Prepared for PrEP? More food for thought

theNewCondom

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 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

Another excerpt from a previous Diaries article on PrEP said “One of the potential

A Jagged Little Pill

A Jagged Little Pill; Dont miss AIDSMAP’s piece on PrEP for yet more discussion, info and facts.

advantages of PrEP is that those who are unable to negotiate condom use with their sexual partners, would still be able to reduce their risk of infection, (especially women living and struggling to protect themselves  in machismo/misogynistic cultures or where wars break out…PrEP could theoretically be given to women who may be able to protect themselves from the ravages of war rapes and HIV incidence?) And, people who inject drugs may be able to protect themselves much more effectively despite being in higher risk environments.” However, nothing is ever so straightforward.

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.

However do click here for INPUDS INTRODUCTION TO PrEP and information on how it all relates to the drug using community. A thorough run through of the data in a one sitting, article size piece of information that’s reprintable and available for dissemination to your peers and drug user groups etc. It provides a useful position statement on the subject as well.

Where is the World Health Org Standing on PrEP?

Status of PrEP globally: the CDC and the WHO
(Excerpt from INPUD’s introduction to PrEP) “PrEP has been approved for use in some

Truvada; FDA approved for use in PrEP

Truvada; FDA approved for use in PrEP

countries. Notably, the United States Center for Disease Control (CDC) recommends PrEP for groups at high risk of HIV exposure, including at risk HIV negative men who have sex with men, at risk HIV negative people who inject drugs, as well as persons of any gender in serodiscordant couples. It is recommended by the CDC as an element of a comprehensive set of HIV prevention services, to be accompanied by quarterly monitoring of HIV status, pregnancy status, side effects (which can include nausea, cramping, and long-term effects including kidney problems), medication adherence, and risk behaviours. The CDC note that PrEP delivery for people who inject drugs should be integrated with prevention and clinical care for additional health concerns, which, in this context, include hepatitis B and C infection, abscesses, and overdose.”

And a Few Other Views?

Below is an article I’ve linked from a blog by the highly respected UK based HIV activist, Silvia Petretti. This excerpt from her blog which is entitled HIV Policy Speak Up  gives her usual refreshing look at yet another tricky HIV subject.  In Silvia’s blog piece on PrEP, Silvia looks at an important UK based study called PROUD which was released this year which looks at “how men who have sex with men who are HIV negative can take Truvada,  a drug used to treat HIV , to prevent getting the virus through sex. The Proud study showed that Truvada could offer an 86% protection to HIV. But Silvia reminds us that “Truvada…is relatively safe. However, it must not be forgotten that it has potentially harmful effects, especially on the kidneys and bones. People who take it need to be strictly monitored.”

Silvia does however, look further into the case for women and she raises some good points about women and PrEP, pointing out issues we must take on board sooner rather than later as rolling out PrEP picks up pace. There is a unique role in PrEP for women, especially women who use drugs and sell sex who face violence and rape on a regular basis, as do many millions of women and girls across the world.

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

Money for big pharma...

Money for big pharma…

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).

– advocacy for PrEP is likely to undermine advocacy for proven harm reduction interventions (this has already happened on a rhetorical level in Russia with the Chief Sanitary Physician announcing that given that PrEP could be provided, there is no need to provide methadone)
– given that proven harm reduction interventions are far from scale, PrEP is a costly, and moreover unethical diversion from the core interventions
– there is no evidence that PrEP reduces transmission via blood borne routes, only sexually
– the only trial so far conducted specifically with injectors was multiply flawed – both ethically and methodologically
Get in touch with your views or add them to the comments section below.
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About Erin

Freelance writer and journalist for the global drug user press
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