E-DRUG: Meeting statement

E-drug: Meeting statement
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     PREVENTION OF HIV TRANSMISSION FROM MOTHER TO CHILD:
       MEETING ON PLANNING FOR PROGRAMME IMPLEMENTATION

GENEVA, 23-24 MARCH 1998

MEETING STATEMENT

Background
Transmission of HIV from mother to child can occur during pregnancy
and delivery, as well as through breastfeeding. Such mother to child
transmission of HIV represents a major cause of morbidity and
mortality among young children, particularly in developing countries
with a high prevalence of HIV infection. Interventions to prevent
mother to child transmission of HIV, including recent breakthroughs in
antiretroviral therapy, offer immediate opportunities to : (i) save
children's lives; (ii) reduce the impact of HIV on families and
communities; and (iii) strengthen maternal and child health services.

In addition to the long regimen (ACTG 076) proven effective in 1994, a
CDC-sponsored trial in Thailand demonstrated in February 1998 that
the use of a shorter zidovudine regimen, which is more feasible and
affordable in developing countries, is also effective. This shorter
regimen, involving the administration of zidovudine to mothers during
the last four weeks of pregnancy and during delivery, has been shown
to reduce mother to child transmission by half among women who do
not breastfeed. An integrated prevention programme which combines
the use of this regimen and the use of safe alternatives to
breastfeeding would be effective in reducing mother to child
transmission of HIV among breastfeeding populations. Recent
cost-effectiveness data suggest that in many developing countries this
intervention is comparable to other public health interventions. It is
clear that there is an urgent need to begin to implement such
interventions to reduce the transmission of HIV from mother to child.

Taking interventions to scale
Any national strategy to prevent mother to child transmission of HIV
should be part of broader strategies to prevent the transmission of
HIV and STDs, to care for HIV-positive women and their families, and
to promote maternal and child health. The ability to make widely
available, and as soon as possible, the interventions to reduce HIV
transmission from mother to child depends on political will,
affordability of the interventions, and the strength of existing human
resources and infrastructures. Powerful means of effecting change lie
in demonstrating the success of interventions to reduce mother to
child transmission of HIV, as well as the costs of not acting to prevent
this kind of transmission.

Three factors that affect the affordability of interventions to prevent
mother to child transmission are : (i) the cost of drugs; (ii) the cost of
safe alternatives to breastfeeding; and (iii) the cost of HIV tests. WHO
has added zidovudine for mother to child transmission to the Essential
Drug List. Glaxo-Wellcome has recently offered zidovudine at
substantially reduced prices. Further negotiations are planned to
minimise the cost of each of these components.

Service delivery, including voluntary HIV counselling and testing,
represents a further set of costs. In countries with well-functioning
health systems, the additional service delivery costs of interventions to
prevent mother to child transmission may be affordable. Other
countries may require more substantial investments in order to
strengthen their health infrastructure to allow for the incorporation of
large scale interventions. Where applicable, traditional health and
community support systems should also be fully utilised. Such
investments will have a broad beneficial effect on the health sector
more generally and should be encouraged.

Optimum Context
The following parameters describe the optimum context in which to
implement effectively the interventions necessary to reduce
transmission of HIV from mother to child:

A. All women should have knowledge about HIV, and should have
access to the information necessary to make appropriate choices about
HIV prevention and about sexual and reproductive health and infant
feeding in the context of HIV.

B. HIV counselling should be available for pregnant women and
those contemplating pregnancy. Such counselling should address the
needs of pregnant women and women living with HIV, including
reproductive health issues such as family planning and safe infant
feeding. Active referral and/or networking for follow-up counselling,
comprehensive care, and social support should be available for the HIV
positive woman and her family.

C. Pregnant women, and those contemplating pregnancy, should
have access to voluntary HIV testing, to test results with the least
possible delay, requiring that appropriate laboratory services be
available to process such tests, and to counselling.

D. All pregnant women should have access to antenatal, delivery
and post-partum care, and to a skilled attendant at birth. For the
shorter zidovudine regimen to be effective, at least one antenatal visit
with follow up is needed before 36 weeks, and preferably before 34
weeks, of gestation. In order to benefit from this intervention, women
who access antenatal services prior to 36 weeks should have access to
HIV voluntary counselling and testing. Skilled care during delivery is
also needed; the shorter zidovudine regimen also involves
administration of zidovudine during labour and delivery.

