More than forty years ago, in June 1981, a mysterious disease emerged in California and New York. It would soon become one of the most well-known—and urgent—health challenges of our time.
Today, there are nearly 38 million people in the world living with human immunodeficiency virus (HIV). Each year, 1.5 million more are newly infected with the virus.
There is no cure for HIV, and if left untreated, it can lead to Acquired Immunodeficiency Syndrome (AIDS). But over the last 25 years, Johnson & Johnson’s commitment to HIV/AIDS research has helped make groundbreaking progress toward ending the epidemic, including the introduction of effective, lifesaving treatments, and significant strides toward a vaccine to stop the virus’ spread. In fact, in 1985 Dr. Paul Janssen—the namesake of the Janssen Pharmaceutical Companies of Johnson & Johnson—set up a research collaboration in Belgium to start screening compounds that might help fight HIV, which helped contribute to a Janssen treatment that was approved in 2008.
Most recently, the company, in partnership with ViiV Healthcare, secured approval from the U.S. Food and Drug Administration (FDA) for the first-ever long-acting injectable regimen for the treatment of HIV infection. “A lot of people thought it could never be done,” says Brian Woodfall, Global Head of Development, Infectious Diseases at the Janssen Pharmaceutical Companies of Johnson & Johnson, “but through innovative science and strong collaborations, we’ve been able to get there.”
Over the years, Johnson & Johnson has brought nine drugs to market to help ensure that, for millions of people, HIV is not a death sentence, but instead a treatable condition. It’s been a long road, and Johnson & Johnson has been innovating every step of the way. Here, we take a look back at the decades-long work the company has done to help give the world more hope in the face of HIV/AIDS.
Today, there are nearly 38 million people in the world living with human immunodeficiency virus (HIV). Each year, 1.5 million more are newly infected with the virus.
There is no cure for HIV, and if left untreated, it can lead to Acquired Immunodeficiency Syndrome (AIDS). But over the last 25 years, Johnson & Johnson’s commitment to HIV/AIDS research has helped make groundbreaking progress toward ending the epidemic, including the introduction of effective, lifesaving treatments, and significant strides toward a vaccine to stop the virus’ spread. In fact, in 1985 Dr. Paul Janssen—the namesake of the Janssen Pharmaceutical Companies of Johnson & Johnson—set up a research collaboration in Belgium to start screening compounds that might help fight HIV, which helped contribute to a Janssen treatment that was approved in 2008.
Most recently, the company, in partnership with ViiV Healthcare, secured approval from the U.S. Food and Drug Administration (FDA) for the first-ever long-acting injectable regimen for the treatment of HIV infection. “A lot of people thought it could never be done,” says Brian Woodfall, Global Head of Development, Infectious Diseases at the Janssen Pharmaceutical Companies of Johnson & Johnson, “but through innovative science and strong collaborations, we’ve been able to get there.”
Over the years, Johnson & Johnson has brought nine drugs to market to help ensure that, for millions of people, HIV is not a death sentence, but instead a treatable condition. It’s been a long road, and Johnson & Johnson has been innovating every step of the way. Here, we take a look back at the decades-long work the company has done to help give the world more hope in the face of HIV/AIDS.
- 1981
A Mysterious Illness Begins to Spread
The first cases of the disease that would come to be known as AIDS are reported. The U.S. Centers for Disease Control and Prevention (CDC) publishes a report of a strange condition in five young, previously healthy gay men in Los Angeles. Multiple infections, the report notes, indicate that the patients’ immune systems have stopped working.
One year later, the CDC uses the term AIDS for the first time. In 1983, scientists in France identify HIV as the cause of AIDS, and an American research team independently isolates the same virus in 1984. - 1987
The First Drug to Treat HIV is Approved
The FDA approves the first medication for the treatment of HIV, an antiretroviral that was first developed in the 1960s to treat cancer. Its approval launches a new era of drug development.
In December of the next year, 1988, World AIDS Day is observed for the first time. Its theme: Join the Worldwide Effort. - 1996
Building on its Early Screening Efforts, Johnson & Johnson Sets Off on a Mission to Develop New Drugs
In a major breakthrough, additional antiviral drugs are approved from new drug classes, and a “cocktail” treatment approach becomes the standard of care. As a result, for the first time, HIV treatment can now prevent people from dying of AIDS. “This was the big year,” says Woodfall. “We learned that with a three-drug cocktail you could suppress viral replication very well.”
Patients are treated with a combination of at least three drugs selected from at least two classes of antiretrovirals: Nucleoside reverse transcriptase inhibitors (NRTIs), which work by blocking the enzyme the HIV virus uses to copy itself in the body, and protease inhibitors, which work by preventing the production of viral proteins.
“In July of 1996 at the Vancouver AIDS conference, results were unveiled showing how well a three-drug combo of NRTIs and protease inhibitors worked,” says Woodfall, “and that was really the tipping point.”
According to the CDC, death rates from HIV infection declined in the U.S. between 1996 and 1997, thanks to the new three-drug treatment.
