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«PrEP_BHIVA_BASHH_PS Update_14September15_Final Updated BHIVA-BASHH Position Statement on PrEP in the UK Sheena McCormack, Sarah Fidler, Martin ...»

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PrEP_BHIVA_BASHH_PS Update_14September15_Final

Updated BHIVA-BASHH Position Statement on PrEP in the UK

Sheena McCormack, Sarah Fidler, Martin Fisher, Yusef Azad, Tristan Barber, Gus Cairns,

Valentina Cambiano, Dan Clutterbuck, Monica Desai, David Dunn, Julie Fox, Yvonne Gileece,

Margaret Kingston, Charles Lacey, Heather Leake Date, Fabiola Martin, Alan McOwan, Koh-Jun

Ong, Andrew Phillips, Iain Reeves, Ann Sullivan, George Valiotis, Laura Waters

With help from Andy Copas, Tom Doyle, Jonathan Elford, Noel Gill, Graham Hart, Ford Hickson, Roy Kilpatrick, Veronica Nall, Tony Nardone, Roger Pebody, Deenan Pillay, Lisa Power, Peter Scott, Helen Weiss all of whom provided written comments on the original statement, or contributed on the Community Calls Purpose of statement Recent results from clinical trials of PrEP have made it clear that this biomedical prevention tool could have a major impact on the HIV epidemic in the UK(1, 2). The intention of this updated Position Statement is to inform the UK healthcare workers on the role of antiretroviral preexposure prophylaxis (PrEP) in the setting of the UK epidemic, so that they can have an informed discussion with their patients.

Commissioning policies placing PrEP within a combination prevention package will be central to the delivery of high quality HIV prevention services, and should be developed as soon as possible.

This work is in progress in England, but as yet a commissioning policy is not yet in place in any of the UK nations. It is true that clinicians can prescribe medicines for non-licensed indications (as is the case for post-exposure prophylaxis [PEP]), but their freedom to do so is constrained by cost pressures, and a coordinated national response is required to ensure equity of access and to maximise the public health impact of PrEP in each nation in the UK.

It is not possible to review the evidence for this biomedical intervention in isolation, as PrEP (systemic and topical) is one of several methods in the prevention package, and one of four biomedical tools available, the other three being medical male circumcision, PEPSE and treatment of an HIV positive individual to reduce the risk of viral transmission.

We therefore broadened the scope of the Position Statement published in the International Journal of STDs and AIDS in 2013 to attempt to put the evidence for PrEP in context, both in terms of the characteristics of the UK epidemic and the evidence for other biomedical interventions. This update takes account of new evidence collected in Europe, and the policy activities in England. We took note of the updates to other guidelines around the topic of prevention, including those that are in development and out for consultation.

Methods The previous statement was amended to incorporate the most recent evidence, including the results of the PROUD trial which was conducted in 13 sexual health clinics in England(1).The draft was circulated for comment to the original writing group on the 26th March 2015. The writing group requested that two further topics be included, one outlining how to support patients who PrEP_BHIVA_BASHH_PS Update_14September15_Final are purchasing Truvada online, and a second commenting on the dosing schedule to recommend – daily or on-demand(2). A further amendment was circulated on 5th May before posting the consensus statement for public consultation on the association websites.

Consensus statements HIV remains an infectious disease of major public health importance in the UK with an  estimated 107,800 infected individuals, a quarter of whom are not aware of their HIV status (3). The UK HIV epidemic most affects Black African, gay and other men who have sex with men (MSM) communities. In 2013, 3,250 new infections were diagnosed in MSM (the highest ever number) and 2,470 (76%) of these were probably acquired within the UK(3). The number of MSM estimated to have acquired HIV in the UK each year has not decreased in the last decade.

The majority of HIV prevention efforts in the UK have focused on behaviour change, mainly  the use of condoms and testing behaviour. Since 2011 provision of antiretroviral therapy to reduce the risk of onward transmission has been formally included as an effective prevention method in the BHIVA HIV treatment guidelines, although the commissioning policy to support this is still under review. There was limited new funding for motivational interviewing to be implemented in accordance with national guidelines, and clinics have been under increasing pressure to make savings which has restricted access to this as well as to treatment for prevention. Whilst cross-sectional datasets of outcomes and impact provide some insight, there has been no systematic approach to the evaluation of behavioural interventions on a national basis.

Ten randomised controlled trials have reported on the use of pre-exposure prophylaxis,  five providing evidence for the effectiveness of daily oral tenofovir(4, 5) or Truvada(1, 4, 6,

7) and one for Truvada taken before and after sex(2). Effectiveness for oral tenofovir based regimens has been demonstrated in three of three trials in MSM(1, 2, 6), one of one trial in predominantly heterosexual serodiscordant couples(4), one of one trials in young heterosexual adults(7) and one of one trials in injecting drug users(5). A seventh trial assessing tenofovir 1% vaginal gel applied before and after sex observed a modest reduction in HIV incidence in women in Kwazulu-Natal(8) but this was not confirmed in the subsequent trial conducted in South Africa(9) (Table 1). Two randomised placebo controlled trials conducted in women in Sub-Saharan Africa observed no benefit in the modified intent to treat analysis for daily oral tenofovir or Truvada or daily tenofovir 1% vaginal gel(10, 11). The discrepant results are explained by low levels of adherence observed in the trials that did not see a reduction in HIV incidence - less than a third of women on the active arms had detectable drug at the first study visit. Biological efficacy is supported by subset analyses conducted in women using gel who had detectable drug(9, 11).

