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* SARA Project and
LINKAGES Project, Academy for Educational Development, Washington, DC 20009
2To whom correspondence should be addressed. E-mail: epiwoz{at}aed.org.
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONLITERATURE CITED |
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101/1000. IMR-based analyses can help to guide government policy decisions about which infant feeding strategies to invest in and emphasize for HIV-positive mothers in different settings.
KEY WORDS: • mother-to-child transmission • HIV type 1 • breastfeeding • policy • antiretroviral prophylaxis
Each year, HIV infects 
640,000 children worldwide, mainly due to mother-to-child transmission (MTCT)3 during pregnancy, at the time of delivery, and postnatally through breastfeeding (BF) (1). In the absence of interventions to prevent transmission, 5 to 10% of infants born to HIV-positive mothers are infected with HIV during pregnancy; 10 to 20% are infected around the time of delivery; and another 10 to 20% become infected through BF for 18 mo or longer (2).
In industrialized countries, anti-retroviral (ARV) combination therapy, elective Caesarian delivery, and avoidance of all BF have reduced MTCT rates to <2% (3). New guidelines issued by WHO on the use of ARV drugs to prevent infant HIV infection in resource-limited settings recommend single, dual, and triple therapy options that would reduce the risk that an infant will be born with HIV to 5–14%, with combination regimens producing the greatest effect (4). Research is now underway to examine the safety and efficacy of extended ARV prophylaxis given to BF mothers and/or their infants to prevent postnatal HIV transmission (5).
WHO currently recommends avoidance of all BF by HIV-positive mothers if replacement feeding (RF) is affordable, feasible, acceptable, sustainable, and safe (AFASS) (6). Otherwise exclusive BF (EBF), followed by early BF cessation as soon as RF is AFASS, is recommended. Recommendations further suggest that HIV-positive women should be counseled about the risks and benefits of BF and RF in order to make fully informed feeding decisions (6).
The recommendation to breastfeed exclusively is based on the known benefits of EBF for protection against diarrhea and other infectious diseases (7,8). Two reports also suggest that EBF protects against infant HIV infection (9,10). Early BF cessation is recommended to prevent continued exposure to HIV because the risk of acquiring HIV continues for as long as BF is practiced (11).
The rate of postnatal HIV transmission among infants who were exposed to HIV but uninfected at 4 wk or later was recently estimated in a meta-analysis of data from 9 African studies at 8.9 infections per 100 child-years of any BF, remaining constant over time (11). The rate of postnatal HIV transmission among infants who were EBF for up to 3 mo in a large study in Zimbabwe was 5.1 per 100 child-years of BF (10). In that study, postnatal HIV transmission from 1 to 6 mo was 1.3% (95% CI: 0.0–3.3) in those infants who were EBF (10). However, this and other estimates of postnatal transmission do not include infections that occur during the first weeks of life because of difficulties in distinguishing infections during this period from those occurring during pregnancy and delivery (12). Within-study comparisons of infection risks in breastfed and nonbreastfed infants suggest that BF-associated HIV transmission in the first 6–8 wk ranges from 2.6 to 6.3% (13–16), with a mean of 2.8%/mo.
Efforts to introduce and scale up MTCT prevention programs have increased dramatically in the past 5 years (4). As governments are preparing guidelines and scaling up, they face difficult choices about which interventions to invest in. Initially, there are choices regarding the best ARV prophylaxis regimen to use and there is the decision about which strategies to invest in to prevent postnatal HIV transmission: RF from birth, most often with provision of commercial infant formula to low-income HIV-positive mothers, or EBF followed by early BF cessation. Both postnatal interventions involve costs, potentially stigmatize the HIV-positive mother, and involve non-HIV–related risks, yet there is little guidance to enable governments to balance these factors in order to make informed policy decisions.
To facilitate informed policy decisions, we used mathematical simulation modeling to estimate rates of HIV transmission and non-HIV–related deaths among infants up to 24 mo of age in line with WHO recommendations for infant feeding by HIV-positive mothers. Three policy scenarios were compared: (1) RF from birth by HIV-positive mothers (RF24); 2) EBF up to 6 mo followed by early BF cessation at 6 mo (EBF6); and 3) the "no intervention" scenario where usual infant feeding practices prevail (BF24). Usual feeding practices include early predominant and mixed BF and continued BF for up to 2 y or longer (17).
