“The unbelievable science of HIV drug development is still pushing unbelievable new innovations into the market.”
That’s how longtime HIV treatment activist Mark Harrington, executive director and cofounder of Treatment Action Group, greeted the Jan. 21 announcement by the U.S. Food and Drug Administration (FDA) that it had approved Cabenuva (cabotegravir/rilpivirine) as the first-ever long-acting injectable HIV regimen.
It’s the realization of a dream that HIV scientists and activists have had for years: a regimen that doesn’t require daily, or even weekly, doses. Instead, those who go on Cabenuva will have to take the regimen in daily pill form for only a month before switching to a monthly visit to a health care provider for a shot in the butt.
Why Cabenuva’s Approval Is So Historic
“We have to take a big step back to understand the technical breakthrough this represents and how cool it is to now have the option of getting a once-monthly injection instead of taking a daily pill or pills,” says Harrington. And he should know: He’s been living with HIV since 1985, when there were absolutely zero treatments for HIV. Even once HIV medications first became available in the late 1980s, it took another 15 or so years before those treatments became not only truly effective, but largely free of horrible side effects.
Since about the early or mid-2000s, notes Harrington, HIV treatment regimens have gotten increasingly easy on the body, not to mention as simple as requiring just one pill a day. Cabenuva, he says, represents the next step toward the ideal: a once-yearly shot, perhaps even a once-in-a-lifetime shot, that tamps down HIV and its harmful long-term impacts.
And it’s very likely that the same switch—from daily oral pill to periodic injection—will happen soon with pre-exposure prophylaxis (PrEP), the HIV meds used to prevent HIV, which have now existed for nearly a decade. Hence, the approval of Cabenuva signals a huge leap forward for both the treatment and prevention of HIV.
“Folks are extremely excited about this—me included,” says Venita Ray, the deputy director of Positive Women’s Network-USA, who has been living with HIV since 2003. “When I think back on the amount of pills and the toxicity we had to deal with years ago, it’s huge to be given yet another new option in terms of choosing the quality of life that we want.”
Switching to Cabenuva: How to Decide?
So, fellow folks living with HIV, now that it’s been approved, why not simply switch from your current regimen to Cabenuva? After all, in the ATLAS and FLAIR studies leading to the regimen’s FDA approval, which included more than 1,100 participants in 16 countries, it worked as well as leading pill regimens and caused side effects—such as injection-site pain—in fewer than 5% of patients, a typically low threshold that does not impede FDA approval.
What’s more, there’s study data suggesting that Cabenuva takers might even be able to get their shot once every other month. If that dosing schedule gets approved, it would mean six provider visits a year rather than 12.
But for Harrington, this raises a question that will likely be asked by many folks with HIV, including this writer, when it comes to whether to switch: “Why would I visit the doctor that much?”
The truth is, by this point, many of us get our HIV meds via monthly or quarterly visits to the pharmacy, or even via mail order. And if our CD4 count and viral load are looking good, we only need to have our HIV labs done as seldom as once or twice a year. That makes living with HIV a nearly do-it-yourself affair.
Plus, there are now several one-pill-a-day HIV treatment regimens that are virtually side-effect–free—so many options that one can’t even keep up with the ads for all of them on mainstream TV.
So, indeed, why make that burdensome trip to the doctor’s office for a monthly (or even bimonthly) shot in the butt—which can hurt “somewhat,” says Harrington, according to the studies?
Ray says she’s open to the idea, but it depends on how quickly she could get in and out of her doctor’s office for that monthly shot. “I spend more time in the waiting room than in the office currently, but I don’t even go every six months, so this monthly visit would have to be really easy for me,” she says.
Ray and Harrington both suggest that in the short term, Cabenuva may well prove most attractive to those in the global HIV population “who, for various reasons, may not prefer daily pill-taking,” as Harrington puts it. That includes folks who, for example, don’t want their intimate partners or family members to find their HIV pills (perhaps out of a fear of shaming stigma or even violence), who are intermittently without shelter, or who—because of drug use, mental illness, or many other reasons—just aren’t able or willing to keep track of a daily pill-pop.
But, Harrington notes, such folks may struggle to show up for their regular shot for some of those very same reasons. Whether it’s in the U.S. or in places like Africa, people may live in a rural area where the nearest clinic is miles away and hard to get to. Some combination of mental illness, substance use, and homelessness—the very challenges that complicate taking a daily pill—may also complicate showing up to a monthly clinic appointment. In which case, folks who are prescribed Cabenuva would be at the same risk for unmanaged HIV and viral rebound as those who stop taking their daily pills.
