E-DRUG: Nevirapine, MTCT and Africa (2)
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[WHO 3x5 website has a report from a recent expert meeting. "The most
efficacious regimen among those recommended for prevention of MTCT for women
with HIV who do not need ARV treatment is zidovudine (ZDV) from 28 weeks
with single dose nevirapine (NVP) at onset of labour for the mother and
single dose NVP plus one week ZDV for the infant." See
http://www.who.int/3by5/arv_pmtct/en/. WB]
Antiretroviral drugs and the prevention of mother-to-child transmission of
HIV infection in resource-limited settings
Expert consultation, Geneva, 5-6 February 2004
A summary of main points from the meeting
Background
WHO convened a technical consultation in Geneva on 5 and 6 February 2004
with scientists, policy-makers, programme managers and community
representatives to review the experience with programmes and recent evidence
on safety and efficacy of different antiretroviral (ARV) drug regimens for
the prevention of mother-to-child transmission (MTCT) of HIV. This
information was reviewed in the context of rapid expansion of ARV treatment
in resource-limited settings using simplified and standardized drug
regimens. Prior to the consultation a draft set of recommendations had been
issued for public comment, which is now under revision in the light of
comments received and the recommendations made at the technical
consultation.
Key recommendations
Women who need ARV treatment for their own health should receive it,
following revised ARV treatment guidelines recently posted by WHO. The use
of ARV treatment when indicated during pregnancy will improve the health of
the mother and substantially decrease the risk of transmission of the HIV
virus to the infant.
Women who do not need treatment, or do not have access to treatment, should
be offered ARV prophylaxis to prevent MTCT using one of a number of ARV drug
regimens known to be safe and effective.
The most efficacious regimen among those recommended for prevention of MTCT
for women with HIV who do not need ARV treatment is zidovudine (ZDV) from 28
weeks with single dose nevirapine (NVP) at onset of labour for the mother
and single dose NVP plus one week ZDV for the infant.
Alternative but less efficacious regimens include one based on ZDV alone
(from 28 weeks of pregnancy and through labour for the mother and for one
week for the infant), one using the combination of ZDV plus lamivudine (3TC)
(from 36 weeks of pregnancy, through labour and one week postpartum for the
mother, and for one week for the infant), and a regimen comprising a single
dose of NVP to the mother and to the infant (which does not need to be
initiated until labour).
The selection of the ARV drug regimen should be made at national level,
based on issues of efficacy, safety, drug resistance, feasibility, and
acceptability.
The consultation participants made these recommendations based on a thorough
review of the current evidence and careful consideration of issues of
efficacy, safety and practicality.
New data reviewed
In particular, the consultation participants reviewed available scientific
evidence on the emergence of resistant HIV strains associated with use of
some ARV drugs for prophylaxis, which has raised concerns about future ARV
treatment options for the mother or, if infected, the infant. They felt,
however, that the evidence regarding the degree of impact of such resistance
is not as yet conclusive. New data from the observational study conducted by
Lallemant et al. in Thailand suggest that the regimen of ZDV and single dose
of NVP could dampen the mother�s response to ARV treatment initiated in the
first months after delivery. These data were taken into account in
developing the above recommendations. However, the consultation participants
felt that the implications of these preliminary data on subsequent treatment
options for women were unclear and require further study. They noted that
more definitive clinical trials assessing this issue are under way. Until
further evidence is available it was the group�s expert opinion that the ZDV
plus single-dose NVP regimen can be recommended for the prevention of MTCT
because of its considerable efficacy in reducing MTCT (by 80%, from the
transmission rates observed with short-course ZDV alone, down to an absolute
level under 2%), its simplicity and its safety profile for mother and
infant. In view of these results, the government of Thailand is implementing
this regimen nationwide for the prevention of MTCT, alongside its efforts to
scale up ARV treatment for all in need.
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