Community consensus statement on the use of ARV treatment as prevention (draft paper for discussions)
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22.04.2013

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Community consensus statement on the use of ARV treatment as prevention

1. This is a community consensus statement on the use and prescription of antiretroviral therapy (ART) to people living with HIV to reduce their risk of transmitting HIV.
2. There is now conclusive evidence from the HPTN 052 trial in 2011 that viral suppression by ART in an HIV positive person very considerably reduces their risk of transmitting HIV through vaginal sex: in this trial, the observed reduction in risk was 96%. There is considerable consensus among researchers that this is likely to be the case for anal sex and needle sharing too.
3. This presents both enormous opportunities to people with HIV but also considerable challenges.
4. Even before the HTPN052 trial, the so-called "Swiss Statement" in 2008 declared that, under certain conditions, viral suppression would render people with HIV virtually non-infectious.
5. The statement was welcomed by many members of the HIV-positive community and their partners. The Statement was originally developed in order to counter unjustified criminal prosecutions for HIV transmission or exposure, and many hoped it might help relieve the burden of guilt, anxiety and fear of criminal liability many people with HIV felt at the prospect of transmitting HIV.
6. Equally, concerns have been raised by people with HIV and others that using universal ART as prevention as a public health measure could lead to a situation where people with HIV would be pressured into taking ART, regardless of clinical need.
7. In addition, access to ART for treatment is still restricted globally and in parts of Europe: in a number of countries the vulnerable communities that need it most have the worst access to treatment, prevention and testing for HIV due to criminalisation and stigmatisation.     
8. For people with HIV, then, the provision of ART as prevention has to balance:
a.  advocacy for, and facilitation of, provision of ART to patients who wish or need to take it to reduce their risk of transmitting HIV, even if they fall outside criteria for its provision as treatment;
b. advocacy for, and safeguarding of the rights of, patients who do not need or are not yet ready to take ART for clinical reasons and do not need, or wish, to take ART for prevention reasons;
c. continued advocacy for the right to equality of access to HIV treatment, prevention and testing for all affected communities.
9. The crucial issue that links these three concerns is the safeguarding of patient choice.
10. In the case of people who want ART as prevention, cost pressures already threaten to restrict access to ART, or to the most effective and tolerable ART, to people who need it as treatment. Strong advocacy and the provision of accurate information on the positive impact to the individual and to public health will therefore be needed to ensure funders and health systems provide ART to those who want it for prevention reasons.
11. In an era of financial challenges, where in the European area and elsewhere  many people still get ill and die from HIV because of lack of access to ART, we need to ensure that providing ART for prevention will not in any way affect efforts to make ART available as treatment to anyone who needs it. ART for prevention and for treatment are not in competition for resources – even conservative mathematical models find that wider access to treatment would result in reduced infection rates in most populations  - and should never be set in opposition to each other. 
12. In the case of people who do not want ART as prevention, there need to be safeguards against health providers using coercion, pressure or legal threat to persuade them to take ART. These safeguards are particularly important if, as has happened in the US, a recommendation that all people with HIV should be prescribed ART on diagnosis is adopted.
13. Even in the case of clinical need, patient readiness to take ART is crucial in order to ensure that patients take ART with the high levels of adherence necessary to suppress HIV, and we welcome and recommend the adoption of the patient readiness paradigm, as outlined in the EACS treatment guidelines, as a model to follow. 
14. Many people with HIV remain unaware of the prevention benefits of ART or are uncertain of the evidence for it, and we also welcome and recommend the adoption by other guidelines of the BHIVA and EAGA statement in the UK that healthcare providers must inform all patients of the potential prevention benefits of ART, and must prescribe it if, on the basis of that information, the patient asks for it.
15. Most models predict that ART by itself will not end the HIV epidemic but will have to be used in combination with other methods. Expanded and open access to HIV testing, injection equipment and condom and lubricants, newer prevention methods such as pre-exposure prophylaxis, microbicides and medical male circumcision, and support for behavioural change and community empowerment will continue to be necessary components of effective HIV prevention programmes. Expanding access to ARTs as prevention should not be a reason to restrict access to other methods of proven efficacy.
16. There remain many areas of uncertainty and lack of evidence that make the choice of whether to take ART as prevention and/or rely on it as a prevention measure difficult. These include:
a. HPTN052, and most of the other evidence we have, concerns transmission between heterosexuals or via vaginal sex alone, and the only other convincing body of evidence we have refers to its efficacy in preventing mother-to-child transmission. There is an urgent need for more research into the use of ART to reduce transmission via;
a.i. Anal sex: in this case there is a small amount of evidenceviii suggesting a considerable reduction in risk with the use of ART, but large observational studies in gay men and heterosexuals who have anal sex is urgently needed. We welcome studies such as the PARTNER Studyix  and Opposites Attract studyx designed to answer this question.
a.ii. Needle and drug equipment sharing: in this case there is very little evidence and we again need an observational study in injecting drug users to assess the reduction in risk offered by ART.
b. STIs: While there is clear evidencexi that most STIs significantly increase the risk of both transmission of and infection with HIV on people not taking ART or their partners, there is relatively poor evidence on whether the same increase in risk applies to people taking fully-suppressive ART.
c. Clinical risk/benefit of ART in people with high CD4 counts: There is very poor, and disputed, evidence as to whether ART offers any clinical benefit, over the risk of side effects, to people with CD4 counts over 500 cells/mm3 or even 350 cells/mm3. In this respect we welcome the Start Study, which is designed to answer this question for CD4 counts over 350cells/mm3, but we may need further studies to establish the risk/benefit ratio at higher CD4 counts.
d. Risk compensation. As the BHIVA/EAGA statement in the UK notes, ART is at least as efficacious as 100% attempted condom use in reducing HIV transmission, and from the evidence we have, probably more efficacious. Concern remains however about the epidemiological consequences if people on ART and their partners were to reduce their use of condoms because they feel safer from infection (“risk compensation”) and some mathematical models do find that if condom use fell significantlyxvii  (or partner numbers rosexviii), HIV incidence might rise despite ART provision. We therefore need:
d.i. ongoing research in different populations to monitor possible changes in behaviour and risk attendant on the more widespread use of ART as prevention or as PrEP;
d.ii. research in Europe to assess the efficacy of comprehensive ‘combination-prevention’ not based solely on condoms or ART alone; an example is the PopART studyxix currently taking place in Zambia and South Africa, though the European context would require a different study design.
e. We also strongly support the continued supply and promotion of condoms as a method of proven efficacy in preventing HIV and emphasise that, unlike ART, they also prevent most of the other STIs that in themselves cause considerable morbidity and some mortality.
17. The lack of available evidence as to the efficacy of treatment as prevention to the groups and in the circumstances mentioned above should not be used as a reason to exclude people from access to treatment as prevention. Instead it should be seen as a call for more action in research in these areas.
18. The advent of ART as prevention faces both providers and recipients of HIV prevention methods and support with a considerable paradigm shift in what HIV prevention actually involves, who should provide it and what methods should receive priority. An ongoing programme of training and information is needed to help HIV prevention workers, advocates and recipients respond optimally to what is likely to be a new era in the prevention of HIV.