances of pregnancy raise additional issues that are related to potential drug toxicity to the mother and fetus, which affect the choice of antiretroviral drugs to be used. For HIV-infected pregnant women who do not require therapy for their own health, antiretroviral drugs are recommended for prevention of mother-to-child transmission. Highly active antiretroviral therapy is recommended for all women with HIV RNA levels of ≥1000 copies/mL, along with consideration of elective cesarean delivery. For women with HIV RNA levels of <1000 copies/mL, a 3-part zidovudine prophylaxis regimen (prenatal, intrapartum, and neonatal) should be used alone or in combination with other antiretroviral drugs. In the United States, current human immunodeficiency virus (HIV) testing guidelines recommend an opt-out approach for pregnant women, whereby HIV testing is incorporated routinely into the standard panel of prenatal tests with the option to decline. Current recommendations for the initiation of treatment of HIV infection in pregnant women are the same as those for nonpregnant women. However, the special circumstances of pregnancy raise additional issues that are related to potential drug toxicity to the mother and fetus, which affect the choice of antiretroviral drugs to be used. For HIV-infected pregnant women who do not require therapy for their own health, antiretroviral drugs are recommended for prevention of mother-to-child transmission. Highly active antiretroviral therapy is recommended for all women with HIV RNA levels of ≥1000 copies/mL, along with consideration of elective cesarean delivery. For women with HIV RNA levels of <1000 copies/mL, a 3-part zidovudine prophylaxis regimen (prenatal, intrapartum, and neonatal) should be used alone or in combination with other antiretroviral drugs. Recommendations regarding human immunodeficiency virus (HIV) screening, prophylaxis, and treatment of pregnant women have evolved considerably in the United States over the last 25 years, reflecting changes in the epidemic and the science of prevention. Not long after acquired immunodeficiency syndrome (AIDS) was first described in 1981, the possibility of mother-to-child transmission of the new syndrome was proposed.1Centers for Disease Control and PreventionUnexplained immunodeficiency and opportunistic infections in infants: New York, New Jersey, California.MMWR Morb Mortal Wkly Rep. 1982; 31: 665-667PubMed Google Scholar Scientific consensus that gathered to support this theory included reports of infants with AIDS who had not had significant contact with their mothers after delivery, which suggested that infection had occurred before or during birth.2Cowan M.J. Hellmann D. Chudwin D. Wara D.W. Chang R.S. Ammann A.J. Maternal transmission of acquired immune deficiency syndrome.Pediatrics. 1984; 73: 382-386PubMed Google Scholar Even though significant gaps still exist in our knowledge of the exact timing and mechanisms of mother-to-child transmission of HIV, substantial evidence has accumulated to document the risk of mother-to-child transmission, and concerted research efforts have brought about a dramatic decrease in such transmission, at least in the industrialized world, with interventions such as combination antiretroviral prophylaxis, cesarean delivery, and avoidance of breastfeeding.3Centers for Disease Control and PreventionAchievements in public health: reduction in perinatal transmission of HIV infection: United States, 1985-2005.MMWR Morb Mortal Wkly Rep. 2006; 55: 592-597PubMed Google Scholar In addition, the treatment of HIV disease during pregnancy has changed considerably, with an increasing proportion of women receiving highly active antiretroviral therapy throughout pregnancy.3Centers for Disease Control and PreventionAchievements in public health: reduction in perinatal transmission of HIV infection: United States, 1985-2005.MMWR Morb Mortal Wkly Rep. 2006; 55: 592-597PubMed Google Scholar This article describes the evolution of US recommendations for HIV screening, prophylaxis, and treatment of HIV-infected women that have contributed to this remarkable public health success in the arena of mother-to-child HIV transmission.The Evolution of the Centers for Disease Control and Prevention (CDC) HIV Screening Guidelines for Pregnant WomenThe CDC released its first set of recommendations for HIV testing of pregnant women in 1985.4Centers for Disease Control and PreventionRecommendations for assisting in the prevention of perinatal transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus and acquired immunodeficiency syndrome.MMWR Morb Mortal Wkly Rep. 1985; 34: 721-722PubMed Google Scholar These recommendations acknowledged that the only available strategy for reducing the risk of perinatal transmission was