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Pandemics & Epidemics

A woman looks away while a healthcare professional gives her a COVID-19 vaccination

HIV

It has now been more than 40 years since the first cases of what would become known as AIDS AIDS Acquired immunodeficiency syndrome , caused by HIV HIV Human immunodeficiency virus , were reported in 1981. While a cure continues to evade our best science, groundbreaking innovation in advanced treatments have helped transform HIV from a terminal illness into a manageable condition, enabling those affected by the virus to enjoy productive lives.

Health for Humanity 2025 Goals | Global Health Equity

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Access to HIV Treatment
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On track
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On track
Progress: Completed and submitted regulatory filing packages in two RLS RLS Resource-limited settings countries (Botswana and South Africa).

Global HIV Prevalence34

37.7 million
people across the globe with HIV in 2020 (53% women and girls).
28.2 million
people with HIV accessing antiretroviral therapy (ART) globally as of June 2020 (9.5 million people without access to ART).
63%
of all new HIV infections in sub-Saharan Africa in 2020 were women and girls.
680,000
people (approx.) died from AIDS-related illnesses worldwide in 2020, compared to 1.3 million in 2010, a testimony to the effectiveness of and access to treatment.
37.7 million
people across the globe with HIV in 2020 (53% women and girls).
28.2 million
people with HIV accessing antiretroviral therapy (ART) globally as of June 2020 (9.5 million people without access to ART).
63%
of all new HIV infections in sub-Saharan Africa in 2020 were women and girls.
680,000
people (approx.) died from AIDS-related illnesses worldwide in 2020, compared to 1.3 million in 2010, a testimony to the effectiveness of and access to treatment.

Long-acting injectable HIV treatment regimen

After a long history of developing progressive treatments for HIV, we achieved another highly significant milestone in HIV drug development: FDA FDA U.S. Food and Drug Administration approval of the world’s first long-acting injectable (LAI) HIV treatment regimen,35 approved for both an every-month dosing schedule (12 injections per year) in January 2021 and an every-two-months dosing schedule (six injections per year) in February 2022. The LAI regimen includes two antiretroviral drugs, one developed by Janssen (rilpivirine) and the other by ViiV Healthcare (cabotegravir).

The LAI regimen replaces a daily two- or three-drug oral regimen with two injections administered on the same day either every one or two months, significantly easing the burden of medication and facilitating adherence. Further, 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. LAI regimens could provide solutions to these challenges and, supported by ongoing efforts to expand access to HIV treatment, help transform the lives of those living with HIV while bringing us closer to our commitment of making HIV history.

In 2021, Johnson & Johnson and ViiV Healthcare submitted regulatory filings for the every-other-month dosing schedule of the cabotegravir + rilpivirine LAI regimen in Botswana and South Africa. This marks the first such filings in resource-limited settings, illustrating our commitment to help ensure innovative products reach patients in need in LMICs LMICs Low- and middle-income countries as quickly as possible.

Additional developments helping make HIV history in 2021 included:

Mosaico continues global Phase 3 HIV vaccine trial: Our large-scale efficacy study, Mosaico, continued to run in 2021. Mosaico aims to test the safety and efficacy of a specific composition of an investigational HIV vaccine regimen among men who have sex with men and transgender individuals and is being conducted in the Americas and Europe. The regimen is based on ADVAC viral vector technology, which Janssen successfully used in the development of our COVID-19 and Ebola vaccines.

Our other large-scale Phase 2b HIV vaccine clinical trial, Imbokodo,36 was discontinued in 2021 after data showed the investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa at elevated risk of acquiring HIV. Though the trial did not continue, following completion of all vaccinations in 2020, further analysis of the Imbokodo study is ongoing, and the study has provided enough data to progress with key immunological research to help inform future research in this field.

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Imbokodo enrolled approximately 2,600 young women across 23 trial sites in five countries in sub-Saharan Africa for four vaccination visits over one year.

The high incidence of HIV among young women in sub-Saharan Africa reminds us that, despite great progress made in treatment and prevention, HIV remains a major health challenge for the region. This underscores the need to apply the knowledge that will be gained from this trial to continue to advance the pursuit of a global HIV vaccine.
Professor Glenda Gray
President and Chief Executive Officer, South African Medical Research Council (SAMRC) and Imbokodo’s Protocol Chair

HIV prevention for women and girls: The dapivirine ring, recommended in 2021 by the WHO WHO World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches, was a popular choice among African adolescent girls in a recent study.

The dapivirine ring is a long-acting HIV prevention method specifically for women, developed by the International Partnership for Microbicides and based on Janssen’s ARV ARV Antiretroviral compound. The flexible, silicone ring is discreet, easy to use, has minimal side effects and only needs to be replaced monthly.

In July 2021, Microbicide Trials Network (MTN) presented interim data showing a strong preference for the dapivirine ring and higher adherence than previously observed.

