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Once-daily formulation of Prezista for the treatment of HIV-1 infection

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Elijah Amooti
Member
Posts: 158
Once-daily formulation of Prezista for the treatment of HIV-1 infection
Posted on: January 24 2013, 06:14 pm

Dear  United Kingdom Community Advisory  Board Members

Please see below a press release announcing the launch of an 800mg one tablet, once-daily formulation of Prezista for the treatment of HIV-1 infection. The new formulation means that patients will be able to reduce their once-daily Prezista tablet intake by half and may therefore contribute to improved adherence to HIV medication.
Dr  Mark also  commented on this  new  fomulation.
Enjoy  the news  mainly  those ones who  have  been  taking  the  two  yellow  tablets.
Best wishes  to  you  All
Elijah  Amooti

Janssen launches new 800mg PREZISTA® (darunavir) tablet for the treatment of HIV*

 

- New formulation allows eligible patients to reduce darunavir tablet intake by half -

 

High Wycombe, 24th January 2013: Janssen has launched an 800mg formulation of PREZISTA® (darunavir), a protease inhibitor (PI) for once-daily oral administration for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment experienced adult patients with no darunavir resistance associated mutations and who have plasma HIV‐1 RNA <100,000 copies/mL and CD4+ cell count ≥ 100 cells x 106/L.1 The new formulation has been developed to allow eligible patients to reduce their once-daily dosage of darunavir by half thereby lessening the daily pill burden. Darunavir is always taken in combination with ritonavir and other HIV medicines together with food.1

 

The availability of the new dosage is based on study C176 which evaluated the 400mg tablet formulation of darunavir versus the 800mg formulation. The study included 128 healthy volunteers who received treatment under fasting (n=83) or fed conditions (n=45). The results showed the rate  and extent of absorption were similar between the intake of a single 800mg dose of darunavir formulated as an 800mg tablet or as two 400mg tablets.2

 

“Reduced pill burdens have an important role to play in increasing adherence to HIV treatment and the prevention of drug resistance and virologic failure,” said Dr Mark Nelson, HIV Service Director, Chelsea and Westminster Hospital. “The efficacy and tolerability of darunavir is well documented so the availability of a more convenient form of the drug will be welcome news in the HIV medical community.”

 

It is estimated that 100,000 people will be living with HIV in the UK in 2013 and approximately 6,000 new diagnoses are confirmed each year.3 Thanks to treatment advances over the past three decades, HIV is no longer considered a fatal illness in developed countries.4 However, adherence to treatment is essential in order to prevent low drug levels in the blood allowing the virus to become resistant to treatment.5 Current evidence suggests that after eight months of treatment, only 65% of patients achieve 100% compliance to treatment.5

 

“Alongside the research and development of the three antiretrovirals Janssen now have approved for the treatment of HIV, we’ve invested significant time and resource in the development of simpler treatment regimes,” stated  Dr Peter Barnes, Medical Director, Janssen UK.  “In earlier clinical trials programmes, the regime for darunavir involved four tablets, so we are delighted to be in a position to offer a more convenient one tablet, once-daily option for the treatment of what for many people is now a chronic condition.”

-ENDS-

 

Notes to the Editor

 

*About PREZISTA® (darunavir)1

Darunavir 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 adult patients as well as antiretroviral therapy (ART) experienced paediatric patients from the age of 3 years and at least 15 kg body weight.

 

Since its initial approval in 2007, darunavir has also been indicated for use in HIV‐1 infected treatment naïve and treatment‐experienced adult patients, including those who have been highly pre‐treated, in combination with ritonavir and other ARTs. For treatment‐experienced adult patients, the licensed dosing for darunavir is 600mg taken with 100mg ritonavir twice daily with food or 800mg taken with 100mg ritonavir once daily with food for patients with no darunavir resistance associated mutations and who have plasma HIV‐1 RNA <100,000 copies/mL and CD4+ cell count ≥ 100 cells x 106/L. For treatment‐naive adult patients, the licensed dosing for darunavir is 800mg taken with 100mg ritonavir once daily with food.

 

For more information see the Summary of Product Characteristics:

http://www.medicines.org.uk/EMC/medicine/27325/SPC/Prezista+75+mg%2c+150+mg%2c+400+mg%2c+600+mg+800mg+film-coated+tablets+and+Oral+suspension+100mg+ml/

 

About the C176 study2   

The C176 study examined the effect of 800mg darunavir, either as one 800mg tablet formulation, or as two 400mg tablets in the presence of low dose ritonavir under fasted and fed conditions. The two formulations were randomly assigned and administered to healthy volunteers and the plasma concentrations of ritonavir and darunavir measured.

 

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson is dedicated to addressing and solving the most important unmet medical needs of our time, including infectious disease (e.g. HIV/AIDS, hep C and tuberculosis), oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain) and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, Janssen develops sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.

 

More information can be found on www.janssen.co.uk

 

References

1.       PREZISTA® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/EMC/medicine/27325/SPC/Prezista+75+mg%2c+150+mg%2c+400+mg%2c+600+mg+800mg+film-coated+tablets+and+Oral+suspension+100mg+ml/ (accessed January 2013).

2.       Kakuda et al. 2012. Bioequivalence of the 800mg tablet formulation of darunavir compared to the commercially available 400mg tablet formulation. Poster 32. International Workshop on Clinical Pharmacology of HIV Therapy, Barcelona 2012.

3.       Health Protection Agency. 2012. HIV in the United Kingdom: 2012 Report. Available at: http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317137200016 (accessed January 2013).

4.       The Antiretroviral Therapy Cohort Collaboration. 2008. Life expectancy of individuals on combination antiretroviral therapy in high-income countries: a collaborative analysis of 14 cohort studies. The Lancet 372: 293-299.

Mannheimer S, et al. 2002. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus‐infected persons in clinical trials. Clinical Infectious Diseases 34: 1115‐1121.

 


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