News about Apretude (cabotegravir) 2-month injectable PrEP

[fskn]

Information is starting to trickle in about Apretude (cabotegravir), the 2-month PrEP injection recently approved in the US. A practical "getting started" brochure for providers is out but I don't think there's an open link yet. You can read information for patients in text form, here:

[think before following links] https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF#page36

The bad:

• Must be given by a medical professional

• Only supplied by a small number of specialty pharmacies

• Insurer, medical provider, specialty pharmacy, and patient assistance program (if required) need to coordinate

• Resistance to the whole drug class (integrase inhibitors) is possible if you do get HIV; HIV testing before every injection matters, as does starting a different form of PrEP if you stop injections

The good:

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

• Patient assistance will be available to people with private (not Medicaid, Medicare, VA, TriCare) insurance; up to $7,850/year;

[think before following links] https://apretudecopayprogram.com/

• 7-day window for injections

• California is already warning insurers that they cannot avoid covering this drug or impose barriers; guidance for Department of Insurance-regulated plans (Department of Managed Health Care to follow suit) with useful background about illegal practices like pre-authorization:

[think before following links] http://www.insurance.ca.gov/0250-insurers/0300-insurers/0200-bulletins/bulletin-notices-commiss-opinion/upload/CDI-Bulletin-2021-10-Preventive-Services-Coverage-for-HIV-PrEP.PDF

It may be a little while yet before Apretude is available, but if you are interested in injectable PrEP, this may be a good time to start talking with your medical professional.

Please share news and experiences in this thread.

Edited February 3, 2022 by fskn
Fix links

[BBArchangel]

Thanks for the information on this, FSKN. I have not been following it closely enough. Personally I’m satisfied with my Descovy, But this is one more option, and options are always good. Are you familiar with the UCLA medical program involving a cure, an actual cure, for HIV? Reportedly it’s just gone into human trials.

[hntnhole]

Thanks, fskn, for the update.  I think I'll copy this to the letter-writing program and print it, and discuss with the doc next week at the regular checkup.  

[bbpoznow]

great idea will talk to the doc about it

[PozBearWI]

Thanks @fskn.  Nice to have a friend here who is tapped into the information unfolding about HIV treatments and prevention.  I am pretty happy with Descovy and will discuss a 2-1-1 plan with my clinic.  That could be a terrific compromise and save the system some unnecessary expense.  

[fskn]

@BBArchangel, I'll send you a private message to learn more about the UCLA cure research program/study.

@hntnhole and @bbpoznow, please report back! It will be interesting to hear what your doctors already know, or are willing to find out, about this brand-new PrEP option. I'll also be curious whether you encounter any roadblocks if it might be right for you medically and if you are interested in it.

I had initially been optimistic about Kaiser San Francisco (which already has a program for Cabenuva, the monthly cabotegravir + rilpivirine injection for HIV treatment), but they're already trying hard to quell interest in injectable PrEP, including spreading incomplete information about research findings to patients who dare to ask. Apretude would cost them more, require more staff effort (not just in administering the injections, but also in coordinating insurance coverage, patient assistance rebates, and delivery from an external pharmacy), and in general, entail change, which people generally avoid.

@WiChaser, FYI, Descovy hasn't yet been recommended for intermittent/"2-1-1" use — only Truvada, so far. That constraint aside, in case your doctor isn't familiar with intermittent PrEP, encourage them to check the 2021 CDC PrEP guidelines, published late last year, with a new chapter for intermittent PrEP. If you are comfortable sharing, let us know what you decide on.

5 hours ago, WiChaser said:

Nice to have a friend here who is tapped into the information unfolding about HIV treatments and prevention.

Thanks. What can I say, I'm an altruistic top who likes to verify the effectiveness of new treatment and prevention options by regularly breeding bottoms! I also like to administer booster injections...of cum. Why should people have to wait 5 or 6 months? 😈😏

In all seriousness, I believe that science matters, implementation and access matter, and that if we as a community continue to speak up and stay involved, we can help each other.

[bbpoznow]

will do  if I can ever get into  see my doc , been hard since covid 

[Bearseeder]

1 minute ago, bbpoznow said:

will do  if I can ever get into  see my doc , been hard since covid 

If you've been hard that long, you may need to see a doctor. 😉

[hntnhole]

1 hour ago, fskn said:

please report back

My next appt with the vampires is on Wednesday, and it takes a couple of days to get the results.  So, I'll have an update around the end of next week ....

[BBArchangel]

This is one of several articles about how he UCLA research into an actual cure.