pregnancy prevention and that the benefits of knowing one’s HIV status were few, given the lack of treatment options. The 1985 recommendations identified certain groups of women who were at high risk for HIV infection who should be counseled regarding HIV and offered testing. These groups included women with signs and symptoms of infection, intravenous drug users, women who were born in countries with a higher burden of heterosexual transmission of HIV, sex workers, and sex partners of men at increased risk. Nonpregnant women with positive test results could be encouraged to delay pregnancy. However, women who were already pregnant could be offered only additional medical and support services to manage opportunistic infections and psychologic concerns and be advised not to breastfeed their infant because of the potential for transmission of HIV through breastfeeding. These guidelines did not endorse routine testing of all women or counseling and testing among women who were considered not at high risk. This recommendation was motivated by concern about the interpretation of test results in low prevalence populations (ie, the repercussions of false positive results in an environment in which considerable stigma and fear surrounded a diagnosis of HIV infection).Only a few years passed, however, before it became apparent that risk-based screening was failing to identify substantial numbers of infected women.5Barbacci M.B. Dalabetta G.A. Repke J.T. et al.Human immunodeficiency virus infection in women attending an inner-city prenatal clinic: ineffectiveness of targeted screening.Sex Transm Dis. 1990; 17: 122-126Crossref PubMed Scopus (46) Google Scholar, 6Minkoff H.L. Landesman S.H. The case for routinely offering prenatal testing for human immunodeficiency virus.Am J Obstet Gynecol. 1988; 159: 793-796PubMed Scopus (32) Google Scholar Many physicians and public health officials believed that being able to notify a woman of her HIV status was important enough to justify expanded screening beyond defined risk groups, despite the few options for treatment of a woman’s own disease or prevention of perinatal transmission.In 1994, 1 of the most significant breakthroughs in the history of the HIV/AIDS epidemic was announced. On February 21, 1994, the Pediatric AIDS Clinical Trials Group (PACTG) announced results of a randomized, double-blinded clinical trial, PACTG 076, that had demonstrated that a 3-part regimen of zidovudine (starting in the second trimester of gestation and continuing in labor and to the infant for 6 weeks after birth) was effective in lowering the risk of perinatal HIV transmission by approximately two-thirds. In addition to being effective, zidovudine was found to be safe in this setting, with no serious or short-term side effects of zidovudine therapy detected for women or their infants when compared with placebo.7Centers for Disease Control and PreventionRecommendations of the US Public Health Service Task Force on the use of zidovudine to reduce perinatal transmission of human immunodeficiency virus.MMWR Recomm Rep. 1994; 43: 1-20Google Scholar, 8Connor E.M. Sperling R.S. Gelber R. et al.Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment: Pediatric AIDS Clinical Trials Group Protocol 076 Study Group.N Engl J Med. 1994; 331: 1173-1180Crossref PubMed Scopus (3308) Google Scholar The announcement of an intervention that offered significant protection against HIV infection for infants was a turning point for perinatal HIV prevention strategies. Although stigma and discrimination against persons with HIV and AIDS were still present, there were now real benefits to learning one’s HIV status. Treatments for the protection of an individual’s health had been available for several years, and now prophylaxis could be provided to pregnant women to lower the risk that they would pass the virus to their children.In response to this development, the CDC developed new recommendations for HIV testing among pregnant women in 1995. For the first time, the US Public Health Service recommended routine HIV counseling and voluntary testing for all pregnant women.9Centers for Disease Control and PreventionUS Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women.MMWR Recomm Rep. 1995; 44: 1-15Google Scholar Increasing scientific data on the safety and effectiveness of zidovudine for prevention of mother-to-child HIV transmission and some advances in advocacy and protections for persons who were infected with HIV had shifted the balance of benefits and risks. However, these guidelines maintained a strong emphasis on the provision of counseling before and after testing, specific informed consent, and the voluntary nature of testing. The recommendations stated that pretest counseling should include information on HIV