Subject: Single-dose nevirapine is safe and effective. But health facilities must switch to more effective regimens wherever possible.
From: TAC News Service
Date: Wed, 15 Dec 2004 17:15:13 +0200
To: news@tac.org.za

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 wherever possible

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 developing world.

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 012 trial.


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.

Background


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 and prosecuted.

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:


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 http://www.tac.org.za/newsletter/2004/ns15_07_2004.htm .

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