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How Long Can You Live With Hiv Without Treatment

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U.Southward. FDA Approves CABENUVA (rilpivirine and cabotegravir) for Use Every Two Months, Expanding the Label of the First and Simply Long-Acting HIV Treatment

CABENUVA offers virologically suppressed adults living with HIV an injectable handling pick administered as few equally six times a year.

TITUSVILLE, N.J., Feb. 1, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.South. Nutrient and Drug Administration (FDA) has approved an expanded characterization for CABENUVA (rilpivirine and cabotegravir) to be administered every two months for the treatment of HIV-ane in virologically suppressed adults (HIV-i RNA less than 50 copies per milliliter [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. The novel regimen was co-adult as part of a collaboration with ViiV Healthcare and builds on Janssen's 25-yr commitment to brand HIV history. ViiV Healthcare is the marketing authorization holder for CABENUVA in the U.South.

(PRNewsfoto/Janssen)
(PRNewsfoto/Janssen)

CABENUVA was approved by the U.S. FDA in January 2021 as a once-monthly, complete regimen for the handling of HIV-i infection in adults to supervene upon the electric current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml).1 CABENUVA is comprised of two carve up injectable medicines, rilpivirine extended-release injectable break in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, and ViiV Healthcare'southward cabotegravir extended-release injectable suspension in a single dose vial. Prior to initiating treatment of CABENUVA, oral dosing of rilpivirine and cabotegravir should be administered for approximately one month to appraise the tolerability of each therapy. The U.S. FDA Blessing allows CABENUVA to be dosed monthly or every two months.

"The expanded characterization approval for CABENUVA—to exist administered every two months—marks an important footstep forward in advancing the treatment landscape for people living with HIV," said Candice Long, President, Infectious Diseases & Vaccines, Janssen Therapeutics, a Division of Janssen Products, LP. "With this milestone, adults living with HIV have a treatment option that farther reduces the frequency of medication."

Click to Tweet : #BREAKING: The @US_FDA has approved a new dosing choice for people living with #HIV. Larn more near this exciting milestone in the HIV handling landscape: http://bit.ly/38rPgFi

"An important goal for u.s.a. in HIV is alleviating the need for daily medication, which can serve equally a constant reminder for people living with the condition," said James Merson, Ph.D., Global Therapeutic Expanse Head, Infectious Diseases, Janssen Research & Development, LLC. "With this new treatment selection that reduces CABENUVA dosing frequency to but vi times per year, we are revolutionizing HIV therapy for people living with HIV in the U.S."

The U.S. FDA approving of long-acting rilpivirine and cabotegravir for use every two months is based on the global ATLAS-2M phase 3b trial results, which demonstrated that every-two-calendar month dosing was non-junior to in one case-monthly dosing.2 Not-inferiority was determined by comparing the proportion of participants with plasma HIV-1 RNA ≥ 50 c/ml using the U.S. FDA Snapshot algorithm at Calendar week 48 (Intent-to-Care for Exposed population), which showed that the every-two-calendar month arm (9/522 [1.7%]) and once-monthly arm (5/523 [1.0%]) were similarly effective (adapted difference: 0.eight%, 95% conviction interval [CI]: -0.half-dozen%, ii.ii%). The written report too constitute that rates of virologic suppression, a fundamental secondary endpoint, were similar for every-two-month dosing (492/522 [94.3%]) and one time-monthly dosing (489/523 [93.v%]) (adjusted divergence: 0.8%, 95% CI: -2.one%, 3.7%). The most common adverse reactions (Grades i to four) observed in ≥2% of participants receiving long-acting rilpivirine and cabotegravir were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. In ATLAS-2M, the type and frequency of adverse reactions reported in participants receiving long-acting rilpivirine and cabotegravir once monthly or every two months for 48 weeks were similar. In the every-two-calendar month arm, rates of serious adverse events (SAEs: 27/522[v.2%]) and withdrawals due to adverse events (AEs: 12/522 [two.3%]) were low and similar to those experienced in the in one case-monthly arm (SAEs: 19/523 [three.6%], withdrawals due to AEs 13/523 [2.5%]).2

"Every clinician wants to be able to provide a patient with a treatment that is right for them, and there are a number of factors that become into that determination," said Tony Mills, MD*, CEO of Men's Health Foundation in Los Angeles, CA. "With this blessing, there is an of import added option for physicians to address patient's preferences for less frequent dosing."

The once-monthly version of rilpivirine and cabotegravir injectable handling has also been approved by the European Commission, Health Canada, the Commonwealth of australia Therapeutic Goods Administration, and the Swiss Agency for Therapeutic Products. The every-ii-months version has also been approved by the European Committee, Health Canada, and the Swiss Agency for Therapeutic Products. Regulatory reviews go on with boosted submissions planned throughout 2022.

* Tony Mills, MD, has received research support from Janssen and has served as a paid consultant to the company. He has non been compensated for any media work.

About ATLAS-2M (NCT03299049)
The ATLAS-2M Phase 3b trial is an ongoing, randomized, open up-label, active-controlled, multicenter, parallel-group trial designed to assess the non-junior antiviral activity and prophylactic of long-acting rilpivirine and cabotegravir administered every 8 weeks (every two months, 3ml dose of each medicine) compared to every iv weeks (once monthly, 2ml dose of each medicine) over a 48-calendar week treatment menstruation in ane,045 adults living with HIV-1.2 Subjects were required to be virologically suppressed for six months or greater, on a outset or 2nd antiretroviral regimen, with no prior virologic failure. The master outcome measure for the trial is the proportion of participants with HIV-1 RNA ≥50 c/ml at Week 48 using the U.Due south. FDA Snapshot algorithm (intent-to-treat exposed population).