risk behaviors, the risk of mother-to-child transmission if the woman were infected, and the availability of therapy to reduce this risk. Provisions were also included to ensure that women who declined testing, or declined treatment if positive, were not denied care or subjected to discrimination. After the receipt of positive HIV test results, the guidelines stated that women should receive posttest counseling that included an explanation of the clinical implications of a positive test result, information about HIV-related medical and other intervention services, the risk for mother-to-child HIV transmission and ways to reduce this risk, the prognosis for infants who become infected, reproductive options, recommendations to abstain from breastfeeding, and an assessment of the potential for negative psychologic and social effects that result from HIV infection.9Centers for Disease Control and PreventionUS Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women.MMWR Recomm Rep. 1995; 44: 1-15Google ScholarIn 1996, Congress passed the Ryan White CARE Act, which provided funding for testing and treatment and additional strategies to combat the HIV/AIDS epidemic. A provision of this legislation called on the Institute of Medicine to conduct an evaluation of state efforts to reduce mother-to-child HIV transmission and an analysis of the existing barriers to further reductions in transmission in the United States.10Institute of MedicineReducing the odds: preventing perinatal transmission of HIV in the United States. National Academy Press, Washington, DC1999Google Scholar The committee found that, despite considerable efforts to implement the US Public Health Service recommendations, the number of children who were born with HIV remained too high, often because of lack of timely diagnosis of maternal HIV infection. Their central recommendation was to implement universal HIV testing with patient notification as a routine component of prenatal care, a strategy referred to as “opt-out” testing. They stressed that extensive pretest counseling had proved to be a barrier to providing testing for many providers. Incorporating HIV testing into the standard panel of prenatal tests could increase the number of women who were offered testing, while still ensuring notification to the patient that testing would be done and preserving her option to decline. Associated recommendations that were designed to increase the proportion of pregnant women who were tested for HIV included educating prenatal providers on the value of HIV testing, adoption of professional recommendations and performance measures to encourage testing, improvement of care for HIV-infected persons, maintenance of federal funding for perinatal prevention of HIV, and collection of appropriate surveillance data.As a result of the Institute of Medicine report, several professional groups, including the American College of Obstetricians and Gynecologists and American Academy of Pediatrics, issued new guidelines that supported the recommendations of the Institute of Medicine and endorsed universal HIV testing with patient notification as a routine component of prenatal care.11Human immunodeficiency virus screening: joint statement of the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.Pediatrics. 1999; 104: 128Crossref PubMed Scopus (8) Google Scholar The CDC convened consultations to discuss these recommendations and published revised recommendations for HIV screening of pregnant women in 2001 that replaced the 1995 recommendations. The revised recommendations emphasized that HIV testing should be a routine part of prenatal care and recommended simplification of the testing process to reduce barriers to testing but maintained a strong commitment to the voluntary approach to HIV testing.12Centers for Disease Control and PreventionRevised recommendations for HIV screening of pregnant women.MMWR Recomm Rep. 2001; 50: 63-85PubMed Google Scholar These guidelines also recommended the provision of pretest counseling, with a preference for face-to-face counseling, but allowed for the possibility of written or electronic formats.In 2002, a CDC assessment of prenatal HIV screening rates was published that found that testing rates were generally lower in jurisdictions with laws that mandated pretest counseling and specific written consent before an HIV test (the “opt-in” approach) and were generally higher in areas with opt-out testing.13Centers for Disease Control and PreventionHIV testing among pregnant women: United States and Canada, 1998-2001.MMWR Morb Mortal Wkly Rep. 2002; 51: 1013-1016PubMed Google Scholar After the publication of this study, the CDC issued a “Dear Colleague” letter that endorsed the practice of routinely incorporating HIV testing in the standard