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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