Next month, an individual will be taking the United Kingdom government to court, accusing it of failing to implement an equitable policy regarding access to lifesaving drugs. It's not the anticancer drug Herceptin that will be under the spotlight this time, but post exposure prophylaxis (PEP) following sexual exposure to HIV.
The equal access to PEP campaign argues that whilst HIV PEP is available to all healthcare workers accidentally exposed to HIV, there is widespread inequality within the UK when it comes to PEP access after possible sexual exposure to HIV. This, says the campaign, contravenes Article 2 of the European Convention on Human Rights (ECHR) - the right to life - and it is demanding that the government's Department of Health (DoH) act immediately to reduce the many current barriers to HIV PEP access following sexual exposure to HIV.
These include:
- informing all HIV-positive individuals about HIV PEP;
- training all healthcare workers about HIV PEP following sexual exposure;
- providing 24-hour access to HIV PEP at every Accident & Emergency department in the UK.
More controversially, the campaign is also demanding:
- a clarification of policy regarding HIV PEP availability after 72 hours;
- education about HIV PEP to be included as part of sex education in secondary schools;
- a major nationwide information campaign about HIV PEP.
What is PEP?
HIV PEP requires a short course of antiretrovirals (a combination of two or three anti-HIV drugs, once or twice daily, depending on the regimen, for 28 days), given as soon as possible after probable exposure to HIV (up to 72 hours, but preferably much, much earlier).
The concept of HIV PEP has been around almost as long as antiretrovirals themselves, but for many years was provided only to healthcare workers who were accidentally exposed to HIV, either after being unintentionally pricked by a 'sharp' or needle that they had used on someone who was - or was likely to be - HIV-positive, or exposed to possibly HIV-infected blood via the mucous membranes (e.g. the eyes).
These kind of healthcare accidents are known as occupational exposure to HIV. Published data exist regarding the effectiveness of occupational PEP, and these can be read here. However, a recent European survey found that some cases of occupational HIV transmission occur despite prompt PEP.
More recently HIV PEP has been used in some countries as a way of attempting to prevent HIV infection following possible exposure to HIV through both gay and heterosexual sex, including unprotected sex, condom accidents and sexual assaults. This is known as community or non-occupational exposure.
The first data on non-occupational PEP began to be published at the end of the 1990s, and a review of studies published between 1997 and 2003 can be read here.
Relatively large non-randomised studies from Amsterdam and San Francisco published in the past couple of years have found that PEP after possible HIV exposure during sex between men is effective, although not completely protective, and that the availability of PEP neither led to a huge increase in demand, nor generally led to more risky sex following PEP.
"Part of the spectrum of sexual health services"
Some of the campaign's aims have already been achieved with the publication of guidelines by the British Association for Sexual Health and HIV (BASHH) for the use of PEP following sexual exposure (which can be downloaded in full from the BASHH website here) and their very recent recognition by Sir Liam Donaldson, the DoH's Chief Medical Officer in a 'Dear PCT/SHA Letter'.
Although the BASHH guidelines were published in a peer-reviewed journal only two months ago, they had been made publicly available at least two years earlier and were reviewed in the March 2004 issue of AIDS Treatment Update.
The BASHH guidelines include strongly worded recommendations regarding three of the campaign's particular aims:
- They recommend that information about PEP should be "proactively provided" to all people diagnosed with HIV, "particularly if in a serodiscordant relationship";
- They recommend that "24 hour access [to PEP] should be available" from A&E, with follow-up in an HIV or sexual health clinic "at the earliest opportunity";
- They also refer to the importance of A&E staff training, which are covered more comprehensively by the DoH's HIV PEP guidelines.
The DoH HIV PEP guidelines were written by the Chief Medical Officer's Expert Advisory Group on AIDS (EAGA) and were last revised in February 2004 (they can be downloaded in full from the DoH website here).
Unlike the BASHH guidelines the current DoH guidelines focus primarily on occupational exposure to HIV by healthcare workers. Controversially, the 2004 guidelines provided scant guidance regarding HIV PEP use for non-occupational exposure "due to lack of any evidence of efficacy".
However, on April 6th, the Chief Medical Officer alerted Primary Care Trusts (PCTs) and Strategic Health Authorities (SHAs) in England to the existence of the BASHH guidelines via a letter which included the following recommendations:
Media-savvy, high-level activism
It seems very likely, given the timing of Sir Liam's letter, that he was influenced by behind-the-scenes negotiations with the equal access to PEP campaign. The orchestrator of this impressive (but sometimes factually erroneous) campaign is a well-spoken 35 year-old HIV-positive gay man from Kent who prefers to remain anonymous, but who is calling himself 'Robert Jenkins'.
'Robert' and his campaign were granted legal aid for a judicial review on the grounds of public interest, and he insists that he is not seeking any financial reward: "This is a question of getting the policies right so people aren't needlessly infected with HIV," he tells aidsmap.
The campaign began in earnest in April 2005 when 'Robert' and his HIV-positive partner hired Frances Swaine, a human rights specialist at the law firm Leigh, Day and Co, to challenge the DoH's PEP provision policies.
'Robert' has told the mainstream media that he began the equal access to PEP campaign partially because he inadvertently infected his boyfriend after a condom accident, and that his boyfriend was implicitly denied access to PEP because they were not made aware by the DoH that PEP existed. Indeed, 'Robert' appears to be a very media-savvy activist who knows how to get the attention of the press to further the campaign's aims.
'Robert' is utilising the model of high-level activism similar to that of the American Civil Liberties Union, which has been advocating for individual rights by litigating, legislating, and educating the public on a broad array of issues affecting individual freedom, including HIV. This is unusual in the UK, however, where we have traditionally relied on less litigious methods to effect changes in policy.
Raising awareness of, and improving access to, PEP after sexual exposure to HIV, are laudable aims, but some of his methods are being questioned by several people closely involved in the creation of HIV PEP policy, who spoke with aidsmap about the campaign, but preferred to remain off-the-record.
"..it is important also to consider post-exposure prophylaxis (PEP) which can prevent HIV transmission taking place after non-occupational exposure to HIV. PEP is an emergency treatment, and to be effective in preventing HIV, it must be prescribed as soon
The letter can be downloaded in full from the BASHH website here. Minutes from a recent EAGA meeting suggest that their guidelines are in the process of being revised again, and this time are likely to echo BASHH's recommendations.
"No grey areas"
In particular, there are questions regarding his erroneous statement, via a press release dated April 11th, that "there is a wealth of current medical evidence that shows, although PEP is claimed to be 100% effective if administered within 72 hours, it is still effective if taken after 72 hours - although not 100%."
When asked by aidsmap to produce this "wealth of evidence", 'Robert' admitted that he wasn't sure of the exact studies. After much research, aidsmap could not find a single published study which suggests that PEP is effective after 72 hours, but there are several, including recent studies from Amsterdam and San Francisco, which find that PEP is not 100% effective even when administered within 72 hours.
The BASHH guidelines recommend the following: "The use of PEP following potential sexual exposure to HIV is only recommended where the individual presents within 72 hours of exposure."
However, several pages earlier in a discussion of factors that that influence the efficacy of PEP, they also suggest the following: "PEP may be less or ineffective if initiated after 72 hours of the exposure, but may be considered after this time if the exposure is 'high risk'."
This means that PEP after 72 hours may be considered on a case-by-case basis, but 'Robert' argues that this is "too ambiguous". He uses a recent example of a gay man possibly exposed to HIV via unprotected anal intercourse whom, he alleges, sought PEP just a few hours after the 72 hour deadline at an A&E department well-known for dispensing PEP - because he only found out that PEP existed at this late stage - and was turned away.
Some people involved in PEP access advocacy argue that the 72 hour deadline is arbitrary, based on theories of biological plausibility obtained mainly via animal studies. One study (Miller) suggests that the window of opportunity to abort HIV infection is between 48-72 hours, since it takes that long before HIV can be detected in lymph nodes. Other studies (Pinto; Spira) suggest it can take up to five days before HIV can be detected in blood.
"Where do they draw the line?" asks 'Robert'. "Under the European Convention on Human Rights there should be no grey areas; it's either prescribed or it isn't."
Nevertheless, most experts would say that PEP is an emergency treatment that has the best chance of working when it is accessed within hours, rather than days, of exposure.
A flaw of the current PEP publicity campaign, borne out by qualitative research recently presented by Sigma Research at the recent CHAPS conference (Dodds), is that even some highly PEP-savvy gay men think that receiving PEP at 72 hours provides as good a chance of success as receiving PEP within several hours of exposure.
The equal access to PEP campaign adds to that confusion by asserting that PEP is "100% effective" within 72 hours, and may do more harm than good by inadvertently encouraging people to wait even longer to access PEP.
"That's not what's being asked for," argues 'Robert'. "There is no suggestion at all that people should wait for up to 72 hours [to access PEP]. What we're saying is, if you only find out about PEP 80 hours afterwards, because it hasn't been widely advertised...you must go immediately to A&E and demand to be triaged immediately. At the moment people are being refused after 72 hours. We feel it's wrong; people should be given a chance."
Aiming high
Although the equal access to PEP campaign appears to have alienated some of the people involved in creating and publicising current PEP policy; some of its statements are wildly inaccurate; and several of its demands are controversial and may even be counterproductive; the campaign has already been extremely effective in bringing debate around the issue of the provision of PEP for sexual exposure to HIV into the mainstream.
Further examples of how well the campaign is organised includes the delivery of press releases highlighting different aspects of the campaign (and which have lead to coverage in The Times, The Guardian, and on BBC Radio 4's Law in Action, amongst others) and - the icing on the cake - the hiring of high-profile barrister David Wolfe of Matrix Chambers, who specialises in challenging the decisions of government through judicial review.
Mr Wolfe explained his judicial review strategy to Law in Action in February: "We have to show that PEP does contribute to HIV safety, that the government has not done sufficient to publicise them (sic), and that this might make a difference," he said.
When asked if he was planning to accuse the government of unlawful PEP policies, he replied: "We are suggesting that the government may not have done enough to comply with Article 2. Yes."
"Even if we don't win, this is forcing people to think about PEP," says 'Robert'. "We are asking for a judge to look at all the facts and say what is balanced and fair practice. We don't think that we're going to get everything that we're asking for. But in order to strike a balance you've got to ask for more than you actually think you're going to get.
"You've got to aim high to get what you want in the long run."
A national PEP campaign?
It might seem surprising that the equal access to PEP campaign is receiving little public support from the major players in UK HIV PEP policy, in particular the Terrence Higgins Trust (THT). This may be because THT was contracted by the DoH to deliver a national information campaign for HIV PEP after sexual exposure via CHAPS, and they find themselves in an understandably difficult situation given that their PEP information campaign is likely to be one of the main areas examined under judicial review.
In fact THT/CHAPS began providing information about PEP after sexual exposure to HIV in 1998, through a booklet aimed at gay men entitled, 'The Whole Picture'. In 2004, with funding from the DoH, they undertook a pilot PEP awareness campaign aimed at gay men in London and Brighton, which went national in June 2005.
Research presented at the recent CHAPS conference (Hickson) suggests that this targeted campaign was very successful, increasing PEP awareness amongst gay men nationally from 22% in 2003, to almost 40% in 2005, with a smaller, but still substantial, increase in seeking and taking PEP. Nevertheless, the investigators concluded that taking PEP is still a relatively rare event. Another presentation (Dodds) highlighted that some gay men who sought PEP last year were "driven away from services" with "inappropriate refusals."
'Robert' questions whether the CHAPS campaign was truly national, making comparisons with a recent well-funded Department of Information campaign highlighting the need for organ donors. "We want more money spent on publicising PEP," he says. "£80,000 and 50,000 leaflets is clearly insufficient."
Controversially, he argues for a national PEP publicity campaign on a par with the 1980s AIDS 'tombstone' TV ads. This is likely to be counterproductive, potentially overwhelming the NHS with the 'worried well': most experts argue that information about PEP's availability should be targeted at the populations most 'at risk' for acquiring HIV in the UK.
"Of the HIV infections acquired in the UK, over two-thirds of those diagnosed last year were as a result of sex between men. It therefore makes sense for any programme of work on PEP to start by targeting the group where the greatest numbers of HIV infections are occurring," explains THT in their FAQs on the CHAPS microsite. "The CHAPS PEP programme is focusing on gay men because that's what CHAPS is funded to do, but the information in the programme has been created to be easily transferable and adaptable to any other HIV priority group in the UK. By targeting the first phase of PEP work at gay men, THT and other CHAPS partners are NOT saying that information on PEP should not be available to other groups of people."
'Robert' also wants PEP to be taught in schools. "Some teachers are already teaching about PEP," he claims. "That's the best place to start educating people about PEP, at the same time that you're talking about safer sex and HIV."
However, even though it is currently recommended that sex education be taught in secondary schools by the UK government's Department for Education and Skills ("Young people need to be aware of the risks of STIs including HIV and know about prevention, diagnosis and treatment.") it is not mandatory.
'Robert' argues that "there's method in our madness", and that by asking for things that are unlikely to be achieved via a judicial review, he is creating awareness and debate regarding the larger picture of the UK's poor sexual health, and the lack of mandatory realistic and practical sex education in schools. "Perhaps this will be the first step to force sexual education in schools," he says.
Dodds C et al. PEPSeekers: Men's experiences of accessing PEP following sexual exposure. CHAPS 9, Leeds, March 2006.
Hickson F et al. Post-Exposure Prophylaxis and gay men in the UK: differential changes in awareness, seeking and using, 2003-2005. CHAPS 9, Leeds, March 2006.
Miller RJ et al. Human immunodeficiency virus and AIDS: insights from animal lentiviruses. J Virol 74: 7187-95, 2000.
Pinto LA et al. Immune response to human immunodeficiency virus (HIV) in health care workers occupationally exposed to HIV-contaminated blood. Am J Med 102: 21-4, 1997.
Spira AI et al. Cellular targets of infection and route of viral dissemination after an intravaginal inoculation of simian immunodeficiency virus into rhesus macaques. J Exp Med 183: 215-25, 1996.