Item #30: Nevirapine and a Study with 561 People

The HIV transmission rate reported for nevirapine in the HIVNET 012 study was 13.1%. However, without antiviral treatments, mother-to-child transmission rates vary from 12% to 48%. The HIVNET 012 outcome is higher than the 12% transmission rate reported in a prospective study of 561 African women given no antiretroviral treatment.

Farber quotes Turner referring to a study of 561 people.

We are not sure what the 561 person study is that Turner refers to. No reference is supplied by Farber. We have given references above demonstrating that transmission is generally in the 25% region after a few months.

Turner is referencing an African study published in 1998 that stated that “Presence of HIV-infection was assessed in 158 children [of HIV-positive mothers]…Overall, 19 children were diagnosed as HIV-infected [12%, even though there was no access to antiretroviral therapy or other interventions] ” [1]

The website aidstruth.org, run by mainstream AIDS researchers, published an accusatory article by Nathan Geffen and Jeanne Bergman that notes correctly that this Ladner research was interrupted by the tragic civil war in Rwanda. They unfortunately then leap to the conclusion that, if this missing data was known, “The actual figure for perinatal HIV transmission was almost certainly much higher [than 12%]”.

Dr. Valendar Turner, the main target of this piece, has responded effectively at theperthgroup.com/LATEST/Geffen.html.

Additional research by us uncovered another study that produced very similar results, an HIV transmission rate of 7.2% at birth, in a much more stable African country, Tanzania. No war interrupted this trial. Consequently, data on HIV status on birth was available for 838 of 925 mothers:
“The Tanzania Trial of Vitamins was conducted between 1995 and 2003 among 1078 HIV-1-positive women who were pregnant at enrollment to ascertain the effect of vitamin supplements on MTCT, pregnancy outcomes, and other survival and health endpoints…Antiretroviral medications were not available in Tanzania at the time of the study…Of the 925 live births that occurred in the group of women considered for analyses, HIV status at birth was known for 838; of these, 60 (7.2%) were positive.” [2]
By comparison, the HIVNET 012 study in Uganda gave the rate of HIV transmission for nevirapine as “8.2% at birth” and “11.9%” at 6 weeks [3]. The latter figure is similar to the 6-week rate of 11.1% in the placebo group of another large clinical study in Tanzania that did not involve antiretrovirals [4]. Furthermore, a large prospective study in South Africa, in which “no woman received antiretroviral therapy,” reported that the 3 month rate was only 14.6% “for those exclusively breastfed for 3 months” [5]; this is only slightly higher than the 13.1% for nevirapine at 3 months (3). In Kenya, the 3 month HIV transmission rate with nevirapine “was 18.1%, similar to the 21.7% before the intervention” [6].
In the study of nevirapine and AZT in Uganda [3], 120 of “the 616 assessable babies,” or 19.5% , were left out of the 3 month analysis (see section, “Primary efficacy analysis”). This proportion is only slightly less than the 22% (60 of 275) who were missing from follow-up in the Ladner study [1] due to civil war in Rwanda.
The main point, that the Gallo document ignores, is that trials without a placebo cannot conclude that either active treatment A (e.g. AZT) or active treatment B (e.g. Nevirapine) is better than doing nothing (i.e. a placebo). It could be argued that in the Tanzanian trial [2], which was conducted by Harvard researchers, the rate of HIV seropositivity in infants was reduced due to the provision of vitamin supplements. But, if that is the case, it is shocking that less effective toxic drugs are preferred over cheap and non-toxic vitamins (which also have other benefits unlike drugs intended to be specific for HIV).

1. Ladner J et al. Chorioamnionitis and pregnancy outcome in HIV-infected African women. J Acquir Immune Defic Syndr. 1998 Jul 1; 18(3): 293-8.
2. Villamor E et al. Wasting during pregnancy increases the risk of mother-to-child HIV-1 transmission. J Acquir Immune Defic Syndr. 2005 Apr 15; 38(5): 622-6.
3. Guay L. A. et al. HIVNET 012 randomized trial. Lancet 354:795-802, 1999.
4. Baylin A. et al. Effect of vitamin supplementation to HIV-infected pregnant women on the micronutrient status of their infants. Eur. J. Clin. Nutr. 59:960-968, 2005. (See Table 1.)
5. Coutsoudis A et al. Influence of infant-feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa. Lancet 354:471-476, 1999.
6. Quaghebeur A. et al. Low efficacy of nevirapine (HIVNET012) in preventing perinatal HIV-1 transmission in a real-life situation. AIDS 18:1854-6, 2004.