European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion For Once-Daily PREZISTA® (darunavir) as Part of Combination Therapy for Treatment-Naïve Adults With HIV-1

Cork, Ireland .- The Committee for Human Medicinal Products (CHMP) has issued a positive opinion recommending approval for once-daily dosing of 800 mg PREZISTA® (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naïve adults (those who have never taken HIV medication before). Darunavir, a protease inhibitor, was developed by Tibotec Pharmaceuticals, and Tibotec, a division of Janssen-Cilag, is the organisation responsible for marketing the brand in Europe.

The positive opinion from the CHMP, the committee responsible for the scientific assessment of new medicinal products, will be reviewed by the European Commission, which then has authority to approve medicines for use throughout the European Union.

The CHMP’s positive opinion is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the ongoing, randomised, controlled, open‑label phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1-infected adults. Patients received 800 mg darunavir once daily with 100 mg ritonavir as part of combination therapy.

Darunavir, co-administered with low dose ritonavir, is currently indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI). Darunavir was given conditional approval by the European Commission in February 2007. The full marketing authorisation from the European Commission for treatment-naïve adult patients is expected in the coming months.

Important Safety Information

In the registrational studies, darunavir was generally well tolerated versus the investigator selected PIs. The majority of the adverse reactions reported in patients who initiated therapy with darunavir 600 mg co-administered with 100 mg ritonavir twice daily were mild to 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 (≥ 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.