PAGE 11
HIV NUTRITION UPDATE
VOLUME 9, ISSUE 4
MEDWATCH:  Truvada®
(Emtricitabine and Tenofovir DF)
By  Stuart Katsh, MS, RD

(Continued from page 10)

 

Black Box Warnings
 
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/tide analogues alone or in combination with other antiretrovirals.
  • Truvada® is not indicated for the treatment of chronic hepatitis B virus (HBV) infection. The safety and efficacy of this drug is not established in patients co-infected with HIV and HBV.
  • Severe acute exacerbations of HBV have been reported in those patients who discontinued Tenofovir DF or emtricitabine. Hepatic function should be monitored closely in all patients co-infected with HBV and HIV who stop using Truvada®.
 
 

Drug, Food, and Herb Interactions
 

  • When Truvada® is administered with didanosine, the Cmax (the highest plasma concentration of a drug between doses) and area under the concentration-time curve (AUC- plasma concentration of a drug, usually over a 24 hour period; average amount of medication that is consistently available) of didanosine increases significantly. Current recommendations are to decrease the dose of didanosine to 250 mg in all patients weighing more than 60 kilograms (kg). There are no dosing recommendations for patients weighing less than 60 kg.
  • Atazanavir and lopinavir/ritonavir have been shown to increase Tenofovir DF concentrations. No dosage adjustments have been recommended.
  • Truvada® decreases the AUC and Cmin (lowest plasma concentration of a drug) of atazanavir. It is recommended to co-administer atazanavir (300 mg) with ritonavir (100 mg) when combined with Truvada®.
  • Careful monitoring is recommended when Truvada® is given with other medications known to have renal and/or hepatic toxicity.
  • Interactions between Truvada® and specific herbs are unknown but people should avoid using any herbs known to interact with HIV medications. Herbs with known precautions should be avoided as well. This may include St. John's Wort, Silymarin (Milk Thistle), garlic, and others.

 
(Continued on page 12)

 
 
 
 
 
 
 
 
 
 
"The safety and efficacy of this drug is not established in patients co-infected with HIV and HBV."

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 

 


 
 
 
 
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5/15/2005