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Published on 13 November 2009

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Prezista monotherapy shows similar efficacy and safety as combination therapy

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48 week data presented by Tibotec, a division of Janssen-Cilag, demonstrates that a once daily dose of PREZISTA (darunavir), a protease inhibitor, boosted with ritonavir as a monotherapy is non-inferior to the same boosted dose of darunavir taken in combination with other antiretrovirals in treatment-experienced HIV-positive adults.

Patients included in the study had baseline viral loads of less than 50 copies/ml, were virologically suppressed and had no history of virologic failure while on combination therapy. The data comes from a phase IIIb, multi-centre, open-label trial called MONET (Monotherapy in Treatment-Experienced Adults).

In addition to the MONET 48-week efficacy results, Tibotec is presenting 21 other abstracts on its compounds at the European AIDS Society Conference in Cologne, Germany.  These abstracts include 96-week efficacy and safety data on once daily darunavir in treatment-naive patients (ARTEMIS study). Tibotec is also presenting 96-week safety and efficacy data on its non-nucleoside reverse transcriptase inhibitor etravirine (DUET studies) as well as data on TMC278, its third antiretroviral which is in late stage clinical development (ECHO and THRIVE studies).

“Darunavir has been available as a twice daily formulation for treatment-experienced adult patients for the past year and in that short time has already made a significant contribution to treatment options,” said Dr Jose Arribas, lead MONET investigator, Hospital de La Paz, Madrid, Spain.

“The studies on darunavir demonstrate the efficacy of darunavir, both as a monotherapy or in combination with other antiretrovirals for adults living with HIV.

For treatment-experienced adult patients, the current licensed dosing for darunavir is 600mg taken with 100 mg ritonavir twice daily with food in combination with other antiretrovirals.

Tibotec



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