This risk analysis differs from previous modeling exercises (18–20) in that the present approach uses the most recent age- and feeding-pattern–specific data on HIV transmission during BF (10,11) and it considers the age-related changes in the non-HIV–related risks of not BF (21). In addition, this analysis examines the effect of non-HIV–related risks, specific to different settings and characterized by infant mortality rate (IMR) on the results of these comparisons. IMR is a statistic readily available to policy decision-makers. The purpose of our analysis is to inform the HIV and infant feeding policy of governments. These findings are not intended for individual counseling of HIV-positive mothers.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONLITERATURE CITED |
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Country simulation. To illustrate our comparisons, we use data from Ethiopia where the IMR in rural areas, home to 85% of the population, is 115/1000 live births, and where the IMR in urban areas is 97/1000 live births (24). Antenatal HIV prevalence is 3.7% in rural and 13.2% in urban areas (25). Ethiopia is selected because it is in the process of rapidly expanding its MTCT prevention programs; there are rural/urban variations; and its IMR has not increased as a result of the HIV pandemic (24).
First, by setting the HIV prevalence to 1, we estimate the number of HIV infections and non-HIV–related deaths per 1000 live births among infants born to HIV-positive mothers in urban and rural areas for each feeding scenario: 1) RF24: 0% of HIV-positive mothers initiate BF; 2) EBF6: 96% of HIV-positive mothers initiate BF and EBF and then all stop BF at 6 mo; 3) BF24: 96% of HIV-positive mothers initiate BF, which is primarily nonexclusive, diminishing to 88% in y 2 of life, consistent with data from the Ethiopia 2000 Demographic and Health Survey (24).
Next, we estimate the total number of HIV infections and non-HIV–related deaths for urban and rural infants born to HIV-positive and uninfected mothers under Scenario 3, where there is no postnatal intervention.
Critical IMR values and sensitivity analysis. A critical value is the value for which the number of HIV-free survivors is the same for 2 intervention scenarios being compared, holding all other values constant. Critical IMR values were estimated to identify populations, characterized by the IMR, where the optimal postnatal intervention strategies would vary, in order to inform policy discussions. The sensitivity of the critical IMR values was examined by rerunning the model simulations using the lower and upper estimates of the 95% CI for estimates of the age-specific risks of no BF (R), postnatal HIV transmission during EBF and early cessation (T2EBF6), and postnatal transmission under the default scenario with no postnatal intervention (T2BF24) (see Table 1).
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONLITERATURE CITED |
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10,000 urban and 15,600 rural infants will become infected with HIV each year through BF.
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25/1000, the best outcome is observed with short-duration EBF (EBF6). RF from birth (RF24) produces a poorer outcome than no postnatal intervention (BF24) at all when IMR 101/1000 live births.
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONLITERATURE CITED |
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In rural and urban Ethiopia, where the IMR is 115 and 97 deaths per 1000 live births, respectively, RF results in the poorest outcome (rural) or is as bad as no intervention at all (urban), suggesting that it should not be generally promoted as an infant feeding strategy to reduce mother-to-child transmission of HIV. In both environments, the best strategy is EBF for 6 mo with early BF cessation.
Several limitations of this analysis deserve mention. First, uncertainty persists about some of the assumptions used. For example, our conservatively high estimate of the risk of HIV transmission through BF in the first weeks is based primarily on differences in rates of seroconversion between breastfed and nonbreastfed infants in 4 studies (13–16) because current testing methods cannot determine the precise timing of transmission in infants who are polymerase chain reaction negative at birth and test positive in the first weeks of infancy. The large variation in rates among studies suggests cautious interpretation.
Second, our estimate of postnatal transmission rates for EBF infants is based on the findings of 1 observational study in Zimbabwe (10). This study is the largest in Africa to date, with 2060 mother-infant pairs included in the analysis, comparable in size to the breastfeeding and HIV infant transmission study meta-analysis sample (11). Early EBF was associated with reduced risk of postnatal HIV transmission in the Zimbabwe study after taking into account other explanatory variables, including maternal baseline CD4 cell count, arm circumference, presence of severe anemia, marital status, age, and death during follow-up, suggesting a robust relation. Furthermore, the postnatal transmission rate used in the EBF scenario is comparable to preliminary findings from the Reducing Risk of HIV-1 Transmission from Mother to Infant Through Breastfeeding Using Antiretroviral Prophylaxis in Infants trial, which provided infants with ARV prophylaxis during BF (27). This gives support to the policy comparisons that favor investing in interventions to make BF safer for HIV-positive mothers versus RF from birth in resource-constrained settings.
Third, the age-specific risks of death due to artificial feeding are taken from a pooled analysis of 3 observational studies in populations where mothers chose to feed artificially for reasons unrelated to HIV (21). To avoid the influence of pre-existing illness on mortality risk, this analysis did not include children who were sick at the time they stopped BF or who died within 7 d of BF cessation. Our analysis indicated that the IMR critical values presented here are sensitive to these risk estimates, ranging from 15 to 43/1000 live births for comparisons of EBF and RF. However, the relative risk of mortality due to no BF is likely to be greater in situations where BF is avoided due to maternal HIV or to related illness (28) than in situations where RF is chosen for reasons unrelated to HIV, suggesting that the critical value for EBF (6) is more likely to be at the lower end of this range estimate. Population-based data on the risk of death due to artificial feeding, when the decision to avoid BF is made because of HIV, are urgently needed.
