FOR WIDEST DISTRIBUTION
Sections 27(1) and (2) of the Constitution require the
government to devise and implement within its available resources a
comprehensive and co-ordinated programme to realise progressively the
rights of pregnant women and their newborn children to have access to
health services to combat mother-to-child transmission of HIV. ...
The policy for reducing the risk of mother-to-child transmission of HIV
as formulated and implemented by government fell short of compliance
with the requirements ...
3. Government is ordered without delay to ... [r]emove the
restrictions that prevent nevirapine from being made available for the
purpose of reducing the risk of mother-to-child transmission of HIV at
public hospitals and clinics that are not research and training sites.
4. The orders made in paragraph 3 do not preclude government from
adapting its policy in a manner consistent with the Constitution if
equally appropriate or better methods become available to it for the
prevention of mother-to-child transmission of HIV."
- Constitutional Court Judgment, 5 July 2002
The Treatment Action Campaign welcomes the recommendation of the
Medicines Control Council that a combination of antiretrovirals be used
to prevent mother-to-child transmission transmission of HIV instead of
the current protocol in the public sector which uses just one
antiretroviral, nevirapine. Combination regimens are more effective than
the current single-dose nevirapine regimen. However, it is crucial, as
well as a legal obligation of government, that health facilities
currently implementing the single-dose nevirapine regimen are allowed
to continue doing so until they have the capacity to upgrade to
combination regimens. The Department of Health must as soon as possible
ensure health facilities are given the resources they need to upgrade
to the combination regimens.
Statements attributed to the Minister of Health, Manto
Tshabalala-Msimang, at the International AIDS Conference in Bangkok have
caused unnecessary public confusion about nevirapine. The Minister
should have used the occasion to talk about the benefits of the South
African mother-to-child transmission prevention programme, which has
saved many lives and is possibly the largest in the world. She also
could have announced that her department is considering improving the
current regimen. Instead, public confidence in the current single-dose
nevirapine regimen has been undermined needlessly.
Pregnant women need to be able to choose whether or not to participate
in the mother-to-child transmission prevention programme based on clear
public messages. Since there are many benefits to the programme, it is
important to encourage participation by explaining the facts clearly and
correctly. This is the purpose of the remainder of this statement.
- The single-dose nevirapine regimen for mother-to-child
transmission prevention involves a pregnant HIV-positive woman taking a
single dose of nevirapine when she is in labour and the child taking a
single dose of nevirapine syrup shortly after birth. There are minor
variations in the size of the dose. According to all available evidence,
this regimen is safe and effective for mother-to-child transmission
prevention. Since its implementation in South Africa, it has prevented
HIV-infection in thousands of children.
- A strain of the virus that is resistant to nevirapine has been
detected in a large minority of women after they use the single-dose
nevirapine regimen. Scientists are not sure, but this might mean
these women will not be able to use nevirapine or antiretrovirals in the
same class as nevirapine (such as efavirenz) effectively as part of
triple-drug therapy for their own treatment, or for mother-to-child
transmission prevention if they have a subsequent pregnancy. This is
called drug resistance. It has been known to be an issue with
single-dose nevirapine since before the mother-to-child
transmission prevention Constitutional Court case between the TAC and
the Minister of Health. This resistance issue does not affect the
safety of nevirapine. (Technical Note: Scientists are not certain
of how prevalent resistance is after single-dose nevirapine or what its
consequences are for being able to use nevirapine in the future. In
studies, a form of the virus resistant to nevirapine is found in the
blood of between 30 to 50% of women who have used a single-dose
nevirapine regimen. There is also evidence, presented at the Thailand
conference, that the resistant strain of the virus is no longer
detected in all except 14% of women six months after they took the
- Other more complex regimens using nevirapine and other
antiretrovirals are more effective at reducing mother-to-child
transmission. Any combination of antiretroviral therapy can result in
resistance but the best combination of medicines for reducing
transmission from mother to child and avoiding resistance would be to
use three antiretroviral medicines (known as triple-drug combination
therapy) where medically indicated. With the introduction of treatment
for AIDS into the South African public health service, it makes sense
to keep as many antiretroviral drug options as possible open to
pregnant HIV-positive women for when they later develop AIDS. Therefore
switching the mother-to-child transmission protocol to one which is
more effective and results in less resistance is sensible.
- With regard to drug resistance, the problems encountered with
antiretrovirals are quite similar to resistance problems encountered
with anti-viral, anti-fungal and antibiotic medicines. (Technical
Note: The extremely fast rate of reproduction and mutation of HIV
renders it more challenging to deal with than most other viral, fungal
and bacterial infections.)
- In the Western Cape Province, a combination of AZT and nevirapine
is used to prevent mother-to-child transmission prevention. This regimen
is more effective than single-dose nevirapine (see the abstract from the
New England Journal of Medicine copied below this statement).
Nevertheless, there are other, even better, regimens.
- The Minister of Health suggested in Bangkok that the TAC forced
government to adopt the single-dose nevirapine regimen. It is true that
the TAC forced government to implement a country-wide mother-to-child
transmission prevention programme by taking the Minister of Health to
court. This action has saved the lives of thousands of children.
However, it is not true that the TAC forced the government to adopt the
single-dose nevirapine regimen for mother-to-child transmission
prevention. This regimen was the Department of Health's choice for the
mother-to-child transmission prevention pilot sites implemented in 2001.
