Is PrEP a realistic and ethical intervention for people who inject drugs?admin
Is PrEP a realistic and ethical intervention for people who inject drugs?
HIV Australia | Vol. 13 No. 2 | July 2015
By Chris Gough
‘[PrEP] is a very expensive way to reduce the risk of HIV transmission, when we know that NSP (needle syringe programs) and handing out harm reduction supplies is such an effective way to reduce HIV, and a lot cheaper.
‘I would rather see a focus on the 15 million people who can’t get access to ARV’s, rather than trying to get injecting drug users on PrEP.’
— WHO survey, 20141
Several recent papers have examined whether pre-exposure prophylaxis (PrEP) is a realistic and ethical intervention to address the transmission of HIV in people who inject drugs (PWID).
The World Health Organization (WHO), as well as the peer-based International Network of People Who Use Drugs (INPUD) have investigated the attitudes of people in the drug using community, as well as experts in the field.2 3
This article outlines those findings and discusses their implications for people who inject drugs, both in Australian and internationally.
PrEP is the use of antiretroviral treatment (ART) by HIV-negative people to reduce the risk of acquiring HIV.
Several populations of people at risk of HIV exposure have been identified as prime candidates for PrEP: gay men and other men who have sex with men (MSM), serodiscordant couples, young women, sex workers, and people who inject drugs.4
While demand for PrEP is growing amongst the gay community, groups representing sex workers and people who inject drugs have conducted surveys which have identified reservations about the use of PrEP in their communities.5 6
Surveys carried out by the WHO among PWID and health experts reflect similar concerns.7 Atop the concerns for people who inject drugs is the lack of evidence for PrEP’s efficacy in PWID communities.
To date, there has only been one study on PrEP use among the drug using community, and its results are widely regarded as flawed.8
Public health and the individual
Before investigating the nuances of PrEP and PWID, it is important to clarify the distinction between public health strategies targeting PWID as a population and the diverse health needs of the individuals which make up this population.
The inclusion of PWID as a key population for PrEP would pave the way for new public health strategies focusing on PWID, such as the funding of PrEP initiatives and legislation targeting PWID.
This would have major consequences for PWID communities and individuals (both HIV-negative and HIV-positive); therefore, the inclusion of the PWID population as being ‘key’ must be considered thoroughly and seriously.
At the level of the individual, it must be recognised that the members of the PWID community are diverse and have different opinions and prerequisites for a healthy life.
PWID cut across all walks of life; injecting drug users may be a member of a serodiscordant couple, a sex worker, a gay or bisexual man, or may simply wish to access PrEP to help protect their health.
These individuals should all have the option to access any prevention option proven to be safe and effective, cheaply and easily.
Concerns around population level PWID PrEP programs
The WHO and peer groups such as INPUD have concerns about a public health roll-out of PrEP and its effects on the PWID community, particularly given the criminalised nature of drug use and the systemic problem of stigma and discrimination.910
The first issue that must be raised concerns mandatory versus voluntary PrEP treatment.
Mandatory use of PrEP would cause massive human rights violations and may appear attractive to countries controlled by repressive regimes, with no stomach for harm reduction services.
In such countries, PWID are often seen simply as vectors of disease and have no access to targeted health services such as needle and syringe programs or pharmacotherapy.
‘There is a concern that in some countries this will be used to identify possible “vectors” of transmission, especially among key populations and to force them into treatment to prevent transmission to others.’
— WHO survey, 201411
INPUD’s recent PrEP background paper highlights these risks. It cites an example where, in 2013, Gennady Onishchenko (the Chief Sanitary Inspector of the Russian Federation) noted that PrEP could serve as an alternative to methadone opiate substitution, the provision of which is opposed by the Russian government.12
‘In the EECA region [eastern Europe and central Asia], people are deeply alarmed by the possibility of their governments picking up on PrEP.
‘[It] raises a whole series of human rights threats and risks: registries that could be shared with the police, compulsory attendance, a whole range of potential human rights infringements . . . ’
— WHO survey, 201413
There is also concern that PrEP may be used in some countries to sideline proven harm reduction services such as NSP and pharmacotherapy.
