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publicado em 30/03/2013 às 10h53:00
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Anvisa approves appointment of new drug against AIDS for children

Remedy will be presented in the form of chewable tablets to facilitate the treatment of children aged two to 12 years

 
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The antiretroviral raltegravir, manufactured by MSD laboratory and commercially known as Isentress, will be presenting new chewable tablets of 25 mg and 100 mg to facilitate the treatment of children aged two to 12 years old infected with HIV.

Besides the new formulation, the National Health Surveillance Agency (ANVISA) is also extending the indication of the tablet 400 mg for ages 6-12 years.

The medication is only available in Brazil belonging to a novel class of antiretrovirals (which inhibits the integration of HIV genetic material in human DNA) and is already successfully used in adults to combat the AIDS virus.

The laboratory reports is now working to update the package leaflet with the recommendation for pediatric use and awaits the pricing of chewy version to launch in the domestic market.

Raltegravir and the integrase inhibitor manufactured by Merck, indicated in combined therapy for treatment of HIV infection in adults and pediatric patients from the age of two (naïve or not). It works by inhibiting the integration of HIV genetic material in human DNA by the integrase enzyme and demonstrated rapid antiviral activity.

The inhibition of integrase to perform this essential function limits the ability of the virus to replicate and infect new cells. Other drugs for use in HIV inhibit other enzymes critical to the process of replication of HIV protease and reverse transcriptase.

Currently, raltegravir is the only integrase inhibitor approved for the treatment of HIV

Currently, raltegravir is the only integrase inhibitor approved for the treatment of HIV. The FDA approved this drug as the first drug in a new class of drugs known as inhibitors of HIV integrase, for use in adult patients in October 2007, by prioritizing log analysis of medication.

The project was designed to provide patients early access to promising new drugs for the treatment of serious diseases based on clinical data that showed positive effects of therapy with these drugs. In Brazil, the drug approved by ANVISA, began to be released next year.

Raltegravir is approved in combination therapy in more than 45 countries for use in adult patients with HIV who had never received treatment and in more than 90 countries for use in adult patients with HIV who have already received treatment. And now also has a pediatric indication in some countries (USA and Brazil).

The drug does not cure HIV infection. Patients must stay on continuous therapy to control HIV infection and decrease HIV-related illnesses.

Source: AGENCIA AIDS
   Palavras-chave:   Raltegravir    Isentress    ANVISA    The National Agency for Sanitary Vigilance    Laboratory MSD   
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