panel of tests for all pregnant women with the option to decline.14Gerberding J.L. Jaffe H.W. ”Dear Colleague” letter.2003Google Scholar In 2006, the most recent CDC recommendations for HIV testing were published. Recommendations regarding HIV screening for pregnant women were incorporated into general recommendations for all adults and adolescents, and opt-out HIV screening was recommended for all adults aged 13-64 years who seek care in healthcare settings, including pregnant women. The 2006 guidelines codified and strengthened the recommendation for opt-out screening in pregnant women.15Centers for Disease Control and PreventionRevised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings.MMWR Recomm Rep. 2006; 55: 1-17Google ScholarThe 2006 recommendations also strengthened the CDC’s recommendation for rescreening during pregnancy. A second HIV test during pregnancy was first mentioned in the 1995 guidelines, which recommended that women who test negative early in pregnancy and continue to practice high-risk behavior should be retested during the third trimester.9Centers for Disease Control and PreventionUS Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women.MMWR Recomm Rep. 1995; 44: 1-15Google Scholar The recommendations for a second test during pregnancy were repeated in the 2001 guidelines, which again recommended retesting in the third trimester (before 36 weeks of gestation) for women who had tested negative but remained at high risk for acquiring HIV. This recommendation was also strengthened by adding a caveat that routine universal retesting could be considered in healthcare facilities with high HIV prevalence among women of childbearing age.12Centers for Disease Control and PreventionRevised recommendations for HIV screening of pregnant women.MMWR Recomm Rep. 2001; 50: 63-85PubMed Google Scholar After the publication of these recommendations, new analyses demonstrated that a second HIV test during the third trimester is as cost-effective as other commonly accepted health interventions, even in populations with relatively low HIV prevalence.16Sansom S.L. Jamieson D.J. Farnham P.G. Bulterys M. Fowler M.G. Human immunodeficiency virus retesting during pregnancy: costs and effectiveness in preventing perinatal transmission.Obstet Gynecol. 2003; 102: 782-790Crossref PubMed Scopus (52) Google Scholar In addition, emerging research from New York has suggested an increasing proportion of infants with perinatal HIV infection are born to women who acquire HIV infection during pregnancy.17Warren B. Glaros R.H.S. Residual perinatal HIV transmissions in 25 births occurring in New York state.in: Presentation at the 2005 National HIV Prevention Conference, Atlanta, GA2005Google Scholar These findings support expanded recommendations for a second HIV test in the third trimester. Although the latest recommendations continue to note that a second screen may be considered in all areas, a second test is recommended specifically for all women in 22 states with elevated HIV incidence, for women who are served in facilities in which prenatal screening reveals a prevalence of at least 1 per 1000, and for women who are at high risk of acquiring HIV infection.18Branson B.M. Handsfield H.H. Lampe M.A. et al.Centers for Disease Control and PreventionRevised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings.MMWR Morb Mortal Wkly Rep. 2006; 55: 1-17PubMed Google ScholarBefore the release of the 2001 recommendations, new research demonstrated reductions in the risk of mother-to-child HIV transmission, even if antiretroviral prophylaxis was not given during pregnancy and could only be given during labor and/or to the newborn infant.19Guay L.A. Musoke P. Fleming T. et al.Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial.Lancet. 1999; 354: 795-802Abstract Full Text Full Text PDF PubMed Scopus (1466) Google Scholar Therefore, the 2001 guidelines also recommended that women with unknown status at labor and delivery should be tested promptly to allow for intrapartum and neonatal antiretroviral prophylaxis, if positive.12Centers for Disease Control and PreventionRevised recommendations for HIV screening of pregnant women.MMWR Recomm Rep. 2001; 50: 63-85PubMed Google Scholar Testing could be accomplished either by expedited standard testing (with return of results within 12 hours) or preferably with rapid testing, which could be done at the bedside, to allow the prompt initiation of antiretroviral prophylaxis in women with a positive HIV test while still in labor. However, at the time the guidelines were published, only 1 rapid test was available commercially in the United States.Since 2001, several additional rapid tests have been approved by the Food and Drug Administration (FDA) for use in the United