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World AIDS Day – how has treatment changed?

This article was originally written in 2021 but has been updated to reflect on any major breakthroughs and changes since then.

Every year the 1st of December marks World AIDS Day which helps raises awareness of the virus, how far research has come and for all those living with the disease.

In our latest article, we look at the latest research towards the HIV and AIDS virus.

There are approximately 39,000,000 people living with Human Immunodeficiency Virus (HIV), with 1,700,000 people infected each year; there is no cure. If left untreated, it can develop into Acquired Immunodeficiency Syndrome (AIDS), which until recently had been a death sentence coupled with huge moral stigmatism and misunderstanding.

According to ClinicalTrials.gov, there are over 3,500 studies listed at varying different stages to find a cure for HIV, yet despite its emergence in the early 1980s this complex virus has remained incredibly difficult to treat and manage, both medically and socially.

1^st December marks World AIDS Day, an international event to highlight and raise awareness of the virus yet public awareness and understanding have been equally as difficult to treat, as the virus itself. That being said, huge advances have been made in the development of new therapeutics which have changed the tide of the disease so much so that no longer does diagnosis lead mean a death sentence.

Timeline of HIV/AIDS

1981 – The first cases of what would become known as AIDS are identified – US Centres of Disease Control and Prevention (CDC) publishes a report on several healthy homosexual men whose immune systems seemed to have stopped working.
1982 – CDC uses the term AIDS for the first time.
1983 – French research group identifies HIV for the first time as the cause of AIDS; it’s also identified by an American group independently the following year.
1987 – First antiretroviral drug approved by the FDA; a drug first used in the 1960s to treat cancer.
1988 – World AIDS day is marked for the first time.
1996 – A significant breakthrough is made when new antiviral drugs are approved from new drug classes, and a “cocktail” treatment approach becomes the standard of care. As a result, for the very first time, HIV treatment can now prevent people from dying of AIDS. 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.
1997 – According to the CDC, this was the year in which a decline in cases was recorded for the first time.
1999 – The World Health Organization (WHO) announces that HIV/AIDS has become the fourth biggest killer worldwide and the number one killer in Africa. WHO estimates that 33 million people are living with HIV worldwide, and that 14 million have died of AIDS.
2010 – The National Institutes of Health (NIH) announce the results of the iPrEx study, showing that a daily dose of HIV drugs reduced the risk of HIV infection among HIV-negative men who have sex with men by 44%, supporting the concept of pre-exposure prophylaxis (PrEP) in a targeted population.
2015 – Results from the Strategic Timing of AntiRetroviral Treatment (START) study indicate that HIV-positive individuals who start taking antiretroviral drugs before their CD4+ cell counts decrease have a considerably lower risk of developing AIDS or other serious illnesses. Subsequent data releases show that early therapy for people living with HIV also prevents the onset of cancer, cardiovascular disease, and other non-AIDS-related diseases.
2017 – The UK Health Security Agency (UKHSA), started conducting the PrEP Impact Trial with the Chelsea and Westminster Hospital NHS Foundation Trust. This is believed to have been the largest ever real-world study of its kind.
2020 – The PrEP Impact Trial concludes with a total of 157 sexual health clinics involved. The study involved 24,000 people taking part across England.
2021 – Breakthrough approvals of bi-monthly injection of cocktail of antiretroviral drugs offers significant advancement in the treatment for HIV. The National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Document (FAD) recommending a combination of two long-acting injections for the treatment of HIV in adults. This treatment involves having Vocabria (cabotegravir long-acting injection) in combination with Rekambys (rilpivirine long-acting injection).This announcement is a positive outcome, as this is the first time a HIV treatment has ever been appraised and approved by NICE. As a result of this outcome, it means that eligible people living with HIV in England and Wales will soon be able to receive the complete long-acting injectable regimen once every two months, following an initiation phase, as opposed to regular, daily oral treatment. Advancements in modern medicine are happening at pace across all disease areas, and HIV and AIDS are evidence of collaboration across the scientific and pharmaceutical communities. 98% of people living with HIV in the UK are on effective treatment and 97% can no longer pass the virus on.
2022 – The National Institutes of Health launches clinical trial of three mRNA HIV vaccines. At the end of 2022, 29.8 million people (76% [65–89%] of all people living with HIV) were globally accessing antiretroviral therapy, up from 7.7 million in 2010. AIDS-related deaths have been reduced by 69% since the peak in 2004 and by 51% since 2010 on a global scale.
2023 – A Phase 1 trial of a new novel vaccine known as VIR-1388 is being conducted in the USA and Africa. The purpose of the trial is to assess the vaccine for its safety and ability to induce an HIV-specific immune response in people. A recently published journal on the research conducted from the PrEP Impact Trial found that the PrEP drug reduced the chances of getting HIV by 86%. Clinical trials suggested it was 99% effective.

