Let’s be clear from the start. My history is one of being an opponent of treatment as prevention (TasP) - and a vocal one at that. But that was then and this is now, a time where the arguments of yore are no longer at all persuasive. So I’ve changed my mind and I now fully support TasP.

To be honest, mine is not a popular stance in Eastern Canada, but I’m in good company elsewhere. I’m referring to endorsement of TasP by the  World Health Organization, the International AIDS Society, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the British Columbia Centre for Excellence in HIV/AIDS, (BC-CfE), the Terrence Higgins Trust, not to mention luminaries like Barack Obama, Hillary Clinton, Bill Clinton and Canada’s own Stephen Lewis.

But those names in themselves do not stir me.  It’s the opportunity that TasP, particularly in the absence of any other current strategy to see an end to AIDS in our lifetime, while improving the health of those with the virus. As Stephen Lewis has said utilizing TasP has become a “moral imperative”, a matter of ethics and of human rights. “What is urgently needed is for the Canadian government to do the right thing and that is to expand HIV testing and treatment nationwide.”

Leading treatment as prevention researcher/advocate Dr. Julio Montaner, a former head of the International AIDS Society, echoes his words, saying  “It is imperative for the Canadian government to mobilize political will and funds to nationally expand testing, treatment and support to people living with HIV/AIDS. This is the moral thing to do if we want to end AIDS and secure the health of our future generations.”

They are both right, of course

All of which leads me to say I was delighted to respond to the British Columbia Centre for Excellence in HIV/AIDS' invitation to endorse their efforts to secure a national AIDS strategy for Canada incorporating TasP.  You’ll find my words quoted in their press release below.

*************************

New study reinforces effect of antiretroviral treatment on prevention of HIV and calls for national action

Study stresses need for political will and funding to implement the made-in-Canada Treatment as Prevention strategy to save lives and prevent new infections 

Vancouver, B.C. [May 14, 2013] — A new study from the BC Centre for Excellence in HIV/AIDS (BC-CfE) and University of British Columbia shows there is strong and consistent evidence that expanded use of highly active antiretroviral therapy (HAART) decreases HIV transmission across a variety of geographical regions and sub populations. 

Researchers reviewed scientific evidence published in peer-reviewed journals about the benefit of HAART among HIV-positive individuals in preventing HIV transmission. Their analysis of existing literature reinforced the strong relationship between use of HAART and reduced transmission among not only stable heterosexual serodiscordant (where one partner is HIV positive) population, but also high-risk groups such as men who have sex with men (MSM) and injection drugs users (IDU).

“There is no doubt HIV Treatment as Prevention is a game changer,” said Dr. Julio Montaner, director of the BC-CfE and senior author of the study. “It is imperative for the Canadian government to mobilize political will and funds to nationally expand testing, treatment and support to people living with HIV/AIDS. This is the moral thing to do if we want to end AIDS and secure the health of our future generations.”

Study authors noted the effectiveness of abstinence promotion, condom use and needle exchange programs have been limited. In 2010 there were 2.5 million new infections, 1.8 million AIDS-related deaths and 390,000 children infected globally, with disproportionate representation in low-income countries. Only 54 per cent of HIV-infected individuals with severe immunodeficiency are on HAART, and only 20 per cent of people with HIV know their status.

Over the years, scientific evidence has mounted nationally and internationally in favour of HAART’s impact on reducing disease progression to AIDS and death and secondarily decreasing HIV transmission. In B.C., between 1996 and 2009, the number of individuals receiving HAART increased from 837 to 5,413 and the number of new HIV diagnoses fell from 702 to 338 per year (52 per cent decrease). The rates of HIV testing increased throughout the study period. In addition, in 2011, the HIV Prevention Trials Network (HPTN) reported that HAART led to a 96 per cent reduction in HIV transmission among serodiscordant couples.