Two of the randomised trials were conducted in European MSM populations and reported  early this year. PROUD was an open-label design in which half the participants had access PrEP_BHIVA_BASHH_PS Update_14September15_Final to daily Truvada in the first year and half did not(1). IPERGAY was a placebo-controlled design evaluating an event driven regimen of Truvada (two tablets before sex, and one a day for two days after the last condomless anal sex act)(2). In both trials the incidence in the control group was much higher than anticipated, 8.9/100 person years in PROUD and 6.6/100 person years in IPERGAY. The incidence seen in PROUD is eighteen fold higher than the estimated incidence based on the overall MSM populations in England. The reduction in HIV was also the highest seen to date in intent to treat analyses (86% in both trials).

PROUD also demonstrated the feasibility of delivering PrEP through sexual health clinics using simple and easy to apply inclusion criteria. IPERGAY demonstrated that an event driven regimen, which required half as much drug as a daily regimen overall, was also highly effective at reducing acquisition of HIV.

The momentum following these two European trials reinforces the need to rethink our  overall strategy for HIV prevention. The continued increase in infections being identified in MSM, acquired within the UK, underscores the urgent need to do so. Central to the prevention strategy is full engagement of the most affected communities.

As a consequence of the high HIV incidence in the non-PrEP and placebo groups and the  large effect size in both trials, the numbers that need to be treated in populations similar to those enrolled in the PROUD and IPERGAY studies to avert one infection in a year are very low, 13 and 18 respectively. A preliminary cost-effectiveness evaluation using the eligibility criteria for these two trials and the 86% reduction in HIV incidence, suggests that daily PrEP for MSM will be cost-effective if HIV testing continues at the current rate and there is no substantial change in the proportion of MSM who manage their risk with condoms(12). The cost of drug, which is approximately half using the IPERGAYdosing schedule, is a key driver of the cost-effectiveness, as is the background incidence in the population seeking PrEP.

It is helpful for health care workers to be aware of the international response to the  evidence. Tenofovir vaginal gel is not licensed for prevention anywhere; Truvada is licensed for prevention in the US(13), and submissions are under review in Australia, Brazil, South Africa and Thailand, and on a named patient basis in France. Truvada is licensed for treatment in the UK and Europe and used off label for prevention as PEP. The drug comes off patent in Europe in 2018 and this is relevant for the cost-effectiveness analyses. The Centre for Disease Control and Prevention has issued guidance for US clinicians to support daily oral Truvada in anyone at sexual risk of acquiring HIV, and the World Health Organisation issued a new recommendation in July 2014 that PrEP is an additional HIV prevention choice in a comprehensive HIV prevention package among MSM(14, 15).

At the time the iPrEx trial reported, a number of concerns were expressed about the  widespread use of PrEP by a range of stakeholders, including the gay communities, sexual health and HIV commissioners, the European regulatory authorities, clinicians and the research community. These concerns included cost, not only of drug but the feasibility of delivering it, the emergence of drug resistance and toxicity. A major concern was the PrEP_BHIVA_BASHH_PS Update_14September15_Final possibility that people would drift away from consistent condom use or be pressurised to do so by their partners and peers, and that this would outweigh the protective effect of PrEP as this was expected to be modest based on iPrEx (~50% reduction in HIV). PROUD was designed to address this major concern and to obtain a measure of ‘real-world’ effectiveness. The benefit observed in PROUD was high, and there was no difference between the group on PrEP and the group not on PrEP in terms of sexually transmitted infections. The European Centre for Disease Control has revised their previous statement which expressed concern about risk compensation, and now recommends that “EU Member States should give consideration to integrating PrEP into their existing HIV prevention package for those most at-risk of HIV infection, starting with MSM.” A PrEP sub-group of the National Clinical Reference Group was established in September  2014 to scope the work to be done for a commissioning policy in England. The aim of the sub-group is to assemble the necessary information including the cost-effectiveness analysis of a PrEP programme in England, to enable a decision to be taken in time for the 2016/17 financial year.

Clinicians need to know how to respond to patients who are seeking PrEP, including  patients who have or plan to purchase Truvada online. The first thing to assess is why they think they need PrEP. It may be helpful to see them with their regular partner if they are in a monogamous serodiscordant relationship in which the positive partner has undetectable viral load, to discuss the evidence that treatment prevents transmission and to encourage them to enrol in the PARTNER study(16). If the positive partner is not on treatment or is not yet virally suppressed, then there may be a role for PrEP for the negative partner. MSM and transgender women who are having condomless anal sex with casual male partners would clearly benefit from PrEP as this was the eligibility for PROUD and IPERGAY. It is important to have access to a 4th generation HIV test and serum creatinine with timely return of the results (within one week) and it may be appropriate to wait for the result before taking the first tablet when starting PrEP. However, PrEP can start the day of the tests, provided the point of care antibody test is negative and there is no suspicion of acute HIV infection, and should be started promptly when risk is a continuum. An early check within the first month of starting PrEP is useful and this is an opportunity for an additional 4th generation HIV test if indicated. Otherwise screening for HIV and STIs whilst on PrEP should continue according to the current recommendations (3 monthly). Renal safety can be checked at these visits through urinalysis with additional tests according to clinic practice if there is 1+ of protein and no other explanation for this, such as infection. If there is sufficient concern that the Truvada is counterfeit, a sample could be collected for tenofovir levels.

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