It was known even then that more effective regimens existed, usually
involving AZT. But for reasons not made clear, the single-dose
nevirapine regimen was chosen. This was arguably a reasonable choice
though; single-dose nevirapine is simple to administer and a good
starting point for the rollout of a mother-to-child transmission
prevention programme. The Constitutional Court judgment, quoted at the
beginning of this statement, states that nevirapine or other appropriate
methods may be used.
- TAC's stance, as articulated in numerous media interviews as well
as written statements, has consistently been that regimens other than
the single-dose nevirapine can be introduced into the public sector
wherever possible (e.g. see TAC's statements on 26 July 2000,8 August 2000,2
October 2001, 25 October
2001 and 31 July
2003 as well as the court
papers in the mother-to-child transmission prevention case).
- Where there is a current lack of capacity in a clinic, the
single-dose nevirapine regimen is the minimum acceptable regimen for
mother-to-child transmission prevention. But where such lack of
capacity exists, clinics must be given the resources they needs to
upgrade. Also, where an HIV-positive woman presents late to an antenatal
clinic (e.g. during labour), single-dose nevirapine might be the only
regimen available to her.
- Transmission due to the method of infant feeding (breast-feeding
versus formula) should not be confused with the safety and efficacy of
single-dose nevirapine or any other regimen. However, the TAC endorses
the World Health Organisation stance on this issue, which, greatly
abbreviated, is that HIV-positive pregnant women should receive accurate
counselling on the matter and then make their own choice.
Since the Minister's statement in Bangkok, the TAC has received calls
from members of the public wanting to know if they should stop using
nevirapine as part of their triple-drug antiretroviral therapy. We have
also been asked if nevirapine should stop being used as part of
mother-to-child transmission prevention. The answer to both these
questions is obviously no. Clearly such confusion is concerning.
The science of mother-to-child transmission, as with any other active
scientific endeavour, is evolving and improving all the time. It is
possible that a few years from now better options for preventing
mother-to-child transmission will become available; this would not
negate the validity of decisions taken today based on the best available
science. It is essential that government conveys accurate scientific
information to the public without causing confusion. There are
currently a number of good antiretroviral regimens for preventing
transmission, albeit that some are better than others. HIV-positive
pregnant women must be offered at least one of these regimens,
preferably the best one withing government's available resources.
[END OF STATEMENT]
The abstract below, published in the New England Journal of Medicine a
few days ago, adds further weight to the evidence of the efficacy of
nevirapine as part of an AZT regimen.
Here is the NEJM abstract:
Published at www.nejm.org
July 9, 2004
Single-Dose Perinatal Nevirapine plus Standard Zidovudine to Prevent
Mother-to-Child Transmission of HIV-1 in Thailand
Marc Lallemant, M.D., Gonzague Jourdain, M.D., Sophie Le Coeur, M.D.,
Ph.D., Jean Yves Mary, Ph.D., Nicole Ngo-Giang-Huong, Pharm.D., Ph.D.,
Suporn Koetsawang, M.D., Siripon Kanshana, M.D., Kenneth McIntosh, M.D.,
Vallop Thaineua, M.D., for the Perinatal HIV Prevention Trial (Thailand)
Background Although zidovudine prophylaxis decreases the rate of
transmission of the human immunodeficiency virus (HIV) type 1
substantially, a large number of infants still become infected. We
hypothesized that the administration, in addition to zidovudine, of a
single dose of oral nevirapine to mothers during labor and to neonates
would further reduce transmission of HIV.
Methods We conducted a randomized, double-blind trial of three treatment
regimens in Thai women who were receiving zidovudine therapy during the
third trimester of pregnancy. In one group, mothers and infants received
a single dose of nevirapine (nevirapine-nevirapine regimen); in another,
mothers and infants received nevirapine and placebo, respectively
(nevirapine-placebo regimen); and in the last, mothers and infants
received placebo (placebo-placebo regimen). The infants also received
one week of zidovudine therapy and were formula-fed. The end point of
the study was infection with HIV in the infants, established by
Results Between January 15, 2001, and February 28, 2003, a total of 1844
Thai women were enrolled. At the first interim analysis, the independent
data monitoring committee stopped enrollment in the placebo-placebo
group. Among women who delivered before the interim analysis, the
as-randomized Kaplan-Meier estimates of the transmission rates were 1.1
percent (95 percent confidence interval, 0.3 to 2.2) in the
nevirapine-nevirapine group and 6.3 percent (95 percent confidence
interval, 3.8 to 8.9) in the placebo-placebo group (P<0.001). The
per-protocol transmission rate in the nevirapine-nevirapine group, 1.9
percent (95 percent confidence interval, 0.9 to 3.0), was not
significantly inferior to the rate in the nevirapine-placebo group (2.8
percent; 95 percent confidence interval, 1.5 to 4.1). Nevirapine had an
effect within subgroups defined by known risk factors such as viral load
and CD4 count. No serious adverse effects were associated with
Conclusions A single dose of nevirapine to the mother, with or without a
dose of nevirapine to the infant, added to oral zidovudine prophylaxis
starting at 28 weeks' gestation, is highly effective in reducing
mother-to-child transmission of HIV.
Notice: To coincide with presentations at the 15th International AIDS
Conference, this article was published at www.nejm.org
on July 9, 2004.
It will appear in the July 15 issue of the Journal.