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8th December 2023
HIV pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition but greater provision is needed to meet the ‘large unmet need’ and maximise the potential of a national programme, say researchers who led a large trial of its use in England.
Results from the largest real-world study of PrEP provided through 157 sexual health clinics across the country found the treatment reduced the chances of getting HIV by 86%.
Reporting the findings from more than 24,000 participants in the journal The Lancet HIV, the researchers said provision of PrEP considerably reduced HIV acquisition across several years of use.
The PrEP Impact Trial was led by the UK Health Security Agency (UKHSA) and Chelsea and Westminster Hospital NHS Foundation Trust and funded by NHS England in order to inform routine commissioning of the drug, which has been in place since October 2020.
Evidence from the trial now confirms its effectiveness in the ‘real world’ but concluded there would now need to be a ‘substantial expansion’ in access, beyond the level given in the trial, the researchers said
‘Urgent work is required to ensure equity of access for all who might benefit,’ they concluded.
The paper comes as the UK Government is looking at making PrEP available in settings other than specialist sexual health services, including GP practices, in order to meet the target of zero HIV transmissions by 2030.
A road map on measures to ensure equitable access is expected from the HIV Action Plan Implementation Steering Group by the end of this year.
Dr John Saunders, UKHSA deputy head of programme delivery and service improvement for STI and HIV Division, said: ‘This trial has further demonstrated the effectiveness of PrEP in preventing HIV transmission and has, for the first time, shown the protective effect reported by earlier trials, but at scale and delivered through routine sexual health services in England.
‘Now we know just how effective PrEP is in real-world settings, substantially reducing the chance of acquiring HIV. It’s vital that all those who can benefit from PrEP can access it. HIV testing and PrEP is available for free from sexual health services.’
John Stewart, national director for specialised commissioning at NHS England and co-chair of the PrEP Impact Trial Oversight Board, said: ‘Not only did the trial directly prevent many cases of HIV, help normalise the use of PrEP, remove stigma and pave the way for a routinely commissioned clinically and cost-effective PrEP service; but it also made a very real contribution towards our goal of ending new cases of HIV by 2030.’
Professor Kevin Fenton, the Government’s chief advisor on HIV and chair of HIV Action Plan Implementation Steering Group, said PrEP was a ‘powerful tool that reduces the risk of acquiring HIV’.
He added: ‘Expanding access to, and the uptake of, PrEP is key to our ambition to end HIV transmission in England by 2030, and a public health priority.’
Dr Ann Sullivan, chief investigator for the PrEP Impact Trial and consultant physician in infectious diseases and HIV at Chelsea and Westminster Hospital NHS Foundation Trust, said: ‘The PrEP Impact Trial has further demonstrated the effectiveness of PrEP in preventing HIV transmission and has provided key insights, including identifying subgroups where more work is needed to increase access to PrEP and prevent HIV transmissions.
‘It is reassuring that this research has further confirmed the protective effect of PrEP reported by earlier trials, when taken correctly and delivered through routine clinical services, which will continue to shape the delivery of HIV prevention across England.‘
Earlier this month, the UK’s Department of Health and Social Care announced it would expand a successful opt-out testing programme for HIV and other bloodborne viruses in emergency departments in England.
A version of this article was originally published by our sister publication Pulse.
1st December 2023
An opt-out testing programme for bloodborne viruses in emergency departments in England is to be expanded after the success of schemes in extremely high prevalence areas of HIV, the Department of Health and Social Care has announced.
Almost 4,000 people have been identified as having HIV and hepatitis B and C through the opt-out testing programme that was launched in April 2022 at 34 emergency departments in areas with the highest prevalence of HIV.
The new testing programmes will be launched in 46 further emergency departments across 32 high-prevalence areas of England.
Backed by £20 million in funding from the National Institute for Health and Care Research, the expanded initiative is expected to save, and improve the quality of, thousands of lives, particularly from groups less likely to come forward for routine testing.
It is part of the Government’s ambition to reduce new HIV transmissions in England by 80% in 2025 and end new transmissions of HIV by 2030, all while getting people into the right care.
Richard Angell, chief executive of the Terrence Higgins Trust, referred to the announcement as a ‘testing turbo boost that’s needed if we are to end new HIV cases by 2030’.
‘It’s hugely significant that an additional two million HIV tests will be carried out in A&Es over the next year thanks to a temporary but wholesale expansion of opt-out HIV testing to 46 additional hospitals,’ he said.
‘The evidence is crystal clear: testing everyone having a blood test in emergency departments for HIV works. It helps diagnose people who wouldn’t have been reached via any other testing route and who have often been missed before.
‘It also saves the NHS millions, relieves pressure on the health service and helps to address inequalities with those diagnosed in A&E more likely to be of black ethnicity, women and older people.’
Also commenting on the announcement, health and social care secretary, Victoria Atkins, said: ‘As well as promoting prevention for all, the more people we can diagnose, the more chance we have of ending new transmissions of the virus and the stigma wrongly attached to it.
‘This programme, which improves people’s health and wellbeing, saves lives and money.’
The existing bloodborne virus opt-out testing programme provides joined-up care so previously undiagnosed patients, or those disengaged from their care, gain access to medication and a treatment and care pathway.
During the first 18 months of the programme, 33 emergency departments conducted 1,401,866 tests for HIV, 960,328 for hepatitis C and 730,137 for hepatitis B.
It identified 934 people unknowingly living with HIV or disengaged with their care. A further 2,206 people were identified as having hepatitis B and 388 were disengaged from hepatitis B care. And 867 people were found to be living with hepatitis C and 186 were identified as being disengaged from care.
