Updated May 20, 2021
The future of HIV treatment is already changing. In January, the Food and Drug Administration approved a new treatment called Cabenuva, which would get rid of daily pills and introduce a once-a-month injectable medication. Cabenuva is the first injectable to be FDA-approved for HIV, however the approval use is currently only for individuals who are undetectable and in stable condition.
This current limited application of Cabenuva is something Dr. Stacy Lane, founder of Central Outreach Wellness Center, has been advocating to change. On May 7, Dr. Lane shared an open letter she had written to UPMC For You in regards to their denial of compassionate use for Cabenuva on one of her clients. “We have used HIV medications outside of FDA approval since the start of the epidemic to save lives. To start insisting on FDA approval now will have people dying, and in light of U=U [Undetectable=Untransmittable], also fuel transmission.” wrote Dr. Lane in her appeal. This led Dr. Lane to have a two-hour-plus long conversation with UMPC where she had to take things to the grievance level. UMPC conceded their denial and approved Dr. Lane’s use of Cabenuva for her client, but she says her fight is not over with them.
A large part of her frustration centers around the fact that this is the one time the state of Pennsylvania has not allowed everyone to use this new HIV medication after its FDA approval. They want it to be used strictly to the stipulation in the approval for those who are controlled on medication. “We have never made people use HIV meds on label,” Dr. Lane said. “HIV meds have always been able to be flexible. because we realize that with HIV resistance and its difficulties we need all the tools in our box to do what is best for our patients.” Many insurance providers are allowing access to the medication, but Dr. Lane says that the Medicaid population will struggle because the state has not yet evaluated it.
Dr. Lane is advocating for Cabenuva as a “game changer” in many facets. There are countless competing needs that might make taking a daily pill a struggle for individuals, and this injectable would create an empowering lifestyle switch. Clients have told Dr. Lane, “they don’t feel HIV positive until I have to take that pill every day.” From the dawn of HIV medication, through taking a handful of pills three times a day to the evolution of once-a-day pills, Dr. Lane believes that the elimination of daily medication could help shift the stigma.
The horizon for Cabenuva’s range of uses looks bright as well. Dr. Lane is hopeful that FDA approval will be coming for its uses as PrEP for those who are HIV negative. Although the Cabenuva injectable comprised of cabotegravir and rilpivirine is not being studied in a PrEP setting, a long-acting cabotegravir is.
It is important to talk to your doctor to learn more and to see if Cabenuva is right for you. “HIV care has to be personalized for people’s bodies and people’s lifestyles,” says Dr. Lane. “Only an HIV positive person can decide, with help from their doctor, which medicine is best for them.”
Before starting injections, patients would be given an oral lead-in for about a month to ensure they do not have an allergy and will be able to tolerate the medication. The treatment consists of two shots in the buttocks. The shots are considerably large and more intense than something like a flu shot. They can only be given in-person by a doctor and must be received seven days before or after your Target Treatment Date. If a scheduled injection is missed, daily oral therapy can be used as a replacement. The most common side effects include injection site reactions (pain, tenderness, bruising, hardened mass, itching), fever, tiredness, nausea, headache, muscle or bone pain, sleep problems, dizziness, and rash. Again, it is crucial to speak with your doctor to learn more about Cabenuva and other HIV treatment.
Dr. Lane urges the importance of continued advocacy. Awareness needs to be constantly raised within the community so we can be proactive and do our part, from getting tested regularly to starting PrEP. Fierce advocacy is still needed today for transparent and open access to HIV treatments to save lives and stop the spread.
Updated May 20, 2021 at 3:48 pm to clarify that Cabenuva, comprised of two injectable medicines, ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine, is not being studied in PrEP setting and that cabotegravir is.