Through our Janssen Pharmaceutical Companies, we are committed to the ongoing R&D of innovative solutions to fight HIV across the continuum of care. By partnering with others and utilizing our scale, we aim to make HIV history. In 2019, we again made significant progress, both in terms of supporting access to HIV therapy, and also through groundbreaking research to develop the world’s first preventative HIV vaccine.
Advancing science to prevent and treat HIV/AIDS
- Imbokodo moves forward: In 2019, together with our partners, we were pleased to achieve full enrollment in our Phase 2b proof-of-concept efficacy study evaluating an investigational preventative vaccine against HIV-1 infection. This important step is part of our Imbokodo1 study to evaluate Janssen’s mosaic-based preventative vaccine in 2,600 young women across five southern African countries where women and girls experience high rates of HIV transmission. The mosaic-based concept is designed as a global vaccine that should prevent infection by a wide range of viral strains responsible for the HIV epidemic. We expect initial results from Imbokodo by late 2021 that will confirm whether it can safely and effectively reduce the rate of new HIV infections.
- Mosaico gets started: Another significant advancement in 2019 was our announcement together with our partners to launch a second efficacy study, Mosaico, to test Janssen’s mosaic-based preventative vaccine concept by accelerating a parallel Phase 3 efficacy study that will evaluate the vaccine regimen in men who have sex with men (MSM), and in transgender people aged 18 – 60. It aims to recruit 3,800 participants at more than 50 clinical trial sites across North America, South America and Europe—making it Janssen’s largest study to date for the investigational preventative vaccine and one that focuses on communities that continue to face discrimination and challenges to access HIV treatment. Initial results from Mosaico are expected in 2024.
- Reducing the burden of HIV treatment for patients: In early 2019, we announced positive results of the novel, investigational, long-acting two-drug injectable regimen in two major Phase 3 studies—the Antiretroviral Therapy as Long- Acting Suppression (ATLAS) trial and the First Long-Acting Injectable Regimen (FLAIR) trial. The positive results from both studies showed that our treatment regimen (Janssen's rilpivirine and ViiV Healthcare's cabotegravir), injected monthly, had similar efficacy in maintaining viral suppression in adults living with HIV-1 when compared to a standard of care, daily, oral three-drug regimen. Following this outcome, we submitted a Marketing Authorization Application to the European Medicines Agency for rilpivirine long-acting as part of this monthly injection treatment regimen. In addition, later in 2019, we were able to confirm positive top-line results from the Phase 3 ATLAS-2M study which indicated that dosing every two months was as effective in maintaining viral suppression as monthly dosing in adults living with HIV-1 infection. These developments signal unprecedented advances in treatment for people living with HIV, potentially reducing a regimen of daily medication to just six injections per year.
- One submission to the U.S. Food and Drug Administration by ViiV Healthcare for ViiV’s cabotegravir LA together with Janssen’s rilpivirine LA.
- Two parallel submissions to the European Medicines Agency—one for rilpivirine LA by Janssen and one for cabotegravir LA by ViiV Healthcare.
Improving youth HIV therapy
In 2019, we expanded our New Horizons Collaborative, an innovative, integrated approach to improve access to antiretroviral (ARV) therapy for children and adolescents living with HIV in countries with the highest burden of pediatric HIV to include Cameroon, Nigeria, Rwanda and Zimbabwe, and to provide access to treatment until the age of 24 to enable a smooth transition into national adult HIV care. Worldwide, approximately 1.7 million children under age 15 have HIV.2 Generally, access to ARVs and treatment outcomes for children and adolescents are worse than those for adults across Africa. As a multisector partnership, the New Horizons Collaborative aims to improve and scale up ARV therapy for children and adolescents through increased awareness and research, strengthening health systems, and improving access to HIV medicines. Through the program, Johnson & Johnson provides treatment free of charge. The New Horizons Collaborative was recognized by the Access to Medicine Foundation as a best practice in pediatric HIV care.
Additionally, in sub-Saharan Africa, we advanced our partnership with DREAMS Thina Abantu Abasha, a youthled peer-to-peer initiative aimed at reducing the rate of HIV infections among adolescent girls and young women (AGYW). Through this program, in 2019, we reached 1.2 million AGYW, including all 19 – 24-year-olds who underwent HIV testing for the first time.
Additional initiatives to make HIV history
We maintain our pledge to the MenStar Coalition, which brings together global partners to expand the diagnoses and treatment of HIV infections in men, particularly in sub-Saharan Africa. This is a key step forward to breaking the cycle of HIV transmission and ultimately ending the HIV/AIDS epidemic as a public health threat. In 2019, we further committed resources to develop and deploy key insights about key emotional and health system barriers men face in accessing HIV treatment.
As part of our longstanding global fight to eliminate HIV, and to support nurses at the front lines of care, Johnson & Johnson commissioned the 5B documentary film. 5B is an inspirational story of the unsung heroes of healthcare working on the world’s first ward dedicated to treating AIDS patients at San Francisco General Hospital at the height of the epidemic in the early 1980s. Told through the voices of nurses and staff, 5B highlights the individuals who provided quality healthcare, compassion and the power of human touch during a time of great uncertainty. A portion of the film’s proceeds are used to fund HIV/AIDS projects in Africa.
We launched the first (BAND-AID®)RED campaign collaboration between BAND-AID® Brand Adhesive Bandages and (RED), a group of companies who partner and provide critical funding, awareness, and resources to help fight AIDS. Through this partnership, we hope to mobilize people everywhere to #bandtogether against HIV/AIDS. The purchase of a box of (BAND-AID®)RED Bandages helps provide a day’s worth of lifesaving medication to an HIV patient in sub-Saharan Africa.
As part of the Janssen-Pepal Leadership Challenge, 224 employees from Belgium and the Netherlands are engaged in a program in Uganda to help devise community-based interventions to generate impact on adolescent sexual and reproductive health. Starting in 2019, our employees are visiting Uganda in four cohorts spread over two years, working with government adolescent health workers, peer leaders and specialists from Baylor College of Medicine Children’s Foundation – Uganda. The Janssen-Pepal Leadership Challenge combines development of employees and strengthening of healthcare systems in low-resource settings, positively impacting patients, healthcare professionals and healthcare systems.