From life ending
to life changing

40 years of progress in HIV/AIDS diagnostics

"As a patient and advocate I have witnessed the response to HIV shift to a more transformative 21st century approach, guided by best science, for a uniting of combination prevention/protection, and more universal access to effective treatments and diagnostics."

Ben Collins
patient advocate and HIV positive since 1982

The last 40 years have been an incredible scientific journey in the battle against acquired immunodeficiency disease (AIDS) – first to identify the cause of this new and mysterious disease, then to develop effective treatments and contain what had become a deadly, global health threat.

So much has happened in such a short time that it’s easy to forget how far we’ve come in the treatment of HIV – and that diagnostics played a crucial role in the remarkable achievements against a disease once considered an inescapable death sentence.

Combatting the AIDS epidemic meant waging a war on two fronts: medical and cultural. Patients, their families, healthcare professionals and even celebrities joined forces to raise awareness and to fight the stigma associated with HIV infection.

In vitro diagnostics (IVDs) paved the way for a greater understanding of the disease by supporting clinicians in diagnosing HIV, reducing the spread of infection and contributing to the development of better treatments. This combination of widespread testing and new therapies made HIV much less scary.

A patient must be able to trust a HIV test result. As the HIV virus continuously mutates diagnostic tests must be able to keep up with new emerging variants. We use the latest science to improve the sensitivity and specificity of diagnostic tests, constantly developing better techniques. My career at Roche over the last 25 years has been fascinating!
Dorothea Sizmann Lifecycle Team Project Leader for Infectious Diseases, Roche Diagnostics

We want to give you a glimpse of this transformative journey. Show you the courageous people behind the science, and those in the public eye fighting the stigma shrouding the AIDS community – together these people put their hearts and minds into tackling the AIDS epidemic and helped with our ability to cope with it.

How did certain death turn into a celebration of life?
The evolution of HIV care starts here

 
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First clinical observation of AIDS in the US
A mysterious epidemic with unusual symptoms breaks out.
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Initial cases were discovered in a group of injecting drug users and gay men with unusual symptoms of rare opportunistic infections mostly seen in people with a compromised immune system. A surprising number of the gay men developed a rare skin cancer called Kaposi's sarcoma (KS). This prompted the US Centers for Disease Control and Prevention (CDC) to form a task force to address the epidemic and coin the name Acquired Immunodeficiency Syndrome (AIDS).1

‘Patient number 1’
The first patient in the UK is identified, leading to an avalanche of diagnoses and deaths.
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Jonathan Blake became ‘patient number one’ at Middlesex Hospital, one of the first people diagnosed with HTLV-3 (later known as HIV) in the UK. This was the start of an avalanche of diagnoses and deaths.

"I was 33 and given a terminal diagnosis. I felt very isolated and vulnerable. Amazingly I am still here but there is an emotional side that needs to be addressed, along with continuous testing and monitoring."

Jonathan Blake
HIV activist and HIV positive

Discovery that HIV is caused by a virus
Two research groups simultaneously identify the new virus.
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Two research groups, one led by Robert Gallo in the US and one by Luc Montagnier in France, published their discoveries separately in Science. Both groups had discovered the same retrovirus behind Human Immunodeficiency Virus (HIV).2

The ‘boy that changed the world’
An American teenager is banned from school.
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Ryan Wayne White, an American teenager living with haemophilia, was infected through a contaminated blood transfusion and given only six months to live. After being rejected from school because of his AIDS diagnosis, Ryan became the face of HIV/AIDS. Doctors knew he posed no risk, but HIV/AIDS was feared and poorly understood by the public so many parents and teachers demonstrated against his return to school. The battle attracted worldwide attention, with Ryan becoming a celebrity and advocate for HIV/AIDS research and public education.

Before Ryan, most people thought AIDS was an illness affecting only the gay community. This stigma shifted as Ryan (and later other prominent HIV-positive people) began to openly advocate for more AIDS research and public education to address the epidemic.

First diagnostic test for HIV is developed
The first HIV test is designed to screen blood products.
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Once HIV was identified, companies began to develop tests that could detect the antibodies found in the blood after being infected. The first HIV antibody screening assays using Enzyme-Linked Immunosorbent Assay (ELISA) technology were licensed by the US Food and Drug Administration (FDA). Later in 1985, the insurance companies started using these tests to assess an individual's risk of developing AIDS. As it takes time for most individuals to develop antibodies to HIV, these tests only become positive 6 to 12 weeks post infection, leaving a window of uncertainty and delay.

First International AIDS Conference
Scientists, clinicians, leaders and advocates gather for the first time to find a way to control the threat.
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Every single world region had diagnosed at least one case of AIDS by the end of 1985.3 To build scientific knowledge in the fight against HIV, the World Health Organization (WHO) and the US Department of Health hosted the first International AIDS Conference in Atlanta, US.

