HIV AND INFANT.html
OPINION
HIV and infant feeding – one step forward, two steps back
H Saloojee1, MB BCh, FCPaed (SA), MSc
G Gray2, MB BCh, FCPaed (SA)
J A McIntyre3,4, MB BCh, FRCOG
1Division of Community Paediatrics, University of the Witwatersrand, Johannesburg
2Perinatal HIV Research Unit, University of the Witwatersrand
3Anova Health Institute, Johannesburg
4Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town
The recent decision by the South African Department of Health to
withdraw the provision of free replacement (formula) feeds to
HIV-exposed infants has hardly evoked any response from clinicians,
health professionals or civil society groups. This paper argues that
the decision is short-sighted, lacks an adequate evidence base, and is
retrogressive and unconstitutional. Nine supporting arguments are
presented and an alternative policy proposed.
The recent ‘Tshwane Declaration of Support for Breastfeeding
in South Africa’ championed by the national Department of Health
seeks to promote breastfeeding and halt practices deterring optimal
breastfeeding in South Africa (SA).1
The Declaration’s intentions are most welcome, including greater
support for the Baby Friendly Hospital Initiative which facilitates
breastfeeding soon after birth, increasing numbers of community health
promoters who will visit homes and support mothers with breastfeeding,
workplace support for breastfeeding mothers, and stricter monitoring of
the milk industry’s compliance with the code of marketing of
breastmilk substitutes.
However, one decision stands out as short-sighted, poorly evidenced
and retrogressive. The plan to remove the provision of free replacement
(formula) feeding to infants of HIV-positive women is frankly
bewildering. HIV accounts for over 50% of child mortality in SA,2
and is primarily responsible for the loss of hard-earned gains in child
health in South Africa over the past two decades. Postnatal
transmission of HIV through breastfeeding is now the commonest form of
mother-to-child transmission (MTCT), and its contribution is increasing
as programmes introduce more effective antenatal and perinatal ARV
regimens. Annually, more
than half a million infants globally acquire HIV through breastfeeding,
highlighting the failure of previous strategies, including those
promoting exclusive breastfeeding.
There are currently only two recognised postnatal preventive
strategies – antiretroviral prophylaxis provided to mother or
infant, and avoiding HIV exposure through replacement feeding. To
deliberately discard one of these two strategies is a luxury that the
country can ill afford and requires substantial evidence that the
strategy is either ineffective or results in major harm. Evidence to
support either of these contentions in the South African setting is
simply lacking.
REPLACEMENT (FORMULA) FEEDING REMAINS A LEGITIMATE HIV PREVENTION STRATEGY
Multiple strategies are currently available to prevent HIV
transmission in adults. Despite good evidence about the benefit of
condoms, microbicides, circumcision and pre- and post-exposure
prophylaxis, among others, the search continues for different and more
effective prevention options such as an HIV vaccine. Clearly, a single
strategy could never meet the needs of all. If the Department of Health
were to summarily withdraw the provision of any one of the established
HIV prevention strategies, the HIV community would be toyi-toying in
the streets.
Yet the government’s decision to remove a well-evidenced child
HIV prevention strategy – replacement feeding – has hardly
elicited a whisper from HIV activists, clinicians or civil society. Is
it that they have been cowed into inaction because supporting
replacement feeding is somehow automatically viewed as being
anti-breast? Certainly, this was the fate of the authors of this piece
when we recently wrote an opinion piece in the Mail & Guardian questioning the validity of the Department’s decision.3
Supporters of the Department’s proposal lambasted the
newspaper’s irresponsible behaviour in publishing the piece. They
went on to describe us as ill-informed and ‘dissidents’.4
Such malicious name-calling demonstrates a degree of intolerance
unbecoming of fellow scientists on a decision that has great scientific
and public health importance and deserves rigorous debate.
Indeed, at an open public debate hosted by the SA HIV Clinicians
Society in Johannesburg in October 2011, over 70% of the more than 120
attendees (who included doctors, nurses, policy makers and
nutritionists) voted against the Department’s proposed change. A
similar percentage of attendees agreed that provinces should be free to
determine their own policy rather than being forced to offer a single
option. Clearly the views of many important stakeholders have not been
considered in the Department’s decision, and there appear to be
many dissidents lurking out there. The most silent voice has been that
of HIV-positive women.
