• 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 » Juluca (dolutegravir and rilpivirine)

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

Juluca (dolutegravir and rilpivirine)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Juluca is a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). 

    Juluca is specifically indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

    Juluca is supplied as tablets for oral administration. The recommended dosage is one tablet taken orally once daily with a meal. One tablet of Juluca contains 50 mg of dolutegravir and 25 mg of rilpivirine. If Juluca is coadministered with rifabutin, take an additional 25-mg tablet of rilpivirine with Juluca once daily with a meal for the duration of the rifabutin coadministration. 

    Clinical Results

    FDA Approval

    The FDA approval of Juluca was based on two pivotal phase III clinical trials, SWORD-1 and SWORD-2, which evaluated the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four-drug regimen. SWORD-1 and SWORD-2 were replicate 148-week, randomized, open-label, non-inferiority studies designed assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy. The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48. Results showed the 2-drug regimen achieved non-inferior viral suppression (HIV-1 RNA less than 50 copies per mL) at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (CAR 485/511 [95%], dolutegravir + rilpivirine 486/513 [95%] [adjusted difference  -0.2% (95% confidence interval CI: 3.0%, 2.5%), pooled analysis]). Virologic suppression rates were similar between treatment arms.

    Side Effects

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

    • diarrhea
    • headache

    Mechanism of Action

    Juluca is a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Strand transfer biochemical assays using purified HIV-1 integrase and pre-processed substrate DNA resulted in IC50 values of 2.7 nM and 12.6 nM. Rilpivirine is a diarylpyrimidine NNRTI of HIV-1 and inhibits HIV-1 replication by noncompetitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β, and γ.

    Additional Information

    For additional information regarding Juluca or HIV-1 infection, please visit https://us.juluca.com/

    Approval Date: 2017-11-01
    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