Should Providers Discuss Breastfeeding With Women Living With HIV in High-Income Countries? An Ethical Analysis

Transcription

1 Clinical Infectious Diseases VIEWPOINTS HIV/AIDS Should Providers Discuss Breastfeeding With Women Living With HIV in High-Income Countries? An Ethical Analysis Grace Johnson, 1 Judy Levison, 1 and Janet Malek 2 1 Department of Obstetrics and Gynecology, and 2 Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas As men and women with human immunodeficiency virus (HIV) are living longer, healthier lives and having children, many questions regarding reproduction in the context of HIV arise. One question is whether breastfeeding is an option for mothers living with HIV. The established recommendation is that women living with HIV in high-income countries avoid breastfeeding. However, some women may still choose to breastfeed for a variety of personal, social, or cultural reasons. Nonmaleficence ( do no harm ) must be weighed against maternal autonomy. We propose that providers caring for women in this situation are ethically justified in discussing breastfeeding as a reasonable, though inferior, option. Providers should pursue a shared decision-making approach, engaging in open conversations to learn about the mother s preferences and values, providing education about risks and benefits of various feeding options, and together with the mother formulating a plan to ensure the best possible outcome for the mother and baby. Keywords. HIV; breastfeeding; high-income countries; shared decision-making. The number of people living with human immunodeficiency virus (HIV) is increasing in the United States and other highincome countries [1], and more men and women affected by HIV are expressing a desire to have children [2, 3]. The increased effectiveness and simplicity of antiretroviral regimens provide those living with HIV the opportunity to live long, healthy lives and to have children who are free of HIV. As these men and women embark on their reproductive journeys, they face many questions regarding having and raising children in the context of HIV. One issue that has recently attracted international conversation is whether breastfeeding is an option for mothers living with HIV in high-income countries. As Yudin et al point out, it may be time to consider the clinical significance of this complicated dilemma [4]. The current guidelines from the Committee on Pediatric AIDS/American Academy of Pediatrics (AAP) state that In the United States, where clean water and affordable replacement feeding are available... [we] recommend that HIV-infected mothers not breastfeed their infants, regardless of maternal viral load and antiretroviral therapy [5]. They may choose from other replacement feeding options including formula feeding, use of a wet nurse, banked human milk, and heat treatment of breast milk. Received 16 April 2016; accepted 10 August 2016; published online 29 August Correspondence: G. Johnson, 6651 Main St, Ste 1020, Houston, TX (grace.jamail@ bcm.edu). Clinical Infectious Diseases 2016;63(10): The Author Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, journals.permissions@oup.com. DOI: /cid/ciw587 However, there are women who still desire to breastfeed despite this recommendation. One woman might desire to breastfeed to promote bonding with her infant or may prefer to breastfeed due to its well-established health benefits. Another woman, having emigrated from a region of the world in which breastfeeding along with use of antiretrovirals is recommended, may have successfully breastfed an HIV-negative infant in the past and desire to breastfeed again [4]. Another woman, fearful of disclosing her HIV status to her family or social circle, may believe that foregoing breastfeeding sends a message that she is infected [6]. Yet another woman may have traveled to the United States to deliver her baby with plans to return shortly after delivery to her home country where safe alternatives may not be uniformly accessible [7]. Although the official recommendation is to avoid breastfeeding, the same committee that created these guidelines recognizes that an HIV-infected woman receiving effective antiretroviral therapy (ART) with repeatedly undetectable HIV viral load in rare circumstances may choose to breastfeed despite intensive counseling [5]. The most recent guidelines published by the Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission in 2015 similarly agree that women may feel pressure to breastfeed despite the recommendation [8]. This acknowledgement of the unique circumstances of mothers living with HIV regarding infant feeding opens the door for an exploration of the provider s role in counseling mothers living with HIV, moving beyond the simplistic categorical imperative to avoid breastfeeding and into a more robust discussion of the alternatives, risks, and benefits of various feeding modalities CID 2016:63 (15 November) HIV/AIDS