States, and additional research has described the acceptability and accuracy of rapid testing during labor and delivery. The Mother-Infant Rapid Intervention at Delivery study found that rapid testing is feasible and accurate and delivers timely results for women in labor.20Bulterys M. Jamieson D.J. O’Sullivan M.J. et al.Rapid HIV-1 testing during labor: a multicenter study.JAMA. 2004; 292: 219-223Crossref PubMed Scopus (177) Google Scholar The 2006 recommendations specifically recommend the use of a rapid HIV test for screening women who arrive in labor with unknown or undocumented HIV status and reiterate recommendations to initiate antiretroviral prophylaxis to prevent mother-to-child HIV transmission based on the rapid test result, without waiting for confirmatory results.18Branson B.M. Handsfield H.H. Lampe M.A. et al.Centers for Disease Control and PreventionRevised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings.MMWR Morb Mortal Wkly Rep. 2006; 55: 1-17PubMed Google Scholar These recommendations are also reflected in the most recent guidance from the American College of Obstetricians and Gynecologists.21American College of Obstetricians and GynecologistsPrenatal and perinatal human immunodeficiency virus testing: expanded recommendations: ACOG committee opinion number 304.Obstet Gynecol. 2004; 104: 1119-1124Crossref PubMed Scopus (26) Google ScholarUS Public Health Service Guidelines for Prophylaxis and Treatment of HIV-Infected Pregnant WomenWithin 2 months of the release of the results from the PACTG 076 trial, interim guidance was issued by the US Public Health Service that supported the use of zidovudine as described in the PACTG 076 protocol.22Centers for Disease Control and PreventionZidovudine for the prevention of HIV transmission from mother to infant.MMWR Morb Mortal Wkly Rep. 1994; 43: 285-287PubMed Google Scholar On June 6-7, 1994, the US Public Health Service convened a workshop of invited guests that included representatives from the medical, scientific, public health, and legal communities to develop recommendations for the use of zidovudine to reduce perinatal HIV transmission and to provide guidance for clinicians and public health professionals in interpreting the results of the PACTG 076 trial. Based on feedback from this workshop, the US Public Health Service Task Force, which was composed of obstetric and pediatric HIV experts and federal agency representatives, issued more extensive guidance for the use of zidovudine to reduce perinatal HIV transmission.7Centers for Disease Control and PreventionRecommendations of the US Public Health Service Task Force on the use of zidovudine to reduce perinatal transmission of human immunodeficiency virus.MMWR Recomm Rep. 1994; 43: 1-20Google Scholar These guidelines, which are now more than a decade old, were notable for several features that are still reflected in the current 2006 guidelines23Public Health Service Task Force. Recommendations for use of antiretroviral drugs in pregnant HIV-1 infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States: 7-6-2006 update. Last accessed: August 22, 2006. Available at: http://AIDSinfo.nih.gov.Google Scholar such as (1) the inclusion of clinical situations, later termed clinical scenarios, that present hypothetic clinical scenarios with discussion and recommendations to help clinicians with decision-making and (2) the clear distinction between prophylaxis to prevent perinatal transmission as opposed to treatment for the benefit of the woman’s own health. The guidelines emphasize that pregnancy should not be a reason to defer antiretroviral therapy when it is needed. Although there is a need for antiretroviral prophylaxis for the prevention of transmission to the infant and although issues that are related to potential drug toxicity to mother and fetus affect the choice of antiretroviral drugs that are used for treatment, these concerns should be dealt with in the context of assuring optimal treatment to preserve the mother’s health.In January 1998, updated guidelines were issued that included more general recommendations for the use of antiretroviral drugs in pregnancy, expanding the previous guidelines’ focus on zidovudine. By this time, there were 11 FDA-approved antiretroviral drugs, and these powerful new drugs were being used in highly active drug combinations. The title of the document now included “maternal health”, which reflected further emphasis on considerations beyond mother-to-child HIV transmission to address issues for the pregnant woman’s own health.24Centers for Disease Control and PreventionPublic Health Service Task Force recommendations for the use of antiretroviral drugs in pregnant women infected with HIV-1 for maternal health and for reducing perinatal HIV-1 transmission