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Published on 25 February 2009

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Prezista approved as part of combination therapy

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Tibotec Pharmaceuticals Ltd has announced that PREZISTA (darunavir) with low-dose ritonavir has been approved as a once-daily, 800 mg dose for treatment-naïve adult HIV patients (those who have never taken HIV medication before) as part of combination therapy.

In addition, the company is also launching a new 600 mg tablet for use in treatment-experienced adult HIV-1 patients (those who already have experience taking HIV medication) as part of combination therapy.

Darunavir, a protease inhibitor (PI), was developed by Tibotec Pharmaceuticals Ltd, Cork, Ireland. Tibotec, a division of Janssen-Cilag Ltd, is the organisation responsible for marketing the brand in the United Kingdom and Europe. Tibotec is a division of Janssen-Cilag and a member of the Johnson & Johnson family of companies.

Darunavir for treatment-naïve patients with HIV
For treatment-naïve patients with HIV, darunavir 800 mg is now available as two 400 mg tablets, to be taken once daily with low dose ritonavir as part of combination therapy. This new formulation with once daily dosing offers greater convenience for treatment-naive patients.

The approval of darunavir’s expanded licence 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 known as ARTEMIS. This study compared the efficacy and safety of darunavir to lopinavir, the current most dispensed PI in the UK, in treatment-naïve adults with HIV.

The study met its primary endpoint, and the 48-week data showed that darunavir was non-inferior to lopinavir for virologic response (confirmed HIV RNA < 50 copies/mL). The pre-planned safety and efficacy analysis at 96 weeks was a secondary endpoint.

At 96 weeks, the study showed darunavir was non-inferior and superior to lopinavir for virologic response (pre-defined test for superiority). Significantly more patients in the darunavir arm reached an undetectable viral load (<50 copies/mL) compared to patients in the lopinavir arm.

“We welcome PREZISTA’s availability as an effective, once-daily option for adults who have never taken HIV medication before. It has made a significant contribution in the care of treatment-experienced adults with HIV for the last two years, and this is an important treatment development for patients,” said Mark Nelson, MD, Consultant Physician and Deputy Director of HIV Research at Chelsea and Westminster Hospital, London, United Kingdom.

The availability of darunavir for treatment-naïve patients in the United Kingdom provides caregivers and patients with an important additional option for managing HIV.

Darunavir for treatment-experienced patients with HIV
Darunavir is now available in the United Kingdom as a 600 mg tablet for treatment-experienced patients with HIV.  The new formulation replaces the 300 mg tablet, therefore halving the number of darunavir tablets a HIV patient must take each day from four to two. The recommended oral dose for treatment-experienced patients remains 600 mg to be taken with 100 mg ritonavir twice daily.

HIV patients must follow strict dosing regimens to ensure their treatment is successful. HIV treatments often have a high pill burden, requiring patients to take different numbers of pills at the same time. High pill burdens can make adherence to treatment more difficult, thereby decreasing the effectiveness of the medication and increasing the risk of both disease progression and death.

Tibotec understands how important it is to help improve treatment options and quality of life for patients, and continues its commitment to develop new, more convenient formulations and making them available as quickly as possible.

Darunavir was first approved by the European Commission in February 2007 for use in highly-treatment experienced patients, and was approved for use in treatment-experienced patients in December 2008. The European Commission authorised darunavir’s treatment-naïve indication on 29 January 2009.

Johnson & Johnson



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