FDA Approved The Long-Acting Injectable Cabenuva

FDA Approved The Long-Acting Injectable Cabenuva

The Food And Drug Administration (FDA) approved the use of Cabenuva medication treatment for HIV.  While there have been groundbreaking methods to help control the impact of this virus on the human body, treatment has not yet been approved until earlier this year. HIV has been a growing concern in the health sector.


Who’s The Manufacturer Of Cabenuva?


This medication is made and manufactured by ViiV Healthcare and is a blend of rilpivirine and cabotegravir.

ViiV Healthcare is owned by GlaxoSmithKline (GSK), along with Pfizer and Shionogi Limited as shareholders.

Cabotegravir is originally from ViiV, which is currently marketed as Cabenuva, Rilpivirine is from Janssen, which is under the Johnson & Johnson company.

What Is Cabenuva and How Can It Be Used?


Cabenuva is a whole regimen and treatment for HIV-1 infected adults that are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) and can be used to substitute the present and commonly used antiretroviral regime.


It contains a mix of Cabotegravir and an injectable version of rilpivirine, two kinds of HIV medicines.  Cabenuva offers two injectable suspension kits — one for the first dose and another for the continuation dose.


The initiation dose comprises a Cabotegravir 600 mg/3 mL & rilpivirine 900 mg/3 mL while the continuation dose comprises the rilpivirine 600 mg/2 mL & cabotegravir 400 mg/2 mL.


Take note that Rilpivirine 25-mg and cabotegravir 30-mg oral pills must be taken once a day for a month to check the patient’s tolerance before taking the course.


The starting dose cost about $5,940, while the continuation dose is priced at $3,960 per month.


Image source: medscape.com


How Successful Is Cabenuva?


Initially, the approved dose is to be given once per month. But a new supplemental New Drug Application (sNDA) has been filed last February to the FDA, proposing to modify the dose to twice a month instead.


According to clinical trials, though it’s being promoted to be taken once a month, individuals who took it twice a month confirmed to have no substantial gap than those who took it after.


Meanwhile, the efficiency of the therapy is at 95%, giving it a huge thumbs up to healthcare providers, particularly those supporting the causes of HIV-1.


“PRC provides workforce, legal, and behavioral health services for all those affected by HIV/AIDS in San Francisco,” CEO of PRC Brett Andrews stated during ViiV’s press release. “For years, a number of our customers have struggled to manage their health when working to stabilize key facets of their lives. Cabenuva will offer people living with HIV greater freedom to pursue vocational, educational, and other opportunities, like traveling, with no need for daily oral medication administration. A long-acting regimen is an innovation we’ve been waiting for.”


What Are the Potential Side Effects of Cabenuva?


The most common responses a person injected with Cabenuva were sleep disorders, rash, headache, pyrexia, fatigue, muscle pains, and dizziness.


For the rare and extreme cases, acute reactions such as hypersensitivity and skin reactions with fever were reported. However, the skin reactions were subsequently regarded as linked to organ dysfunctions.


Other extreme effects were Hepatoxicity and depressive disorders, amongst others.


When Be Will Cabenuva Available?


The drug’s manufacturer began rolling out Cabenuva in February of 2021. It’s available from specialty shops and specialty distributors as long as you have the appropriate documentation to acquire the treatment.


How Can Cabenuva Work?


Cabotegravir and rilpivirine works whenever the former interferes with the integrase enzyme while the latter interferes with the reverse transcriptase enzyme. These enzymes are those needed by HIV-1 to replicate themselves and infect additional.


However, these drugs interfere with those enzymes stopping the virus from multiplying, preventing all sorts of disease and body deterioration.


Testings rolled out to succeed before they obtained the Cabenuva approval from the FDA and are thought to be far effective compared to previous treatments for the virus.


“One of the scientific community, we recognize the innovation behind Cabenuva is 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, full long-acting regimen, allowing for a dramatic decrease in the frequency of dose, but it was preferred by the majority of clinical trial members when compared to their previous daily oral regimens. The FDA support of Cabenuva underscores the value of community-centric research, and I am happy this new option will be available for those who have HIV.”



Where To Get Cabenuva?


For today, Cabenuva can be acquired in two ways: by a specialty pharmacy and a specialty distributor.


The therapy is available from an accredited specialty pharmacy throughout the ViiV online portal, provided a patient may give the requirements.


On the other hand, specialty distributors are through their Buy & Bill method, which is also done via their website.


