HIV is one of the most complex global health challenges we face. It affects more than 37 million people globally. While the world is making tremendous progress to curb the course of the global HIV epidemic, many challenges remain in the areas of prevention, treatment, access and public education.
Johnson & Johnson has been on the front lines of fighting HIV for decades. Our commitment to make HIV history includes the discovery and development of transformational HIV medicines, including simplified treatment regimens, a preventive HIV vaccine and early science for a functional cure. Further, we engage in initiatives around the globe to improve access to our medicines, undertake valued partnerships to advance the fight, and support dedicated work to help reduce the impacts of HIV among vulnerable populations, particularly women, adolescents and children.
New Products and Solutions
Over the last 10 years, Janssen Pharmaceutical Companies of Johnson & Johnson has established itself as a committed partner in the fight against HIV, introducing eight medicines for the treatment of this devastating disease. We continue our extensive efforts to bring effective treatments to people living with HIV, helping to combat resistance, simplify treatment, and discover new solutions toward fulfilling the dream of a preventive HIV vaccine and a potential strategy for HIV functional cure.
In 2017, a pilot project in Africa with the World Health Organization (WHO) to speed approval of Janssen’s HIV drug, INTELENCE (etravine), has made steady progress, with 11 regulatory authorities in 11 sub-Saharan African countries now having approved use of the medicine for treatment of children with HIV. The pilot has effectively reduced the approval process from what is normally a two-year wait to between three and eight months.
Similarly, in 2017 we brought two new treatment options to people living with HIV. In the European Union (EU), Janssen-Cilag International NV announced the European Commission approval of SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]) – the only darunavir-based single-tablet regimen approved for treatment of HIV-1. With the EU being the only region of the world where new HIV infection cases are still on the rise, approval and availability of SYMTUZA helps to fulfill patient needs and simplifies treatment, with the added benefit of helping people with improved treatment adherence and viral suppression.
A new drug application to the U.S. Food and Drug Administration (FDA) for SYMTUZA was also made for the treatment of HIV-1 infection in adults and adolescent patients aged 12 years and older. The FDA filing was based on results from two pivotal Phase 3 studies presented in October 2017 at the annual global forum on infectious disease (Infectious Disease Week in San Diego) and the European AIDS Conference in Milan, Italy.
In 2017, we announced the FDA approval for JULUCA (dolutegravir and rilpivirine), developed in collaboration with ViiV Healthcare, the first single-pill, complete two-drug regimen for treatment of HIV type 1 (HIV-1) infection in certain adults living with the disease who are virologically suppressed. JULUCA was also filed in Europe.
2020 Goal UpdateDevelop and deliver innovative, lifechanging solutions to address the world’s major health challenges.TargetCollaborate on Phase 3 trials and make regulatory submissions for rilpivirine LA, the first all-injectable depot regimen for HIV.ProgressIn collaboration with ViiV Healthcare, completed recruitment into Phase 3 clinical trials of the all-injectable regimen (cabotegavir LA from ViiV Healthcare and EDURANT [rilpivirine] LA from Janssen).StatusOn track
HIV remains a leading global threat to women’s health and is the primary cause of death among women of reproductive age in Sub-Saharan Africa. Taking an important step forward to help stem the rise of HIV infection rates in Sub-Saharan Africa, the nonprofit International Partnership for Microbicides (IPM) announced submission of an application for the monthly dapivirine vaginal ring to the European Medicines Agency, a successful outcome of our multi-year public-private partnership with IPM. Dapivirine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, blocks HIV’s ability to replicate itself inside a cell. In combination with safe sex practices, this vaginal ring is designed to reduce the risk of HIV-1 infection in HIV-negative adolescents and young women, offering a discrete prevention tool for women to stay HIV-free. European approval and WHO prequalification could pave the way to approvals in regions where women face the highest HIV risk.