Fourth, IMR is used in this analysis to capture the risks associated with no BF in diverse populations because IMR reflects the burden of infectious disease, poor hygiene and sanitation, and limited access to quality health care, and these are the same conditions that increase the risks of RF for young infants. We illustrated this using data from Ethiopia, where IMR has largely been unaffected by HIV. Although most deaths associated with HIV occur after infancy, caution is advised when applying these findings to settings where IMR is highly influenced by the effects of the HIV pandemic (29). In these settings, policy-makers are advised to utilize IMR that do not include the effects of HIV, such as estimates prior to the acceleration of the epidemic, or to draw conclusions with due caution.
Fifth, although this analysis assumes that all HIV-positive mothers comply with the feeding scenarios being simulated, not all mothers follow WHO-recommended advice. The impact of imperfect behavioral compliance on postnatal HIV transmission and non-HIV–related child deaths can be estimated for individual countries by changing the BF prevalence assumptions (B). However, the impact imperfect compliance on the IMR critical values varies depending on which behavior is examined. Lower compliance with EBF6 (i.e., nonexclusive BF) will increase postnatal HIV transmission, moving it toward the higher bounds of T2EBF6 (Table 1). The effect of this increased transmission risk on the IMR critical value is estimable from Figure 4 (top). For example, as noted previously, when the upper bounds of T2EBF6 and the point estimate of R are assumed, EBF6 produces a better outcome than RF24 in settings where IMR > 56/1000 live births. In contrast, lower compliance with RF24 will simultaneously increase transmission due to HIV exposure and reduce non-HIV–related deaths due to the protective effects of breast milk in uninfected children (data not shown). Any BF among mothers in the RF24 scenario will decrease the critical IMR below which RF24 is safer than EBF6 and will increase the IMR above which no intervention (BF24) is safer than RF24.
Sixth, the purpose of this analysis is to allow policy-makers to compare WHO-recommended infant feeding options for HIV-positive mothers at the population level. However, population level analyses should be done with care. IMR may vary substantially among different subpopulations within countries. For example, in Ethiopia, where the IMR in urban areas is 97/1000, it may fall below the threshold of 25/1000 live births in some households with high socioeconomic status. It is therefore important to stress that this population level policy analysis is not intended to supplant individual counseling where the principle of informed choice linked with individual risk assessment is paramount. These findings, however, may be used to help guide counseling about individual risks, also taking into account the mothers’ health status, her environment, and the care and support she receives (30). Furthermore, these findings should not impede expansion of programs for HIV-infected mothers who require ARV treatment. Providing treatment for women with advanced HIV disease is likely to further reduce the risks of postnatal HIV transmission (4,5).
Finally, mathematical simulation modeling requires a number of assumptions that simplify the difficult choices confronting governments as well as families affected by HIV/AIDS. We feel that such simulations are useful because they enable policy-makers to compare different postnatal intervention strategies objectively, as well as to understand the impact of inaction on postnatal HIV infection. As more governments introduce and scale up PMTCT programs, they will be making decisions about HIV testing protocols, ARV drug regimens, and procurement of breast milk substitutes for RF. Introducing breast milk substitutes into health programs has been controversial (31), and problems of compliance, stigma, spill-over, and mixed feeding have been documented (32–34). It is essential that decision-makers have tools to evaluate whether such procurement is appropriate for their programs or whether other strategies, such as EBF with nutrition support for children after early BF cessation, produce greater public health benefits and merit direct support.
Greater attention should be given to prevention of postnatal HIV transmission in MTCT prevention programs. Failing to address postnatal HIV transmission or investing in the wrong postnatal strategies will undermine the success of these programs, resulting in higher infant and child mortality as well as loss of credibility and political support. Findings from new research on making BF safer for HIV-positive mothers, through extended ARV prophylaxis, prevention and treatment of breast infections, and EBF, must urgently be put into practice.
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FOOTNOTES |
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3 Abbreviations used: AFASS, affordable, feasible, acceptable, sustainable, and safe; ARV, antiretroviral drug; BF, breastfeeding; BF24, breastfeeding from birth up to 24 mo with no intervention; EBF, exclusive breastfeeding; EBF6, exclusive BF from birth up to 6 mo and complete cessation at 6 months; HFS, HIV-free survival; IMR, infant mortality rate; MTCT, mother-to-child transmission of HIV type 1; RF, replacement feeding; RF24, replacement feeding from birth.
Manuscript received 22 November 2004. Initial review completed 2 January 2005. Revision accepted 22 February 2005.
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TOPABSTRACTMETHODSRESULTSDISCUSSIONLITERATURE CITED |
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