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.

  1. ehis said:

    I can believe is possible
    that HIV can be cure what
    a great man he have done
    it for me also I never
    believe all this comment
    and post about him, I was very sick, I am HIV
    positive over 9year,just
    last year I keep reading
    the testimony post about
    this man named DROBI
    they said that the man is so powerful he have cured to
    different diseases, I keep
    monitor the post of some
    people about this man and
    I found out this man is real
    I contacted him for help because I was having such
    problem this man reply to
    my email after some
    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
    him, and he said that he
    want to have some consultation on it how to
    get me cure I wait for his
    respond this man reply me
    back after some minute he
    said that I need to provide
    so thing need for the curing I try and do so after
    everything is done I found
    out I was again my
    strength back my tissue
    start developing he ask me
    to go for hospital test I did and I found out there was
    no HIV found in my body
    again what a miracle
    thanks doctor for help me
    out from this illness i will
    continue doing this according to my promise if
    you need his help just
    contact him now through
    his email or phone
    number: DROBI6997@GMAIL.COM. OR +23408104071425

  2. lucy said:

    Please help me thank dr uroko for his good work I really believe HIV
    have cure I was HIV positive over since 1year plus before I come
    across a comment dr uroko that he have cure to any disease and virus
    but when I saw it i have it in mind that he can’t cure HIV I just
    decided to give a try I contact him that night lucky to me he said yes
    but I don’t believe him I think it was a scam or some thing like that
    but I still hold on to see the work of dr uroko if he is saying the
    true he ask for different thing and some question about me I give him
    all the detail he needed and I wait to see his reply to my problem
    after all the thing is done he ask me to go for check up I went for
    hiv test I cant believe I was negative thanks dr uroko for help me
    for not dying at this young age if you need help contact him now

  3. lucia said:

    hello everyone,
    i don’t just know the reason why some people is finding it difficult to believe that there is a cure for HIV, i have been HIV+ since last three years with my girlfriend but today i am happy that i am HIV_ with herbal medicine of Dr uroko the great healer,i was browsing the internet searching for help when i came across a testimony shared by someone on how Dr uroko cure his HIV i was so much in need of getting his treatment but after all Dr uroko brought a smile to my face with his herbal medicine. i am so much happy today that we have someone like this great healer out there, so my people out there kindly contact this great heal;er on his email address: drurokospellcaster@gmailco please sir keep your good work cause there are people out there who is in need of your healing medicine.once more contact him now: drurokospellcaster@gmail.com

  4. john said:

    Good morning everyone, my name is john park from Pakistan, I have been suffering from
    HIV/Aids for over 4years now, and suddenly, i have spent all my money all to make sure
    i get healthy all day, but happily, last month January 12th 2013, I came in contact
    with a traditional doctor also known as a chief priest on a newspaper who is called Dr
    ohen who has help much people to cure their aids disease, firstly i taught it was a joke until i contacted him ” ‘ohentemple@gmail.com ” and he said that if i am ready
    for this work, i told him yes, and he collected my details and told me that after he
    has finished consulting his oracle he will run back to me on when to go for a medical
    check up, i was unhealthy ling surprise. And truly last week Monday Dr ohen called me
    to quickly go for a medical checkup, which I did, only to find out that I was not with
    any HiV disease anymore, my friends and families who left me before run back to me. I
    now found out that God in Heaven is using this man to bless and heal us all, he is a
    great and powerful man, again I say to you sir, that God Almighty will uplift you and
    your great work you did for I and other people. Please i will sincerely advice all HIV
    patient to contact this great powerful man called Dr ohen for your solutions now at
    ohentemple@gmail.com he will help you on your HIV
    problems…..email:ohentemple@gmail.com or call doctor +2348163397178

  5. I want to say hello to the world at large, I am very grateful for the good deeds DR. AIRHOHO did for me, I was a HIV patient, everything went bad for me, I couldn’t do things with my friends anymore, I loosed my job, I loosed everything, I was even waiting for death itself, I went searching on the internet I saw many testimonies on how different spell casters helped people in curing their deadly diseases, I collected one spell caster’s email, which DR. AIRHOHO I emailed him and he answered me, I told him all problems, he ask me not to worry, that I will be free from the deadly disease, which I did, he casted the spell, and told me that he will send a holy water to me through courier services, I was surprised, because he did not mention it to me before, I paid for the courier delivery service, I got a holy water, he asked me to drink it which I did and he asked me to go for a medical check-up in a hospital, I went to the hospital I went for a HIV test, I was tested HIV negative, I was shocked, I asked myself, “is there still good helpers out there”? I promised to share my testimony to the whole world, I’m now free, I have a better job, if you are passing through pains you need help you can share your problems to DR. AIRHOHO through airhohobreezspellcaster@gmail.com +2348155166695

  6. jane wembli said:

    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

  7. mrs elena said:

    I am MRS ELENA HOMSON from RUSSIA, my facebook username is enena homson.i want to use this

    medium to testify of how i got cured from HIV AIDS, HIV AIDS is known not to have a cure,

    i contacted this disease in 2008, i have done all my best to get cured from this disease

    but all to no avail until a friend of mine told me about a healing spell dr OVIA on the

    internet who helps people cure any kind of diseases including HIV AIDS, Cancer, Herpes

    etc, at first i doubted if it was real but decided to give it a try,i have gone to many

    hospital and herbs there were know positive change on it.until i contacted this spell

    caster he helped me cast a healing spell and i was healed within 72hours (3days) i am

    really happy today then i decide to let the whole world know that there is a great man

    that can cure all kind of disease with asking for payment.if you also have any disease

    that is related to it, please Contact this great spell caster for any kind of disease or

    ailment via this email OVIATEMPLESPELLCASTER@GMAIL.COM OR call him via +2349032500038

  8. MY LIFE IS BACK, Am so happy to share this testimony on how Dr ADELEKE BELLO, was able to heal me from HIV Disease, well i was detected positive on 23th may 2016, and ever since i have been looking for a way to treat and cure this disease from me, but all ways i try there was no solution, few weeks ago i saw a testimony of some people on how Dr ADELEKE BELLO,,was able to cure them from HIV disease, still on i heard about it on media when a young lady also gave her testimony about this same Dr, well left with no hope i message Dr ADELEKE BELLO,, telling him all my problem, he told me what we where going to do, that he was going to send me a portion which i am going to take, and after which i took this herb portion he sent to me, he told me to go back to the hospital for check up and after i have done that i should come and tell him the good news result, at first when i saw the message i was so shock and still did not believed i will be cured, well friend to make my story short i am HIV negative now after many time of sorrow, i am Negative, and my sickness are gone, i thank God for leading me to this man….you can email him on (DR.ADELEKEAYODELE1960@GMAIL.COM) or you can also call him +2349035594773 he can be of help to you on any problem like


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