Cabenuva Approval and Updates: What You Need To Know
HIV continues to be a growing concern in the health industry. While there have been groundbreaking ways to help control the effect of the virus on the body, a treatment has yet to be approved until earlier this year when the Food And Drug Administration (FDA) approved the use of Cabenuva drug treatment for HIV.
Who Is The Manufacturer Of Cabenuva?
This drug is made and manufactured by ViiV Healthcare and is a combination of cabotegravir and rilpivirine.
ViiV Healthcare is owned by GlaxoSmithKline (GSK), with Pfizer and Shionogi Limited as shareholders.
Cabotegravir is originally from ViiV, which is now marketed as Cabenuva. Rilpivirine, meanwhile, is from Janssen, which is under the Johnson & Johnson company.
What Is Cabenuva and How Is It Used?
Cabenuva is a complete regimen and treatment for HIV-1 affected adults who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) and is used to replace the current and commonly used antiretroviral regime.
It contains a combination of cabotegravir and an injectable version of rilpivirine, two types of HIV drugs.
Cabenuva provides two injectable suspension kits -- one for the initial dose and another for the continuation dose.
The initiation dose contains a cabotegravir 600 mg/3 mL & rilpivirine 900 mg/3 mL while the continuation dose contains the cabotegravir 400 mg/2 mL & rilpivirine 600 mg/2 mL.
Take note that cabotegravir 30-mg and rilpivirine 25-mg oral tablets must be taken once a day for a month to test the patient’s tolerance before taking the regimen.
The initiation dose cost about $5,940, while the continuation dose is priced at $3,960 per month.
How Effective Is Cabenuva?
Initially, the approved dosage is to be given once a month. However, a new supplemental New Drug Application (sNDA) has been submitted last February to the FDA, proposing to change the dosage to twice a month instead.
According to clinical trials, although it is being marketed to be taken once a month, people who took it twice a month proved to have no significant difference than those who took it once.
Meanwhile, the efficacy of this treatment is at 95%, giving it a big thumbs up to healthcare services, especially those supporting the causes for HIV-1.
“PRC provides legal, workforce and behavioral health services for those affected by HIV/AIDS in San Francisco,” CEO of PRC Brett Andrews said during ViiV’s press release. “For years, many of our clients have struggled to manage their health while working to stabilize key aspects of their lives. Cabenuva will provide some people living with HIV greater freedom to pursue vocational, educational and other opportunities, like travel, without the need for daily oral medication management. A long-acting regimen is an innovation we have been waiting for.”
What Are the Possible Side Effects of Cabenuva?
The most common reactions a person injected with Cabenuva were rash, sleep disorders, headache, fatigue, pyrexia, muscle pains, and dizziness.
For the extreme and rare cases, acute reactions like hypersensitivity and skin reactions with fever were reported. However, the skin reactions were then seen to be related to organ dysfunctions.
Other extreme effects were hepatoxicity and depressive disorders, among others.
When Will Cabenuva Be Available?
The drug’s manufacturer started rolling out Cabenuva in February of 2021. It is available from specialty pharmacies and specialty distributors as long as you have the proper documentation to acquire the treatment.
How Does Cabenuva Work?
Cabotegravir and rilpivirine works when the former interferes with the integrase enzyme while the latter interferes with the reverse transcriptase enzyme. These enzymes are the ones needed by HIV-1 to copy itself and infect further.
However, these drugs interfere with those enzymes rejecting the virus from multiplying, preventing all kinds of infection and body deterioration.
Testings rolled out to be successful before they got the Cabenuva approval from the FDA and are believed to be far effective than the previous treatments for the virus.
“Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful,” Dr. David Wohl, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, said. “Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior daily oral regimens. The FDA approval of Cabenuva underscores the value of community-centric research, and I am pleased this new option will be available for those living with HIV.”
Where To Get Cabenuva?
For now, Cabenuva can be acquired in two ways: from a specialty pharmacy and a specialty distributor.
The treatment is available from a licensed specialty pharmacy through the ViiV online portal, provided a patient can provide the requirements.
On the other hand, specialty distributors are through their Buy & Bill method, which is also done through their website.
Here are the registered specialty pharmacies:
- AHF Pharmacy
- Coordinated Care Network
- Curant Health
- CVS Caremark
- Humana Specialty Pharmacy
- Kroger Specialty Pharmacy
- Mail-Meds Clinical Pharmacy
- Walgreens/AllianceRx Walgreens + Prime
Here are the registered specialty distributors:
- ASD Healthcare
- Besse Medical
- Cardinal Health Specialty
- Curascript Specialty Distribution
- McKesson Plasma and Biologics
- McKesson Specialty Health
With Cabenuva’s 95% efficacy, people are starting to think positively of their future and are optimistic about the effects of the drug, especially after the FDA’s approval.
What are your thoughts about Cabanuva?