2 In this article, we offer a discussion of the provider s ethical obligations as they apply to counseling regarding infant feeding options for mothers living with HIV. JUSTIFICATION FOR CURRENT GUIDELINES Early in the HIV epidemic, formula was recommended worldwide. However, in areas where formula is expensive, may be contaminated with unsafe water, or is not consistently available, infant mortality rates rose [9]. Therefore, breastfeeding became the recommendation in low-income nations while formula or other alternative feeding remained the recommendation in high-income countries. Recommendations for high-income countries include initiation of ART in the antepartum period, appropriate labor management, postexposure prophylaxis for the infant, and avoidance of breastfeeding. A population-based study undertaken in the United Kingdom and Ireland by Townsend et al to evaluate the effectiveness of these interventions in preventing mother-to-child-transmission (MTCT) between 2000 and 2006 found the rate of transmission to be 1.1% 1.2% [10, 11]. Another retrospective cohort study by Forbes et al examining transmission rates in Canada between 1990 and 2000 found the risk of MTCT to be 0.4% 1.0% [12]. On the basis of these and other similar studies, it is generally accepted that if these recommendations are followed, the risk of a mother with HIV transmitting the disease to her child is about 1%. Prior to the availability of ART for breastfeeding mothers in Africa, Nduati et al in 2000 demonstrated a 16.2% risk of HIV transmission with breastfeeding [13]; Coutsoudis et al in 2004, examining rates of late postnatal transmission (ie, via breastfeeding), estimated that the overall risk of late postnatal transmission was 8.9 (95% confidence interval [CI], ) transmissions per 100 child-years of breastfeeding, with the cumulative probability of late postnatal transmission at 18 months being 9.3% [14]. More recent studies examining rates of transmission with various regimens of antiretrovirals for the mother and/or infant suggest a significant reduction in breastfeeding risk compared with the pre-art era (see Breastfeeding is likely lower risk than has previously been accepted, below). Very few data exist in the United States and other highincome countries for rates of transmission with breastfeeding. A population-based study by e et al using data from the New York State Department of Health from 1988 to 2008 evaluating the effectiveness of various interventions undertaken in New York to prevent MTCT of HIV reports an odds ratio (OR) of 4.42 (95% CI, ) associated with breastfeeding [15]. A cross-sectional study by Whitmore et al using data from the Centers for Disease Control and Prevention s Enhanced Perinatal Surveillance System between 2005 and 2008 to evaluate missed opportunities for prevention reports an adjusted OR of 4.6 (95% CI, ) for breastfeeding compared with not breastfeeding [10]. The AAP guidelines cite these and other similar studies in pointing to the increased risk of transmission with breastfeeding and the relative ease and availability of alternative feeding in the United States. The conclusion is that avoidance of breastfeeding offers the lowest risk of transmission of all feeding options. Such an approach aims to minimize the possibility of harm to the infant and so is in line with healthcare providers professional obligation to promote the well-being of their patients. In other words, it fulfills the provider s well-known duty of nonmaleficence and so enjoys at least prima facie ethical support. CHALLENGING THE JUSTIFICATION FOR HARDLINE COUNSELING AGAINST BREASTFEEDING Hardline Counseling Against Breastfeeding Is Not as Safe as It Seems In practice, taking a hardline stance with mothers living with HIV against breastfeeding may not reduce HIV exposure to the degree that it does theoretically. While it is possible to calculate the risk differential between replacement feeding and breastfeeding, this number relies on questionable assumptions. One assumption is that women are strictly giving replacement feedings or are exclusively breastfeeding. A second assumption is that patients will automatically comply with the provider s directive to avoid breastfeeding. However, the fact that providers do not discuss breastfeeding with mothers living with HIV does not mean that mothers are not breastfeeding. If a provider takes a hardline stance against breastfeeding, this may preclude the woman from vocalizing herinfantfeedingpreferencesorplanstoherphysician,as she may believe he or she would not respond favorably, and the provider will miss opportunities to tailor his or her counseling to educate the mother in a way that would help her make the most appropriate choices for her baby s health. Of particular concern is the possibility that women may engage in intermittent breastfeeding, alternating formula with breast milk, if they lack a safe space to discuss their preferences with their physician. This may be the case if a woman faces pressure to breastfeed when around certain family or friends [6]. Intermittent feeding carries roughly twice the risk of transmission of exclusive breastfeeding [16 20]. Thus, women who breastfeed intermittently are engaging in riskier behavior than if they were to exclusively breastfeed. To some degree, these realities erode the ethical justification for hardline counseling against breastfeeding. If taking a hardline approach is less successful at reducing risk in practice than it is in theory, the provider s duty to take that approach is not as weighty. Breastfeeding Is Likely Lower Risk Than Has Previously Been Accepted Breastfeeding likely has a lower risk of HIV transmission than has previously been accepted. As mentioned previously, the World Health Organization (WHO) recommends breastfeeding to mothers in low-income countries. In 2010 the WHO, HIV/AIDS CID 2016:63 (15 November) 1369