“I am living proof of the long-term benefits of HIV treatment,” said Bob Leahy, editor of PositiveLite.com, Canada’s online HIV magazine, and someone who has lived with HIV for 20 years. “HAART has allowed me to live a normal and productive lifestyle and this is nothing short of a miracle for people like myself who have been given a second chance. It makes so much sense, and is the right and ethical thing to do, to ensure we quickly scale up testing across Canada so that every HIV-positive person has access to HAART, both to improve their own health and to very significantly reduce the risk of transmission.”

The Joint United Nations Programme on HIV/AIDS (UNAIDS) recently reported a 10 per cent drop in HIV/AIDS funding from 2009 to 2010 to support the Universal Access pledge. The U.S.’ budgeted contribution to the Global Health Initiative is projected to fall 10.8 per cent for 2013.

“We have the tools to end HIV/AIDS, and B.C. is a shining example of what can be achieved through universal implementation of Treatment as Prevention,” said Stephen Lewis, co-director of AIDS-Free World and renowned HIV/AIDS activist. “We are talking about human lives and the future health of Canadians. We cannot afford any further debate or more expensive clinical trials to prove what we already know. What is urgently needed is for the Canadian government to do the right thing and that is to expand HIV testing and treatment nationwide.”

The B.C. pioneered Treatment as Prevention strategy has led to the widespread expansion of HAART coverage in British Columbia. It has demonstrated a marked decrease in morbidity, mortality and new HIV cases. As the only province to implement the Treatment as Prevention strategy, B.C. stands alone as the sole province to show a consistent decline in new HIV diagnoses since 1996.

“While expansion of Treatment as Prevention will no doubt be lifesaving, evidence shows the long-term financial benefits can be tremendous,” said Dr. Bohdan Nosyk, lead author of the study and health economist at the BC-CfE. “HAART has evolved beyond individual health benefits to the HIV-positive person to secondary preventive benefits for the community at large. Failing to expand HIV funding can reverse the gains made against the epidemic and undermine the promise of HIV Treatment as Prevention.”

Research by the Canadian AIDS Society suggests the lifetime economic cost of each HIV infection is over $425,000, including health care costs and lost productivity.

Every year, 3,300 men and women in Canada are diagnosed with HIV infection and it is estimated more than 71,000 Canadians are now living with HIV.

The full study authored by several renowned HIV/AIDS experts and published in AIDS, official journal of the International AIDS Society, can be found here.

What is Treatment as Prevention?

The Treatment as Prevention strategy has been pioneered by BC-CfE’s Dr. Julio Montaner. It involves widespread HIV testing and immediate provision of anti-HIV drugs known as HAART to medically eligible people with HIV. The BC-CfE has demonstrated that the benefits of early HAART treatment are twofold: it reduces the level of HIV in the blood to undetectable levels thus improving the health of people with HIV, and decreases the level of HIV in sexual fluids to undetectable levels thus reducing the likelihood of HIV transmission by more than 95 per cent. In 2009, the BC government invested $48 million over four years in the BC-CfE-led Seek and Treat for Optimal Prevention of HIV/AIDS (STOP HIV/AIDS) pilot project. The intent of the pilot is to expand HIV testing and treatment among hard-to-reach populations such as injection drug users in Vancouver’s inner city and Prince George.

Treatment as Prevention is internationally recognized by organizations such as the World Health Organization, International AIDS Society and the Joint United Nations Programme on HIV/AIDS (UNAIDS). Treatment as Prevention has been endorsed by U.S. President Barack Obama, Secretary of State Hillary Clinton and former U.S. President Bill Clinton as an effective strategy in the fight against HIV/AIDS.

Since the last International AIDS Conference in Vienna in 2010, the landscape has changed significantly.  Two years ago, for instance, HPTN 052 was not even in our collective vocabulary.  Now it’s ubiquitous, and the issues it raised – the promise of a 96% reduction in transmission rates for those on treatment (although it’s not quite that simple) are a principal focus of AIDS 2012, as they should be. But where is Canada on this and other recent advances – and are we slipping from our position as once world leaders in the response to HIV?