Further, a U.S. National Institutes of Health funded Phase 3b study, DELIVER (MTN-042), showed encouraging interim safety results for the use of the dapivirine ring late in pregnancy.

The study is ongoing among pregnant women who are HIV negative in four sub-Saharan African countries with a high prevalence of HIV/AIDS, especially in women. MTN is also conducting a study on the ring’s safety and use among women who are breastfeeding (MTN-043).

We need to have a range of HIV prevention options so that women can choose the one that works best for them. The dapivirine vaginal ring is something they can control—putting the power to reduce their HIV risk in their hands.
Zeda Rosenberg, Sc.D.
Founder and CEO, International Partnership for Microbicides
HIV Ring with Caption
88%
of study participants said they liked the monthly dapivirine ring during the six months they were asked to use it.
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Several studies have shown that pregnancy is associated with an increase in susceptibility to HIV acquisition.37

HIV treatment in the last mile: Many people worldwide still live beyond the reach of traditional healthcare systems and without access to care. Closing this “last mile” of health delivery and ensuring global, equitable access to modern HIV treatments is one of the most significant challenges in global health. We funded a multiyear pilot study program with the Infectious Diseases Institute in Kampala, Uganda, to test the feasibility of delivering lifesaving HIV treatments quickly, efficiently and reliably to people in need in the Kalangala District using customized medical drones. The Kalangala District comprises 84 islands on Lake Victoria, accessible for drug supply and to health workers only by boat, often in adverse weather conditions, which cause delays to deliveries and safety risks for health workers.

The first regularly scheduled medical drone flight took place in April 2021. The program serves five landing sites across the region, reaching approximately 100 people living with HIV and has the potential of reaching more than 1,000, if it scales. The program also offers an opportunity for researchers to quantify the effectiveness of medical drones' HIV drug delivery through a Randomized Control Trial that will help inform future efforts to scale drone technology to solve other last mile delivery challenges in Uganda and elsewhere.

How Medical Drones Are Helping Deliver Life-Saving HIV Drugs to Remote Africa | Johnson & Johnson
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Pediatric HIV treatment and prevention: Getting HIV treatments to those who need them remains a challenge in many parts of the world, especially in sub-Saharan Africa. A combination tablet, containing our product PREZISTA (darunavir) in a fixed-dose combination with ritonavir 50mg, received WHO Prequalification, enabling its use in helping address the high unmet need in second- and third-line treatments for adults and children in an accessible and affordable form. Further, data from the Nucleosides and Darunavir/Dolutegravir in Africa study38 was published in The New England Journal of Medicine, demonstrating the efficacy of ritonavir-boosted darunavir as a second-line treatment. Following these successes, along with the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), we announced our renewed commitment and the next phase of the New Horizons Collaborative, which includes an extension of our darunavir donation program and a commitment to continue enrolling new pediatric HIV patients through at least 2025. This is also an important step toward meeting our commitments to help tackle the challenge of pediatric HIV as part of the Rome 5 Paediatric HIV and TB Action Plan.

A girl sits on her mother's lap while having her arm measured by a healthcare professional.

Florence Nagawa performs a routine checkup at a hospital in Uganda. Photo by Devex/Grainne Harrington.

In 2021, EGPAF recognized Johnson & Johnson as its Corporate Hero and Angel Sponsor.

Johnson & Johnson is a co-founder of the New Horizons Collaborative, which aims to improve treatment and care for children with HIV in 11 countries across the region through drug donation and capacity building.

Johnson & Johnson's New Horizons Collaborative has saved thousands of lives and addressed some of the most daunting obstacles posed by the HIV pandemic. We are just thrilled to celebrate 30 years of collaboration with Johnson & Johnson this year.
Chip Lyons
President and CEO, Elizabeth Glaser Pediatric AIDS Foundation

HIV diagnosis and treatment for men: As a founding member of the MenStar Coalition, we continue to support strategy and programs aiming to expand the diagnosis and treatment of HIV infections in men, particularly in sub-Saharan Africa.

MenStar has contributed to initiating more than 2.2 million men aged 15+ years onto treatment and has achieved 94% viral suppression among those men since 2018.

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Partnership for HIV prevention: In sub-Saharan Africa, DREAMS (Determined, Resilient, Empowered, AIDSfree, Mentored and Safe) Thina Abantu Abasha (DTAA), a youth-led, peer-to-peer HIV prevention program, continues to empower adolescent girls and young women (AGYW) with leadership, employability, sexual and reproductive health and rights information, and skills in two South African provinces. In 2021, the DTAA program reached more than 1.3 million AGYW through a reading competition, targeted radio programming and extensive use of social media.

Since 2018, the DTAA program has reached almost 4 million adolescent girls and young women.

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To learn more about our mission to end HIV, visit jnj.com/hiv.

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