3 recognizing the reduction of HIV transmission during breastfeeding when the mother or baby was maintained on ART, updated the guidelines encouraging breastfeeding among women in low-resource nations [21, 22]. Their recommendations were supported by multiple studies. The Kesho Bora study demonstrated a cumulative 12-month transmission rate of 5.4% among mothers who stayed on antiretrovirals (1.8% of the infants were already infected at delivery and 3.3% were infected by 6 weeks, suggesting a transmission via breastfeeding rate of 2.1% 3.6%). However, only 70% of these women had undetectable viral loads at delivery, and serial viral loads were not followed postpartum [23]. In the Breastfeeding and Nutrition study, Chasela et al demonstrated an HIV transmission risk after birth of 4.1% and 2.6% among babies whose mothers continued ART while breastfeeding vs babies maintained on antiretrovirals; of note, viral loads again were not followed among the breastfeeding mothers [24]. The Mma Bana trial evaluated the risk of perinatal HIV transmission in Botswana among 760 women randomized to 3 different antiretroviral regimens during pregnancy and breastfeeding. Viral loads remained undetectable in >90% of participants in all groups. Among 709 live-born infants, the authors reported 8 cases of transmission (1.1%), of which only 2 were a result of breastfeeding. Transmission due to breastfeeding was therefore <0.3% [25]. Most recently, the Promoting Maternal and Infant Survival Everywhere study, a trial of 2431 mother-infant pairs in Africa and India randomized to maternal or infant antiretroviral regimens, showed transmission rates at 6, 9, and 12 months of 0.3% (95% CI,.1.6), 0.5% (95% CI,.2.8), and 0.6% (95% CI,.4 1.1), with no significant difference between the arms [26]. Confirmation of well-suppressed virus with undetectable viral loads appears to confer protection against transmission during breastfeeding. Existing studies examining transmission via breastfeeding have primarily taken place in Africa or other resource-limited settings an environment unlike the United States or other high-income countries. Limited information exists regarding actual transmission rates in these countries. Although the above-cited studies by Whitmore et al and Birkhead et al report a 4.4 (95% CI, ) to 4.6 (95% CI, ) OR for transmission associated with breastfeeding in the United States, many of the subjects in these studies had late diagnoses, received no ART, and did not achieve optimal viral suppression [10,15]. As a result, this number is higher than would be expected with timely diagnoses, early initiation of ART, and optimal viral control. Additionally, the early African studies were based on antiretroviral regimens available in the early 2000s, and most did not follow viral loads during breastfeeding. Among women with documented well-suppressed viral loads during breastfeeding, transmission was well under 1% [25, 26]. New studies are needed to examine the rates of transmission with improvements in therapeutic options and resources for close monitoring available to women living with HIV in high-income countries. In light of these more recent studies, it is likely that the risk of breastfeeding is lower than has been accepted in the past. As a result, the difference in risk between alternative feeding and breastfeeding may be small enough that the argument supporting a provider s nonmaleficence-based duty to take a hardline counseling approach against breastfeeding loses much of its force. Other ethical considerations may come into play that justify exploring preferences regarding breastfeeding with the mother. A Word of Caution About Counseling Mothers With HIV Regarding Breastfeeding One concern about discussing breastfeeding with mothers living with HIV is that it may lead women who otherwise would not have considered breastfeeding to do so, leading to higher rates of transmission. Similarly, it is possible that breastfeeding advocates may misunderstand this approach, inappropriately promoting breastfeeding as the preferred option for all mothers living with HIV. The possibility of an inadvertent increase in breastfeeding and HIV transmission risk is a legitimate concern. However, as discussed above, this risk is likely smaller than has previously been accepted. Additionally, withholding information due to fear that it will be taken out of context and misused is paternalistic. These concerns do not justify a