I think we are. Not that there isn’t some good news, things we can be proud of  - and we’ll get to those in a minute, but in the last year particularly, that has been overshadowed by an overwhelming statis that has set in.  So while other countries have recorded remarkable progress in reducing infection rates, for instance, we now flounder, the product of an unsympathetic government and a community that has grown sluggish, uncoordinated and, dare I say, timid.

So where does Canada stand in 2012?  Let’s get the bad news out of the way first.

On criminalisation, we do in fact lead other countries – but in the worst possible way. The number of prosecutions for non disclosure here surpasses any other country on a per (HIV+) capita basis. Our response to this, while vigorous, has been ineffective.  Praiseworthy  efforts  by community advocates in Ontario to introduce prosecutorial guidelines to limit the number of prosecutions have instead been met by efforts from the Crown Attorney’s Office to make disclosure laws much, much harsher – with, they suggest,  disclosure required for any sexual act regardless of the risk. If successful, this will see prosecutions sky-rocket. It’s a prospect worthy of Iran, and, of course, potentially a major defeat for our community.

Moving to treatment as prevention, ironically a concept fostered in Canada, the world has been taken by its potential as a powerful tool, if not to end the epidemic but perhaps bring it to its knees, along with other prevention technologies. It’s clearly a key focus of IAS 2012, in fact, to see how the world can move towards implementing treatment as prevention, despite huge challenges, not the least of which is a worldwide reduction in the kind of foreign aid needed to make this happen. But where does Canada stand? We are undeniably a divided country, arguing over whether it works or not, and not just in regard to gay/bi men. No one has focussed on those divisions more pointedly than our foremost proponent of treatment as prevention, IAS past-president Dr Julio Montaner of the BC Centre for Excellence in HIV/AIDS. “Unacceptable” and “reprehensible” were the terms he used to describe Canada’s position in an interview with me for PositiveLite.com last year.

Just this week, in a letter to Canada's Minister of Health, Montaner said "You can prevent death, you can prevent morbidity and you can stop transmission. You can deliver on an AIDS-free generation. All you need to do is implement what we already know and we get it done within your political term."

One is not used to thinking of the US as a model, given the huge problems in access to care and treatment that country experiences, but our neighbours to the south have officially embraced treatment as prevention ahead of us.  It will be a challenge for them to make it work. But three other recent innovations have left Canada trailing also. Earlier this year, the US was quick off the mark in introducing revised guidelines which recommend, in many situations, that HIV treatment should start immediately on diagnosis. That, oddly, has left scarcely a ripple in Canada.  True, Canada has no national guidelines – healthcare is a provincial matter and so there is no real equivalent for the US guidelines – but Canada’s collective silence has nevertheless has been deafening.  Given that some of the benefits of starting treatment are better health outcomes, although some would dispute this, I would expect in the interests of newly infected individuals, there would have been a more vigorous debate here.

Are you HIV-negative, sexually active, a frequent tester (we hope so), heard  pre-test counselling a thousand times and think access to an at-home oral HIV test would both serve your needs and keep you even safer?  OraQuick has been approved in the States to do just that.  It’s not available in Canada.  OraQuick manufacturers have yet to make application to sell the product in Canada, but the wrangling has already begun, and I’m predicting will sink this product’s chances of increasing our HIV testing platforms here, a necessary step in bringing our new infection rates down. Kudos though to sane voices like that of respected researcher Montreal’s Dr. Mark Weinberg  who are stating quite noisily that Health Canada needs to approve the test.

And just this week, the FDA announced approval of Truvada for PrEPin the States, the first officially approved drug for use in HIV prevention, considered by most observers a major breakthrough in the war against HIV. Again, implementation is problematic. But where is Canada?

All this is well and good, you say, but we are winning the war on new infections in Canada, aren’t we? Or at least they are not spiralling out of control?  New infection rates are, in fact, stable. But people like Dr Montaner call stable “unacceptable“. "To have the knowledge, much of which has been produced here, to know how to treat, control and stop this epidemic and not implement it because of lack of political will is unacceptable and reprehensible” he told me. 

