PrEP?! Not another acronym! Help! PrEP stands for Pre Exposure Prophylaxis (- Not the similar sounding PEP, which is Post Exposure Prophylaxis). Keep reading, all will be made clear. This is one of the latest HIV subjects on the table these days, with debate now rather well formed. The utilisation of the realms of research that has finally began to emerge now after the numerous PrEP trials that have lasted through the last decade.
In a nutshell, what is PrEP?
(Excerpt from earlier INPUD Diaries article) “It is an experimental HIV prevention strategy that, if proven, would use HIV drugs / anti retrovirals (ARVs) to drastically reduce the risk of HIV infection in HIV negative people who may be at a greater risk of contracting it due to circumstance etc.” However, while the empirical research is coming in, there remains questions. Some big ones. INPUD has taken a clear position, that among other things, PrEP must not come to eclipse other essential harm reduction interventions. It also loudly questions the ethical position of advocating for #PrEP for PWID not living with HIV is unethical when 4% of people who inject drugs and living with HIV are not receiving ART.
“People who use and inject drugs must have the right to choose for themselves which HIV prevention options best suit them, and all well-evidenced options must be available.”
The previous INPUD blog excerpt from PrEP’s early days in 2009 continues with this statement, “So, could PrEP, through the ingestion of a single drug (or combination) taken daily, reduce the chance of exposure to HIV infection – in HIV negative people? If found to be effective, how would such a prevention approach be rolled out? And to whom? In combination with what other prevention measures? And would HIV negative people even adhere to such a potentially uncomfortable and serious drug regime with no immediate tangible benefit – and perhaps even possible long term consequences from such a drug regime? And what about drug resistance – could we be making a rod for our own backs?“
INPUD rolls out a useful introduction on PrEP for the drug using community
Well, INPUD has released a basic introduction statement to Pre-Exposure Prophylaxis (PrEP) for people who inject drugs, outlining some of the pros, cons, and concerns surrounding this relatively new method for preventing HIV infection. INPUD states “People who took pre-exposure prophylaxis every day were significantly less likely to get infected with HIV. In an open label study, involving men and transwomen where participants were offered PrEP at the end of the trial, there was zero new HIV incidence amongst those who took between 4 and 7 doses per week, suggesting that PrEP could be somewhat forgiving with regard to missed doses.” INPUD went on to warn however that “Though clinical trials have shown efficacy for PrEP, INPUD stress that PrEP must not come to eclipse other essential harm reduction interventions. People who use and inject drugs must have the right to choose for themselves which HIV prevention options best suit them, and all well-evidenced options must be available.”
The advantages among the complexities
The data is flooding in
All the previously developed trials are finally coming in for the real number crunching and many have just been published.. “The research has looked at a range of transmission routes in diverse populations such as; Serodiscordant couples (one positive, the other negative); heterosexual men and women in high prevalence areas; people who inject drugs; gay men and other men who have sex with men. ” However, most of the now conceptualized data out there seems to focus on gay men and not on women and drug users, both who could potentially have a real part to play in properly targeted and thoughtfully implemented PrEP pilots etc. More on this in Silvia’s blog.
Where is the World Health Org Standing on PrEP?
And a Few Other Views?
In her blog Silvia asks the uncomfortable yet important questions but clearly states “I believe that it has been proven that PreP, if provided properly, could save many lives. I know that PrEP research has been community driven, and this is also important. But Silvia asks, “What about other vulnerable populations, such as black women and migrants? What about trans women? All the data we have here [in the UK] is about men who have sex with men, and this worries me. I have so many questions in my head….For now I would just like to share some questions I have regarding women’s access to PrEP that keep popping into my head. What are yours?…”
You can see the key questions Silvia raises in her blog such as:
- How will healthcare providers be trained in providing PreP to women? How will they be trained to deal with HIV stigma and gender based violence?
