Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Theo Smart
Richard Pollard, M.D., reported on a study comparing AZT to nevirapine plus AZT in 60 AZT-experienced volunteers (abstract 325). The nevirapine plus AZT cohort saw viral load reduced by a median of over 1.57 log (98 percent), but viral load was on its way back to baseline by week four and at baseline by week fourteen. CD4 cell counts had increased by a median of 60 at week eight but were back to baseline by week 28.
Nevirapine's developer, Boehringer Ingelheim also presented a paper on the duration of the drug's effect (abstract 141) based on an analysis of three separate studies including ACTG 241 -- a "convergent combination" study of nevirapine/AZT/ddI. The addition of nevirapine to AZT or AZT/ddI regimens did delay the "return of viral load to baseline" by a few months. Viral loads may linger slightly below their pretreatment value for months without being significantly different from that value.
In March, Boehringer Ingelheim, intends to request FDA marketing approval for nevirapine. While awaiting approval, the company has announced plans to proceed with an expanded access program to provide nevirapine to people with CD4 counts below 50. For more information on eligibility, call 800/595-5494.
Note: Due to an error in the trial announcement, last month's Treatment Issues published an incorrect telephone number for information on the currently enrolling large clinical trial of nevirapine. The correct number is 919/544-3170.
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