|HIV drugs||Nevirapine||Side effects||General|
|A phase I/II study of the safety and pharmacokinetics of nevirapine in HIV-1-infected pregnant Ugandan women and their neonates (HIVNET 006).|| ||Musoke P et al.
| ||“There were five serious adverse events including two deaths in the infants in cohort 1 [out of 8!]. Only one of the five serious adverse events was thought by the investigators to be possibly, but not likely study drug related [but, without a control group, it is possible that all adverse events were related]...In cohort 2 there were seven serious adverse events [out of 13], including two infant deaths, although none were related to the study drug”|
| ||AIDS. 1999 Mar 11;13(4):479-86.||1999|
|Serious adverse events attributed to Nevirapine regimens for postexposure prophylaxis after HIV exposures - worldwide 1997-2000.|| ||Center for Disease Control.
| ||No abstract|
| ||MMWR 2001 Jan 5; 49(51): 1153-6.||2001|
|Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial.|| ||Guay LA, Musoke P, Fleming T, et al.
| ||The Guay et al study of nevirapine showed that both mothers and babies had a high rate of clinical and lab abnormalities (over 80% of mothers), serious adverse events (about 20% of babies by 18 months) and deaths (6.8% of babies).|
| ||Lancet 1999; 354: 795-802.||1999|
|Drug firm withdraws nevirapine|| ||Wise M E Jan
| ||"Problems which US officials said were "potentially quite serious" prompted the withdrawal of an application for approval to allow pregnant women and newborn babies to take... nevirapine for preventing mother-to-child HIV transmission. John Wecker of Boehringer said that the decision came after researchers at the National Institute of Allergy and Infectious Diseases audited a 1999 clinical trial conducted in Uganda for the NIAID by Johns Hopkins University researchers... and published in the British journal Lancet.. (NIAID : "Although no evidence has been found that the conclusions of HIVNET 012 (the Uganda trial) are invalid or that any trial participants were placed at an increased risk of harm, certain aspects of the collection of the primary data may not conform to FDA regulatory requirements" : the irregularities appear to have concerned in part the under-reporting of toxic reactions to the test drugs). LaMontagne (NIAID) said there often were differences of opinion between the Hopkins researchers and the Uganda hospital staff of what constituted a "serious adverse event." He called it "professional differences of opinion."... The pharmaceutical company continues to donate nevirapine to programs in some 23 countries where the drug is used to help prevent mother-to-child HIV transmission, Wecker said." (until such time as it becomes established by usage as ‘the standard of care’)|
| ||Business Day (South Africa) March 23, 2002||2002|
|The trouble with nevirapine|| ||Brink Anthony
| ||Soon after licensing in South Africa, nevirapine hit a bump in the road. Approval of the drug by the MCC presented a grand opportunity to Triangle Pharmaceuticals, an American pharmaceutical corporation founded by former GlaxoSmithKline Director of Research and AZT promotor, David Barry. Eager to cut a slice of the AIDS-drugs action, it needed some guinea pigs on which to try out its experimental drug Coviracil (Emtricibatine, alias FTC), ahead of a licence application to the FDA... Fifty rand to each for every hospital visit – about five dollars. Triangle engaged Quintiles Transnational, described at the time by a Yank newspaper, the Raleigh News and Observer, as “the world’s largest pharmaceutical services company”, to conduct a clinical trial with Coviracil in combination with nevirapine and two other drugs, lamivudine (3TC, an AZT lookalike) and stavudine (d4T, another one). Dr Mariette Botes, an ‘AIDS expert’ at the University of Pretoria and head of the AIDS clinic at Kalafong Hospital in Pretoria, was hired to run the trial there, one of sixteen sites at which the study was conducted. Its subjects were drawn from Atteridgeville, a largely impoverished dormitory complex outside Pretoria for Sotho speakers. The study was called FTC 302. It was an abattoir... Several people died on the drugs... An official investigation found that two of the dead died of liver failure, one of pancreas failure (both conditions caused by acid lacidosis, a standard side effect of antiretrovirals), and two of neurological damage (likewise). Other trial subjects suffered deafness, impaired speech, anal bleeding, sores that wouldn’t heal, abdominal pains, weight loss, fevers, pneumonia, insomnia, vomiting, and depression. The investigation concluded that nevirapine had probably caused the liver damage that had killed two of the women.|