The FDA has just approved Gilead drug Descovy as the newest treatment for HIV-positive people 12 years and older.
Gilead touted the the drug’s arrival and provided important details about it in a press release:
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.
However, they make it clear that the drug isn’t intended for use as PrEP and may cause some complications for users with Hepatitis B:
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.
Gilead’s Executive Vice President of Research and Development and Chief Scientific Officer Norbert Bischofberger had this to say:
How about we take this to the next level?
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“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.”
In our opinion, the more tools we can have in the fight against HIV/AIDS, the better. This is amazing news, and we hope it helps to simplify treatment for people living with HIV.
Peter Jonsson
…..?
dwes09
It doesn’t seem to offer any additional benefit over other antiretrovirals, does not seem to have fewer contraindications, and just like all of the existing treatments needs to be taken for the remainder of the patient’s life. And it is intended to be used in combination with other existing drugs, so offers no new hope to those plagued with side effects.
I don’t get how this is “amazing news”. A vaccine, a treatment that clears the virus from the body rather than simply keeping it dormant in its hiding places, a public health policy that actually works to end transmission…those would be amazing news. This is moderately good news.
o.codone
Maybe it does address the issue of side effects, but the article doesn’t provide that information. If you can use smaller doses of existing antiretrovirals and have fewer side effects, that works. And maybe this new pill doesn’t have ANY side effects. That would be nice.
IDK, I just wish all my positive friends comfort and solace in the battle against HIV. And, of course, meds that work.
dwes09
@o.codone: “I just wish all my positive friends comfort and solace in the battle against HIV. And, of course, meds that work.”
Absolutely!
And you are correct (I did some additional reading), this form of tenofovir is safer for users and enables equal control of viral load with lower dosage. So I need to temper my criticism. Safer for bones and kidneys.
joe
This is the same drug as Truvada only the Tenofovir has been “updated”. Currently in Truvada it has “tenofovir disoproxil fumarate” or TDF, the brand name for this drug by it’s self is called Viread. The new reformulated Tenofovir is is called “tenofovir alafenamide fumarate” or TAF. The new version has less side effects and from what I’ve read its 90% MORE effective with less side effects. Gilead seems to be changing all their HIV meds that contain TDF to TAF because this new formula is way better.I have hep b and am on TDF (Viread). If someone out there can explain why a hep b person can’t take this please let me know,I didn’t understand their explanation. I have read several places that I could used Viread alone as PREP or even be on Truvada as PREP. Also it seems weird that this can’t be used as PREP as these ingredients are the same. Any docs out there that can help?
QJ201
Truvada goes generic in 2017… So meet Descovy!
joe
@QJ201: EXACTLY…and so does my med Viread, interestingly enough, they had this new TAF version for several years or more, no doubt holding it out till mine goes off patient.
Stache
Any new class of drugs is good for drug resistance problems.
Brian
Adding chemicals to your body is a surefire way of weakening it. The human body does not like chemicals, simple as that. Chemicals weaken the immune system. Many of the symptoms associated with HIV were actually caused by the chemical drugs that were taken in an attempt to treat HIV.
Be very careful about the drugs firms, the FDA and the CDC. They are not always on the side of logic. Their relationships with each other need to be questioned and exposed. One wonders if the drugs firms bribe people to win approval for their chemical drugs.
Kieru
@dwes09: Queerty didn’t write a very exhaustive article – but the “Yay” factor for this drug is that it achieves the same results as some existing medications at a fraction of the dosage.
Essentially if an HIV+ person used this drug instead of say, Truvada, they have a lower chance of developing kidney issues from long-term use. That’s pretty spectacular.
Stache
@Brian: Says the idiot who believes Hiv doesn’t cause aids but just poor lifestyle choices.
Kieru
@joe: According to other articles I’ve read, Descovy can cause Hepatitis B to “worsen”. So I assume whatever symptoms a person experiences with Hep B become exacerbated.
joe
@Kieru: well this is what confuses me i know for a fact i can take truvada as prep. truvada has the same ingredients as this new med, except it has the reworked version of this TAF/TDF. this new version is replacing the old one on most all there hiv meds. i just need to research this more. i did read that they are waiting till my version goes off patient in a year then they will roll this out
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