In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. (...) But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it. (shrink)

Published data show that new HIV prevention strategies including treatment-as-prevention and pre-exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV-based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the provision (...) of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment-as-prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment-as-prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment-as-prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV-based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations. (shrink)

In many countries around the world, people who inject drugs remain at high risk of HIV acquisition not because effective forms of prevention are unknown, nor because they find effective prevention undesirable, but because those in charge, mainly politicians but also bureaucrats, find evidence-based practice politically unacceptable. The evidence for preventive efficacy of harm reduction strategies, most prominently needle and syringe programmes but also treatment programmes such as opiate substitution, is irrefutable.1 However, political responses to drug use issues are varied (...) and complex, so the will to implement appropriate harm reduction programmes in the interests of public health remains lacking in too many jurisdictions. As a consequence, the discussion of how best, in the context of research, to reduce HIV incidence in populations of people who inject drugs but are not offered comprehensive access to known prevention strategies is—tragically—an important one. Dawson et al 2 focus on access to sterile injecting equipment and recognise that this should remain the ‘default’ standard of prevention for HIV prevention trials involving people for whom injecting drug use is the primary risk factor for HIV acquisition. ‘Standard of prevention’ means the background or minimal HIV risk reduction interventions offered to all participants in a trial, regardless of what other investigational interventions they are assigned to receive. The standard of prevention concept is grounded in the ethical principle of beneficence—that researchers and sponsors are obliged to maximise benefits and minimise risks to participants in research studies.3 …. (shrink)