NO EVIDENCE THAT THE NEW PROPOSAL WILL MAXIMISE HIV-FREE CHILD SURVIVAL IN SA
Supporters of the withdrawal of replacement feeding will quickly
point out that it is not just the acquisition of HIV infection but
overall child survival (HIV-exposed children staying alive) that
matters. That is correct. The pertinent question then is whether
replacement feeding inevitably results in increased child mortality in
SA. The primary author of the Mail & Guardian piece attacking our stance readily acknowledged in a paper published in the Bulletin of the World Health Organization
in 2011 that ‘… no determination has been made about which
feeding practice will maximize HIV-free survival nationally’.5
Much of the evidence arguing that HIV-free survival (being alive and
HIV uninfected) is similar for formula-fed and exclusively breastfed
infants originates from countries such as Zambia, Malawi and rural
Botswana. However, the extremely high background mortality in the study
children (e.g. 21% in Zambia)6
because of the high burden of infectious disease, poor hygiene and
sanitation, and limited access to quality health care, easily masks any
possible benefits of replacement feeding (since so many children die).
These dismal conditions are much less likely in South African settings.
In rural KwaZulu-Natal, for instance, the probability of HIV-free
survival at 18 months was marginally higher in HIV-exposed infants who
had never been breastfed compared with infants who had ever been
exclusively breastfed (80% v. 75%, p=0.05), the difference being mostly attributed to acquisition of infection through breastfeeding.7
A second confounder present in most studies is that since few trials
randomised feeding choice, higher-risk women (with lower CD4 counts)
were directed to, or selected, replacement feeding. This obviously
attenuates possible benefits of replacement feeding.
Evidence from diverse African cities such as Nairobi8 and Abidjan9
convincingly indicates that replacement feeding can be safely supported
in these settings and can reduce HIV infection rates, without
jeopardising child survival. With safe replacement feeding, the
vertical HIV transmission rate can be reduced to less than 2%, even in
a resource-limited setting such as rural Rwanda.10
The high HIV-free survival rate reported in the Rwandan cohort of
infants whose caregivers were supported with exclusive replacement
feeding is remarkable and among the highest reported for a cohort of
HIV-exposed infants.10
SOUTH AFRICA IS NOT A SINGLE HOMOGENEOUS COUNTRY
Using data from poorer southern African countries to argue that
replacement (formula) feeding cannot be undertaken safely in SA is
inappropriate. Over half of South African children are urbanised.11
Many have good access to safe water (62%), sanitation (63%) and
electricity, and these statistics exceed 87% in Gauteng and the Western
Cape, including their townships and informal settlements.12
Under-5 mortality rates (U5MR) vary substantially among provinces and
districts; for example, in 2008 the U5MR in Western Cape was 31/1 000
live births, while it was almost fourfold higher in the Free State
(117/1 000).13 District-level data are unavailable.
At least a third to one-half of SA caregivers should therefore be
able to safely replacement feed their children. SA data from peri-urban
and rural settings such as Paarl, Umlazi and Rietvlei confirm that
formula feeding halved HIV transmission or death among children living
in households with piped water. Among those who had piped water and
fuel and who disclosed their HIV status, the protective effect of
formula was greater (68% reduction).14
Furthermore, the increasing availability of rotavirus and pneumococcal
vaccine in SA is rapidly reducing the incidence and severity of
diarrhoea and pneumonia, two major morbidities associated with
replacement feeding.
This does not mean that that choosing to formula feed an infant in
some rural parts of the country, or in an under-serviced informal
settlement, could ever be considered an appropriate choice. However,
denying individual choice and failing to support a legitimate HIV
prevention strategy in circumstances where this can be safely done
violates caregivers’ and infants’ rights to basic health
care and may be unconstitutional.
