This week the Food and Drug Administration approved the first long-acting HIV treatment. The new drug is administered as a monthly injection and can be used as an alternative to daily antiretroviral pills.
There is currently no cure for HIV, but antiretroviral therapy can significantly reduce and even suppress the amount of the virus inside the body, meaning the level of virus is undetectable, the Centers for Disease Control and Prevention (CDC) explains. If the level of virus in your body is suppressed through antiretroviral therapy, you have “effectively no risk of transmitting HIV to an HIV-negative partner through sex,” the CDC says.
But one major downside of those antiretroviral medications is that they need to be taken daily in order to get the most benefit, which is where the newly approved monthly injection comes in.
This new drug, Cabenuva, is an injectable combination of two antiviral medications (cabotegravir and rilpivirine). It’s administered as two separate injections into the buttocks during the same doctor’s visit. And it’s now FDA approved to treat HIV infections in adults as a replacement for a current antiretroviral regiman, according to the FDA press release.
The approval is based on the results from two clinical trials including 1,182 adult HIV patients, the FDA press release explains. In those studies, the most common side effects associated with the medication were reactions at the injection site, rash, headache, fatigue, fever, nausea, musculoskeletal pain, dizziness, and sleep disorders.
“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” John Farley, M.D., MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”
However, there are some restrictions with the new HIV treatment. The big one is that it is only approved for use in people who are already on an antiretroviral regimen and have a suppressed (undetectable) viral load. And patients who want to switch to Cabenuva will first need to take cabotegravir and rilpivirine as oral medications for one month to make sure they can tolerate the medications.
Cabenuva is also expensive. The initial dose is larger and is expected to cost around $5,940, ABC News reports, while following doses will cost about $3,960 per month. (The exact amount a patient will pay depends on insurance coverage and other factors, though.)
But daily antiretroviral drugs for HIV are expensive too—and the price of those medications has risen significantly since 2012, according to a study published last year in JAMA Internal Medicine. The researchers found that the annual price of antiretroviral therapy then ranged from $24,970 to $35,160. In 2018 the annual price was between $36,080 and $48,000 (about $3,000 to $4,000 per month). The reality is that, in the U.S., HIV medication prices are extremely high, yet we have significantly fewer people with HIV viral suppression compared to other wealthy countries (such as Australia and Canada).
Despite these issues, the approval of this new option gives some people with HIV another crucial way to care for their health. And because it only needs to be taken once a month, some may find it more convenient and easier to keep up with than with daily medications.
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