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Issue No. 17 | April 30, 2010
A Service of the U.S. Department of Health and Human ServicesView HTML version
News and Features 

FDA Approves Kaletra (Lopinavir/Ritonavir) for Once Daily Dosing in Adults

“On April 27, 2010, FDA approved a new dosing regimen for Kaletra (lopinavir/ritonavir) tablets and oral solution. Kaletra can be administered once daily (800/200 mg) in patients with less than three lopinavir resistance associated substitutions. Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V. Of note, once daily administration of Kaletra is not recommended in pediatric patients.”

The complete revised label will be available at the FDA Web site.

More information is available:

FDA Releases New Drug-Drug Interaction Information for Approved Protease Inhibitors

“The approved protease inhibitors for the treatment of HIV-1 infection now all include the following drug-drug interaction information:

  • Revatio (sildenafil) as a contraindicated medication when prescribed for the treatment of pulmonary arterial hypertension
  • Uroxatral (alfuzosin) as a contraindicated medication
  • Recommendation that salmeterol should not be coadministered 
  • New dosing recommendation for Tracleer (bosentan) and Adcirca (tadalafil) when prescribed for the treatment of pulmonary arterial hypertension. Note, coadministration of bosentan and Reyataz (atazanavir) without ritonavir is not recommended.
  • New dosing recommendations for colchicine when prescribed for the treatment of familial Mediterranean fever or gout
  • New dosing recommendations for colchicine when prescribed for the prophylaxis of gout
  • Recommendation that colchicine should not be coadministered with protease inhibitors in patients with hepatic or renal impairment”

The complete revised labels will be available at the FDA Web site.

More information is available:

Study Suggests Impaired Immunity Against Nontyphoidal Salmonella in HIV-Infected Adults Results From Excess Salmonella Antibodies

“Nontyphoidal Salmonellae are a major cause of life-threatening bacteremia among HIV-infected individuals. Although cell-mediated immunity controls intracellular infection, antibodies protect against Salmonella bacteremia. We report that high-titer antibodies specific for Salmonella lipopolysaccharide (LPS) are associated with a lack of Salmonella-killing in HIV-infected African adults. Killing was restored by genetically shortening LPS from the target Salmonella or removing LPS-specific antibodies from serum. Complement-mediated killing of Salmonella by healthy serum is shown to be induced specifically by antibodies against outer membrane proteins. This killing is lost when excess antibody against Salmonella LPS is added. Thus, our study indicates that impaired immunity against nontyphoidal Salmonella bacteremia in HIV infection results from excess inhibitory antibodies against Salmonella LPS, whereas serum killing of Salmonella is induced by antibodies against outer membrane proteins.”

More information is available:

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