Item #23: Hopkins Medical News Hyping Nevirapine?

On September 4, 1999, The Lancet published HIVNET's preliminary results, reporting that “Nevirapine lowered the risk of HIV-I transmission during the first 14–16 weeks of life by nearly 50 percent.” The report concluded that “the two regimens were well-tolerated and adverse events were similar in the two groups.” The article also reported that thirty-eight babies had died, sixteen in the nevirapine group and twenty-two in the AZT group. The rate of HIV transmission in the AZT arm was 25 percent, while in the nevirapine group it was only 13 percent. As Hopkins Medical News later reported, the study was received rapturously. “The data proved stunning. It showed that nevirapine was 47 percent more effective than AZT and had reduced the number of infected infants from 25 to 13 percent. Best of all, nevirapine was inexpensive—just $4 for both doses. If implemented widely, the drug could prevent HIV transmission in more than 300,000 new-borns a year.”

Farber quotes Hopkins Medical News stating that nevirapine is more effective than AZT at reducing MTCT.

This is not the full story. Short-course nevirapine is better than at least one short course AZT regimen that has been tested (i.e. the one tested in HIVNET 012). There are AZT regimens that are more effective than short-course nevirapine. It should be noted that single-dose nevirapine is a sub-optimal regimen for reducing MTCT, in respect of its efficacy. Its advantage lies in its relative affordability and the simplicity of its use, compared to more complex and expensive regimens. It is considered no more than a starting point for resource-poor health facilities or as one measure that can be used for HIV-positive women whose status is determined too late for other antiretroviral regimens (poor or well-off setting). 43

The Gallo document does not challenge the observations of Farber. These are that the reduction in HIV transmission by Nevirapine was received uncritically, that there were no concerns about the quality of the trial, that the absence of a placebo was not noticed and that trials without antiretroviral therapy recording lower levels of HIV transmission were ignored.