Cabenuva is also not indicated for anyone who has had previous HIV treatment failure or has built up HIV drug resistance, a factor that may disqualify many HIV long-term survivors, the very people who may most long for the change after decades of popping pills.
And again, importantly, it does require that the first month of treatment be taken orally. This is to make sure that one has no bad side effects—because meds taken orally will “wash out” of the body quickly, whereas those taken via injection will stay in the system for a long time.
Mixed HIV Community Opinion on Taking Cabenuva
All things considered, who’s interested in Cabenuva? On the HIV Long-Term Survivors Facebook page, which has nearly 5,000 members, I posed that question. I got 45 replies.
Of those, 12 people unequivocally said they weren’t interested, with responses like, “Going to the doctor’s office for a shot (even if every two months) would be more of a burden”; “One pill once per day is less hassle than a 20-minute drive to the doc, look for parking, wait, then a 20-minute drive home”; and (as many pointed out), “I’m already taking other pills daily, so one more or less a day wouldn’t make a difference.”
Conversely, 11 people said they were open to it or were already taking steps to switch. “I have never liked taking pills, even before HIV,” wrote one woman. “My husband, now ex and deceased, transmitted the virus to me. Taking that pill nightly is a constant reminder of that pain. And my current pill has caused weight gain as well.” Said another: “I’ll do it. ... Would love to see if it develops into a longer-lasting injectable. [Doctor] visits would not be an issue for me.”
Others said they’d wait a year or two to see how Cabenuva did out there in the real world, or that they’d wait for the every-other-month version to be approved. A few said they had prior treatment failure, hence were ineligible.
One woman, who is raising a toddler living with HIV, said that although she knew that Cabenuva’s FDA approval was not indicated for children, she wished it were, as getting her child to take their HIV pills daily was a struggle. (On a related note, Cabenuva might be a good choice for young adults, many of whom are at the height of their sex and dating lives, and who may not want to be reminded daily that they are living with HIV—or to have their friends or sex partners see their HIV pills.)
Concerns About Cabenuva Cost
Then there’s pricing. According to a rep for ViiV, the drugmaker behind Cabenuva, the drug’s U.S. sticker price is $5,940 for the one-time initiation dose and $3,960 for the monthly injections after that.
That puts the first-year annual price, not counting the first month of oral pills (which ViiV has said it will pick up the tab for), at $43,560. That's in the (admittedly insane) realm of current popular single-pill regimens such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Dovato (dolutegravir/lamivudine), according to Tim Horn, director of medication access and pricing at NASTAD and co-chair of the Fair Pricing Coalition.
Of course, many people living with HIV won’t be expected to pay the sticker price of Cabenuva, thanks to private or public insurance coverage. The ViiV rep I spoke with said that the company expected Cabenuva to be covered by most private and public plans, and that the company would strive to offer what has generally become a standard level of assistance with patient cost-sharing and copays (via their ViiVConnect website).
Cabenuva’s Approval Doesn’t Fix Our Broken Medical System
Harrington says the excitement over the Cabenuva breakthrough does not erase a larger issue: “We know from the [slow and flawed] rollout of the COVID vaccines that our [U.S.] medical system is fragmentary and broken. Every time we have a [new medical breakthrough], you still have the flaws in coverage.”
This problem, he adds, is undergirded by the highest underlying drug prices in the world—a reality that’s aptly reflected in the cost of HIV meds in the U.S. compared even to other rich countries, such as Canada and much of Western Europe.
Says Horn: “Cabenuva is a major advance that will very likely be beneficial for many people living with HIV. We just need to ensure that ViiV is engaged in good-faith discussions with private and public [coverage plans] to ensure that access is not a significant barrier.”
As for me, like many of the folks on the HIV Long-Term Survivors page, I’m good for now. In addition to my two daily HIV meds, I take three or four other meds for different health issues, so the whole process is no biggie for me. But just as I’ve made small changes to my HIV regimen over the past 20 years when advances occurred, I’m open to more. Maybe when that monthly shot becomes a yearly one—or even a single shot that then allows me to never think about HIV treatment again.
That’s the breakthrough I’m holding out for!