The AIDS ad that shocked a nation
A princess shows compassion after an ad causes panic.
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As more news about AIDS hit the media, this public information film/ad was released in the UK. Its tagline, Don’t die of ignorance, compounded fear and prejudice. In April 1987, at the opening of the UK's first purpose-built HIV/AIDS unit, Princess Diana shook the hand of an infected man without any safety precautions. With this simple gesture, she helped break the myth that HIV/AIDS could be transferred by touch, and showed that the disease was a condition needing compassion and understanding, not fear and ignorance.

The first medicine to treat HIV infection is approved
Promising results proved disappointing.
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The FDA approved an antiretroviral drug known as a reverse-transcriptase inhibitor. It works by slowing the replication of the virus. The drug had been fast-tracked for approval – people needed immediate help – and initial responses to the drug were positive. Lives were prolonged only slightly, however, as the virus mutated and grew resistant to the treatment.

Ryan White dies at 18 years of age
The boy who changed the world's legacy.
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Surprising his doctors, Ryan lived five years longer than predicted, but sadly died one month before his high school graduation on 8 April 1990. Shortly after his death, US Congress passed a major piece of AIDS legislation, the Ryan White CARE Act.

Other key celebrity announcements followed, and other famous people infected with HIV included actor Rock Hudson, tennis player Arthur Ashe, singer Freddie Mercury, writer Isaac Asimov, French philosopher Michel Foucault, designer Tina Chow, Russian dancer Rudolf Nureyev, and Portuguese singer António Variações – illustrating that AIDS is a disease that knows no national boundaries.

Watch video "Legacy of Care" to learn more.

A molecular test kit is introduced to diagnose HIV
Diagnosis in hours.
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A diagnostic test kit using polymerase chain reaction (PCR) technology was developed to help healthcare professionals detect within a few hours the presence of HIV using the virus’s DNA.4 This more sensitive test means diagnosis of patients in earlier stages of infection is possible. Moreover, immediate diagnosis leads to treatment starting right away, and gives the babies born to HIV-infected mothers a better chance at survival

"PCR technology combined with automation led to highly standardized tests with short turnaround time for HIV detection and viral load determination - this was a really big milestone. Extracting HIV RNA had proven difficult because RNA is such an unstable compound. To work on these early inventions, and then later on developing the dual target HIV viral load assay meant we were working at the forefront of HIV testing and that was really exciting!"

Dorothea Sizmann
Lifecycle Team Project Leader for Infectious Diseases, Roche Diagnostics

First protease inhibitors for HIV treatment are available
Still not the cure.
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This second type of antiretroviral medicine suppresses the virus by blocking an HIV enzyme known as protease. Without protease activity, no copies of the virus can be made, interrupting the HIV life cycle. Protease inhibitors are still used today in combination with other antiretrovirals.

Better technique with quantitative testing of virus load adopted
Not everyone's HIV is the same.
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Quantitative diagnostic testing determines the amount of HIV virus circulating in the body. By measuring viral load, doctors can gauge treatment response. Our understanding of how the virus worked then changed - we learned it did not stay dormant, but quickly replicated to build strength, which meant asymptomatic patients could still be infectious. This is why initiatives like the Global Access Program (launched in 2015) are important for providing HIV viral load testing to countries hardest hit by the epidemic.

TV programs tackle social stigma head on
Meet an HIV-positive Muppet.
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In 2002, Kami, the first HIV-positive Muppet, was introduced to South Africa’s Takalani Sesame (one of Sesame Workshop’s many international projects modelled after Sesame Street). While normalising the face of HIV and AIDS, Kami provides a life-affirming remedy to the AIDS stigma. She helps children understand how it is and isn’t transmitted. By touching and interacting with those who are HIV-positive, Kami shows that normal interactions are nothing to be afraid of. It’s a very important message in South Africa, where denial and cultural misunderstanding have been blamed for the country’s alarming infection and death rates throughout the 2000s. Kami later starred in a UNICEF public-service announcement about AIDS and HIV education, appearing with Oprah Winfrey, Laura Bush, and Desmond Tutu.

Fusion inhibitors introduced
A new approach to blocking HIV.
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A new approach to preventing the virus from replicating was developed. By blocking HIV from entering healthy cells where it makes the copies of itself, viral load can be reduced enough to suspend the chain of infection.

Nelson Mandela’s son dies from AIDS
Taboo in Africa, a discussion about HIV in Africa is initiated.
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AIDS became the most important and dedicated cause of Nelson Mandela’s foundation. He launched a charity, to which he gave his Robben Island prison number, 46664, to raise awareness and funds through huge international concerts.

Mandela’s admission in 2005 that his son died from AIDS helped create awareness and initiate a discussion of the taboo in Africa. He went on to set up the World AIDS Trust with former US President Bill Clinton.

