Two HIV-positive gay men in the United Kingdom have announced that they plan to take legal action against the British Government's Department of Health for its lack of a clear policy on non-occupational post-exposure prophylaxis for HIV (NPEP). However, media coverage of the case may simplify the public's perception of NPEP and add to misinformation regarding the myriad challenges of providing and taking PEP after possible sexual exposure to HIV.
The concept of PEP has been around almost as long as antiretrovirals themselves, but for many years was used only for healthcare workers who were accidentally exposed to HIV, usually after being unintentionally pricked by a sharp or needle that they had used on someone who was – or was likely to be – HIV-positive. The American term 'needlestick injury' is now the usual phrase for this kind of accident, which may result in occupational exposure to HIV.
More recently, PEP has been used as a way of attempting to prevent HIV infection following possible exposure to HIV through sex between men, and sex between men and women, as well as injecting drug use (IDU). This is known as community or non-occupational exposure, or NPEP for short.
The two men, who have launched their legal action against the UK Government's Department of Health, have chosen to remain anonymous for now. It appears they are a gay couple, aged 35 and 26, from Kent, in south-east England.
Their solicitor Frances Swaine, head of the human rights department at personal injury specialist law firm Leigh, Day and Co., issued a press release on Monday, entitled 'Couple denied "morning after" pill launch action against Department of Health', and on Monday the story appeared in two media outlets – BBC and The Guardian.
The men say they are launching their legal battle because they believe that had they known about NPEP, the younger man would not have contracted HIV after a condom split during sex. "The only reason my partner has HIV is because they didn't tell me when I was diagnosed that PEP existed," the 35 year-old told The Guardian.
According to The Guardian, the pair are also being represented by David Wolfe, Cherie Booth Blair's barrister colleague from the high-profile Matrix chambers. The couple have been granted legal aid on the grounds of public interest, and the case will probably be heard in the High Court in the new year.
The men are hoping that their legal action will lead to a firm policy on the use of NPEP, training of healthcare workers on the appropriate use of NPEP, and a national publicity campaign.
"The case is being brought to raise awareness about PEP," says Frances Swaine in The Guardian. "The problem is people do not know about it and if they did they would struggle to find a doctor who would give it to them...What we are saying is that there needs to be guidelines on PEP and a campaign to tell people about it...We are asking for guidelines for all members of the population, for publicity along the lines of the old Aids (sic) campaigns, and training for all general practitioners and accident and emergency departments."
Last April the law firm issued a press release in which they outlined the men's case and said they were asking for a judicial review of the Department of Health's regulations regarding the use of PEP for non-occupational exposure.
"Work is underway to mount legal action against the Department of Health on behalf of two men who claim that they should have been given drugs after they were exposed to HIV to prevent the virus taking hold," said the April release. "Their argument is that the drugs should be available to all who need them under government guidelines, which currently only exist for health workers."
The Department of Health’s current PEP Guidelines, updated in February 2004, deal primarily with occupational exposure. Just three of its 20 pages are devoted to sexual exposure, and it makes few specific recommendations: "No data exist on the efficacy of antiretroviral post-exposure prophylaxis following exposure to HIV other than for occupational exposure in a health care setting," the guidelines say, adding that NPEP could be made available on an "individual case-by-case basis. However, due to lack of any evidence of efficacy, at present the Expert Advisory Group on AIDS cannot recommend in favour of, or against its use."
Although the Terence Higgins Trust began a publicity campaign in 2004 to inform gay men that NPEP existed, the campaign only targeted London and Brighton. It was spurred on by the publication of the first UK NPEP guidelines from the British Association of Sexual Health and HIV (BASHH).
The guidelines recommend that NPEP should be given when the source individual is known to be HIV-positive, and the HIV-negative partner has engaged in insertive or receptive anal or vaginal sex. They suggest NPEP should be given within 72 hours of exposure but ideally within 24 hours.
Unlike recent US guidelines, the BASHH guidelines recommend 28 days' treatment with either AZT/3TC (Combivir) or D4T/3TC (Stavudine/Epivir) or tenofovir/3TC (Viread/Epivir) plus the protease inhibitor (PI), nelfinavir (Viracept) or, the boosted PI, ritonavir-boosted lopinavir (Kaletra). They add, however, that if there is evidence that the source patient has current or past history of treatment failure, NPEP should be modified in relation to the drug history and/or to resistance testing if available.
The guidelines, which are voluntary, also state that it is crucial to consider NPEP after sexual exposure as only one strategy in preventing HIV infection and, as such, should be considered as a last measure where conventional, and proven, methods of HIV prevention have failed.
Comment
It has been clear even before BASHH released their NPEP guidelines last year, that major inequities exist throughout the UK regarding both knowledge of NPEP's availability, as well as the actual dispensing of NPEP.
Critics say that the Department of Health has been slow to react to recent evidence suggesting that NPEP is effective as a last-ditch attempt to prevent HIV infection in those at high risk after a possible act (or acts) of sexual transmission, citing concerns over costs and increased risk-taking.
However, US studies have found the NPEP is cost-effective when given to high-risk populations after a possible exposure to HIV.
Nevertheless, a debate is currently raging within the UK regarding whether widespread availability of NPEP – and a campaign to inform the public about it – would increase sexual risk-taking.
It is also a concern that mainstream media reporting of this case may fail to adequately explain the risks, as well as the benfits, of NPEP.
Although both the BBC and The Guardian explain in their coverage that NPEP is, in fact, 28 days' of anti-HIV medicines, and list some of their side-effects, the headlines say otherwise: 'HIV 'morning after pill' battle' (BBC) and 'Gay couple launch fight for right to 'morning after' HIV drug' (The Guardian), erroneously imply that NPEP is a simple-to-take pill.
For detailed information on the scientific evidence for NPEP, visit Treatment to prevent infection: post-exposure prophylaxis on aidsmap.com.