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Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults
Date:10/26/2008

f CYP3A in patients receiving PREZISTA/r. This list of potential drug interactions is not complete.

PREZISTA must be co-administered with 100 mg ritonavir and food to achieve the desired antiviral effect. Failure to correctly administer PREZISTA with ritonavir and food may result in a loss of efficacy of darunavir. Please refer to ritonavir prescribing information for additional information on precautionary measures.

Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/r. During the clinical development program (n=3063), hepatitis has been reported in 0.5 percent of patients receiving combination therapy with PREZISTA/r. Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse events.

Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/r therapy has not been established.

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/r and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of PREZISTA/r treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/r should prompt consideration of interruption or discontinuation of treatment.

Cases of severe skin rash (0.4 percent) and Stevens-Johnson syndrome (<0.1 percent) have been reported in subjects receiving PREZISTA. In clinical trials (n=3063), rash (all grades, generally mild-to-moderate, regardless of causality) occur
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