refusal to counsel women about breastfeeding but rather support a nuanced, practical counseling approach that is grounded in shared decisionmaking to identify the solution that is most appropriate for each individual mother and her baby. The Importance of a Shared Decision-Making Model in Infant Feeding Discussions The ethical imperative for providers to respect patient autonomy is uncontroversial. To exercise autonomy, patients must be made aware of the risks and benefits of all medically reasonable alternatives and empowered to decide which is best for them. Shared decision-making is seen as the ideal process by which such treatment decisions should be made. In this model, physician and patient exchange information and share preferences, considering treatment options in light of the patient s beliefs and values. Both parties then agree upon what should be the ideal result as it combines the recommendations from the physician with the unique values and circumstances of the patient [27]. Given the often complex social, cultural, and familial dynamics for mothers living with HIV, this type of decisionmaking model is particularly useful. To utilize a shared decision-making model with mothers living with HIV, the provider should first explore the woman s beliefs and preferences regarding infant feeding. A full discussion of the risks and benefits of breastfeeding may not be appropriate for every mother as some may have no concerns about foregoing breastfeeding. Levison et al [7], have proposed a simple screening question that can be administered to all women living 1370 CID 2016:63 (15 November) HIV/AIDS

4 with HIV: We recommend not breastfeeding among our mothers with HIV. Is that an issue for you? Asking nonjudgmental questions such as this opens the door for a woman to voice her concerns and preferences. If the mother voices a concern, the provider can initiate a more robust discussion regarding infant feeding that would include validating her desires and seeking to understand her motivation. Ideally, this conversation would begin early in the antepartum period to allow ample time to address her unique concerns. If she strongly desires the bonding involved with breastfeeding over other types of infant feeding, the provider could explore the possibility for other bonding modalities. If she feels social pressure to breastfeed linked to the stigma of HIV associated with avoidance of breastfeeding, the provider could assist her in finding ways to avoid these situations or help her develop an alternative narrative to explain why she is not breastfeeding. In this discussion there is also opportunity to explore alternative feeding options with the mother, such as the use of banked human milk or the use of a lactation surrogate or wet nurse. If, at the conclusion of this discussion, the woman still expresses an intent to breastfeed, the provider has an obligation to ensure that breastfeeding is carried out in the safest way possible. As outlined by Levison et al [7], such management would include ensuring the mother and/or infant is on an appropriate antiretroviral regimen and emphasizing the importance of optimal viral control. It would also include antepartum consultation with the pediatrician who will be caring for the infant, more frequent monitoring of the mother s viralloadduring breastfeeding, and HIV polymerase chain reaction for the infant at set intervals after weaning. Also important in these discussions with women living with HIV who choose to breastfeed is a strong emphasis that exclusive breastfeeding is safer than intermittent breastfeeding. One might object that breastfeeding is not a medically reasonable alternative for mothers living with HIV due to the risk it poses to infants and so need not be discussed out of respect for autonomy. However, as discussed previously, there are reasons to believe that the risk differential is not sufficient to exclude breastfeeding as a reasonable (if inferior) option. If the provider does not use a shared decision-making approach with women living with HIV regarding infant feeding, he or she may miss opportunities to educate the mother about the risk she may be taking if she chooses to breastfeed. Taking a strongly paternalistic approach with hardline counseling against breastfeeding may actually alienate the mother. This would result in a lost opportunity for optimizing care of both mother and infant. CONCLUSIONS In closing, we propose that an approach based on shared decision-making regarding infant feeding with mothers living with HIV is ethically justifiable. This course of action allows providers to balance their duty of nonmaleficence with their obligation to respect patient autonomy. A hardline counseling stance against breastfeeding is not as safe as it seems, as it may preclude a provider from discovering that a woman living with HIV may be breastfeeding intermittently without telling the provider, putting her baby at increased risk. Additionally, for women in high-income countries for whom antiretroviral regimens and close monitoring are available, breastfeeding is likely much