Cabotegravir

ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses

Retrieved on: 
Monday, March 4, 2024
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ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.

Key Points: 
  • ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.
  • Future areas of study will include its potential use in combination with other medicines as a complete, ultra long-acting HIV treatment regimen.
  • ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the HIV community.
  • Based on these combined findings, ViiV Healthcare is no longer pursuing CAB 200 SC + rHuPH20 for ultra long-acting dosing.

Long-Acting Drug Delivery Technologies and Services Global Market Report 2023: Need for Improved Patient Convenience and Compliance Bolsters Demand - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 31, 2023
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The technological advancements in the field of long-acting drug delivery ascertain therapeutic efficacy, safety and improved drug pharmacokinetic and pharmacodynamic profiles.

Key Points: 
  • The technological advancements in the field of long-acting drug delivery ascertain therapeutic efficacy, safety and improved drug pharmacokinetic and pharmacodynamic profiles.
  • Question 8: Which segment, in terms of strategies, accounts for the largest share in the global long-acting drug delivery technologies market?
  • Answer: Presently, micro-encapsulation strategy accounts for the largest share (close to 50%) of the global long-acting drug delivery technologies market.
  • Question 9: Which geography is expected to witness the highest growth rate in the long-acting drug delivery services market?

ViiV Healthcare Presents Positive Data Showing Vocabria (cabotegravir) and Rekambys (rilpivirine) Can Be Successfully Implemented Across a Range of European Healthcare Settings

Retrieved on: 
Monday, October 24, 2022
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Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks by a healthcare professional at the same appointment.

Key Points: 
  • Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks by a healthcare professional at the same appointment.
  • Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
  • oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.
  • Rilpivirine may be present in human milk for up to 4 years in some patients after discontinuation of REKAMBYS.

ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Virologically Suppressed Adolescents Living With HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg

Retrieved on: 
Tuesday, March 29, 2022
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This approval marks the first time a long-acting HIV treatment is available for the adolescent population, underscoring ViiV Healthcares commitment to delivering options for young people living with HIV.

Key Points: 
  • This approval marks the first time a long-acting HIV treatment is available for the adolescent population, underscoring ViiV Healthcares commitment to delivering options for young people living with HIV.
  • Cabenuva is the first and only complete long-acting HIV treatment regimen and is approved as a once monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents.
  • The efficacy of Cabenuva in adolescents is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure.
  • INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells).

U.S. FDA Approves CABENUVA (cabotegravir and rilpivirine) for Adolescents, Expanding the Indication of the First and Only Complete Long-Acting Injectable HIV Regimen

Retrieved on: 
Wednesday, March 30, 2022
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TITUSVILLE, N.J., March 29, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older, weigh at least 35 kg and are on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine.1,2 Co-developed as part of a collaboration with ViiV Healthcare, CABENUVA is the first and only complete long-acting HIV-1 treatment regimen, and the first to be made available for eligible adolescents, building on Janssen's ongoing commitment to fighting HIV and improving HIV treatment options for young people living with HIV. 

Key Points: 
  • The efficacy of CABENUVA in adolescents is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure.
  • The adverse reactions reported by more than one patient (regardless of severity) were injection site pain (n=13) and insomnia (n=2).
  • In January 2021 , the FDA approved CABENUVA to be administered every month to adults living with HIV-1.
  • In February 2022 , the FDA approved an expanded label for CABENUVA to be administered every two months to adults living with HIV-1.

FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

Retrieved on: 
Monday, December 20, 2021
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Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

Key Points: 
  • Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.
  • Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection.
  • Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP.
  • Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen.

FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV

Retrieved on: 
Tuesday, September 28, 2021
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The Priority Review designation of cabotegravir long-acting for PrEP builds upon its prior identification as a Breakthrough Therapy by the FDA.

Key Points: 
  • The Priority Review designation of cabotegravir long-acting for PrEP builds upon its prior identification as a Breakthrough Therapy by the FDA.
  • We believe new options like investigational cabotegravir long-acting for PrEP will help play a significant role in our collective efforts to end the HIV epidemic.
  • ViiV Healthcare will initiate submissions of cabotegravir long-acting for PrEP to other regulatory authorities by the end of 2021.
  • Cabotegravir long-acting for PrEP has not been approved or licensed anywhere in the world for use in HIV prevention.

ViiV Healthcare study shows new long-acting HIV regimen Cabenuva (cabotegravir/rilpivirine) can be successfully implemented in broad range of US healthcare practices, even during COVID-19

Retrieved on: 
Saturday, July 17, 2021
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Additionally, this regimen remained highly acceptable both to healthcare providers and people living with HIV and was strongly preferred by study participants to daily oral therapy.

Key Points: 
  • Additionally, this regimen remained highly acceptable both to healthcare providers and people living with HIV and was strongly preferred by study participants to daily oral therapy.
  • A corresponding trial in Europe, CARISEL, is examining the implementation of long-acting cabotegravir and rilpivirine, dosed every 2-months in certain European healthcare settings.
  • Marketing Authorisations for the long-acting regimen of cabotegravir and rilpivirine were granted by the European Medicines Agency in December 2020.
  • Sustainment of implementation strategies was assessed via surveys and semi-structured interviews of staff study participants as well as patient study participants.

HIV medicines among latest hard-to-find drugs available through AllianceRx Walgreens Prime

Retrieved on: 
Tuesday, May 4, 2021
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b'ORLANDO, Fla., May 4, 2021 /PRNewswire/ -- Cabenuva (cabotegravir/rilpivrine), the first and only once-monthly complete injectable treatment is available through AllianceRx Walgreens Prime for adults living with human immunodeficiency virus type 1 (HIV-1).

Key Points: 
  • b'ORLANDO, Fla., May 4, 2021 /PRNewswire/ -- Cabenuva (cabotegravir/rilpivrine), the first and only once-monthly complete injectable treatment is available through AllianceRx Walgreens Prime for adults living with human immunodeficiency virus type 1 (HIV-1).
  • One in five people living with HIV suffer from chronic diarrhea.\n"I\'m proud of the fact that manufacturers choose AllianceRx Walgreens Prime to manage these life-changing medications for individuals with these conditions," says Tracey James, RPh, senior vice president of pharmacy services at AllianceRx Walgreens Prime.
  • "\nAllianceRx Walgreens Prime, one of the largest specialty and home delivery pharmacies in the country, provides medicine for patients with certain rare, chronic and complex conditions.
  • Known as limited distribution drugs (LDDs), the following specialty medicines are also now available through AllianceRx Walgreens Prime:\nXtandi (enzalutamide) capsules and tablets, manufactured by Astellas, is used to treat prostate cancer when surgery or other medicines have not worked or have stopped working.

ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV

Retrieved on: 
Tuesday, May 4, 2021
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With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill.

Key Points: 
  • With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill.
  • The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection.
  • This translated to an HIV incidence rate of 0.38% (95% confidence interval [CI] 0.20%-0.66%) in the cabotegravir group and 1.22% (95% CI 0.86%-1.66%) in the FTC/TDF group.
  • ISRs in HPTN 084 occurred more frequently in the cabotegravir arm (32%) vs. the FTC/TDF arm (9%), which received placebo injections.