‘The introduction and backing of PrEP is part of a much larger agenda to medicalize the HIV response, which poses a very serious threat to communitybased preventative responses-across all communities.
‘In the context of PWID, the bio-medical magic bullet promised of PrEP, [especially for] governments who are resistant to harm reduction, will be seen as an excuse not to scale up or introduce [proven] harm reduction programming.’14
Concerns around lack of scientific evidence
There is little doubt that in a clinical setting PrEP reduces the transmission of HIV, however, among people who inject drugs, this efficacy may not translate to the real world.
There has only been one study on PrEP as a means of reducing HIV infection in PWID conducted in a real life situation. The Bangkok Tenofovir Study was conducted in 17 Bangkok drug treatment centres, with 2,413 participants over five years.
The study was a randomised, doubleblind, placebo controlled phase 3 study. The results showed a 48.9% reduction in HIV transmission in the PrEP versus placebo group.15
Serious ethical questions have been raised about this study;16arguably, it breaches several of the ethical standards outlined in the Council for International Organizations of Medical Sciences (CIOMS) and WHO ethical standards for biomedical research on human subjects.17
First and foremost, the study failed its ethical obligation to compare the efficacy of PrEP with NSP, the recognised gold standard in HIV interventions for PWID.18
This occurred because Thailand’s narcotics law forbids the distribution of needles and syringes for injecting drug use.
Although clinics in the trial did supply participants with condoms and harm reduction information, as well as bleach for the cleaning of used syringes, no sterile injecting equipment was made available.19
The trial’s inability to negotiate the dispensing of sterile equipment onsite is disappointing because fewer trial participants may have contracted HIV if this had been provided.
It also means that PrEP’s utility as a complementary intervention to NSP services cannot be gauged.
Other concerns are that study participants were paid; that direct daily observation was used; and that participants who were incarcerated were still allowed access to the PrEP medication.20
It therefore remains to be seen how well PWID could adhere to a PrEP regimen without incentive, in conditions where daily observation is not possible, and where incarceration (which is common in such a criminalised population) usually means lack of access to medications.
There is no literature available which discusses the logistics of rolling out PrEP to the drug using community.
Due to the highly criminalised and stigmatised nature of drug use, people who use drugs often shy away from health services and hide their drug use for fear of negative consequences.
Given this fact, it could be difficult to roll out a public health campaign targeting people who use injecting drugs without the support of the PWID community.
The Australian context
The Australian Injecting and Illicit Drug User League (AIVL) is the peak peer based drug user organisation (DUO) in Australia.
AIVL’s membership is made up of the state peer-based drug user organisations, whose membership comprises of people who use injecting drugs.
It is through this network that PWID are given a voice to share their opinions around topics including PrEP.
AIVL is part of INPUD and has adopted the same position on PrEP that is outlined in the INPUD background paper.21
Looking at Australia, AIVL supports the listing of Truvada for use as a preexposure prophylaxis and its inclusion on the Pharmaceutical Benefits Scheme.
What is problematic is the listing of people who use injecting drugs as a priority population for PrEP use. The reason for this lies in the practical realities that Australian injecting drug users face.
The rate of HIV among PWID in Australia is between 1–2%22whereas hepatitisC (HCV) prevalence is between 50–60%.23 24 As PrEP does not protect against HCV, NSPs are the pivotal intervention for injecting drug users as they protect against all blood borne viruses.
Currently, Australia’s NSP system is struggling to deliver the necessary service coverage to injecting drug users due to inadequate funding and legal and policy barriers.
The Australian harm minimisation policy also includes provision of pharmacotherapy programs (methadone, buprenorphine and suboxone treatment).
Recent studies show that pharmacotherapy programs can reduce HIV transmission in participants by 54%25 as well as allowing PWID to stabilise their health and wellbeing in the long term.
These realities mean that DUOs must prioritise and constantly push to increase proven harm minimisation service funding in particular NSP, pharmacotherapy, medically supervised injecting facilities, peer education and community development projects.