HIV-1 is different from HIV-2 infections
Each type of the virus needs its own treatment.
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There are two types of the virus, HIV-1 and HIV-2. Most HIV positive people have HIV-1. It is more virulent, more easily transmitted and the cause of most HIV infections globally, about 95%. HIV-2 is less transmittable, has a slower prognosis and is largely confined to West Africa.

Physicians need to know the difference between the two forms as they are unique virus strains that require specific treatments. To help navigate this complexity, Roche launched a qualitative diagnostic test that differentiates between HIV-1 and HIV -2 infections in 2017.

Plasma separation technology is launched
Sometimes small things completely change the approach to big problems.
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This new technology, the size and shape of a credit card, provides a simple way to collect blood samples and protect them from contamination despite heat and humidity. The samples are used to assess how much of the virus is in the blood - the viral load. This viral load testing measures whether treatment is working and guides clinical decisions to decrease transmission. The innovation behind the card is that it doesn’t require refrigeration. Its launch has meant increased access to HIV testing for patients living in remote areas such as rural Africa because a sample can easily be transported to labs in larger centres for reliable qualitative testing.

Remarkable progress – but work remains
We’ve made incredible progress over the last 40 years in tackling the HIV epidemic. The annual number of people dying from AIDS-related causes worldwide is steadily decreasing from a peak of 2.2 million in 2005 to an estimated 1.8 million in 2010.5 With early diagnosis and appropriate treatment, there’s now the possibility of normal, healthy lifespans for people living with HIV.

However, more open discussions are needed in popular culture throughout the world to educate on prevention and help people understand what it’s like to live with HIV. UNAIDS believes that, over the past two decades, as many as 65 million people have contracted HIV and at least 25 million have died. It’s also believed that there are more than 35 million people living with HIV/AIDS worldwide4 This means there is still a lot of work needed to help prevent infection.

"U=U is the result of significant teamwork between the HIV and scientific communities. When HIV is Undetectable, the virus is Untransmittable: We cannot infect our partners. Still many around the world don’t have access to the drugs and the diagnostics to reach undetectability. We need effective low cost treatments and viral load diagnostics for all. For that we still need community and science cooperation."

Ben Collins
patient advocate and HIV positive since 1982

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References

7) Chappel RJ, Wilson KM, Dax EM. Immunoassays for the diagnosis of HIV: meeting future needs by enhancing the quality of testing. Future Microbiol. 2009 Oct;4(8):963-82. doi: 10.2217/fmb.09.77. Review. Roberts BD. HIV antibody testing methods: 1985-1988. J Insur Med. 1994 Spring;26(1):13-4.

8) Sepkowitz KA. AIDS--the first 20 years. N Engl J Med. 2001 Jun 7;344(23): 1764-72.

9) Laure F, Courgnaud V, Rouzioux C, Blanche S, Veber F, Burgard M, Jacomet C, Griscelli C, Brechot C. Detection of HIV1 DNA in infants and children by means of the polymerase chain reaction. Lancet. 1988 Sep 3;2(8610):538-41

10) Sepkowitz KA. AIDS--the first 20 years. N Engl J Med. 2001 Jun 7;344(23): 1764-72.

11) Piatak M Jr, Saag MS, Yang LC, Clark SJ, Kappes JC, Luk KC, Hahn BH, Shaw GM, Lifson JD. Determination of plasma viral load in HIV-1 infection by quantitative competitive polymerase chain reaction. AIDS. 1993 Nov;7 Suppl 2: S. 65-71.

12) Reeves JD, Doms RW. Human immunodeficiency virus type 2. J Gen Virol. 2002 Jun;83(Pt 6):1253-65. Review.

13) Chin J, Remenyi MA, Morrison F, Bulatao R. The global epidemiology of the HIV/AIDS pandemic and its projected demographic impact in Africa. World Health Stat Q. 1992;45(2-3):220-7 Buonaguro L, Tornesello ML, Buonaguro FM. Human immunodeficiency virus type 1 subtype distribution in the worldwide epidemic: pathogenetic and therapeutic implications. J Virol. 2007 Oct;81(19):10209-19. Epub 2007 Jul 18. Review.

14) Campbell-Yesufu OT, Gandhi RT. Update on human immunodeficiency virus (HIV)-2 infection. Clin Infect Dis. 2011 Mar 15;52(6):780-7. doi: 10.1093/cid/ciq248. Review.

15) Alexander TS. Human Immunodeficiency Virus Diagnostic Testing: 30 Years of Evolution. Clin Vaccine Immunol. 2016 Apr 4;23(4):249-53. doi: 10.1128/CVI.00053-16. Print 2016 Apr. Review.

16) cobas® Plasma Separation Card. https://molecular.roche.com/assays/cobas-plasma-separation-card/

Tags: Science, Society, Infectious diseases