- How are we going to ensure that provision of PrEP for women provides pathways to other key services for women: including mental health services, drug and alcohol services, access to refuges and safe housing (for those exiting abusive relationships) etc. ?
For her article “Are Women Prepared for PrEP and a link to her very interesting blog, click here.
To add to the debate, a very useful article published by Daniel Wolfe, who as Director of the International Harm Reduction Development Program, Open Society Foundations and writing for the Huffington post (see full article here) warns us to not get swept away with the hype that is coming with PrEP. Wolfe goes on to give us a quick look behind the research figures revealing just how impossible it is to supplant the trial results in one country, as an affirmation of what will work in another. In this case it is about the large PrEP trial held over some years involving over 2,400 men and women who use drugs in Thailand.
Wolfe explains “The Bangkok Tenofovir Study was the first study of its kind examining a once-a-day HIV prevention method known as PrEP, or pre-exposure prophylaxis, among a population of injection drug users in Thailand. The study gave a single Tenofovir pill, along with counseling and risk reduction education to half of study participants, and offered placebo and counseling and risk reduction to the other half. Results showed overall reduction of almost 50 percent among those who received the medicine, and reduction of 74 percent for those who adhered best to the daily regimen.”
He continues, “The clinical trial finding that a once-daily pill halved HIV infection among people who inject drugs in Thailand is an important development in HIV prevention science, and brings welcome attention to a group often excluded from clinical trials.”
However, what makes this article so interesting is that he explains just how difficult it is
to assess the relevance of these trials in the real world when supplanted amongst communities of people who use drugs in countries where the simple act of just accessing your medication could be dangerous. For example, Wolfe tells us that the trial relied primarily on “directly observed therapy, meaning that most study participants had to come daily to receive the medicines.” Now to try and expect to roll out a PrEP process and gain similar positive results in another country where “going for an HIV test or even admitting that you have used drugs can result in the addition of your name to government registries shared with police” is outlandish. It also begs the question about the role of big pharma and the over medicalisation of the HIV prevention field.
“Pharmaceuticalization of HIV prevention for injecting drug users without corresponding reform in law enforcement and healthcare delivery is in no one’s interest, and will result in money wasted, new infections, and lives lost.”
In a fascinating piece of additional information which Wolfe says would of given us the chance to compare PrEP to effective needle and syringe programmes, Wolfe tells us where there lies a rather worrying case of missed opportunity; “Firstly, this study had an ethical obligation to compare the pharmaceutical intervention with needle and syringe programs — the recognized standard for HIV prevention among people who inject drugs. This standard was not observed, since the government in Thailand fails to offer needles and syringes through government programs. The omission means we lost a real opportunity to see how this daily pill compared to standard harm reduction services.”
I personally (not INPUD’s views here) have to wonder about the thought processes behind this examination which, if the data came out to be significantly similar and PrEP was compared to good quality NSP services, the drug companies could have lost out in a big way.
Indeed in his summary Daniel Wolfe states things a little more clearly for us saying “Pharmaceuticalization of HIV prevention for injecting drug users without corresponding reform in law enforcement and healthcare delivery is in no one’s interest, and will result in money wasted, new infections, and lives lost.”
Back to INPUD and the WHO
In the INPUD fact sheet on PrEP no 2, it summarises with the statement “The World Health Organisation, in the recently released Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care For Key Populations concluded on the basis of systematic reviews of the scientific evidence, and also the review of benefits, harms, costs as well as values and preferences of the community of people who inject drugs that it should not recommend PrEP for people who inject drugs. INPUD is in the process of developing a position statement on PrEP, so that we can systematically review the evidence and the opinions and values of the community so that they can be taken into consideration in forming policy.”
And finally, if that hasn’t given you some food for thought on PrEP, here are just a few fascinating insights into what concerns drug users have had around PrEP and its future implementation. (Note: INPUD is compiling a multi country consultation around what people think about PrEP and result will be published this year).