A SINGLE INFANT FEEDING OPTION IS INAPPROPRIATE FOR ALL HIV-POSITIVE
WOMEN IN SA
A ‘one-size-fits-all policy’ is certainly simpler to
promote, and the notion that ‘mixed messages lead to mixed
feeding’ makes sense. However, the simplest policy is not
necessarily the best. Until recently infant feeding policy in SA was
made at the provincial level. This makes sense because SA is
heterogeneous in so many respects – the rural-urban mix, the
availability of water and sanitation, the background infant mortality
and the provincial variation in the percentage of mothers with HIV. The
newly proposed policy demands that the whole country assume the same
position – no free formula provision. This position is contrary
even to the 2010 WHO HIV and infant feeding policy, on which the South
African policy is based, which recommended that decisions be made by
‘national or sub-national health authorities’ in
recognition of in-country variances.15
THE NEW PROPOSAL IS RETROGRESSIVE IN TERMS OF SUPPORTING WOMEN’S CHOICE AND ANTI-POOR
Arguing that parents can pay for formula from their own pockets if
they choose this option may seem reasonable, but this denies access to
an estimated 25 000 infants in whom formula feeding may be safely
undertaken, but is unaffordable. Data from Rietvlei, Paarl and Umlazi
confirmed that as many as a third of women living in these peri-urban
and rural settings met the adequacy for replacement feeding criteria,
dubbed AFASS (affordable, feasible, acceptable, sustainable, safe),
despite being poor.14
Disallowing middle- and upper-class women access to free
state-sponsored formula may be justifiable, since access to many health
services for this class of citizens require them to bear the costs
themselves. However, insisting that a poor woman (who qualifies for a
child support grant, for instance) who meets the AFASS criteria be
denied the opportunity to have an HIV-uninfected child, simply because
she is poor, is discriminatory.
THE NEW PROPOSAL IS BASED ON EXTRAPOLATION RATHER THAN FIRM EVIDENCE
Much of the enthusiasm for the proposal to withdraw support for
replacement feeding stems from research suggesting that extended
nevirapine provision to infants for 6 months, or triple antiretroviral
therapy provision to their mothers, can reduce HIV transmission rates
to less than 2% at 6 months in exclusively breastfed populations.
Whether the benefits of antiretroviral prophylaxis continue to 12
months (the suggested duration in SA), and whether the intervention is
equally beneficial in mixed-fed infants (the likely situation in SA),
is unknown. Similarly, the consequences of antiretroviral interruption
while breastfeeding are unclear. There are further unanswered
questions. How serious are the long-term effects of exposure to
multiple antiretroviral drugs in utero
and during breastfeeding? Can adequate adherence be achieved to avoid
emergence of drug resistance? Will there be negative effects on
discontinuation of antiretroviral therapy (ART) after stopping
breastfeeding in women who do not require it for their own health?
THE ABILITY OF THE HEALTH SYSTEM TO SUPPORT THE NEW PROPOSAL IS NOT
GUARANTEED – FAILURE TO DELIVER WILL HAVE DRASTIC CONSEQUENCES
The new proposal is a huge public health experiment and could even
be considered a high-stake gamble. While nevirapine toxicity does not
seem cumulative, the adherence and programmatic challenges of long-term
prophylaxis are untested. Extrapolating data from highly controlled
experimental settings to real-world situations is risky, particularly
in the absence of a single local pilot project demonstrating successful
implementation. At present, not one province has any monitoring or
evaluation plan to establish effectiveness.
Perhaps the most pertinent question is whether many South African
settings that are still battling to provide single-dose nevirapine or
dual therapy are capable of offering this new standard of care. What
should not be under-estimated are the demands on the health system of
the new proposal. It is anticipated that of the approximately 300 000
HIV-positive pregnant women each year, about half will qualify for ART
(for life) for their own health. For these mothers ensuring adherence
is the major issue, since their infants will not be receiving
nevirapine, and if the mother stops taking ART her infant will be left
with no prophylaxis. Mothers not qualifying for ART need to be
convinced to exclusively breastfeed for 6 months, and to provide their
healthy uninfected infants with a daily dose of a drug (nevirapine) for
up to one year. The health service will need to monitor these children
at least monthly and ensure that drug supplies do not falter. The
benefit of extended nevirapine if a mother starts mixed feeding or
forgets to provide the drug for any period is unknown.
A failure to meet any of these requirements will mean that
transmission rates of infant HIV could start escalating again. All the
problems of ensuring an adequate formula supply that have plagued the
PMTCT programme will be replicated with extended nevirapine or ART
provision, except that the consequences of a failed supply line will be
far worse; while mothers still had to feed their infants and make
alternative plans when formula was scarce, it is less likely that they
will do so when nevirapine or ARTs runs out at a clinic.
Little consideration seems to have been taken in the new proposal of
the myriad of situations where initiation or continuation of
breastfeeding of HIV-exposed infants will not be possible, such as
mothers returning to work or school, grannies caring for grandchildren,
and abandoned or orphaned children.
SOUTH AFRICAN DATA INDICATE REPLACEMENT FEEDING AS AN HIV-PREVENTION STRATEGY
IS COST EFFECTIVE DEPENDING ON
MORTALITY RATES
During this time of fiscal restraint where healthcare resources are
finite, information about both effectiveness and costs is important for
policy makers as evidence-based decisions are made. When the issue of
costs was raised during the recent breastfeeding consultation, the
comment that ‘a back of the envelope calculation shows that
breastfeeding is much cheaper and more cost-effective than formula and
could save R200 million a year’ was met with wild applause. This
type of feeble evidence to support a major policy shift is unfortunate.
