Health : FDA Approves Descovy as New HIV Treatment
The FDA yesterday approved Gilead’s newest therapy for HIV-positive individuals aged 12 and older. There is already buzz that this could be the new PrEP, though it has not yet been approved for use as a prophylaxis against HIV.
Read the press release below:
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
Descovy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care. As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health,” said Norbert Bischofberger , PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “With today’s approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide.”
The approval of Descovy is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to a F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen.
The approval also is supported by a Phase 3 study (Study 109) evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naïve adolescents. Finally, bioequivalence studies demonstrated that Descovy achieved the same drug levels of TAF and emtricitabine in the blood as Genvoya.
Descovy does not cure HIV infection or AIDS.
You can read the full press release here.
This post was written by STEPHEN LUCIN at HIV Equal
Oh boy! Let’s poz up some more gay boys with bb anal so we can make more money! “Just take a pill, bitches!” You trust Gilead? You stare down the barrel of an AK-47 on auto much?
MistrFistr: always something mean to say.
Drastic…
Thanks for this update. Interesting and good to know that there are more meds available.
Descovy is NOT approved for use as a PrEP and it will be several YEARS per Gilead for testing to establish whether or not it could be used as a PrEP. This med treats HIV only. Descovy has a boxed warning regarding the risks of lactic acidosis and severe hepatomegaly with steatosis, as well as posttreatment acute exacerbation of hepatitis B virus (HBV).
My first thought was WOW that’s GREAT. I was just becoming sexually active in the 80’s and the “Gay Cancer” hit. Or as haters said, the plague God sent to eliminate gay men. I’ve seen a plethora of our community die. Most of whom could have been saved by this medication and the other meds. WOW this is GREAT. And of course I will still practice safe sex.
Gee, whatever happened to staying HIV negative to start with? Im with Mistrfistr..spot on, man. Yet another body destroying pill for a fatal virus that should been prevented to start with. If you are a bug chaser, you deserve all thst goes with it.
Does anyone else get the impression that the gay community is terminally suicidal and has a deathwish and thinks its cool to take as many others with them as they can?
Yes i . I know in the black community, there are so many black men who are out here fucking raw like there is a cure. They seem to don’t care about getting infected or passing it on to someone else. It’s freaking crazy. That’s the hiv infection rate is so high in the black community. SAD!
Mr. Fister has a point! You don’t see corporations racing for a cure, do you; of course not. That would be contradictory to theirs business model. Which happens to be—take a popular disease and invent proprietary therapies to treat symptoms; Let the money flow galore! Never a cure. That just doesn’t make sense from a profit point of view.
Is this legal? Of course. Is it moral? That’s another conversation.
I like this blog when it channels opinions and facts, but not name calling. That was junior high fellas.
I think this is wonderful news.
I trust Gilead because they supply StribilD and it’s kept me healthy for two years while dealing with hiv
As stockholder I am all for profit so gilead genius marketing of old antiviral truvada as prep and finding the less than a smart population to sell it to and now I refer to us gays well is awesome. That makes me tons of $$$. As a gay guy with half brain I claim to have I understand that we are being taken for suckers. So I have very mixed feelings about this. Confoms are sure no fun but hell they are soooo much cheaper and the only side effect apart from latex allergy well you might lose a hardon lol
I’m with MistrFistr and Detryy23. A new “convenient” med which is very similar to the meds we already have, maybe just as effective in slowing HIV while poisoning our bodies, providing another excuse for some to play Russian roulette with their health and others, the set-up for yet another series of HIV mutations, and $$$$$$ for Gilead. Time for me to buy some shares too!
So, which HIV Gilead product is right for you? Ugh
It’s your life.
It seems ppl without HIV can be a little insensitive to gay men who have it. But that par for the course in America. There are people who have been raped or, perhaps, born with HIV who are very interested in breakthroughs in treatment. Of course we know pharmaceutical companies profit from these drugs and that protected sex is much more safe, but why is there such a spirit of condemnation in these responses to an article, which might me a wealth of knowledge to someone who needs treatment? Keep in mind there are some infected who had no control over there status.
I agreee with TRUTHBTOLD. What about the people out here who are carrying it and don’t know it. That’s how I wound up with it. Safe sex didn’t work for me. So what now? Condoms aren’t 100% effective. You guys are missing the point. The point is to cure THIS plague. There are other things out here that poison us…Got High Blood Pressure? Take this to fix that. Oh, limp dick from HBP meds? Take this Viagra. On HBP and taking Viagra? Go ahead and sniff poppers and risk a sudden possibly fatal drop in blood pressure just because you want to bust that one good nut! See where I’m going with this? No one is pointing their fingers at all that are they??! Stop being selfish and be more compassionate to mankind. That’s the reason everyone is at odds and no one is coming out on top but the people who start the fights and sit back in the background and watch what happens.
I’ve been taking complera for 3 year’s and haven’t experienced no problem-HIV undetectable!Kevin