Professor Kevin Fenton, the Government’s chief advisor on HIV and chair of the HIV Action Plan Implementation Steering Group, said: ‘We know HIV is most commonly unknowingly spread by people who don’t know their status. Knowledge is power in preventing HIV transmission and accessing life-saving care.’
He added: ‘The opt-out testing programme will boost our progress to identify the estimated 4,500 people who could be living with undiagnosed HIV and help us ensure we meet our 2030 ambition, with the possibility to save thousands of lives in the process.’
27th July 2023
Cabotegravir – the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option proven superior to daily oral emtricitabine/tenofovir disoproxil fumarate in reducing HIV acquisition – has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Suitable for use in high-risk adults and adolescents weighing at least 35 kg to reduce the risk of sexually acquired HIV-1 in combination with safer sex practices, cabotegravir is an integrase strand transfer inhibitor, which prevents the HIV virus from integrating into the genetic material of human immune cells.
Developed by ViiV Healthcare, the CHMP positive opinion relates to the oral 30 mg tablet, which may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine, as well as the 600 mg prolonged-release injectable suspension.
The injection is administered six times per year by a healthcare professional and is initiated with a single 600 mg (3 ml) injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3 ml) injection every two months.
This represents an important step in the prevention of HIV, especially given the failure of a HIV vaccine earlier in 2023. Cabotegravir, which is sold under the brand name Apretude, has already been approved for use in the US, Australia, Zimbabwe, South Africa, Malawi, Botswana, and Brazil.
Kimberly Smith, head of research and development at ViiV Healthcare, said: ‘The expansion of prevention options is critical if we are to end the HIV epidemic. Long-acting options have the potential to play an important role in reducing challenges such as inconsistent adherence to taking daily pills, and stigma associated with oral PrEP use that can be faced by people who could benefit from PrEP.‘
She added: ‘With the CHMP positive opinion, we are hopeful that people in Europe will soon be able to benefit from greater choice.‘
The human immunodeficiency virus (HIV) remains one of the most important communicable diseases in Europe, with approximately 100,000 new diagnoses across the continent each year. Infection is associated with serious disease, persistently high treatment and care costs. Despite progress being made in the delivery of HIV treatment and prevention services, plus a continuous decline in the incidence of new cases, HIV still leads to a significant number of deaths and shortened life expectancy.
The positive opinion for cabotegravir in Europe was based on the results of two randomised, double-blind, placebo-controlled trials. The first, HPTN 083, compared the long-acting injectable cabotegravir, given intramuscularly every eight weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine for the prevention of HIV infection in at-risk cisgender men.
The primary end point was incident HIV infection, which was reduced by 76% in participants given cabotegravir (Hazard ratio, HR = 0.34, 95% CI 0.18 – 0.62).
The second trial, HPTN 084, compared the efficacy of injectable cabotegravir with daily oral tenofovir diphosphate plus emtricitabine for HIV prevention in uninfected women. This time, there was an even greater reduction in the risk of HIV infection in the cabotegravir group (HR = 0·12, 95% CI 0.05 – 0.31, p < 0.0001).
1st December 2021
A key theme of World AIDS Day 2021 is a call to end the division, disparity and disregard for human rights which has become associated with HIV infection. Acquired immunodeficiency syndrome (AIDS) was first recognised as a new disease in 1981 when a number of homosexual men succumbed to unusual opportunistic infections and rare malignancies.
It was later identified that these cases were due to infection with the human immunodeficiency virus type 1 (HIV-1) which is spread via sexual transmission through the lower genital and rectal mucosa, and it is these routes of infection that account for the vast majority of current and new infections. HIV targets the immune system, weakening an individual’s defence against many infections and as the virus both destroys and impairs the functionality of immune cells, those infected with the virus gradually become immunodeficient.
Although antiretroviral therapy (ART) has been available for many years and while the treatment is not curative, it does provide longer lives for patients and reduce HIV transmission. However, to date, there is still no effective vaccine but this might change as a trial is about to begin at Oxford University.
Despite the advances in treatment provided by ART, the HIV virus continues to represent a global major health challenge. According to the World Health Organization (WHO), the virus has already claimed 36.3 million [27.2–47.8 million] lives and WHO estimates that in 2020, there were 37.7 million [30.2–45.1 million] people living with HIV, of whom, over two thirds (25.4 million) reside in the African Region.
In order to access ART and associated counselling services for those with HIV, it is imperative to have equality of access to HIV testing, especially in areas of African, where the virus affects a huge number of people. Sadly however, a 2020 analysis from 16 countries in sub-Saharan Africa, revealed that while relative socioeconomic inequalities in uptake of HIV testing in the region have decreased to some extent, absolute inequalities have persisted or increased.
Other data have been equally pessimistic. The Start Free, Stay Free, AIDS Free initiative which began in 2015 and has a five-year framework which called for a super Fast-Track approach to ensure that every child has an HIV-free beginning, that they stay HIV-free through adolescence and that every child and adolescent living with HIV has access to antiretroviral therapy.
The approach focused on 23 countries, 21 of which were in Africa, that accounted for 83% of the global number of pregnant women living with HIV, 80% of children living with HIV and 78% of young women aged 15–24 years newly infected with HIV. The group’s most recent report from 2020 provides additional evidence of the current inequalities of access among those with HIV, revealing how nearly half (46%) of the world’s 1.7 million children living with HIV were not on treatment in 2020 and 150,000 children were newly infected with HIV, which is four times more than the 2020 target of 40,000.
Despite having being discovered over 30 years ago, and with treatments that enable infected individuals to live a virtually normal life, HIV is still very much a global health concern. Given the current enormous and global effort directed towards fighting COVID-19, it is hoped that the 2021 World AIDS Day call can gather an equal amount of energy in both reducing the inequality of access to testing and treatment as well as ending HIV.
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