But are new infection rates in Canada stable? We really don’t know. The most recent Health Canada data on hand in the form of PHAC surveillance reports is from 2009. Now we know that our provincial health structure complicates reporting, but the questions remains: how can we track the effectiveness of this nation’s response  to the epidemic on the basis of numbers which reflect the prevention efforts  and behavioural trends of half a decade ago? The answer is, of course, you can’t.

Where else are we trailing? Well, it’s hard not to argue that in 2012 our collective commitment to GIPA (Greater Involvement of People Living with HIV/AIDS) seems lukewarm at best. Just look at the number of persons living with HIV being sent to Washington. Time was when provinces like Ontario fielded community members to attend  in large numbers,  IAS Toronto and Mexico City being prime examples. But these are harder economic times and GIPA is something we do only do if we can afford it. So few will be there.

And, in 2012, we in Canada still don’t have a national organization for people living with HIV, a united voice, like NAPWA in the States, for instance. 

Having said all this, not all is doom and gloom. In some of the most important markers of all – PHA longevity for instance - we are doing better all the time. Our drug regimes  - and more people have access to them here than in most nations - are simpler, easier to take, and have much improved side effect profiles than even five years ago. Standards of HIV care for many remain very high.

Public attitudes to HIV are improving too. Let’s ignore for the moment that an overwhelming majority of the public supports jailing those who don’t disclose their status, In fact the notion is surprisingly popular even amongst the ranks of people living with HIV.  Other attitudinal markers show good progress.  For instance, the CANFAR-commissioned report on public attitudes, knowledge and perceptions of HIV in Canada released this year indicates that HIV stigma may be declining, based on a number of measures.  For example, the report indicates . . .

• Substantial and increasing majorities of Canadians report that they are comfortable interacting with people living with HIV/AIDS in several situations
• Today, more than three quarters of Canadians would be comfortable working in an office where someone had HIV/AIDS (those who report that they would be “very comfortable” is up 7 points from 42% in 2006 to 49% in 2011) .
• Almost three-quarters (72%) would be comfortable shopping at a small neighbourhood grocery store where the owner had HIV/AIDS (those who would be “very comfortable” is up 4 points since 2006 and up 8 points since 2003).
• Six-in-ten (60%) Canadians would be comfortable if their child was attending a school where one of the students was known to have HIV/AIDS. Those who would be “very comfortable” is up 5 points since 2006.

Lower numbers than we would hope perhaps, but it’s the trend that is important. It’s the result of a lot of work, community education efforts that are paying off.

What else is going well?  It’s too early to measure results, but there are exciting things happening on the prevention front as we gain a better understanding of the drivers of behavior, particularly in the gay/bi men’s community, which continues to account for the lion’s share of new infections in Canada. Interventions drawing on gay men’s resilience, for instance, or applying a harm reduction approach to risk behaviour, could produce results that will turn things around.

And while advocacy is a dirty word (funders don’t like) it, activism in Canada is not entirely dead.  In fact a revitalized AIDS ACTION NOW! is more active, at least in Toronto, than in a very long time, and doing sterling work to boot.

All in all, it’s a mixed bag – a good news/bad news report card for Canada - but perhaps it’s always been like that.  What I think has changed in the context of AIDS 2012 is that Canada went to earlier conferences wearing the cloak of world leaders in all things HIV, our mission to teach.  People like our own Stephen Lewis, although representing the UN, were our mouthpiece. World leaders on HIV no longer, we have lots to be proud of, not least in our survival as one of the first nations affected by the epidemic, with thousands still alive and living proud, strong lives.  So Canada goes to Washington this time humbled and not to lecture or berate, but to acknowledge that we, as much as any other nation present, have much to learn.