E. There should be follow-up of children at least until 18 months,
especially for nutrition and for childhood illnesses.

Key principles
The following are some of the key principles that should underpin the
implementation of all interventions to prevent mother to child
transmission :

A. The right to protect oneself from HIV infection, including
through:
(1) access to full information about HIV, including information on
mother to child transmission, information from relevant research, and
information concerning one's serostatus; and (2) access to the means of
prevention, such as condoms and relevant HIV/STD health services.
This requires the integration of HIV prevention, including prevention
of mother to child transmission, into existing systems, e.g. education,
health care (including traditional health care), and community and
women's development (non-governmental and community-based
organisations, traditional community leadership, etc.)

B. The right to decide whether or not, and when, to bear a child.
This requires access to information about family planning and access to
family planning services. It also requires community and family
acceptance of a woman's or a family's decisions.

C. The right to voluntary/informed consent and confidentiality in
HIV testing, counselling and treatment, including choices made in the
context of mother to child transmission. This involves training of
health care workers, including traditional health care workers, in
providing informed consent and protecting confidentiality, and should
lead to voluntary, informed, and when possible, supported
decision-making on these and related issues.

D. The right to an environment which enables women, parents and
families to make choices that protect their health and that of their
loved ones, and to act upon these choices. This includes reducing
stigma and discrimination related to HIV and to mobilising communities
for support. It also includes improving access to health care, including
voluntary counselling and testing, antiretroviral treatment in
pregnancy, treatment for opportunistic infections, and to the conditions
necessary to use safe alternatives to breastfeeding.

E. The right to ethical research, including research that does no
harm, is conducted with informed consent and with the participation of
communities in research design and implementation, and involves the
dissemination of research results to affected communities.

Unresolved issues
The efficacy of zidovudine in preventing HIV transmission to the child
from an HIV positive mother who breastfeeds is currently not known.
Zidovudine may provide some degree of protection, although probably
less than the protection it provides to infants who are not breastfed.
Since the majority of HIV positive women facing transmission from
mother to child are women who breastfeed, it is critical to resolve this
issue. It is also necessary to learn more about the effect on the
morbidity and mortality of infants born to HIV positive women of
introducing alternatives to breastfeeding.

Nevertheless, the greatest reduction in mother to child transmission
of HIV is likely to occur when an integrated prevention programme is
implemented which combines the provision of zidovudine and safe
alternatives to breastfeeding. In some countries, it may prove to be
impractical to implement simultaneously access to zidovudine and access
to safe alternatives to breastfeeding. In these situations, the
implementation of one prevention component should not be delayed
until the other is feasible. Furthermore, if a woman chooses not to use
both zidovudine and safe alternatives to breastfeeding, she should still
have access to the intervention of her choice and should be supported
to carry out the use of this intervention safely and effectively.

Other unresolved issues involve the efficacy of even shorter regimens
of zidovudine than that used in the Thai study, and the efficacy of
interventions which do not require knowledge of serostatus, such as
Vitamin A supplementation and vaginal cleansing for prevention of
mother to child transmission. Results from ongoing research will
indicate whether or not these can be proposed as effective
interventions on their own, or only as measures complementary to an
antiretroviral regimen.

Additional research is also required on issues such as factors
influencing the uptake of voluntary testing and counselling, not
returning for HIV test results, adherence to the regimen, and
acceptance of interventions to prevent mother to child transmission.

The Need for Action and Support
A global effort is needed to promote the updating and scaling up of
interventions to prevent mother to child transmission of HIV.
Furthermore, there is an ethical imperative to support the introduction
of the shorter zidovudine regimen in countries in which trials have
been completed, and to encourage the initiation of such interventions
in countries which have the capacity and willingness to support them.
Recognising the urgency of the situation and at the same time the fact
that it will take time to mobilise new resources for these interventions,
it is recommended that a phased approach be taken in the introduction
of such interventions. Such an approach would tailor implementation to
utilise fully and immediately existing national and local capacities, with
a concrete plan to build on these initial efforts over time. Where the
capacity to implement these interventions is limited, efforts should
begin immediately to increase capacity, with a plan to introduce these
interventions as soon as possible.

Coordination mechanisms
Mechanisms are being established through UNAIDS, in close
collaboration with UNICEF and WHO, to coordinate and support efforts
for accelerated capacity-strengthening and technical development, and
to scale up the implementation of interventions to reduce mother to
child transmission. These mechanisms will facilitate the exchange of
information, mobilise resources, help to coordinate research, and
resolve remaining policy, programmatic and technical issues. Key actors
are presently discussing the nature and functioning of these
coordination mechanisms.

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