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Issue No. 8 | February 26, 2010
A Service of the U.S. Department of Health and Human ServicesView HTML version
News and Features 

FDA Reports: Clinical Trial Data Suggest the Combination of Invirase (Saquinavir) and Norvir (Ritonavir) May Affect the Electrical Activity of the Heart

“The U.S. Food and Drug Administration (FDA) is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir). The data suggest that together the two drugs may affect the electrical activity of the heart.

“The changes to the electrical activity of the heart possibly associated with these drugs, known as prolonged QT or PR intervals, can be seen on an electrocardiogram (EKG). A prolonged QT interval can increase the risk for abnormal heart rhythms, including a serious abnormal rhythm called torsades de pointes. …

“FDA's analysis of these data is ongoing. However, healthcare professionals should be aware of this potential risk for changes to the electrical activity of the heart. Invirase and Norvir should not be used in patients already taking medications known to cause QT interval prolongation such as Class IA (such as quinidine,) or Class III (such as amiodarone) antiarrhythmic drugs; or in patients with a history of QT interval prolongation. …

“This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.”

More information is available:

Reported at CROI: Early Development of Gene Therapy for HIV Promising

“Existing AIDS drugs allow many patients to live fairly normal lives despite being infected with HIV. But they can cause a variety of side effects, and some patients become immune to them over time. …

“In [a] new study, the [University of] Pennsylvania [research] team tested a gene therapy approach in which scientists first remove immune cells from patients, tinker with their genes and then put them back into the bodies of the patients.

“Eight HIV-infected people took part in the study. After the genetically modified cells were placed back into the patients, ‘we stopped HIV treatment and tried to see what happened,’  [Dr. Pablo] Tebas said. …

“The levels of HIV fell below the expected levels in seven of the eight patients, the team found. …

“It's still early in the development of the treatment: the current research is in phase 2 of the customary three phases of research that new medical treatments go through.

“If gene therapy does become a treatment for HIV patients, it may be best for those who aren't doing well on existing antiretroviral drugs, said John Rossi, chairman of the molecular and cellular biology department at the Beckman Research Institute of City of Hope Medical Center near Los Angeles. …

“And it's not clear how long the treatment would last, he said, since the immune cells aren't permanent.”

More information is available:

  • MedlinePlus: News article

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