Oct 18, 2017
With an FDA decision for ibalizumab pending, data about a group with multidrug resistance show that the antibody is effective.
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With an FDA decision for ibalizumab pending, data about a group with multidrug resistance show that the antibody is effective.
Hello, Dr. Gallant. I was wondering if there is a way for me to get Ibalizumab and how to proceed in order to apply for it. I live in France, but will travel to the U.S. and would even live in there, if necessary. I was told that I would need an American doctor to sign the papers for me and send it to Taimed Biologics for the Expanded Access Programme. If I travel to New Mexico would you do it for me? Thank you very much for any help whatsoever.
We are not participating in the ibalizumab trials because we don’t have any patients who need the drug. You’d have to find a U.S. (or French) site that was participating in the program.
Hi there Doctor! With all the advances we've seen in the last few years in antiviral therapy and now the cures for Hep C I was wondering what can be expected in the HIV community in the next year or two. Is there any new medications like Triumeq coming out or some new advancement that's in it's last stages? Your the best! Thank you so much for all your time and work you have done.
The photo I’ve chosen represents what we used to call the “pipeline”: the HIV drugs being developed. I’m afraid it’s slowed to a trickle. There’s nothing huge coming out in the next few years, and we won’t see anything resembling what’s happened with hepatitis C for a while.
Probably the most important new drug will be tenofovir alafenamide (TAF), a new prodrug of tenofovir that we expect to have less bone and kidney toxicity than TDF (Viread), the current prodrug of tenofovir. Because it achieves higher intracellular tenofovir levels than TDF, it is also expected to have greater activity against nucleoside analog-resistant virus.
TAF will be available in new versions of what are today known as Complera, Stribild, and Truvada. We also expect to see the first single-tablet protease inhibitor regimen: a combination of darunavir (Prezista), cobicistat (Tybost), emtricitabine (FTC, Emtriva) and TAF.
For greater convenience, we’ll soon have coformulated versions of darunavir plus cobicistat and atazanavir (Reyataz) plus cobicistat (“D/C/F/TAF”). People taking protease inhibitors will no longer have to take a separate tablet of ritonavir (Norvir).
But as I said, the pipeline isn’t gone, it’s just diminshed. Doravirine is a new NNRTI that has activity against virus that is resistant to the existing NNRTIs, including etravirine (Intelence). Cabotegravir is an integrase inhibitor that may be able to be given as an injection every 1-3 months for treatment or PrEP. A long-acting regimen of cabotegravir plus the NNRTI rilpivirine (Edurant) is also being studied. Ibalizumab is a monclonal antibody that binds to the CD4 receptor and blocks entry of the virus into the cell. It is being studied for treatment and prevention. BMS-663068 is another entry inhibitor that works by binding to viral gp120.
FDA OKs Ibalizumab, a Sterile Biologic for HIV
FDA OKs Ibalizumab, a Sterile Biologic for HIV
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WuXi PharmaTech and TaiMed Biologics announced that the FDA has approved the first batch of the ibalizumab drug substance and sterile drug product, manufactured at WuXi’s biologics facilities, for ongoing treatment of patients under…
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