TMC 114
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TMC114, also known as darunavir (DRV), was developed by Tibotec Pharmaceuticals. and was first approved by the United States Food and Drug Administration in June 2006. It was approved by the European Medicines Evaluation Agency in February 2007.
Two years after it granted darunavir accelerated approval, the U.S. Food and Drug Administration (FDA) has approved a new dosage regimen for a new patient population. Traditional approval, expands the indication for darunavir/rtv to include treatment-naïve patients and marks a major milestone both for Tibotec and the HIV community. Darunavir/rtv is now an option for HIV-1 infected patients across the treatment spectrum in the U.S. and more recently in the EMEA and Canada. With the expanded indication, Tibotec is able to reach new communities of patients and to establish darunavir as an important treatment option for initial therapy as well as for those who have failed previous regimens. The new dosage for treatment-naïve patients (those who have never been on HIV drug therapy) is a once-daily dose (800 mg darunavir, taken as two 400 mg tablets with 100 mg of ritonavir) - a simple regimen. Once daily dosing regimens have been shown to increase patients' adherence to treatment. The darunavir/rtv once-daily regimen has shown good tolerability combined with high efficacy rates in clinical trials making darunavir/rtv an excellent option for treatment-naïve patients.
The FDA traditional approval is based on 48-week clinical trial data from two ongoing phase III trials TMC114-C214 (TITAN) and TMC114-C211 (ARTEMIS). The EU full approval was obtained following the renewal applications fulfilling all remaining specific obligations.
In the EU, darunavir 400 mg, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in antiretroviral therapy (ART) naïve adults. Darunavir 300 mg and 600 mg, co administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in treatment experienced adult patients, including those that have been highly pre treated.
TMC114 Clinical Trials
Two phase IIb controlled and randomized studies, POWER 1 (TMC114-C213) and POWER 2 (TMC114-C202) were conducted. Main Publications from the Phase IIb program are:
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Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials in Lancet 2007.
The two pivotal phase III trials that supported darunavir's full approval by the FDA were TITAN in early treatment-experienced patients and ARTEMIS in treatment-naïve patients. Further details are available from www.clinicaltrials.gov .
Main publications from the Phase III program include:
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48 week data (efficacy and safety) of DRV/rtv in early treatment experienced patients (TITAN study) of DRV/rtv 600/100 mg bid dose. Published in the LANCET.
- 48 week data (Efficacy and Safety) of DRV/rtv in treatment naïve patients (ARTEMIS study) of DRV/rtv 800/100 mg qd dose. Published in JAIDS (July 2008).
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