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September 20, 2010

Switch to nevirapine can happen at any CD4 count, says European drug regulator

aidsmap: "People with HIV who have an undetectable viral load can safely switch to nevirapine (Viramune) at any CD4 cell count, the European Medicines Agency has concluded.

"The agency has issued a revised Summary of Product Characteristics to allow switching in people with suppressed viral load who want to switch to nevirapine for reasons of tolerability or cost.

"The agency’s Committee for Medical Products for Human Use reviewed evidence from clinical studies to determine whether people who switched to nevirapine from an existing antiretroviral regimen had an increased risk of liver toxicity or hypersensitivity reaction at higher CD4 cell counts.

"People who have never taken antiretroviral treatment are at increased risk of these reactions at higher CD4 cell counts. Women with CD4 counts above 250 and men with CD4 counts above 400 should not start treatment with the drug, regulatory agencies have ruled.

"However, evidence from cohort studies conducted prior to the ruling has demonstrated that switching to nevirapine after achieving an undetectable viral load is not associated with an increased risk of toxicity, even if a person’s CD4 count has risen above the CD4 count thresholds that rule out use of the drug in untreated people."