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Johnson & Johnson to Present New Data for Investigational Preventive Vaccine and Single-Tablet Treatment Regimens for HIV-1 at AIDS 2018

Originally Published by Johnson & Johnson.

As part of its commitment to make HIV history, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that over ten company-sponsored and partnered presentations will be presented at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam, The Netherlands (23-27 July). Johnson & Johnson will also be hosting a major satellite symposium, Biomedical Research Innovations in the Prevention, Remission and Cure of HIV/AIDS, which will take place immediately prior to the opening ceremony of the conference on July 23.


Notable Janssen presentations at AIDS 2018 will include the first long-term immunological data for the company’s investigational preventive vaccine regimen against HIV-1. Janssen’s mosaic-based regimen is designed as a “global vaccine” with the goal of preventing HIV infections due to a wide variety of HIV-1 subtypes responsible for the worldwide pandemic. Findings up to one year after last vaccination on safety and immunogenicity (ability to elicit an immune response) will be presented from the Phase 1/2a APPROACH study. Initial data from APPROACH were published in The Lancet on July 6, 2018, and showed a robust HIV immune response among a high percentage of healthy volunteers.

“The progress made in the last thirty years in the fight against HIV is remarkable, yet there is still much more to be done to achieve the UN’s target of ending the epidemic by 2030,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “In our quest towards a world without HIV, we are partnering with others to achieve the very best science. From our clinical trials of an investigational vaccine to exploring ways to transform the efficacy and tolerability of therapy, we aim to change the trajectory of health for humanity.”

Janssen will also present new data for SYMTUZATM, the darunavir-based single-tablet regimen for the treatment of HIV-1 infection, for which FDA approval is pending. These data include Week 48 results from the pivotal EMERALD trial, providing evidence on the efficacy and safety of switching from a boosted protease inhibitor-based regimen to a single-tablet regimen of SYMTUZATM in the treatment of HIV-1. Results from subgroups according to baseline regimen will be presented.

Johnson & Johnson is also proud to support its partners at AIDS 2018, harnessing extensive resources, pushing boundaries and exploring solutions to tackle some of the today’s most pressing public health challenges. Johnson & Johnson is committed to reducing the burden of HIV among the world’s most underserved populations through collaborations exploring multiple solutions, from investigating the role of a dapivirine-coated vaginal ring and its potential to reduce HIV transmission, to how cellphones may be used to support adherence to antiretroviral therapy.

A selected list of company and partnered data is listed below:

New data for our investigational vaccine regimen

APPROACH: This Phase 1/2a study will describe long-term safety and immunogenicity data in humans for investigational “mosaic”-based, prime-boost regimens that are designed to elicit an immune response against a variety of HIV subtypes prevalent worldwide.

  • Oral presentation from 11:45 CEST (05:45 EDT) on Tuesday 24 July (Abstract #10764); Venue E105-108

HPX1002/IPCAVD010: This Phase 1 study explores the immunologic responses of shorter mosaic-based vaccine regimens.

  • Oral presentation by Janssen’s partner Beth Israel Deaconess Medical Center (BIDMC) from 12:00 CEST (06:00 EDT) on Tuesday 24 July (Abstract #11441); Venue E105-108

New data for SYMTUZATM, the darunavir-based single-tablet regimen
EMERALD: Week 48 data in the pivotal EMERALD trial of HIV-1, providing evidence on the efficacy and safety of switching from a boosted protease inhibitor-based regimen to a single-tablet regimen of SYMTUZATM. Results from subgroups according to baseline regimen with be presented.

  • Poster presentation from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #5718); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

DIAMOND: Interim findings from the Phase 3 DIAMOND trial will provide evidence on the use of SYMTUZATM for the treatment of HIV-1 within community programs that use a Test-to-Treat model.

  • Poster presentation from 12:30-14:30 CEST (06:30-08:30 EDT) on Wednesday 25 July (Abstract #5095); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Final results of pilot study with darunavir/cobicistat/rilpivirine
PREZENT: Data will provide a first look at the final 96-week results of a pilot study into darunavir with cobicistat and ripilvirine in HIV-positive treatment-nave participants.

  • Poster presentation in partnership with IIS from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #4347); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Longer-term data for JULUCA, the first licensed two-drug maintenance treatment for HIV
SWORD 1 and 2: Data presented will show the evidence for durable maintenance of HIV-1 suppression to 100 weeks with a two-drug, single-tablet regimen combining ViiV Healthcare’s dolutegravir and Janssen’s rilpivirine, highlighting how it is possible to reduce cumulative ARV exposure while maintaining virological suppression.

  • Poster presentation by ViiV Healthcare from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #11730); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Results from Phase 2b study of an investigational two-drug long-acting injectable regimen comprising of ViiV’s cabotegravir and Janssen’s rilpivirine
LATTE-2: Data will explore patient satisfaction with the long-acting injectable regimen.

  • Poster presentation by ViiV Healthcare from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #6001); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

LATTE-2: Data will explore patient adherence to long-acting cabotegravir and rilpivirine injections through 96-weeks of maintenance therapy

  • Poster presentation by ViiV Healthcare from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #10659); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Cellphone intervention to promote adherence to antiretroviral therapy and improve standard of care

Multi-Octave: Data presented will show the effectiveness of using 2-way cellphone intervention (CPI) to boost 3rd line adherence in ART-experienced individuals.

  • Poster presentation by AIDS Clinical Trials Group from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #5097); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

New data on dapivirine vaginal ring, including variation on packaging and branding to improve product appeal to women, and social and behavioral data around male experiences of ring

Testing potential names and branding of packaging to ensure product is culturally appropriate, acceptable and appealing to women at risk of HIV in high HIV burden countries.

  • Poster presentation by International Partnership for Microbicides from 12:30-14:30 CEST (06:30-08:30 EDT) on Wednesday 25 July (Abstract #8590); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

An exploration of the perceptions and experiences of male sex partners of women participating in the 104-week Phase 3 study using the dapivirine ring, and how these could affect ring use.

  • Poster presentation by International Partnership for Microbicides from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #10591); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Further details on our work in HIV and the breadth of science being driven by Johnson & Johnson companies and their partners is available at jnj.com/HIV.

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