Access to HIV Treatment
We are committed to making our HIV treatments accessible to those in need. Our HIV access and partnership efforts provide affordable and sustainable access to our HIV medicines in resource-limited settings through a variety of licensing agreements and collaborations. In the United States, through Janssen, we provide funding to encourage comprehensive community-based care models for underserved communities of people living with HIV. One of our flagship programs, New Horizons Advancing Therapeutics HIV Treatment, a collaboration with Elizabeth Glaser Pediatrics AIDS Foundation, is a donation program that seeks to build awareness, strengthen capacity, and mobilize action around the unmet needs of HIV treatment-experienced children and adolescents in Sub-Saharan Africa. Through our Health for Humanity 2020 Goals framework, we are expanding access to branded and generic versions of our HIV medicines (PREZISTA, INTELENCE and EDURANT) to more adult and pediatric patients around the world.
2020 Goal updateDeliver innovative healthcare access and training programs that impact a billion lives in underserved areas.*TargetDeliver HIV/AIDS therapy access to a cumulative 130,000 adults and 5,000 children.Progress38,500 adult patients and 630 pediatric patients received access to HIV/AIDS therapy with the branded and generic versions of PREZISTA, INTELENCE and EDURANT.StatusOn track
We also collaborate with researchers to study how our medicines can be used best to help patients in developing countries, and to provide medical education to ensure our medicines are used appropriately in those settings.
We join forces with patient advocacy groups to understand the needs of people living with HIV, strengthen health systems to support them, and provide information on our medicines and access options for patients.
Even with great advances in HIV treatment and prevention in recent years, nearly 1.8 million people still become infected with HIV annually.4 According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), women and girls account for nearly 60% of people living with HIV in eastern and southern Africa.5 The development of a safe and effective vaccine is the “holy grail” and would represent a historic scientific achievement as a turning point in the global fight against HIV epidemic. However, HIV attacks the immune system itself, so stimulating the immune system with a vaccine to mount a protective response is very challenging. At Johnson & Johnson, we believe this challenge can be met with approaches that are both scientifically creative, clinically safe and highly collaborative.
On the eve of World AIDS Day, we announced that Janssen, together with a consortium of global partners, initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine. Primary partners, the Bill & Melinda Gates Foundation and NIH’s National Institute of Allergy and Infectious Diseases, joined forces with our Company and several other partners to advance the potential prevention option, which is designed to be a “global vaccine” that could prevent a wide range of viral strains responsible for the HIV pandemic. The large-scale study, called “Imbokodo,” will evaluate whether the investigational Janssen vaccine regimen is safe, and may be able to reduce incidence of HIV infection among 2,600 study participants in Sub-Saharan Africa.
Adolescent girls and young women in 10 Sub-Saharan African countries are also the target of the DREAMS Partnership & Innovation Challenge, a partnership of the U.S. President’s Emergency Plan for AIDS, the Bill & Melinda Gates Foundation, Girl Effect, Johnson & Johnson, and others. An acronym for Determined, Resilient, Empowered, AIDS-free, Mentored and Safe women, DREAMS has a goal to contribute to the reduction of HIV infection in this population by 40%. It is delivering a core package that combines evidence-based approaches that go beyond the health sector, addressing the structural drivers that directly and indirectly increase girls’ HIV risk, including poverty, gender inequality, sexual violence, and a lack of education.
Additionally, the DREAMS program sponsored an Innovation Challenge, committing to invest in innovative solutions that would help reduce HIV among those most vulnerable to infection. Most winners were from small, community-based organizations with ideas focused on strengthening the capacity of communities to deliver services, keeping girls in secondary school, linking men to necessary services, supporting pre-exposure prophylaxis, providing a bridge to employment, and leveraging data-driven tools to increase impact.
* “Underserved” refers to populations that are disadvantaged because of ability to pay, ability to access care, ability to access comprehensive health care, or other disparities for reasons of race, religion, language group or social status.