The WHO currently does not suggest that PrEP is an effective intervention for PWID due to lack of scientific evidence and survey responses from members of the affected community. Consensus from the drug using community is that making PrEP a priority for PWID is unnecessary and problematic.
DUOs, experts and service providers suggest that PWID are not an appropriate key population for PrEP use. Instead, experts suggest the scaling-up of NSP and pharmacotherapy programs as well as antiretroviral treatment access for HIV-positive PWID is the priority.
Rejection of PrEP as a population health strategy for PWID does not amount to a rejection of an individual’s right to access PrEP, or the inclusion of gay men and other men who have sex with men as key populations.
PrEP is rejected as a prevention strategy for PWID because the most serious barriers to health in PWID remain NSP inaccessibility, criminalisation and stigma and discrimination.
More details of PWID’s views on PrEP will become available when INPUD releases its full position statement later this year.
1 Henderson, M. (2014). Values and preferences of people who inject drugs, and views of experts, activists and service providers: HIV prevention, harm reduction and related issues. World Health Organisation (WHO), Geneva. Retrieved from: www.who.int/iris/handle/10665/128118
3 International Network of People who Use Drugs (INPUD). (2015, March). An Introduction to Pre-Exposure Prophylaxis (PrEP) for People who Inject Drugs: pros, cons and concerns. Background Document. INPUD, London. Retrieved from: www.inpud.net
4 Eisingerich, A., Wheelock, A., Gomez, G., Garnett, G., Dybul, M., Piot, P. (2012). Attitudes and Acceptance of Oral and Parenteral HIV Preexposure Prophylaxis among Potential User Groups: A Multinational Study. PLOS ONE, 7(1), e28238. doi: dx.doi.org/10.1371/journal.pone.0028238
5 INPUD. (2015). op. cit.
6 Scarlet Alliance, Australian Sex Workers Association. (2014). Pre-Exposure Prophylaxis (PrEP) and Early Treatment. Scarlet Alliance, Sydney. Retrieved from: www.scarletalliance.org.au/library/prep_2014
7 Henderson, M. (2014). op. cit.
9 Henderson, M. (2014). op. cit.
10 INPUD. (2015). op. cit.
11 Henderson, M. (2014). op. cit.
12 INPUD. (2015). op. cit.
13 Henderson, M. (2014). op. cit.
15 Choopanya, K., Martin, M., Suntharasamai, P., Sangkum, U., Mock, P., Leethochawalit, M., et al. (2013). Antiretroviral prophylaxis for HIV infection in drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet, 381(9883), 2083–2090. doi: dx.doi.org/10.1016/S0140-6736(13)61127-7
16 Wolfe, D. (2015, 9 June). op. cit.
17 Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva. Retrieved from: www.cioms.ch/publications/layout_ guide2002.pdf
18 Wolfe, D. (2015, 9 June). op. cit.
19 Choopanya, K., et al. (2013). op. cit.
21 INPUD. (2015). op. cit.
23 O’Brien, S., Day, C. Black, E., Thetford, C., Dolan, K. (2007). Injecting drug users’ understanding of Hepatitis C. NDARC Technical Report No. 262. National Drug and Alcohol Research Centre (NDARC), University of New South Wales, Sydney. Retrieved from: ndarc.med.unsw.edu.au
24 Iversen, J., et al. (2014). op. cit.
25 MacArthur, G., Minozzi, S., Martin, S., Vickerman, P., Deren, S. Bruneau, J., et al. (2012). Opiate substitution treatment and HIV transmission in people who inject drugs: systematic review and meta-analysis. BMJ, 345:e5945. doi: dx.doi.org/10.1136/bmj.e5945
Chris Gough has over seven years’ experience working as a peer educator with people who use drugs. He is currently a Health Education Officer at the Medically Supervised Injecting Centre, Uniting Care.
Chris is also a board member of the Australian Injecting and Illicit Drug Users League (AIVL) and the Australian Federation of AIDS Organisations (AFAO) and a member of the International Network of People Who Use Drugs (INPUD).