Switching to Nevirapine (Viramune) Appears Generally Safe for Patients with High
CD4 Cell Counts
By
Liz Highleyman Treatment guidelines recommend
that treatment-naive women with a CD4 cell count above 250 cells/mm3
and men with more than 400 cells/mm3 should
not receive nevirapine (Viramune)
as part of an initial HAART regimen, due to an elevated risk of hypersensitivity
reactions that could cause severe liver toxicity. However, recent studies indicate that switching to nevirapine may be safe
for patients who previously had a CD4 cell count below these levels, but experienced
good immune recovery after starting antiretroviral therapy. Such a switch may
be undertaken since nevirapine is less likely to cause blood fat elevations compared
with efavirenz (Sustiva) or
most protease inhibitors. In an analysis of the ATHENA cohort, for example, investigators found that
patients on HAART with an undetectable viral load who switched to nevirapine after
their CD4 cell count rose above these thresholds were no more likely to experience
serious reactions than treatment-naive people with lower CD4 counts. However,
patients switching with a detectable viral load did have a higher risk.* At
the recent 47th
Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago,
Spanish researchers reported results from a meta-analysis of studies assessing
the safety and efficacy of substituting nevirapine for a protease inhibitor. The
investigators identified 6 trials -- which included a total of 550 patients --
that compared switching from a protease
inhibitor to nevirapine versus continuing on a protease inhibitor-based regimen.
Study participants had full viral load suppression at the time of the switch.
Overall, the mean CD4 cell count was above 500 cells/mm3.
The proportion of women ranged from about 10% to about 50%, and 25% to 40% were
coinfected with hepatitis C. Results ·
Using an
intent-to-treat analysis, replacement of protease inhibitors with nevirapine was
shown to be “non-inferior” to continuing on protease inhibitor-based therapy in
terms of maintaining viral load suppression (81% vs 78%).
·
Rates of
discontinuation due to adverse events were similar in the switch and unchanged
therapy groups (6.81% vs 9.00%).
·
At end of
follow-up, there were no differences between the 2 groups with regard to CD4 cell
counts, cholesterol or triglyceride levels, or body shape measurements.
·
2 of the
studies reported greater improvements in quality of life in the nevirapine group
compared with those who continued on
protease inhibitors. Conclusion Based
on these findings, the researchers concluded that, “Protease inhibitors replacement
with nevirapine is virologically effective and safe in patients with high CD4
lymphocyte cell counts and those with hepatitis C virus infection.” 09/28/07 References J
Ena, A Leach, and P Nguyen. Efficacy and Safety of Protease Inhibitor
Replacement for Nevirapine in patients with High CD4 Lymphocyte Cell Counts: A
Systematic Review. 47th Interscience Conference on Antimicrobial
Agents and Chemotherapy. Chicago, IL.
September 17-20, 2007. Abstract H-371.
F Wit, A Kesselring, L Gras, and others. Incidence of nevirapine-associated hypersensitivity
reactions is different in patients with prior treatment-experience compared
to treatment-naive patients ATHENA cohort. Fourth International
AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention.
Sydney, Australia. July 22-25,2007. Abstract MOPEB008.
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