• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Cabenuva (cabotegravir and rilpivirine, injectable formulation) and Vocabria (cabotegravir, tablet formulation)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Cabenuva (cabotegravir and rilpivirine, injectable formulation) and Vocabria (cabotegravir, tablet formulation)

  • Profile

Profile

Contact Information

Contact: ViiV Healthcare
Website: www.cabenuva.com

Currently Enrolling Trials

    Show More

    General Information

    Cabenuva (cabotegravir and rilpivirine, injectable formulation) is a once-monthly, long-acting (extended release) regimen combining the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC.

     Vocabria (cabotegravir, tablet formulation), is designed to be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

    Cabenuva is specifically indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The FDA expanded the use in March of 2022 to include use in patients 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

    Cabenuva should be administered by a healthcare provider once-monthly as two individual intramuscular injections in the buttocks. Prior to initiating treatment with Cabenuva, oral cabotegravir (Vocabria) and oral rilpivirine (Edurant) should be administered for approximately one month to assess the tolerability of each therapy.

    Cabenuva is also available for every-two-month dosing.

    Mechanism of Action

    Cabenuva (cabotegravir and rilpivirine, injectable formulation) is a once-monthly, long-acting (extended release) regimen combining the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).

    INSTIs, like cabotegravir, 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 infection.

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

    Side Effects

    Adverse effects associated with the use of Cabenuva may include, but are not limited to, the following:

    • injection site reactions
    • pyrexia
    • fatigue
    • headache
    • musculoskeletal pain
    • nausea
    • sleep disorders
    • dizziness
    • rash 

    Clinical Trial Results

    The FDA approval of Cabenuva was based on the pivotal Phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 patients from 16 countries, including the U.S. The studies demonstrated that Cabenuva was as effective as continuing a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.

    In the ATLAS study, Cabenuva met the primary endpoint for noninferiority (the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either Cabenuva or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ≥50 c/mL. Two percent of patients receiving the long-acting injectable and 1% of patients receiving CAR had an HIV-1 RNA level ≥50 c/mL at Week 48 (Treatment Difference 0.7%).

    In the FLAIR study, at Week 48, a comparable number of patients receiving either Cabenuva or daily oral dolutegravir/abacavir/lamivudine therapy had an HIV-1 RNA count ≥50 c/mL, meeting noninferiority criteria. Two percent of patients in both treatment arms had an HIV-1 RNA count ≥50 c/mL at Week 48 (Treatment Difference -0.4%).

    Approval Date: 2021-01-01
    Company Name: ViiV Healthcare
    Back to Listings

    Upcoming Events

    • 25Apr

      Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

    • 26Apr

      FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

    • 27Apr

      Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

    • 17May

      2023 WCG Avoca Quality Consortium Summit

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • tablet

      Digital Intake Platforms Effective as Source of Trial Information, Survey Shows

    • Diversity-360x240.png

      Site Spotlight: EmVenio Research Takes to the Road to Promote Trial Diversity

    • Five Ws

      Consider the Five ‘W’s to Understand Potential Participants

    • QandA-360x240.png

      Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing