HIV Pre-Exposure Prophylaxis (PrEP) 

and NHS England’s lack of investment despite strong evidence

4th Year Liam Sutcliffe reveals the world of Intercalated Degree research from his BSc ClinMed Global Health work last year and unveils the shortcomings of NHS England…

Pre-Exposure Prophylaxis (PrEP) is a combination of two antiretroviral drugs, tenofovir and emtricitabine, produced in one pill with the trade name Truvada. Truvada is taken once a day with the aim of stopping HIV negative individuals from acquiring HIV. There is increasing interest in using PrEP amongst individuals at high risk of acquiring HIV. Side effects of Truvada are mostly reported to be transient and mild, and previous studies have shown the drug to have high efficacy. However, several studies in 4 continents found the use of PrEP as a public health intervention for both gay men and heterosexuals to have low to medium effectiveness.

The PROUD Study

In the UK, the population most affected by HIV is men who have sex with men (MSM). In 2012 the PROUD study was set up at University College London to investigate how effective a public health intervention PrEP would be in the UK amongst MSM.PROUD was a randomised trial originally designed to be 2 years. In the first year, half of the participants would get PrEP and half would not. In the second year, all of the participants would receive PrEP. Participants were recruited who reported having unprotected anal sex before the study and were expecting to have it again. Each participant reported an average of 10 sexual partners in the 3 months prior to enrolling in the study, and on average unprotected anal sex was practiced with 2-3 of these partners. 60% of participants had been treated for a sexually transmitted infection in the previous year.

The first stage of the PROUD study was intended to be a pilot study to investigate the feasibility of a larger trial. The researchers were not expecting to show the effectiveness of PrEP in this phase of the trial. However, when the independent data monitoring committee for the trial reviewed the data, it found a significant risk of HIV infection in those not receiving PrEP compared to a very high level of effectiveness seen in the PrEP group. Given the significant difference between the two groups, this phase of the trial was stopped early for ethical reasons and all participants were offered PrEP.

Amongst participants in the group randomised to not receive PrEP (n = 269), there were 19 HIV infections. In the same period in the group randomised to receive PrEP (n = 275), there were 3 HIV infections. This correlates to an 86% reduction in HIV infection in those receiving PrEP. Of the 3 HIV infections in those receiving PrEP, it is believed that 1 participant contracted HIV the week before the study began (too early for the pre-study HIV test to detect infection), and the other 2 participants were not taking PrEP when they became infected. This shows that PrEP is highly efficacious if taken as directed.

Some argue that if PrEP was to be prescribed in the mainstream, it would lead to an increase in other sexually transmitted infections, as people would abandon condoms with the fear of HIV removed. No difference was found in the rate of sexually transmitted infections between those who received PrEP and those who did not. Participants receiving PrEP generally reported adding PrEP into their existing HIV prevention strategies, such as condom use, rather than replacing their existing strategy with PrEP. The study also evaluated the experiences of participants who were taking PrEP. Common themes included a reduced anxiety surrounding sexual experiences, and a feeling that infection with HIV was no longer an inevitability.

The Implications of the PROUD Study

The PROUD study has certainly shown PrEP to be an effective HIV prevention strategy for MSM who are unable to use condoms consistently for sex. Michael Brady, Consultant in Sexual Health and HIV at Kings College Hospital and Medical Director of the Terrance Higgins Trust, says it would be “really easy to include PrEP into normal regular sexual health service delivery”, given those who present to sexual health clinics are more likely to benefit from PrEP. Dr Brady also continues to explain that if patients have to return to the sexual health clinic for repeat prescriptions of PrEP, it provides opportunities to implement other strategies to promote sexual health such as provision of condoms, talking about safer sex practices and behavioural interventions.

The PROUD study found the number needed to treat with PrEP to prevent one HIV infection was 13. Of course the NHS must be mindful of cost effectiveness, but it is estimated that it costs around £300,000 to treat 1 patient with HIV for their lifetime. As the life expectancy of those living with HIV increases with improved treatment, this figure will surely only rise. Therefore, if PrEP is targeted at those at the highest risk of acquiring HIV, it is likely to be an extremely cost effective intervention.

Yusef Azad, the Director of Policy and Campaigns at the National AIDS Trust also points out that although the PROUD study only looked at MSM, it does not mean that it will not be a useful intervention for other high risk individuals. Other studies have shown PrEP to be efficacious in heterosexual women and men when taken correctly, so any roll out of PrEP on the NHS should include all high risk individuals.

NHS England’s decision against funding PrEP

On March 21 this year, after 18 months of consideration, NHS England published a statement explaining that it would not fund a wide scale roll out of PrEP. It did however pledge £2 million over the next 2 years to provide PrEP to 500 men deemed most at risk in various PrEP testing sites around the country. Whilst further studies into the effectiveness of PrEP are welcomed, this should not stop a wider roll out in the meantime given the strong evidence presented by the PROUD study.

Deborah Gold, Chief Executive of the National AIDS Trust, criticised NHS England, saying that “the decision is not informed by any due process; the amount of money is arbitrary; the claim that more ‘testing’ of PrEP is needed is disingenuous”. She continues, explaining that “500 does not remotely cover the number of gay men at high risk of HIV nor meet the needs of heterosexuals at risk”. It is estimated that around 5000 gay men will get HIV in the UK over the next 2 years. If PrEP had been approved for wide scale roll out by NHS England, this number would be greatly reduced.

PrEP is now available in the USA, Canada, France, Israel and Kenya. The CEO of the Terrance Higgins Trust also criticised the decision, saying that “Today’s decision by NHS England to depart with due process, and, instead, offer a tokenistic nod to what has the potential to revolutionise HIV prevention in the UK, is shameful”.

NHS England states that local authorities are responsible for commissioning HIV prevention strategies. However, NHS England is in charge of other HIV prevention strategies, such as post exposure prophylaxis following sexual or occupational exposure to HIV. Such lack of clarity is enabling different bodies to deny responsibility. A recent petition to the Department of Health calling for PrEP to be made available immediately on the NHS has now gained over 13,000 signatures. Two large randomised trials, PROUD AND IPERGAY, have shown without a doubt that PrEP can significantly reduce HIV infections in high risk groups. NHS England’s decision to turn its back on the evidence is shameful and should be challenged.

Liam Sutcliffe