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Darunavir and the risk of hepatitis

Positive Living article • David Menadue • 22 July 2008

A warning has been issued by Tibotec, the manufacturers of Prezista (darunavir) regarding the risk of developing drug- induced hepatitis while taking the treatment. Apparently, 0.5% of clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. participants who took a combination including darunavir (boosted with ritonavir) developed severe hepatotoxicity. Anyone with a history of liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood.-related complications such as hepatitis B or C are particularly susceptible, so appropriate tests prior to starting darunavir and regular monitoring while on the drug are vital to avoid developing any hepatotoxic reaction.

www.ashmAustralasian Society for HIV Medicine. The peak Australasian organisation representing the medical and health sector in HIV/AIDS and related areas. .org.au

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From Positive Living

This article was first published in the July 2008 issue of Positive Living — more than three years ago.

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