Future of HIV treatments and Vaccines

Some of the biggest advancements in medicine have been made in the development of Vaccines. We have developed lifesaving therapeutic and prophylactic vaccines and changed the landscape of disease such as Smallpox, Polio, Hepatitis, Chickenpox, Covid-19, but HIV has remained illusive due to a number of reasons.

HIV does not fit typical vaccine approaches in a number of ways:

1. The immune systems of almost all people are ‘blind’ to HIV

The immune system, which fights disease, doesn’t respond to the HIV virus. It produces HIV antibodies, but they only slow the disease. They don’t stop it.

2. Vaccines are typically made to mimic the immune reaction of recovered people

However, almost no people have recovered after contracting HIV. As a result, there’s no immune reaction that vaccines can mimic.

3. Vaccines protect against disease, not infection

HIV is an infection until it progresses to stage 3, or AIDS. With most infections, vaccines buy the body more time to clear the infection on its own before disease occurs.

However, HIV has a long dormant period before it progresses to AIDS. During this period, the virus hides itself in the DNA of the person with the virus. The body can’t find and destroy all of the hidden copies of the virus to cure itself. So, a vaccine to buy more time won’t work with HIV.

4. Killed or weakened HIV viruses can’t be used in a vaccine

Most vaccines are made with killed or weakened viruses. Killed HIV doesn’t work well to produce an immune response in the body, though. Any live form of the virus is too dangerous to use.

5. Vaccines are typically effective against diseases that are rarely encountered

These include diphtheria and hepatitis B. But people with known risk factors for HIV might be exposed to HIV daily. This means there’s more chance for infection that a vaccine can’t prevent.

6. Most vaccines protect against viruses that enter the body through the respiratory or gastrointestinal systems

More viruses enter the body in these two ways, so we have more experience addressing them. But HIV enters the body most often through genital surfaces or the blood. We have less experience protecting against viruses that enter the body in those ways.

7. Most vaccines are tested thoroughly on animal models

This helps ensure that they’re likely to be safe and effective before they’re tried on humans. However, no good animal model for HIV is available. Any testing that’s been done on animals hasn’t shown how humans would react to the tested vaccine.

9. The HIV virus mutates quickly

A vaccine targets a virus in a particular form. If the virus changes, the vaccine may not work on it anymore. HIV mutates quickly, so it’s hard to create a vaccine to work against it.

Will a cure be found for HIV and AIDs in the future?

Unfortunately we cannot predict what will happen in the future. However, following recent approval of an injectable HIV-1 treatment from NICE, GlaxoSmithKline (GSK) has high hopes in developing a cure for the virus in the future. GSK have recently announced that is looking to begin human clinical trials of its potential cure for HIV in 2022.

The company shared that it is aiming to develop a cure for the disease by 2030. We will be watching intently with the developments through GSK’s research and what future breakthroughs this will bring.

2023 update

GSK’s ViiV Healthcare aims to establish its new long-acting injectable, Cabenuva, as a standard HIV treatment. In a year-long study against Gilead’s Biktarvy, Cabenuva showed similar antiviral effectiveness when administered every two months.

The SOLAR trial results support Cabenuva’s ability to manage HIV at longer intervals, with 0.7% non-inferiority to Biktarvy. Despite critics noting some virologic failures in Cabenuva, ViiV emphasizes its non-inferior efficacy in three phase 3 trials.

Cabenuva’s less frequent dosing appeals to patients, with 90% preferring it over daily pills, although GSK doesn’t foresee a complete shift from oral drugs.

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