Extended provision of ‘highly effective’ PrEP for HIV backed by researchers

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.

Cabotegravir gains positive CHMP opinion for HIV prevention

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.

Cabotegravir clinical efficacy

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).