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Last updated on April 23, 2014 at 16:13 EDT

European Commission Approves PREZISTA® (darunavir) 800 mg Tablet Once a Day Reducing the Number of Pills Taken by People Living With HIV

January 16, 2013

CORK, Ireland, January 16, 2013 /PRNewswire/ –

Janssen R&D Ireland announced today that the European Commission (EC) has approved a
new PREZISTA(R) (darunavir) 800mg tablet allowing people living with HIV to take one
darunavir tablet once a day. Darunavir is indicated in combination with other
antiretrovirals for the treatment of human immunodeficiency virus (HIV-1) infection in
treatment-experienced and treatment-naive patients with no darunavir resistance-associated
mutations[i].[1] Darunavir is always taken in combination with ritonavir and other HIV
medicines together with food. This new tablet strength has been developed to allow
patients taking darunavir once daily to reduce the number of darunavir tablets by half.

The approval is based on study C176[2] which evaluated the 400 mg tablet formulation
versus the 800 mg formulation. One hundred and twenty eight healthy volunteers, were
included in this study and received treatment under fasting (n=83) or under fed conditions
(n=45). The results of this study show that the rate and extent of absorption were similar
between intake of a single 800 mg dose of darunavir formulated as one 800 mg tablet or two
400 mg tablets.[2]

“Strict adherence to treatment regimens is crucial to prevent virological failure and
the development of drug resistance when treating HIV,” said Brian Woodfall, Vice
President, Medical Affairs, Janssen EMEA. “This single 800 mg tablet formulation is a
direct reflection of the ongoing commitment of Janssen to further develop treatment
options for people living with HIV. With this approval we are providing an alternative
solution and a reduced pill burden which should make it easier for patients to manage
their treatment on a day-by-day basis and keep their HIV at undetectable levels.”

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i. ART-experienced adults with no darunavir resistance associated mutations (DRV-RAMs)
and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count greater than or
equal to 100 cells x 106/l.

It is estimated that currently there are 34.5 million people living with HIV globally,
with 2.5 million people becoming newly infected each year.[3]Thanks to significant
advances in treatment for HIV over the past 30 years a diagnosis for these people is no
longer a death sentence. Yet, data shows that after 8 months of treatment only 65% of
patients will achieve 100% compliance.[4] Missing doses can allow drug levels in the blood
to fall which could allow viral replication to occur and greatly increase the risk of
resistance emerging.[5]

About PREZISTA(R) (darunavir)

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-naive 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 (DVR) is 600 mg
taken with 100 mg ritonavir twice daily with food or 800 mg taken with 100 mg ritonavir
once daily with food for patients with no DRV Resistance Associated Mutations (RAMs)[ii]
and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count greater than or equal
to 100 cells x 10[6]/L. For treatment-naive adult patients, the licensed dosing for
darunavir is 800 mg taken with 100 mg ritonavir once daily with food.

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ii. V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V

Important Safety Information

In the registrational studies, darunavir was generally well tolerated. The majority of
the adverse reactions reported in patients who initiated therapy with darunavir
co-administered with 100 mg ritonavir were mild to moderate in severity. The most frequent
adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea,
immune reconstitution syndrome, nausea, pyrexia and rash. The most frequent serious
reactions are diarrhoea, hepatitis, immune reconstitution syndrome, pyrexia and rash.
Please see the Summary of Product Characteristics for a complete list of all possible side
effects.

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 are nursing.

Darunavir should not be used in patients allergic (hypersensitive) to it or ritonavir
or with severe liver problems.

Due to potential drug interactions, 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. Please see full Summary of Product Characteristics for more details.

About Janssen in HIV – Commitment to Innovative Research & Development

Over the last five years, Janssen has launched three therapies for people living with
HIV. Janssen has a long heritage in HIV and is committed to innovation in HIV therapies.
Janssen is constantly striving for improvements in efficacy, safety and dosing
simplification and is committed to evaluating HIV treatments for a broad range of
patients-from treatment-naive to treatment-experienced-with the goal of helping all
patients achieve an undetectable viral load and a better quality of life.

More information about Janssen can be found at http://www.janssen-emea.com

        1) PREZISTA 800 mg. Summary of Product Characteristics, 2012.
        2) Janssen data on file.
        3) World Health Organization. Global summary of the AIDS epidemic. Available at
          URL: http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed December 3,
          2012.
        4) Mannheimer S, Friedland G, Matts J, et al. The consistency of adherence to
          antiretroviral therapy predicts biologic outcomes for human immunodeficiency
          virus-infected persons in clinical trials. Clinical Infectious Diseases. 2002;
          34:1115-1121.
        5) Aids Map. Adherence. Available at URL:
          http://www.aidsmap.com/Adherence/page/1730785. Last accessed December 3, 2012.

SOURCE Janssen R&D Ireland


Source: PR Newswire