HIV continues to be a priority global health concern, affecting millions of people and their families each year.
At Johnson & Johnson we aspire to make HIV history, including through the public goals we set relating to HIV. See our Health for Humanity 2020 Goals Progress Scorecard for progress we made on HIV in the last five years.
Global HIV Prevalence5
Our Health for Humanity 2025 Goal relating to HIV is no less ambitious and focuses on providing expanded access to our most innovative treatments.
The new regimen’s availability in resource-limited countries would be significant. Because of advances in modern medicine, HIV should no longer be considered a death sentence; however, people with HIV must currently maintain strict, lifelong treatment regimens. Reducing the frequency of medication from daily to six times a year may make adherence easier on a long-term basis. Also, daily pill regimens may create stigma for those living with HIV, creating a barrier to seeking and adhering to treatment due to fear of disclosure. Long-acting injectable regimens could provide solutions to these challenges.
Our HIV treatment and vaccine progress in 2020 includes:
Phase 3 success in HIV treatment regimen: We confirmed 48- and 96-week results of our global Phase 3 trials demonstrating the safety and efficacy of long-acting injectable HIV treatment with our rilpivirine long-acting (LA) and ViiV Healthcare’s cabotegravir LA, offering people living with HIV a new approach for maintaining viral suppression. This novel regimen was co-developed as part of a collaboration with ViiV Healthcare.
Approvals for use of HIV treatment regimen: The first long-acting, two-drug injectable regimen, co-developed in collaboration with ViiV Healthcare, has been approved for the treatment of HIV-1 infection in adults by health authorities around the world. This breakthrough two-drug injectable regimen, combining Janssen’s rilpivirine LA with ViiV Healthcare’s cabotegravir LA,6 enables reduction of daily treatment to just 12 treatment days a year (administered once-monthly), or in some countries, only six treatment days per year (administered once-every-two-months)—see table below. The long-acting injectable regimen was preferred by a majority of clinical trial patients who tried the treatment over their previous daily, oral, three-drug regimen and represents a milestone in enabling a better quality of life for adults living with HIV.
HIV treatment regimen approvals
February: Once-monthly and once-every-two-months regimens approved by the Australian Therapeutic Goods Administration
March: Once-every-two-months regimen approved by Health Canada
Regulatory review is ongoing in several other countries around the world.
Progress in Imbokodo and Mosaico vaccine programs: We won’t stop until we make HIV history. Since 2005, we have progressed the development of our preventive HIV vaccine; we are currently the only company with an HIV vaccine in late-stage clinical development, including two large-scale efficacy studies (Mosaico and Imbokodo) underway. The investigational HIV vaccine regimen is based on ADVAC viral vector technology, which we have successfully reapplied in our development of a COVID-19 vaccine and an Ebola vaccine.
Our two investigational preventive vaccine efficacy studies are progressing in 13 countries with enrollment of 6,000+ participants, despite the challenges presented by COVID-19. As the COVID-19 pandemic spread, the teams overseeing and staffing the Imbokodo study sites in five different African countries quickly secured additional supplies of PPE for trial staff and implemented a variety of controls to ensure the safety of study participants. Despite these challenges, all participants have since completed vaccination. Additionally, the Mosaico trial has now opened enrollment in all trial countries.
At Janssen, we are incredibly proud of this progress in achieving our goal to address some of the biggest health threats of our time. We will continue building on our 25-year commitment to make HIV history and to change the course of the epidemic through our passionate pursuit of innovation, from long-term remission to effective prevention of HIV.
Our GPH GPH Global Public Health team is also collaborating with organizations like the U.S. President's Emergency Plan For AIDS Relief, the Elizabeth Glaser Pediatric AIDS Foundation, the Global Fund to Fight AIDS, Tuberculosis and Malaria and others in those countries hardest hit by HIV.
HIV prevention for women: The first long-acting HIV prevention method specifically designed for women, the monthly dapivirine ring, developed by the International Partnership for Microbicides using exclusive rights to our ARV ARV Antiretroviral compound, received a positive opinion from EMA EMA European Medicines Agency as part of its EU-M4all program. In addition, the WHO WHO World Health Organization prequalified the ring and recommended the product in its updated HIV guidelines, which many countries use to inform their own policies. The dapivirine ring offers women an alternative to existing methods, which can present challenges for some women, such as side effects, adherence to daily dosing regimens or a need for partner cooperation. The flexible, silicone ring is discreet, easy to use, has minimal side effects and only needs to be replaced monthly.
HIV prevention for adolescent girls and young women (AGYW): In sub-Saharan Africa, our collaboration with DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored and Safe) Thina Abantu Abasha (DTAA), a youth-led, peer-to-peer HIV prevention program, continues to empower AGYW aged 14 – 24 with leadership, employability, sexual and reproductive health and rights information and skills in six high-incidence districts in two provinces in South Africa. The program reached 1.4 million young women in 2018 and 2019. In 2020, results of an independent qualitative evaluation of DTAA were published, with encouraging outcomes. Of those evaluated, 64% of sexually active young women aged 19 – 24 reported starting to use condoms, 88% reported starting to use contraception, and 100% reported they were tested for HIV7 as a result of program participation. In light of challenges due to COVID-19, more extensive use was made of social media and communication tools to ensure continued reach to over 1.1 million AGYW in 2020.
HIV treatment for children in sub-Saharan Africa: Our founding role in the New Horizons Collaborative (NHC) aims to provide children with HIV therapies in 11 countries across the region, through drug donation—including our PREZISTA (darunavir) and INTELENCE (etravirine)—and capacity building. Preliminary analysis from a real-world evidence study conducted by EGPAF found that among the children and adolescents enrolled in NHC receiving our medicines, 78% achieved virologic suppression at 12 months.8 In 2020, despite the COVID-19 pandemic, NHC onboarded one new country, the Republic of Congo, and continued to enroll new patients. We are now collaborating with NHC partners to increase the program impact through greater technical assistance and other measures. We have also participated in the High Level Dialogues on Pediatric HIV organized by The Vatican, which resulted in the 2020 Rome 5 Action Plan and a set of specific commitments from Johnson & Johnson focused on young people living with HIV.
HIV diagnosis and treatment for men: As a founding member, in 2018, of the MenStar Coalition, aiming to expand the diagnosis and treatment of HIV infections in men, particularly in sub-Saharan Africa, we have worked with our five collaborators to guide the development of the MenStar strategy and programs. In 2020, we played a key role in launching MINA, a campaign in South Africa that speaks directly to men on health and well-being, including HIV care and treatment. The MINA campaign includes real-life stories from men living with HIV, and resources such as a roadmap to health that depicts the healthcare journey in a clear, concise and motivating manner.
Piloting drones in Uganda: We are currently funding a multiyear pilot program with the Infectious Diseases Institute in Kampala, Uganda, to explore the feasibility of using medical drones to deliver critical treatments where they are needed most, for example, in Uganda’s Kalangala District, which comprises 84 islands in Lake Victoria and has the highest HIV prevalence in the nation. The goals of the program are to bring lifesaving solutions to patients directly and efficiently, protect healthcare workers and allow them more time with patients within their health centers. Today, health workers must travel to patients by small boats, where they face inclement weather and risk drowning to access these areas which will now be served by drones.
For more about our progress in HIV vaccines, treatments and collaborations, see our HIV webpage.