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The CHMP decided that Sustiva’s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents and children three months of age and older. The Committee noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working. The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Sustiva in the past but which sped working, although there is no evidence to suggest that protease inhibitors may not work in these patients. The Committee recommended that Sustiva be given marketing authorisation.
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