Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Immunology | Family Medicine | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Boehringer Ingelheim
Approval Status: Approved June 1996
Treatment Area: HIV infection
Viramune in combination with nucleoside analogues has been
approved by the FDA under its accelerated approval program.
In the first major study presented, ACTG 241, a randomized,
double blind, placebo-controlled trial, researchers followed 398
subjects for 48 weeks at 16 participating investigational sites.
All subjects entering the study had advanced HIV infection with CD4
cell counts of less than or equal to 350 (mean CD4 cell count for
these patients was 153). The study compared the combination of AZT,
ddI, and viramune to the combination of AZT, ddI, and placebo.
Subjects in this trial had received extensive prior nucleoside
therapy. The ACTG 241 study found that the combination of AZT, ddI,
and viramune increased CD4 cell count significantly more than AZT,
ddI, and placebo combination. In a substudy, viral markers were
followed. In these subjects the combination of AZT, ddI, and
viramune, reduced the viral load significantly more than AZT, ddI,
and placebo, throughout the 48 weeks of the trial. The clinical
significance of changes in viral RNA has not been established.
The second major study presented, BI 1046, an international
randomized, double blind, placebo-controlled trial, investigated
viramune in previously untreated subjects. The six-month results
from this twelve-month study compared the combinations of AZT, ddI,
and viramune; AZTand ddI; and viramune and AZT in 151 HIV-1
infected subjects with CD4 counts between 200 and 600. Changes in
CD4 counts through 28 weeks: levels of CD4 in those randomized to
AZT plus ddI plus viramune, and AZT plus ddI remained significantly
above baseline; however there was no significant difference between
these arms. The triple drug regimen containing viramune decreased
the viral load below the limit of detection in about two-thirds of
the subjects, which was significantly greater than either double
In controlled clinical trials, the most common viramune side
effect was rash, which in 7.6% of subjects was considered severe.
Increases in the liver enzymes occurred in 5-10% of subjects
compared with 2-5% in controls. No data are available on disease
progression or survival, however clinical endpoint studies are
Mechanism of Action
Viramune is a non-nucleoside reverse transcriptase inhibitor
(NNRTI), which has a different mechanism of action and a distinct
side effect profile from other classes of currently approved
antiretrovirals. While the nucleoside analogues prevent the growth
of the DNA chain, non-nucleoside drugs directly inactivate the