For further information please see https://clinicaltrials.gov/ct2/show/NCT03299049.

Virtually CABENUVA (rilpivirine and cabotegravir)
CABENUVA is indicated as a complete regimen for the treatment of HIV-one infection in adults to replace the electric current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than fifty copies per ml) on a stable antiretroviral regimen with no history of handling failure and with no known or suspected resistance to either rilpivirine or cabotegravir. CABENUVA is administered past a healthcare provider as two intramuscular injections (rilpivirine and cabotegravir) in the buttocks.

The complete regimen combines rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed past Janssen Sciences Ireland Unlimited Visitor, with the integrase strand transfer inhibitor (INSTI) cabotegravir, adult by ViiV Healthcare. Rilpivirine is approved in the U.Due south. as a 25mg tablet taken one time a 24-hour interval for the treatment of HIV-i in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA copies/ml.

Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.

INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease.

Of import SAFETY Data

CONTRAINDICATIONS

  • Practise not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine

  • Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John's wort

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions:

  • Hypersensitivity reactions, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), accept been reported during postmarketing feel with rilpivirine-containing regimens. While some peel reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries

  • Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA

  • Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Prescribe the oral lead-in prior to assistants of CABENUVA to assistance identify patients who may be at risk of a hypersensitivity reaction

Post-Injection Reactions:

  • Serious mail service-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in claret pressure level, and hurting (e.m., back and chest). These events may accept been associated with inadvertent (partial) intravenous administration and began to resolve inside a few minutes afterward the injection

  • Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid adventitious intravenous administration. Detect patients briefly (approximately 10 minutes) subsequently the injection. If a mail-injection reaction occurs, monitor and treat as clinically indicated

Hepatotoxicity:

  • Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors

  • Patients with underlying liver affliction or marked elevations in transaminases prior to treatment may exist at increased take a chance for worsening or evolution of transaminase elevations

  • Monitoring of liver chemistries is recommended and handling with CABENUVA should be discontinued if hepatotoxicity is suspected

Depressive Disorders:

  • Depressive disorders (including depressed mood, depression, major depression, mood contradistinct, mood swings, dysphoria, negative thoughts, suicidal ideation or endeavor) have been reported with CABENUVA or the individual products

  • Promptly evaluate patients with depressive symptoms

Chance of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:

  • The concomitant utilise of CABENUVA and other drugs may event in known or potentially meaning drug interactions (meet Contraindications and Drug Interactions)

  • Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval

  • CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes

Long-Acting Properties and Potential Associated Risks with CABENUVA:

  • Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (upwards to 12 months or longer). Select appropriate patients who hold to the required monthly or every-2-calendar month injection dosing schedule because not-adherence could lead to loss of virologic response and development of resistance

  • To minimize the potential adventure of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month afterwards the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen equally presently as possible

ADVERSE REACTIONS

  • The well-nigh common adverse reactions (incidence ≥ii%, all grades) with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.

  • The most common injection site reactions (grades 1-3, ≥1%) were pain/discomfort, nodules, induration, swelling, erythema, pruritus, bruising/discoloration, warmth, and hematoma

DRUG INTERACTIONS

  • Refer to the applicable total Prescribing Information for important drug interactions with CABENUVA, VOCABRIA, or EDURANT

  • Considering CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-i infection is not recommended

  • Drugs that are stiff inducers of UGT1A1 or 1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine

  • CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes

Use IN SPECIFIC POPULATIONS

  • Pregnancy: In that location are insufficient human data on the use of CABENUVA during pregnancy to fairly appraise a drug-associated risk for birth defects and miscarriage. Discuss the do good-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for upwardly to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established

  • Lactation: The CDC recommends that HIV 1−infected mothers in the Usa not breastfeed their infants to avoid risking postnatal transmission of HIV-ane infection. Breastfeeding is likewise not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic apportionment for up to 12 months or longer after discontinuing injections of CABENUVA

Please see full Prescribing Information.

Almost the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to brand that hereafter a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we tin can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com and follow us at http://world wide web.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Sciences Republic of ireland Unlimited Company, Janssen Therapeutics, a Division of Janssen Products, LP, and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

To learn more almost Janssen'due south commitment to the prevention and handling of HIV, please visit jnj.com/HIV.

Cautions Apropos Forward-Looking Statements
This press release contains "forward-looking statements" as divers in the Individual Securities Litigation Reform Deed of 1995 regarding rilpivirine and development of potential preventive and treatment regimens for HIV. The reader is cautioned non to rely on these forward-looking statements. These statements are based on electric current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland Unlimited Visitor, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; dubiety of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained past competitors; challenges to patents; product efficacy or rubber concerns resulting in product recalls or regulatory action; changes in beliefs and spending patterns of purchasers of health care products and services; changes to applicative laws and regulations, including global health care reforms; and trends toward health care toll containment. A farther list and descriptions of these risks, uncertainties and other factors tin be plant in Johnson & Johnson's Annual Study on Form ten-1000 for the fiscal twelvemonth concluded Jan three, 2021, including in the sections captioned "Cautionary Note Regarding Forwards-Looking Statements" and "Item 1A. Risk Factors," and in the company's virtually recently filed Quarterly Report on Form ten-Q, and the company'southward subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, world wide web.jnj.com or on asking from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update whatever forrard-looking statement as a effect of new information or future events or developments.

REFERENCES

  1. CABENUVA (cabotegravir, rilpivirine) Prescribing Information. United states of america Approval January 2021.

  2. Overton Eastward et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-ane infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-characterization, stage 3b, not-inferiority study. The Lancet. 2020;396(10267):1994-2005.

© Janssen Therapeutics, Division of Janssen Products, LP 2022 02/22 cp- 291898v1

Cision
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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson

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