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European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion for Once-Daily PREZISTA(R) (Darunavir) as Part of Combination Therapy for Treatment-Naive Adults With HIV-1
Date:11/27/2008

moderate in severity. Thirty percent of the patients experienced at least one adverse drug reaction (at least grade 2 in severity and considered by the investigator at least possibly related to darunavir co-administered with 100 mg ritonavir). The most frequently (greater than or equal to 2 percent) of those reported adverse reactions were diarrhoea (3.9 percent), hypertriglyceridaemia (3.8 percent), rash (2.8 percent), nausea (2.6 percent), hypercholesterolaemia (2.5 percent) and headache (2.0 percent). 2.6 percent of the patients discontinued treatment due to adverse reactions.

Before taking darunavir, patients should tell their doctor if they have any medical conditions, including liver problems, including hepatitis B or C, diabetes, symptoms of infections, change in body fat, haemophilia, musculoskeletal problems, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant or planning to become pregnant, or are nursing.

Darunavir should not be used in patients allergic (hypersensitive) to darunavir or ritonavir or with severe liver problems.

There were some relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications. Patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Darunavir does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Please see full Summary of Product Characteristics for more details.

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company, with offices in Yardley, PA, USA and its main research and development operations in Mechelen, Belgium. Tibotec is dedicate
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