in the United States.MMWR Recomm Rep. 1998; 47: 1-30Google Scholar After publication of these guidelines, the Public Health Service Task Force began meeting by monthly conference calls to review new evidence and regularly update the recommendations. The guidelines, which are now updated several times a year, are posted on a website23Public Health Service Task Force. Recommendations for use of antiretroviral drugs in pregnant HIV-1 infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States: 7-6-2006 update. Last accessed: August 22, 2006. Available at: http://AIDSinfo.nih.gov.Google Scholar so that revised guidelines can be disseminated more rapidly. Each time the guidelines are posted, the changes that are new since the last revision are highlighted so that the reader can quickly review the most recent changes. The guidelines also contain hyperlinks that link the reader to other parts of the guidelines and supplemental information.The current Public Health Service guidelines have evolved considerably over time. They now contain information on >20 antiretroviral drugs, the FDA pregnancy category and information on placental passage, dosing and pharmacokinetics during pregnancy, and animal carcinogenicity and teratogenicity studies. Most of the approved antiretroviral drugs are FDA pregnancy category B or C. However, efavirenz is category D, which indicates that there is evidence of human fetal risk. Severe central nervous system defects, which were consistent with abnormalities that have been seen in animal studies, have been reported in 4 infants after first trimester exposure of efavirenz-containing regimens. Therefore, efavirenz should be avoided during the first trimester. Because efavirenz is a relatively popular choice for combination regimens and because more than one-half of pregnancies in the United States are unintended, it is critical that women who take efavirenz be counseled regarding the risks. Women who are planning to become pregnant should strongly consider the use of regimens that do not contain efavirenz or other drugs with teratogenic potential.Current recommendations for treatment of HIV infection in pregnant women are the same as those for the initiation of treatment in nonpregnant individuals; in the United States, treatment is recommended for all individuals with a CD4 cell count of <200/mm3 or an AIDS-defining illness and should be considered for individuals with a CD4 cell count of <350/mm3.25Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Last accessed: October 23, 2006. Available at: http://AIDSinfo.nih.gov.Google Scholar Standard treatment for nonpregnant and pregnant women is highly active antiretroviral therapy with ≥3 drugs.23Public Health Service Task Force. Recommendations for use of antiretroviral drugs in pregnant HIV-1 infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States: 7-6-2006 update. Last accessed: August 22, 2006. Available at: http://AIDSinfo.nih.gov.Google Scholar For HIV-infected pregnant women who do not require therapy for their own health, antiretroviral drugs are recommended for the prevention of mother-to-child transmission. In the United States, combination therapy with highly active antiretroviral therapy is also recommended for all pregnant women with HIV RNA levels of >1000 copies/mL. For women with HIV RNA levels of <1000 copies/mL, the 3-part PACTG 076 zidovudine prophylaxis regimen can be used alone or in combination with other antiretroviral drugs. Table 1 provides a summary of recommendations for the treatment and prevention of mother-to-child HIV transmission for pregnant HIV-infected women in different clinical scenarios.TABLERecommendations for antiretroviral drug use and prevention of mother to child HIV transmission in pregnant HIV-infected women in the United StatesVariableRecommendationsClinical scenarioHIV-1–infected woman of childbearing potential but not pregnant who has indications for the initiation of antiretroviral therapyHAART as per US treatment guidelinesAvoid drugs with teratogenic potential (eg, efavirenz) in women of child-bearing age, unless adequate contraception ensured; exclude pregnancy before starting treatment with efavirenzHIV-1–infected woman who receives HAART and becomes pregnant WomanContinue current HAART regimen; discontinue drugs with teratogenic potential (eg, efavirenz) or with known adverse potential for the pregnant mother (eg, combination stavudine [d4T] + didanosine [ddI])In general, if woman requires treatment, antiretroviral drugs should not be stopped during the first trimesterIf it is decided to discontinue antiretroviral drugs during the first trimester, stop all drugs (if regimen includes drug with long half-life such as NNRT" @default.
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