Cost, logistics and cultural preferences should be considered in policy
decisions.
A new, unpublished modelling exercise using SA data indicates that
extended nevirapine is a cost-saving intervention in both typical urban
and rural settings and results in improved HIV-free survival. Changing
feeding practices to promote breastfeeding is cost-saving in typical
rural settings, while promoting replacement feeding in typical urban
settings is the most cost-effective feeding option (personal
communication, Mandy Maredza, 1 November 2011).
AN HIV-FREE GENERATION CAN NEVER BE ACHIEVED WHILE BREASTFEEDING CONTINUES
The current call and challenge posed by the UNAIDS, and taken up in
SA national policy, to eliminate MTCT by 2015 (i.e. zero new HIV
infections) is unlikely to be achieved with a single strategy for
infant feeding in SA, since at least 6 000 new infections annually can
be expected in breastfeeding infants provided extended nevirapine. In
reality there will be many more infected children, since implementation
will hardly be perfect because of imperfect behavioural compliance. In
the rush to ensure that SA is on a path to decreasing child mortality
from all causes it is critical to ensure that recent gains in the
number of HIV-exposed children’s lives saved through existing
interventions, including replacement feeding, are not erased.
WHAT A NEW POLICY SHOULD SAY
A more appropriate infant feeding policy for the country would offer
antiretroviral prophylaxis and breastfeeding as the national default
option. However, provinces, and perhaps even districts, should be
allowed the freedom to decide whether they wish to continue to support
the provision of replacement feeding for poor women who meet the AFASS
criteria, based on their own circumstances. Whatever choice women
ultimately make, much more emphasis needs to be placed on a more
supportive environment including adequate counselling, education and
support through community health workers.
The availability of antiretroviral prophylaxis is a big step forward
for HIV-positive women choosing to breastfeed their infants. It’s
a crying shame that in introducing this promising intervention, the
Department of Health has chosen to take the low road (by insisting on a
single option) rather than following the high one where the provision
of safe water, sanitation and other resources, and employment would
also have been prioritised for all citizens, so that any parents
wanting to guarantee a HIV-free future for their child could do so
knowing that the choice of replacement feeding could be safely
supported too.
REFERENCES
1. The Tshwane Declaration of breastfeeding in South Africa.
http://www.confcall.co.za/presentationDownloads.php?recordId=8
(accessed 13 November 2011).
1. The Tshwane Declaration of breastfeeding in South Africa.
http://www.confcall.co.za/presentationDownloads.php?recordId=8
(accessed 13 November 2011).
2. Stephen CR, Bamford LJ, Patrick ME, Wittenberg DF, eds. Saving
Children 2009: Five Years of Data. A Sixth Survey of Child Healthcare
in South Africa. Pretoria: Tshepesa Press, MRC, CDC, 2011.
2. Stephen CR, Bamford LJ, Patrick ME, Wittenberg DF, eds. Saving
Children 2009: Five Years of Data. A Sixth Survey of Child Healthcare
in South Africa. Pretoria: Tshepesa Press, MRC, CDC, 2011.
3. Saloojee H, Gary G, McIntyre J, Violari A. Breast may be best, but
tread cautiously. Mail and Guardian 9 September 2011.
http://mg.co.za/article/2011-09-09-breast-may-be-best-but-tread-cautiously
(accessed 13 November 2011).
3. Saloojee H, Gary G, McIntyre J, Violari A. Breast may be best, but
tread cautiously. Mail and Guardian 9 September 2011.
http://mg.co.za/article/2011-09-09-breast-may-be-best-but-tread-cautiously
(accessed 13 November 2011).
4. Doherty D, Sanders D, Goga A, et al. Stop dithering at death’s
door. Mail and Guardian, 16 September 2011.
http://mg.co.za/article/2011-09-16-stop-dithering-at-deaths-door/
(accessed 13 November 2011)
4. Doherty D, Sanders D, Goga A, et al. Stop dithering at death’s
door. Mail and Guardian, 16 September 2011.
http://mg.co.za/article/2011-09-16-stop-dithering-at-deaths-door/
(accessed 13 November 2011)
5. Doherty T, Sanders D, Goga A, et al. Implications of the new WHO
guidelines on HIV and infant feeding for child survival in South
Africa. Bull World Health Organ 2011;89:62-67.