Here are the registered specialization pharmacies:


  • Accredo
  • AHF Pharmacy
  • Coordinated Care Network
  • Curant Health
  • CVS Caremark
  • Diplomat
  • Fairview
  • Humana Specialty Pharmacy
  • Kroger Specialty Pharmacy
  • Longs/Avita
  • Mail-Meds Clinical Pharmacy
  • Meijer
  • Optum/Avella
  • AllianceRx Walgreens + Prime/Walgreens


Here are the registered specialization distributors:


  • Curascript Specialty Distribution
  • Cardinal Health Specialty
  • Besse Medical
  • ASD Healthcare
  • McKesson Specialty Health
  • McKesson Plasma and Biologics


With Cabenuva’s 95% efficiency, people are beginning to think positively of the future and are confident about the consequences of the medication, particularly after the FDA’s approval.


Walensky will be practicing the reins at the CDC for a significant period in the course of this HIV/AIDS epidemic. Many people affected with HIV do not have a diagnosis, so diagnosed cases do not tell the complete story by any means. Nevertheless, it is notable that the amount of diagnosed cases has been decreasing. In 2018, the most recent year for which a tally is available, 37,968 new cases were diagnosed, and this is 2,868 fewer cases than the 40,836 diagnosed in 2014. In 2018, 5,425 Americans died from AIDS.


Two years ago, the Trump administration proclaimed a 10-year plan to finish to end the HIV epidemic. The program largely hinges on the availability and uptake of drugs to prevent and treat HIV, so medical innovation and methods to disseminate such creation are crucial.


Four improvements to watch out for in 2021 which might have a significant impact on HIV/AIDS prevention and treatment:


1. Inching Closer To a Twice-Annually Injectable For Treatment-Resistant Patients


Gilead is expected to finish regulatory filings this year due to their long-acting self-injectable HIV regimen lenacapavir. Gilead’s long-acting injectable only needs to be inoculated once every six months, a far cry from the daily oral remedies.


If approved, the HIV-1 capsid inhibitor is the first approved therapy of its type. It is intended for heavily treated patients resistant to multiple drugs–a particularly difficult-to-treat group of patients–in combination with other treatments.


The expected regulatory filings will come on the ends of Gilead delivering topline results from the stage 2/3 CAPELLA trial of 36 patients. The data demonstrated that patients taking lenacapavir were more likely to satisfy the study’s primary endpoint of a 0.5 log10 or greater decrease in viral load–a mark chosen to quantify a related change in the quantity of virus in a patient has–compared with placebo.


2. How Might Solo Cabotegravir Play Out?


Excitement is also mounting for the genuine possibility that a long-acting injectable to stop HIV will soon be approved. Since 2020 came to a close, the FDA granted breakthrough designation to ViiV Healthcare’s cabotegravir–among the two drugs in HIV treatment candidate Cabenuva–to preventing HIV. Cabotegravir is administered once every two months.


The treatment has shown its ability to effectively inhibit HIV infection in men who have sex with men and transgender women in a stage 2b/3 trial analyzing the vaccine with Truvada, an FDA-approved HIV prevention oral dose taken every day. The analysis, HPTN 083, was halted early because an interim review indicated that it was powerful. The data demonstrated that cabotegravir injection was 66% more effective at inhibiting HIV infection than Truvada.


3. Continuing The Quest For An HIV Vaccine


Despite all the advancements in HIV treatment, the evolution of an effective HIV vaccine is complex. But vaccine research persists. Janssen’s late-stage, mosaic-based vaccine candidate, which is expected to determine the first results from the stage 2b Imbokodo study as early as this season. As of July this past year, all 2,600 patients in the research have been fully vaccinated.


4. Obtaining More Coverage For HIV Prevention Medication


A new rule will make existing HIV Prevention therapies more accessible. Private insurers are currently gearing up to offer complete coverage for these treatments, also called PrEP, such as Gilead’s Truvada and Descovy, in addition to Teva’s recently available generic version of Truvada, for patients at high risk of obtaining HIV.


Coverage of PrEP, which decreases the risk of acquiring HIV by greater than 90 percent, will probably have significant implications for many patients at risk of HIV, as flat-rate prices for the remedies can run sufferers $1,000 annually with insurance because insurance doesn’t necessarily cover the entire cost of the treatment.


The move follows the U.S. Preventive Services Task Force–an independent panel that reviews the effectiveness and provides recommendations for preventive services–providing PrEP for HIV prevention an “A” recommendation back in 2019. Under the ACA, most insurance companies must cover preventive services that get an “A” or”B” rating from the group.


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