lower risk than has previously been accepted. As a result, a provider s ethical obligation to respect patient autonomy outweighs the prima facie duty of nonmaleficence, justifying a harm-reduction counseling approach. The purpose of this article is not to advocate that women living with HIV should be encouraged to breastfeed. Instead, we argue that it is ethically justifiable for providers to discuss this option with women in the scope of a larger discussion regarding infant feeding options. If a provider is able to explore the mother s context and elicit her feeding preferences, he or she will be able to tailor the counseling to her situation. Together the patient and provider can create a plan that reduces risk of HIV transmission to the greatest extent pragmatically possible. Note Potential conflicts of interest. All authors: No potential conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. References 1. Whitmore SK, Zhang X, Taylor AW, Blair JM. Estimated number of infants born to HIV-infected women in the United States and five dependent areas, J Acquir Immune Defic Syndr 2011; 57: Chen JL, Philips KA, Kanouse DE, Collins RL, Miu A. Fertility desires and intentions of HIV-positive men and women. Fam Plann Perspect 2001; 33:144 52, Cliffe S, Townsend CL, Cortina-Borja M, Newell M-L. Fertility intentions of HIVinfected women in the United Kingdom. AIDS Care 2011; 23: Yudin MH, Kennedy VL, MacGillivray SJ. HIV and infant feeding in resource-rich settings: considering the clinical significance of a complicated dilemma. AIDS Care 2016; 28: Committee on Pediatric AIDS. Infant feeding and transmission of human immunodeficiency virus in the United States. Pediatrics 2013; 131: Tariq S, Elford J, Tookey P, et al. It pains me because as a woman you have to breastfeed your baby : decision-making about infant feeding among African women living with HIV in the UK. Sex Transm Infect 2016; 92: Levison J, Weber S, Cohan D. Breastfeeding and HIV-infected women in the United States: harm reduction counseling strategies. Clin Infect Dis 2014; 59: 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: lvguidelines/adultandadolescentgl.pdf. Accessed 4 September Fawzy A, Arpadi S, Kankasa C, et al. Early weaning increases diarrhea morbidity and mortality among uninfected children born to HIV-infected mothers in Zambia. J Infect Dis 2011; 203: Whitmore SK, Taylor AW, Espinoza L, Shouse RL, Lampe MA, Nesheim S. Correlates of mother-to-child transmission of HIV in the United States and Puerto Rico. Pediatrics 2012; 129:e 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, AIDS 2008; 22: Forbes JC, Alimenti AM, Singer J, et al. A national review of vertical HIV transmission. AIDS 2012; 26: Nduati R, John G, Mbori-Ngacha D, et al. Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial. JAMA 2000; 283: HIV/AIDS CID 2016:63 (15 November) 1371

5 14. Coutsoudis A, Dabis F, Fawzi W, et al. Late postnatal transmission of HIV-1 in breast-fed children: an individual patient data meta-analysis. J Infect Dis 2004; 189: Birkhead GS, Pulver WP, Warren BL, et al. Progress in prevention of mother-tochild transmission of HIV in New York State: J Public Health Manag Pract 2010; 16: Coutsoudis A, Pillay K, Kuhn L, Spooner E, Tsai WY, Coovadia HM. Method of feeding and transmission of HIV-1 from mothers to children by 15 months of age: prospective cohort study fromdurban,southafrica.aids2001; 15: Coovadia HM, Rollins NC, Bland RM, et al. Mother-to-child transmission of HIV- 1 infection during exclusive breastfeeding in the first 6 months of life: an intervention cohort study. Lancet 2007; 369: Coutsoudis A, Pillay K, Spooner E, Kuhn L, Coovadia HM. Influence of infantfeeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa: a prospective cohort study. South African Vitamin A Study Group. Lancet 1999; 354: Iliff PJ, Piwoz EG, Tavengwa NV, et al. Early exclusive breastfeeding reduces the risk of postnatal HIV-1 transmission and increases HIV-free survival. AIDS 2005; 19: Kuhn L, Sinkala M, Kankasa C, et al. High uptake of exclusive breastfeeding and reduced early post-natal HIV transmission. PLoS One 2007; 2:e World Health Organization. Guidelines on HIV and infant feeding Geneva, Switzerland: WHO, World Health Organization. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: recommendations for a public health approach. Geneva, Switzerland: WHO, de Vincenzi I. Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 (Kesho Bora study): a randomised controlled trial. Lancet Infect Dis 2011; 11: Chasela CS, Hudgens MG, Jamieson DJ, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med 2010; 362: Shapiro RL, Hughes MD, Ogwu A, et al. Antiretroviral regimens in pregnancy and breast-feeding in Botswana. N Engl J Med 2010; 362: Taha T, Flynn P, Cababasay M, et al. Comparing maternal triple antiretrovirals and infant nevirapine prophylaxis for the prevention of mother to child transmission of HIV during breastfeeding. Durban, South Africa: International AIDS Society, Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med 1997; 44: CID 2016:63 (15 November) HIV/AIDS