The accelatedly approved antiviral drug is called Prezista or darunavir and used for treatment of HIV infection in the people with infection of the human immunodeficiency virus. FDA warned that Prezista is not a cure but can do combine with other standard therapies.
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Prezista is a new HIV protease inhibitor. The FDA requires that the drug be used with a low-dose of ritonavir and other active anti-HIV drugs. Use of ritonavir, approved in 1996, can slow the breakdown of Prezista in the body so that its effective concentration may remain longer in the patient's system.Bad:
"This approval offers new hope to HIV patients who too often urgently need new therapies in order to maintain their health," said Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs.
"This (HIV) drug is not a cure, but when combined with other standard therapies, it presents one more major step in our effort to help patients combat the effects of the disease."
Today's (24 June/06) accelerated approval is based on evidence from two randomized, controlled studies comparing the safety and effectiveness of the Prezista treatment with other comparable treatments.
The most common side effects reported by patients on the Prezista regimen included diarrhea, nausea, and headache. About seven percent of participants on this combination therapy experienced skin rashes ranging from mild to serious.Link
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