News about Apretude (cabotegravir) 2-month injectable PrEP

[fskn]

Congratulations on starting injectable PrEP, @1stimebare, and  thanks for sharing your experiences.

Check the drug leaflet (available on the manufacturer's Web site) or the US CDC PrEP guidelines (latest revision: 2021) for information about how soon you are protected. You (or your provider, more likely), could also check the HPTN 083 study design, considering carefully the purpose(s) of the lead-in period in that study. Your provider is likely being conservative.

Edited April 7, 2022 by fskn

[1stimebare]

I have a copy of the leaflet, they gave it to me when I got the shot.  Still haven't read it yet I will admit, since I figured seeing the list of possible side affects just after the shot was a good way to talk yourself into believing you had them.  And I have no doubt the doctor is being conservative that's what doctors DO.  At least this one didn't give me a safe sex talk which was all the Primary care doctor gave me when I asked for the prep prescription.

Edited April 8, 2022 by 1stimebare

[1stimebare]

Get my second dose of apretude tomorrow.  Maybe going to Cum union in June at Augusta?

[budapest]

Brilliant news and thank you for sharing. It will be interesting to see and read any updates from the real world use and any side effects or issues. 

Fantastic news that further additional options are out there for our protection and to allow us to enjoy our sexual adventures without worry or constraints. 

[1stimebare]

Well I have had my second dose and had blood work done to see if it is having any negative affects on my liver or kidneys.  Asked the doctor how long yo wait before it has taken effect.  She did not know and started reading the pamphlet, her best answer was 6 to 8 weeks after the second shot for MAXIMUM protection.   Anyone else out here heard differently?  To be honest not like I have not had bare sex before this, but did try to be careful about with who and all I can say was I was lucky never to have been infected because it certainly could have happened but luckily did not.

[fskn]

To avoid unnecessary worry on the part of people considering injectable PrEP, I want to note that the CDC guidelines do not call for liver or kidney testing for injectable PrEP users.

(A medical professional is always the right person to make this call for an individual patient, but the guidelines don't recommend such testing in general.)

It's worth noting that oral PrEP — the Truvada and now Descovy pills that people are used to — requires more safety testing than injectable PrEP.

[1stimebare]

Very true.  The only reason I ended up on injectable is the kidney doctor ruled out the pills in my case because of their side effects.  And the liver issues in my case are unique to me not something that would be required for everyone.  All a part I guess of being older than the average Prep user.

[Guest]

good to know. but for now i still prefer to be a totally unprotected neg hole for  guys

[PillowPrincess0]

"In two large studies, people receiving cabotegravir injections were significantly less likely to get HIV than people receiving Truvada pills; for both, adherence matters"

Do the two studies specify percentage points between the two? If I do do pills I might forget a dose so a 2 month injection might be more convenient.

[viking8x6]

3 hours ago, PillowPrincess0 said:

"In two large studies, people receiving cabotegravir injections were significantly less likely to get HIV than people receiving Truvada pills; for both, adherence matters"

Do the two studies specify percentage points between the two? If I do do pills I might forget a dose so a 2 month injection might be more convenient.

Also, it would be interesting to know whether the studies tried to measure (and correct for) the adherence effect. Measuring would presumably be relatively easy for the cabotegravir, less so for the Truvada.

[fskn]

3 hours ago, viking8x6 said:

Also, it would be interesting to know whether the studies tried to measure (and correct for) the adherence effect. Measuring would presumably be relatively easy for the cabotegravir, less so for the Truvada.

Adherence is the main reason for the difference. This kind of research takes two large groups of people, gives one group real Truvada and fake Cabotegravir (now branded as Apretude), gives the other group fake Truvada and real Cabotegravir, and compares the percentage of people who get HIV in the first group with the percentage infected in the second group. The group sizes and the length of the study are set with the expected number of infections in mind. (If too few infections occur, it's not possible to draw any conclusions.)

Adherence is a problem with oral PrEP, but it can also be a problem with injectable PrEP. There is an excellent chart for the US study (HPTN 083) that plots time of infection against times of  Cabotegravir injections. Almost all HIV infections among people in the real Cabotegravir group occurred either before the first injection (unfortunately, within the window period of the HIV screening test used locally by a study site) or after a person had missed an injection. I'll try to dig up that chart and other useful materials in the next few days.

(In most oral PrEP studies, similar data about individual adherence are collected for a random subsample of participants, who provide hair or dried blood spots. Drug concentrations corresponding to taking at least 4 Truvada pills in a week are usually set as the threshold for adequate minimum adherence, for receptive anal sex. Patients may also complete sex diaries, so that researchers can gauge risk levels. A PrEP study among celibate priests, for example, would not be useful, whereas a PrEP study among sex workers would be extremely informative. But individual adherence is a digression. Given a medically effective intervention like Truvada for PrEP, low adherence across the whole group shows up in a high rate of HIV infections in the group.)

What I don't want is for people to get lost in the statistics. It was established that injectable Cabotegravir for PrEP was not only "non-inferior" but also superior to daily oral Truvada for PrEP.

Injectable PrEP has many advantages, but also a few disadvantages.

It is available free to most Americans who want it and are willing to press their medical providers and their insurers and, if need be, to enroll in one of the manufacturer's two patient assistance programs.

But the decision about injectable PrEP is one to make in consultation with a medical provider.

Edited May 8, 2022 by fskn

[atyl7u]

I just started on Descovy and the PrEP clinic didn't mention anything about injectable PrEP. Anyone know if it's authorized for use in Canada?

[fskn]

@atyl7u, sadly, injectable cabotegravir (US brand name: Apretude) is not approved for HIV prevention in Canada. It doesn't seem as if an application has been submitted.

Injectable cabotegravir+rilpivirine (US brand name: Cabenuva) is approved for HIV treatment in Canada.

Health Canada lists approved and pending initial and supplementary drug  applications here: [think before following links] https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html

[RealCute]

Some more info 

[think before following links] https://www.catie.ca/treatmentupdate-244/long-acting-hiv-treatment-a-major-change-begins

In the article talks about the injectable.

 

[1stimebare]

I certainly did have to press the subject.  First with the doctor and then to get a provider.  One specialty pharmacy took up a lot of time discussing price only to later say they did not provide it and sent the doctor and I elsewhere to get it.  But it finally got approved at no cost.  Second shot has been received and  first test will be at June Cum Union.