[think before following links] https://thehill.com/changing-america/well-being/medical-advances/589696-ucla-researchers-come-closer-to-finding-possible?amp

[1stimebare]

I had an appointment with the doctor this week.  I have been trying to get a prescription for prep for over a year now.  Primary care doctor ignored my first 2 requests.  The physicians assistant finally acted on it when I saw her.  The infectious disease doctor spoke with the kidney doctor who says I can't do either truvada or descovy so only option is the injectable and then they have to closely monitor the liver.  Still waiting for an answer as to cost.  Anyone here on the injectable prep?  If so I would really like to hear your experiences with it.  Please.

[1stimebare]

I had an appointment with the doctor this week.  I have been trying to get a prescription for prep for over a year now.  Primary care doctor ignored my first 2 requests.  The physicians assistant finally acted on it when I saw her.  The infectious disease doctor spoke with the kidney doctor who says I can't do either truvada or descovy so only option is the injectable and then they have to closely monitor the liver.  Still waiting for an answer as to cost.  Anyone here on the injectable prep?  If so I would really like to hear your experiences with it.  Please.  The infectious disease doctor is researching this one herself as she told me she has never yet prescribed it for anyone.  I would be her first time using it.  Would start with either two injections a month apart and then every 2 months or 28 days of pills followed by injections every 2 months.  I suppose I could get a referral from her to a  see a doctor in Raleigh might have more experience with it.  Any thoughts out there.  Part of my problem is a shall we say a complicated medical history that has me on 9 pills a day already due to past cardiac issues.

[ErosWired]

23 minutes ago, 1stimebare said:

Primary care doctor ignored my first 2 requests.

Had any luck finding a new primary care doctor? Doctors who ignore me don’t remain my doctor for very long, and when I fire them I tell them exactly why.

[1stimebare]

Now that I am dealing with the PA I like her, but the next time I come face to face with s.o.b. I will tell him he is fired.

[fskn]

@1stimebare, I'm sorry to hear that you are having difficulty. Have you considered going to a community clinic, possibly GLBT-focused? I'm sure you can find one in Raleigh or in Durham.

Working with one's regular medical provider is ideal, but if the regular provider is slow to act, or lacks specific experience, a focused clinic might be a better setting. Of course, it would be vital that the clinic receive information about your complicated medical history.

Right now no clinician in the US who doesn't also work in research has experience with Apretude (2-month cabotegravir injection for HIV prevention) because it is brand-new. Clinicians who serve sufficient numbers of HIV-positive patients should by now have some experience with Cabenuva (1- or 2-month cabotegravir + rilpivirine injections for HIV treatment), which has been available a little longer.

Both products have the same sorts of implementation challenges: limited networks of pharmacy suppliers; need for an office visit for administration; questions about whether they are covered as prescription drugs or in other categories; etc.

As for cost, as long as your health insurance is not a grandfathered plan (which is not subject to the preventive care mandate) and is not Medicaid in a state that hasn't expanded Medicaid, and especially given that your medical professional has determined that you cannot use Truvada or Descovy, the PrEP injectable should be covered with no out-of-pocket costs, just like the two more typical, oral PrEP options.

If you have a grandfathered plan, the drug manufacturer has a patient assistance program that will help to cover copayments, coinsurance, and deductibles.

If you have no insurance, the manufacturer has a separate patient assistance program.

Although your particular medical situation might make liver testing necessary, one of the advantages of Apretude over Truvada or Descovy for HIV PrEP in general is that less monitoring is recommended. According to Page 51 of the updated (2021) US CDC guidelines,

"TESTING NOT INDICATED ROUTINELY FOR CAB PREP PATIENTS

Based on the results of the CAB clinical trials, the following laboratory tests are NOT indicated before starting CAB injection or for monitoring patients during its use: creatinine, eCrCl, hepatitis B serology, lipid panels, liver function tests."

[think before following links] https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf

This is of course not medical advice, just a reference to the CDC guidelines, whose interpretation is a job for a medical professional.

Sadly, the long delay that you've experienced in starting any form of HIV PrEP is an example of the extra risk to GLBT people's health from living outside GLBT population centers. Here in San Francisco, many public health system patients and private patients are already on Cabenuva injections for HIV treatment, and in my volunteer work I've sat in on several planning meetings over the past few months in which local providers have been preparing to offer Apretude injection for HIV PrEP.

Good luck, and please continue to share your experiences. This dialogue may help lots of other people who are not yet aware of injectable PrEP.

Edited March 12, 2022 by fskn