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Item #8: Comparing Clinical Trial PACTG 1022 to HIVNET 012

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Farber

soon a chorus of condemnation was turned against those who were sensationalizing Hafford's death and the growing HIVNET controversy to condemn nevirapine, which had been branded by the AIDS industry as a “life-saving” drug and a “very important tool” to combat HIV in the Third World.

Gallo

Farber's repeats her mistake on p. 39 col. 3.

Farber fails to inform her readers that she is switching back and forth between a discussion of chronic nevirapine use for treatment with short-course nevirapine for MTCT reduction.

RA

Farber is correctly noting that proponents of Nevirapine in the third world were worried that reports of fatal toxicity in the first world would dent the demand for this drug.

Hafford was not an isolated case, the CDC had previously, in 2001, warned about fatal liver failure when this drug was used for post-exposure prophylaxis [1]. A journal report noted 30 cases of liver toxicity in HIV-negative people taking Nevirapine [2].

While data from one trial cannot be directly extrapolated to a different trial with a different regimen of the same drug, concerns about toxicity should certainly not be ignored. Adverse events will presumably be lower with a single dose but, given that another serious adverse effect of Nevirapine is hypersensitivity reactions, even a single dose could be a serious problem. The manufacturer warned in 2003 that “Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE [Nevirapine]. These have included severe cases of SJS [Stevens-Johnson syndrome, pictures at www.sjsupport.org/pdf/SJS_factsheet.pdf], TEN [Toxic Epidermal Necrosis (skin death)], and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction.” [3]

Refs.

  1. CDC. Serious adverse events attributed to Nevirapine regimens for postexposure prophylaxis after HIV exposures - worldwide 1997-2000. MMWR. 2001 Jan 5; 49(51): 1153-6.
  2. Patel SM et al. Serious Adverse Cutaneous and Hepatic Toxicities Associated With Nevirapine Use by Non-HIV-Infected Individuals. J Acquir Immune Defic Syndr. 2004 Feb 1; 35(2): 120-125.
  3. Guidelines for management of rash with Viramune (nevirapine). Boehringer Ingelheim. 2003 April.

© Copyright January 7, 2008 by Rethinking AIDS.