FDA approves GlaxoSmithKline’s Tivicay, for the treatment of AIDS
August 14, 2013 | By Márcio Barra
GSK announced yesterday that the FDA has given green light for ViiV Healthcare’s Tivicay(dolutegravir) 50-mg tablets, an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). It can be used to treat infected adults who have been treated with other drugs or are new to treatment.
Integrase inhibitors are a new class of antiretroviral agents that block HIV replication in the body by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). In short, they stop the virus from entering cells.
In the SINGLE trial, 88% of study participants on the Tivicay regimen were virologically suppressed versus 81% taking Atripla (efavirenz/emtricitabine/tenofovir) after 48 weeks’ treatment.
Tivicay is an add-on to two standard HIV drugs, Ziagen (abacavir) and Zeffix (lamavidune), both available as generics. Tivicay’s wholesale price will be $1,175 per month, or $14,105 per year, a price that has come under fire from Médecins Sans Frontières (MSF).
“We are deeply concerned that ViiV’s business strategy will result in dolutegravir being priced out of reach in countries excluded from ViiV’s licensing deals,” MSF’s Rohit Malpani said in a statement regarding Tivicay’s cost.
A spokesperson for ViiV commented to PharmaTimes that the company is “committed to helping patients receive access to effective HIV treatment in the US and across the globe”.
Tivicay is owned by ViiV Healthcare, an HIV joint venture between GSK, Pfizer, and Shionogi & Co Ltd in which GSK is the largest shareholder, with a 76.5% stake.
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I can believe is possible
that HIV can be cure what
a great man he have done
it for me also I never
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and post about him, I was very sick, I am HIV
positive over 9year,just
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they said that the man is so powerful he have cured to
different diseases, I keep
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people about this man and
I found out this man is real
I contacted him for help because I was having such
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hours, I inform he about
my problem that I have
this virus for 9year now this man said that I should
not worry and I should not
disappoint him, what he
about to do for me now is
just a gift from his gods
and his father’s that I s should regard him if am
cured I should write the
true about him, I said no
problem because I never
have the believe that I will
be cured someday but thanks god for my life for
curing me through this
man this man ask for my
details which i send for
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start developing he ask me
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for not dying at this young age if you need help contact him now
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hello everyone,
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Truthfully, i was tested HIV + positive last 3years. I keep on managing the drugs i usually purchase from the health care agency to keep me healthy and strenghtful, i tried all i can too make this disease leave me alone, but unfortunately, it keep on eating up my life, this is what i caused myself, for allowing my fiance make sex to me insecurely without protection, although i never knew he is HIV positive. So last few 4days i came in contact with a lively article on the internet on how this Powerful Herb Healer get her well and healed. So as a patient i knew this will took my life 1 day, and i need to live with other friends and relatives too. So i copied out the Dr ihunde the traditional healer’s email id: dr.ihundehivaidscure@yahoo.com and I mailed him immediately, in a little while he mail me back that i was welcome to his temple home were by all what i seek for are granted. I was please at that time. And i continue with him, he took some few details from me and told me that he shall get back to me as soon as he is through with my work. I was very happy as heard that from him. So Yesterday, as i was just coming from my friends house, Dr ihunde called me to go for checkup in the hospital and see his marvelous work that it is now HIV negative, i was very glad to hear that from him, so i quickly rush down to the nearest hospital to found out, only to hear from my hospital doctor called Browning Lewis that i am now HIV NEGATIVE. I jump up at him with the test note, he ask me how does it happen and i recede to him all i went through with Dr ihunde I am now glad, so i am a gentle type of person that need to share this testimonies to everyone who seek for healing, because once you get calm and quiet, so the disease get to finish your life off. So i will advice you contact him today for your healing at the above details: Email ID:dr.ihundehivaidscure@yahoo.com CONTACT HIM NOW TO SAVE YOUR LIFE:dr.ihundehivaidscure@yahoo.com AS HE IS SO POWERFUL AND HELPFUL TO ALL THAT HAVE THIS SICKNESS
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