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The United States Food and Drug Administration (FDA) is updatinginformation on Victrelis (boceprevir). The drug is used as a hepatitis C (HCV) protease inhibitor. It is combined with variousritonavir-boosted human immunodeficiency virus ( HIV ) protease inhibitors. The FDA is stating that it cannot recommend use of the drug at thistime, because it appears to reduce effectiveness of othermedications and has been seen to cause HCV and HIV to increase inthe bloodstream. This is known as the viral load, and obviouslyleads to the diseases becoming more potent and aggressive. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir). Ritonavir is an HIV protease inhibitor thatis taken as a small dose along with other HIV protease inhibitorsin order to increase their levels in the blood and make them moreeffective. This is known as ritonavir boosting. The FDA states that patients should not simply stop taking theirmedicines on FDA advice, but must seek consultation with theirphysician as to the best course of action for their particularsituation. The FDA also issues advice for healthcare professionals who aretreating patients with chronic HCV and HIV, using Victrelis wherethe patient was taking antiretroviral therapy in the form ofritonavir-boosted protease inhibitors. The patient's response tothe drug combination should be closely monitored for any unexpectedincrease in virus levels. The FDA has already issued a warning about Victerlis in Feb. 2012,stating that using Victrelis while taking any one of the threeritonavir-boosted HIV protease inhibitors appeared to reduce thedesired blood levels of both medicines. Obviously this isundesirable because lower blood levels of the drug can lead to lesseffective treatment and higher viral load. The FDA goes on to remind healthcare professionals that there isonly limited information on the use and effectiveness of Victrelisand ritonavir-boosted HIV protease inhibitors when they are usedtogether in patients infected with both HIV and HCV. A smallclinical trial studied treatment of patients with both HIV and HCV,where the HCV infection was treated with eitherpeginterferon/ribavirin or boceprivir plus peginterferon/ribavirinand whose HIV infection was treated with ritonavir-boostedatazanavir, ritonavir-boosted darunavir, lopinavir/ritonavir, orraltegravir ( Isentress ). People who took boceprevir plus peginterferon/ribavirin were morelikely to have undetectable HCV viral loads 12 weeks aftercompleting HCV treatment than individuals who receivedpeginterferon/ribavirin alone. Overall, seven patients had HIVvirologic rebound, 3/64 randomized to receive boceprevir withpeginterferon/ribavirin and 4/34 randomized topeginterferon/ribavirin alone. Preliminary results of this clinicaltrial were presented at the 19th Conference on Retroviruses andOpportunistic Infections on March 6, 2012. The clinical trialabstract is online . The FDA says that the findings of the drug-drug interaction studyand the clinical trial, has caused it to revise the Victrelis druglabel to state that co-administration of Victrelis withritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista(darunavir), or Kaletra (lopinavir/ritonavir) to patients infectedwith both chronic HCV and HIV is not recommended at this time. There is a larger clinical trial in process, to look at HCVtreatment with boceprevir and peginterferon/ribavirin, wherepatients have both HCV and HIV and are taking antiretroviraltreatment that use ritonavir-boosted HIV protease inhibitors. TheFDA intends to update any new information it has about the co-useof the drugs. Written by Rupert Shepherd. We are high quality suppliers, our products such as China Cardboard Counter Displays , China Corrugated Carton Box for oversee buyer. To know more, please visits POP Cardboard Displays.
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