Skip to main content
  • U.S. Department of Health & Human Services
National Institutes of Health (NIH) - Turning Discovery into Health
  • Virtual Tour
  • En Español

Site Menu

  • Home
  • Health Information
    • Health Care Providers & Facilities
    • Health Info Lines
    • HealthCare.gov
    • Science Education Resources
    • NIH Clinical Research Trials and You
    • Talking to Your Doctor

    More »

    Quick Links

    • MedlinePlus Health Info
    • NIH News in Health
    • Wellness Toolkits
  • Grants & Funding
    • Grants Home Page
    • Find Funding
    • Due Dates
    • How to Apply
    • About Grants
    • Policy & Compliance
    • Grants News/Blog
    • Contracts
    • Loan Repayment

    More »

    Quick Links

    • RePORT
    • eRA Commons
    • NIH Common Fund
  • News & Events
    • News Releases
    • Digital Media Kits
    • Media Resources
    • Media Contacts
    • Images and B-roll
    • Events
    • Social Media

    More »

    Quick Links

    • NIH News in Health
    • NIH Research Matters
    • NIH Record
  • Research & Training
    • Medical Research Initiatives
    • Science Highlights
    • Science Education
    • Research in NIH Labs & Clinics
    • Training Opportunities
    • Library Resources
    • Research Resources
    • Clinical Research Resources
    • Safety, Regulation and Guidance

    More »

    Quick Links

    • PubMed
    • Stem Cell Information
    • OppNet
    • NIDB
    • NIH Blueprint for Neuroscience Research
  • Institutes at NIH
    • List of Institutes and Centers
    • NIH Office of the Director
    • Directors of NIH Institutes and Centers
    • NIH Institute and Center Contact Information

    More »

    Quick Links

    • NCI
    • NEI
    • NHLBI
    • NHGRI
    • NIA
    • NIAAA
    • NIAID
    • NIAMS
    • NIBIB
    • NICHD
    • NIDCD
    • NIDCR
    • NIDDK
    • NIDA
    • NIEHS
    • NIGMS
    • NIMH
    • NIMHD
    • NINDS
    • NINR
    • NLM
    • CC
    • CIT
    • CSR
    • FIC
    • NCATS
    • NCCIH
  • About NIH
    • Who We Are
    • What We Do
    • Jobs at NIH
    • Visitor Information
    • Frequently Asked Questions
    • Contact Us

    More »

    Quick Links

    • The NIH Director
    • Take the Virtual Tour
    • NIH…Turning Discovery Into Health®
    • Impact of NIH Research
    • Science, Health, and Public Trust

You are here

Home » News & Events » News Releases

News Releases

News Release

Wednesday, February 21, 2024

Long-acting HIV treatment demonstrates efficacy in people with challenges taking daily medicine as prescribed

HIV-1 Virus Transmission electron micrograph of HIV-1 virus particles (orange) replicating from the plasma membrane of an infected H9 T cell.NIAID

Long-acting antiretroviral therapy (ART) with cabotegravir and rilpivirine was superior in suppressing HIV replication compared to daily oral ART in people who had been unable to maintain viral suppression through an oral daily regimen, according to interim data from a randomized trial. Upon review of these findings, an independent Data and Safety Monitoring Board (DSMB) recommended halting randomization and inviting all eligible study participants to take long-acting ART. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in collaboration with the National Institute of Mental Health, the National Institute on Drug Abuse, ViiV Healthcare and ACTG, a global NIH-funded clinical trials network that designed and implemented the study. NIH accepted the DSMB’s recommendation.

About 70% of people with HIV in the United States who take oral ART achieve viral suppression, according to data from the Centers for Disease Control and Prevention. Viral suppression protects people with HIV from progressing to advanced disease, and prevents HIV transmission to others. In 2021, the Food and Drug Administration approved cabotegravir and rilpivirine as an ART regimen for people with a consistent history of viral suppression. NIAID launched a study in 2019 to understand how this regimen would work in people with previous challenges taking daily oral ART as prescribed and who had not consistently maintained viral suppression.

The study is ongoing across 31 sites in the United States including Puerto Rico. Participants were screened to ensure the HIV in their blood was not resistant to the study drugs and that they met other health and safety criteria. Once enrolled, they received comprehensive and incentivized adherence support while taking daily oral ART to achieve viral suppression. Participants who achieved viral suppression were then randomized to receive long-acting injectable ART every four weeks or to continue taking standard-of-care daily oral ART, with frequent health monitoring.

On February 12, the study DSMB conducted a planned review of interim data and found that long-acting cabotegravir and rilpivirine administered every four weeks had superior efficacy to daily oral ART. The DSMB recommended that all participants should have the opportunity to choose long-acting ART to ensure the best possible health outcomes in the study. Study participants are being notified of these findings and those currently taking daily oral ART will decide with their providers which ART method suits their needs best. All study participants will be monitored for another year.

ViiV Healthcare and Johnson & Johnson provided medications for this study. Detailed interim results will soon be shared through scientific channels.

NIH is grateful to the research sites and volunteers who participate in studies to improve HIV treatment.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health®

###

Institute/Center

The National Institute of Allergy and Infectious Diseases (NIAID)

Contact

NIAID Office of Communications
301-402-1663

Connect with Us

  • Subscribe to news releases
  • RSS Feed

Connect with Us

  • Contact Us
  • X
  • Facebook
  • Instagram
  • YouTube
  • Flickr
  • More Social Media from NIH

Footer

  • NIH Home
  • Virtual Tour
  • En Español
  • Visitor Information
  • Frequently Asked Questions
  • Privacy Policy
  • Disclaimers
  • Accessibility
  • NIH Website Archives
  • Nondiscrimination Notice
  • Freedom of Information Act
  • No Fear Act
  • HHS Vulnerability Disclosure
  • Office of Inspector General
  • USA.gov

NIH…Turning Discovery Into Health®

National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892

U.S. Department of Health and Human Services

Back to Top