Apologies for cluttering inboxes today. This is the first of two
newsletters we are sending due to the need to respond to, and report
on, a number of urgent events.
15 December 2004
Single-dose nevirapine is safe and effective
But public health facilities must switch to more effective regimens
Department of Health has once more issued an unscientific,
irresponsible and inaccurate statement on nevirapine aimed at
undermining public health
Specifically for the media, we emphasise:
The criticisms levelled by the parties involved in the NIH news
story, that broke two days ago, do not provide evidence questioning the
safety or efficacy of short-course nevirapine. It is false, as has been
reported in some places and by the Department of Health, that
short-course nevirapine has been associated with thousands of adverse
events. There is to date not a single reported life-threatening adverse
event associated with this regimen which is used widely in the
The criticisms of the NIH management relate to the conduct of the trial
and the NIH's communication of the problems associated with the HIVNET
The TAC is angry and considering legal advice on the Department of
Health's continued misinformation campaign on nevirapine. Today, yet
again, the Department issued a statement misrepresenting the safety of
nevirapine. It also misrepresented the Constitutional Court order in
the mother-to-child transmission prevention case.
The Department stated today that "unfortunately a court order issued
to us by the Constitutional Court did not allow us to proceed in a more
cautioned manner. The MCC did not recommend
that the use of Nevirapine be stopped altogether, but that it should be
used in combination with other drugs, because it was showing a
significant resistance of up to 50%. This means that the South African
Government's policy to reduce the risk of mother to child transmission
of HIV remains unchanged."
It then concluded "The Department of Health will continue providing
Nevirapine as monotherapy (a single drug) to mothers and babies at
public health facilities until new approach has been decided upon."
But the Constitutional Court order actually states:
"Government is ordered without delay to:
a) Remove 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."
The TAC demands that government immediately implement a policy that
public health facilities wherever possible switch to combination
regimens using AZT and nevirapine, as the Western Cape government has
already done, or triple-drug therapy.
Considering that (1) the Medicines Control Council has
recommended switching over to combination therapy, (2) the
Department of Health is concerned about its choice of nevirapine
monotherapy, (3) there are numerous well-established
combination regimens it can use, there is no excuse for the
Department's continued prevarication.
In 2001, the South African Government chose single-dose nevirapine as
the antiretroviral regimen to use to prevent mother-to-child
transmission prevention. Other, more effective, regimens were
available, but the TAC accepted this decision of the South African
government at the time because it represented an opportunity to start
this programme. The history of how government then failed to implement
the programme and how the TAC then initiated a successful court action
which resulted in the Constitutional Court ordering the government to
implement mother-to-child transmission prevention using nevirapine or
other suitable medicines is well documented on the TAC website.
However, for a long time now, it has been the TAC position that there
are much more effective regimens than single-dose nevirapine and these
should be used wherever possible. The pace of switching over to more
effective regimens for preventing mother-to-child transmission is much
too slow outside the Western Cape.
The US based public research agency, the National Institutes for Health
(NIH) conducted the original study in Uganda examining the safety and
efficacy of single-dose nevirapine. This study is known as HIVNET 012.
In the last three days, a news story has broken in which the NIH is
alleged to have failed to meet appropriate clinical trial standards in
conducting the HIVNET 012 trial. In addition, it is alleged that Edmund
Tramont, chief of NIH's Division of AIDS, rewrote a report published in
early 2003 presenting more
favorable conclusions of the study's conduct than the original draft.
The NIH has also been criticised for its communication of the way the
study was conducted.
The TAC supports an investigation into the conduct of the NIH. If any
cover-up is found to have occurred, those involved must be held liable
It is critical that public confidence in a life-saving treatment used
in many public facilities throughout South Africa and the developing
world should not be undermined without due cause. Therefore, the TAC
points out the following:
- All available evidence demonstrates that nevirapine is safe and
effective for single-dose mother-to-child transmission prevention.
- Evidence confirming the safety and efficacy of nevirapine for
mother-to-child transmission when used as a single-dose or in
combination with other antiretrovirals comes from multiple trials
around the world including ones conducted in South Africa, Thailand and
Uganda. A cohort study in South Africa published of an operational site
has also added to the evidence demonstrating the efficacy of
single-dose nevirapine for mother-to-child transmission prevention.
- The registration of nevirapine for mother-to-child transmission
in South Africa is no longer based on the HIVNET 012 study.
- Tens of thousands of pregnant women and infants have taken
single-dose nevirapine. Not a single life-threatening adverse event has
- No new evidence has been offered to question the safety and
efficacy of nevirapine for single-dose mother-to-child transmission
prevention following the news story that has broken in the last two
days. The questions raised relate to the conduct of the NIH.
- It is however more effective to prevent mother-to-child
transmission using a combination of antiretroviral medicines which may
include nevirapine. Where possible, clinics and hospitals should switch
over to combination therapy. This has been done in the Western Cape but
is occurring too slowly in the rest of South Africa.
- Single-dose nevirapine is associated with a resistant strain of
HIV developing in a high percentage of women. However, it is not clear
if this has a long-term consequence for the antiretroviral treatment
regimens available to such women when they begin treatment, or if other
commonly used but more effective regimens are not subject to the same
- When nevirapine is used as a chronic HIV treatment it is very
effective. In some cases, serious side-effects affecting the liver
occur and with proper monitoring people experiencing such side-
- Clinical trials and research should be conducted to the highest
accepted ethical standards. Therefore, the TAC supports calls for an
investigation into the conduct of the NIH with regard to the HIVNET 012
trial. This is particularly relevant following the recent Vioxx scandal
and allegations that the US based public research body, the Centre for
Disease Control, has willfully underestimated tobacco-related deaths.
- Reporting in South Africa over the last 24 hours regarding this
news story has been sloppy, with many journalists failing to understand
the content or context of what is being debated. This has the potential
to undermine public confidence in nevirapine unnecessarily. Science
reporting in South Africa is generally poor and the TAC will endeavour
in the future to work with journalists and other organisations to
improve the quality of science reporting.
We draw readers attention to a newsletter written by the TAC on 15 July
2004. It contains a more detailed discussion on this subject. See