5. Doherty T, Sanders D, Goga A, et al. Implications of the new WHO
guidelines on HIV and infant feeding for child survival in South
Africa. Bull World Health Organ 2011;89:62-67.
6. Kuhn L, Aldrvandi GM, Sinkala M, et al. Effects of early, abrupt
weaning on HIV-free survival of children in Zambia. N Engl J Med
2008;359:130-141.
6. Kuhn L, Aldrvandi GM, Sinkala M, et al. Effects of early, abrupt
weaning on HIV-free survival of children in Zambia. N Engl J Med
2008;359:130-141.
7. Rollins NC, Becquet R, Bland RM, et al. Infant feeding, HIV
transmission and mortality at 18 months: the need for appropriate
choices by mothers and prioritization within programmes. AIDS
2008;22:2349-2357.
7. Rollins NC, Becquet R, Bland RM, et al. Infant feeding, HIV
transmission and mortality at 18 months: the need for appropriate
choices by mothers and prioritization within programmes. AIDS
2008;22:2349-2357.
8. 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 2000:283:1167-1174.
8. 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 2000:283:1167-1174.
9. Leroy V, Ekouevi DK, Becquet R, et al. 18-month effectiveness of
short-course antiretroviral regimens combined with alternatives to
breastfeeding to prevent HIV mother-to-child transmission. PLoS One
2008;3:e1645.
9. Leroy V, Ekouevi DK, Becquet R, et al. 18-month effectiveness of
short-course antiretroviral regimens combined with alternatives to
breastfeeding to prevent HIV mother-to-child transmission. PLoS One
2008;3:e1645.
10. Franke MF, Stulac SN, Rugira IH, et al. High human immunodeficiency
virus-free survival of infants born to human immunodeficiency
virus-positive mothers in an integrated program to decrease child
mortality in rural Rwanda. Pediatr Infect Dis J 2011;30:614-616.
10. Franke MF, Stulac SN, Rugira IH, et al. High human immunodeficiency
virus-free survival of infants born to human immunodeficiency
virus-positive mothers in an integrated program to decrease child
mortality in rural Rwanda. Pediatr Infect Dis J 2011;30:614-616.
11. Hall K. Children’s access to housing. In: Jamieson L, Bray R,
Viviers A, Lake L, Pendlebury S, Smith C, eds. South African Child
Gauge 2010/2011. Cape Town: Children’s Institute, University of
Cape Town, 2011.
11. Hall K. Children’s access to housing. In: Jamieson L, Bray R,
Viviers A, Lake L, Pendlebury S, Smith C, eds. South African Child
Gauge 2010/2011. Cape Town: Children’s Institute, University of
Cape Town, 2011.
12. Hall K. Children’s access to basic services. In: Jamieson L,
Bray R, Viviers A, Lake L, Pendlebury S, Smith C, eds. South African
Child Gauge 2010/2011. Cape Town: Children’s Institute,
University of Cape Town, 2011.
12. Hall K. Children’s access to basic services. In: Jamieson L,
Bray R, Viviers A, Lake L, Pendlebury S, Smith C, eds. South African
Child Gauge 2010/2011. Cape Town: Children’s Institute,
University of Cape Town, 2011.
13. Statistics South Africa. Mortality and causes of death in South
Africa, 2008: Findings from death notification. Statistical release
P0309.3, 2010.
13. Statistics South Africa. Mortality and causes of death in South
Africa, 2008: Findings from death notification. Statistical release
P0309.3, 2010.
14. Doherty T, Chopra M, Jackson D, et al. Effectiveness of the
WHO/UNICEF guidelines on infant feeding for HIV-positive women: results
from a prospective cohort study in South Africa. AIDS 2007;21:1791-1797.
14. Doherty T, Chopra M, Jackson D, et al. Effectiveness of the
WHO/UNICEF guidelines on infant feeding for HIV-positive women: results
from a prospective cohort study in South Africa. AIDS 2007;21:1791-1797.
15. World Health Organization. Guidelines on HIV and Infant Feeding
2010. Principles and Recommendations for Infant Feeding in the Context
of HIV and a Summary of Evidence. Geneva: WHO, 2010.
15. World Health Organization. Guidelines on HIV and Infant Feeding
2010. Principles and Recommendations for Infant Feeding in the Context
of HIV and a Summary of Evidence. Geneva: WHO, 2010.