PACTG 076 and HIVNET 012 30 September 2004
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Eleni Papadopulos-Eleopulos,
Biophysicist
Department of Medical Physics, Royal Perth Hospital, Western Australia, 6001,
Valendar F Turner, John Papadimitriou, Barry Page, David Causer, Helman Alfonso, Sam Mhlongo, Todd Miller, Christian Fiala

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Re: PACTG 076 and HIVNET 012

PACTG 076 and HIVNET 012

In his rapid response “Neonatal HIV” 28 September 2004 Nicholas Bennett wrote “PACTG 076 clearly showed the usefulness of AZT”.

There is no evidence in the ACTG 076 study which shows that AZT decreases MTC during pregnancy or delivery, or even that such transmission takes place.1 See pages 71-75 of reference 1 available at www.theperthgroup.com under the title "MONOGRAPH".

Nicholas Bennett wrote “HIVNET 012 showed that Nevirapine was more effective and much cheaper, and much simpler than AZT”.

As in PACTG 076, in HIVNET 012 there is no evidence which proves that Nevirapine decreased MCT. In fact, given the pharmacological action of the drug and its pharmacokinetics, one wonders how anyone can propose a protocol such as that used in HIVNET 012 and expect any effect on MTC.1 See page 82-83 of reference 1 as well as the HIVNET 012 presentation under "PRESENTATIONS" at our website.

Our claims are supported by the evidence in the latest study on the effect of nevirapine on MCT entitled “Low efficacy of nevirapine (HIVNET 012) in preventing perinatal HIV-1 transmission in a real-life situation”. Here researchers from Kenya and Belgium wrote “In 1999, before the availability of nevirapine or any other antiretroviral drug, we described an early perinatal transmission rate of 21.7% at 14 weeks. This is similar to the 18.1% transmission at 3 months since the introduction of the nevirapine intervention…Our findings question the usefulness of the current prevention of mother-to-child transmission recommendations based on HIVNET 012, which have been implemented in resource-poor settings, based on just one observation in a clinical research setting…Taking into account the low coverage of the nevirapine regimen, the lack of benefit for maternal health, the concerns about resistance, the enormous deployment of resources needed to provide nevirapine with the current voluntary counselling and testing paradigm, and the reported lack of efficacy in real life conditions, the true health gains of the intervention should be reconsidered”.2

References

1. Papadopulos-Eleopulos E, Turner VF, Papadimitriou JM, Alfonso H, Page BAP, Causer D, et al. Mother to Child Transmission of HIV and its Prevention with ATZ and Nevirapine. Perth: The Perth Group, 2001.www.theperthgroup.com

2. Quaghebeur A, Mutunga L, Mwanyumba F, Mandaliya K, Verhofstede C, Temmerman M. Low efficacy of nevirapine (HIVNET012) in preventing perinatal HIV-1 transmission in a real-life situation. AIDS 2004;18:1854- 6.

Competing interests: None declared