Toward the end of the 1990s, multiple drugs are on the market, but “HIV had become resistant to the first generation of drugs, due to changes in the virus’ genetic makeup,” says Woodfall. Building on Johnson & Johnson’s early compound screening work, “we set off on a mission to find second-generation drugs. The challenge was to find new drugs that could either be given after those others or from the beginning, and take much longer for the virus to become resistant to.” - 2006
Janssen’s First HIV Medication Gets Accelerated Approval
In 2002, Johnson & Johnson acquired Tibotec, a Belgium-based pharmaceutical R&D company making strides in the development of next-generation HIV medicines—and where Johnson & Johnson’s current Chief Scientific Officer, Paul Stoffels, M.D., had worked in the late 1990s, studying these drugs. The company became part of Janssen Pharmaceuticals and began trials on a breakthrough drug.
In 2006, Janssen’s first HIV medication, a next-generation protease inhibitor, is given accelerated approval by the FDA before even finishing Phase 3 trials. “It was very unique in that it looked so good that it was granted approval in Europe and the U.S. before even finishing Phase 3 trials,” says Piet De Doncker, Vice President, Head of Strategy and Portfolio Management in Infectious Diseases, Janssen. “That doesn’t happen often.”
That first Janssen drug approval is soon followed by another in 2008, and it was a “major breakthrough,” says Benny Baeten, Compound Development Team Leader, Janssen. “To put it clearly, until 2006, if a patient had used the first-generation drugs and the virus became resistant, it was a death sentence. These drugs provided a safety net for those who’d become resistant.” - 2011
Continued Progress is Ushered in With a Single-Tablet Treatment Regimen
Johnson & Johnson introduces Janssen’s third HIV medication, a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) . Shortly after, the company partners with ViiV Healthcare to create a single-tablet, multi-drug HIV treatment regimen based on this NNRTI, helping to minimize the number of pills patients need to take in a single day.
“Once you have effective and well-tolerated drugs, you can move on to convenience,” Woodfall says. “So, once we knew we had drugs that were working, it became, ‘Let’s get it from six pills to one pill; from three times a day to once a day.’”
Later, in 2018, the first single-tablet treatment regimen to include a protease inhibitor is introduced by Janssen. 
2017The Imbokodo Vaccine Trial Kicks Off
Johnson & Johnson’s work on a potential HIV vaccine began in 2005. Historically, the global search for such a vaccine has posed a significant scientific challenge due to the unique and complex nature of the virus and the diverse strains found worldwide.
Imbokodo—a large efficacy study of Janssen’s investigational HIV vaccine regimen—launches in southern Africa at the end of 2017. The study ultimately enrolls just over 2,600 female participants between ages 18 and 35 in Malawi, Mozambique, South Africa, Zambia and Zimbabwe.
August 2021 News Update: Vaccinations in the Imbokodo study were completed in June 2020. Data showed that the investigational HIV vaccine regimen did not provide sufficient protection against HIV infection, though it was found to have a favorable safety profile with no serious adverse events.
Nonetheless, “the Imbokodo trial will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV,” says Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.- 2019
The Mosaico Vaccine Trial Launches
In November, the first participant is enrolled in the Mosaico vaccine trial, which is studying Janssen’s investigational HIV vaccine regimen in transgender individuals and men who have sex with men and/or transgender persons in the Americas and Europe.
The Mosaico study is fully enrolled as of 2021, with a total of about 3,900 participants at trial sites across three continents. - 2020
Innovation Marches on With a New Preventive Option
A vaginal ring prophylaxis is given prequalification by the World Health Organization. The microbicidal ring is based on a Janssen antiretroviral compound.
Teams at Janssen had been examining a molecule for use in a potential new oral medication but faced efficacy challenges when in pill form. “However, the molecule was very effective against HIV, so some scientists suggested we do some work to turn it from a pill into a topical,” says Woodfall.
Ultimately, Janssen granted licensure to the International Partnership for Microbicides to develop a vaginal ring prophylaxis. “It’s particularly good for resource-limited settings,” Woodfall says, such as countries in Africa where HIV transmission remains very high. “It’s a preventive measure that women can control.” - 2021
History is Made With a Breakthrough Injectable Regimen
The world’s first long-acting injectable HIV treatment regimen receives FDA approval. The breakthrough, Woodfall says, involved pioneering work other teams at Janssen did previously on injectable anti-psychotic medications. “We applied that same technology,” he explains, “and developed a long-acting formulation with the idea that people with HIV could get an injection once a month or once every two months and keep the virus under control without oral medication.”
Pivotal Phase 3 studies showed that among more than 1,100 patients, the injectable regimen—consisting of two antiretroviral drugs, one developed by Janssen and the other by ViiV Healthcare—was as effective in suppressing viral replication as a daily three-drug oral regimen.
The approval represents another advance in the fight against HIV and a new way to lessen the burden of those living with the virus. “We’ll continue to work on new approaches to HIV treatment beyond this one,” says Woodfall. “We’re paradigm shifting again, and more innovations are being planned.” 
2022A New Treatment Option for Adolescents Living With HIV
The FDA approves the first long-acting injectable treatment regimen for eligible adolescents. This builds on the earlier approval of this codeveloped therapy and offers young people living with HIV a valuable new treatment option.
According to data from the CDC, people ages 13-24 accounted for 21% of all new HIV diagnoses in the U.S. and its territories in 2018. Adherence to treatment may be difficult for children and adolescents, who may skip treatments to hide their HIV-positive status from others. Having more options available, including simplified and long-acting injectable regimens, may be important to ensuring that adolescents can receive treatment on their own terms.
*** This story was updated on July 29, 2022.
