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Updates to the Prezista (darunavir) package insert, specifically sections: 6 Adverse Reactions, 12.4 Microbiology, 14 Clinical Studies and were approved on October 19, 2011 to include results from the 192-week safety, resistance and efficacy data from study TMC114-C211, “A randomized, controlled, open-label Phase 3 trial comparing PREZISTA/ritonavir 800/100 mg once daily versus lopinavir/ritonavir 800/200 mg per day (given as a twice daily or as a once daily regimen) in antiretroviral treatment-naïve HIV-1-infected adult subjects.”
In addition section 5.3 Severe Skin Reactions now includes the following text about PREZISTA/ritonavir + raltegravir containing regimens.
Rash occurred more commonly in treatment-experienced subjects receiving regimens containing PREZISTA/ritonavir + raltegravir compared to subjects receiving PREZISTA/ritonavir without raltegravir or raltegravir without PREZISTA/ritonavir. However, rash that was considered drug related occurred at similar rates for all three groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.
The complete revised label will be posted soon at Drugs@FDA.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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