The FDA in the US has approved the first, long-acting, monthly injection treatment for HIV, replacing the need for some to take daily pills.
The two-shot combo is called Cabenuva, and it comes from the pharmaceutical company, Viiv Healthcare, which is owned by GlaxoSmithKline.
Cabenuva consists of two injections: rilpivirine, commonly sold as Edurant by Janssen, and a new drug, cabotegravir, from ViiV Healthcare. They’re administered as intramuscular injections in your buttocks.
The FDA granted its approval last Thursday (January 21).
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ViiV has also developed a pill form of cabotegravir. Those wanting to switch to injections will need to take the cabotegravir pill for a month beforehand to ensure good tolerance to the drug.
Although the drugs will initially be administered once a month, the company is also trialing the medication for administration every two months, but that’s not been approved by the FDA as yet.
The company says the price of the injections ($5,940 for an initial, higher dose and $3,960 per month afterward) was comparable to the cost of the pill versions.
Related: FDA says injectable PrEP a ‘breakthrough’ therapy as it pends approval
Many people on daily medication have expressed a preference for the idea of a monthly injection. One man, an international lawyer who often has to travel to countries that do not allow entry to people with HIV, told the NY Times, he’d previously always “had this fear of being stopped at customs.”
Health experts also think a monthly injection could be of benefit to those who struggle with a daily pill regime, such as those with substance use or mental health issues.
Lynn Baxter, Head of North America, ViiV Healthcare, said in a statement: “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.”
The medication was trialed on people who were already taking a daily pill and had an undetectable viral load, so it may not be suitable for those who have just been diagnosed or have an elevated viral load.
ViiV will start shipping the medication to wholesalers in February.
ViiV is also seeking approval for cabotegravir to be approved as a form of PrEP. From studies, it has found that an injection of the drug every two months acts just as well as a daily PrEP tablet.
Related: Long-acting PrEP injections show some benefits over daily tablets
M K
I don’t understand the comment from the “international lawyer” who is always concerned about travel to countries that have restriction of those with HIV and how this shot option would change anything… it’s not a cure, but just another way to mask the test results… he would still have HIV just not detectable… at least until he stops taking treatment and is symptomatic again. Just because the test result can’t detect the virus, it is still present, albeit “dormant”.
jow
I think he’s worried about getting caught with the pills in customs. A shot would maintain privacy there.
Chrisk
Oh lord. Maybe you need your caffeine first or something. Lol
Openminded
But he’s still misrepresenting the truth when he goes thru customs. Not saying he should be denied access, but it’s up to each country to write their own laws and those laws should be abided to by visitors, especially, a lawyer.
Vince
Openminded
Yes and most of those backward countries have death or prison penalties for being gay as well. Traveling to those countries is the unfortunate part of his job.
Chrisk
There’s also one coming from Gilead that goes for 6 months.
Openminded
This new injectable gives new meaning to “stick it in my @ss”
Hillers
$5,940 for an initial, higher dose and $3,960 per month after that?? That’s basically a life-long mortgage. Or rent in San Francisco.
geb1966
If you read the whole statement, it says it is comparable to the cost of the daily pills already being paid for. So he’s paying that either way. This monthly injection is a whole lot less inconvenient.
1898
i don’t really get the “less inconvenient” argument. it takes about five seconds to take a pill. five seconds every day = less than three minutes a month.
monthly injection = driving to the doctor’s office, checking in, waiting in the waiting room for 15 minutes, going into the exam room, waiting another 15 minutes… you get the picture. how is that more convenient than taking a pill?
there may be other reasons why the injection is a good option for some people, but convenience isn’t one of them
Openminded
I tend to agree with you 1898. To have PreP with it’s life altering, if not life saving benefits available should be enough to endure taking a pill daily. Anyone who thinks a daily pill is too cumbersome should have lived thru the 70’s and early 80’s. Divert all the R&D time and money to stopping Covid or some other problem and let those too lazy to pop a pill daily suffer the consequences.
glfowler1968
This sounds so great on paper. The reality is that these injections consist of two total, one in each hip intramuscularly, & the costs are ~$4200 per injection. Insurances are really pushing back on paying for this as well as federal funds through RWCA, ADAP State Programs & Medicare. It also has to be given in a clinical setting by a trained clinician every two months which could be an enormous hurdle or block for patients to get to, afford & comply with. I am hearing from my colleagues that are top clinicians & providers in the world like I am & only a handful of successes have been noted. That being said, this would, if rolled out strategically & properly, life saving & lifestyle being freed of the ever consistent daily pill burdens & the side effects that come with those regimens. Should any of you out there that actually read this in it’s entirety & would like to join in collaboration with me to provide a pathway to streamlined treatment utilizing these new regimens, I urge you to reach out to me in a private message for further discussion. Also, feel free to copy & share this throughout your networks of people & resource centers so that they may reach out to me as well. Thank you all who took the time to read this message in it’s entirety. Be well all.