I first met Dr. Julio Montaner around 1996.  He was giving a talk at the International AIDS conference in Vancouver; a few of my friends had told me it would be worth my while to attend his HIV “Up-Date”.  I listened and soon realized that he was an incredible leader in the scientific fight against HIV.  What I discovered over the next few years took me by surprise, a side of Dr. Montaner I had not suspected - that of a humanitarian and a doctor who cared deeply about his patients. 

When I first met Dr. Montaner in his office, he was working in the old part of St. Paul’s Hospital at the end of a long, darkly lit hallway.  In thinking back, I am reminded just how many patients lined that hall - many stood, others sat, and we all waited very quietly and as patiently as possible. In those days, the waiting area had a whole different feel to it. It’s hard to describe, but I felt like I was a comrade to all those who waited with me. We were in this thing together and there was an underlying sense of friendship.  Then, it was not unusual to wait up to two hours to see your specialist and far more people went in with their loved one for support.  There were not many women in line.

I often wonder where some of those patients are now...the ones I knew by name but didn’t see outside of the hospital.  I sometimes fear the worst but hope for the best.

I'd heard he told you what he thought and didn’t pussyfoot around.  I liked that about him because I felt he had far more knowledge than I did about HIV... besides I was going to see him to get cutting-edge advice, not to have my ego stroked.  But as time went on I realized there was much more to him than just science and advice.

I became friendly with his secretary, Patricia and it was through her that I got to know the real Dr. Montaner - “Julio”.  He would stay late, work through his lunch-hour and often see patients who had no appointment - they just turned up as emotional wrecks and he had the job of giving them the facts, a person who wouldn’t judge them. I didn’t envy him his task.

When I first went to visit him, I had chronic PTSD (Post-Traumatic Stress Disorder) and was in deep depression.  While I sat there, he phoned the Psychiatric Department at St. Paul’s and he told me not to worry, I was going to be helped. That afternoon, I was seen by a psychiatrist and immediately given counselling.

On another occasion, I was taking a medication that was new to me and he said a side-effect was psychotic behaviour!  Not long after, I was at the house when the phone rang and it was Julio on the other end of the line.  He asked how I was doing and I told him that I was fine, in fact I was feeling far more confident and had even had the nerve to tell a few people what I really thought about them - it was a whole new me that I liked!  He asked to speak to my husband and then asked to be put back to me...

“You know, maybe this drug is not for you”, he said.

Soon, Julio was examining the theory that a “drug holiday” was a possibility and he let his patients know there was an opportunity to rest from the medication.  He immediately put me on a trial break from the meds, which confirmed to me that he was definitely not a blind proponent of the medication.  Within no time at all, I became extremely tired and could barely keep awake. After testing my blood, I was discovered to have a lower CD4 count and a higher viral load and after three months, I was back on the meds. I believe his quick reaction actually saved my life by not allowing my body to succumb to the virus and by doing so gave me many more years to live.

In later years, I knew one patient who had decided to go to another doctor and the patient had become sick.  Julio told me to tell the patient if they needed anything he would be glad to do whatever he could. It didn’t escape my attention that he didn’t take it personally when his patients changed to a different specialist and he would always be there to care for them.

Over the years, Julio and I both became very aware that I had a high intolerance towards medication and often developed an allergy.  Because of this, he had to be very careful what he prescribed for me and was always watching over me, particularly in the first few weeks on a new med.  I found it very soothing to know that I could contact him and he took my assessment of my own condition seriously.

Once I took matters into my own hands and went off one medication that was bothering me.  I sheepishly arrived at his office within the week.  He asked me how things had been going and I answered:

“well, I don’t think you are going to be thrilled at what I’ve done”

“aye-ya-yai!” he replied and, palms up, he flicked his fingers towards him in an action of “OK, give me the details...”

I gave him the news. He reminded me that it was not a brilliant idea to go off a med without seeking my doctor’s OK beforehand and that going off one could make me resistant to all the other meds I was on.  I smiled and assured him it would be OK; he looked at his computer screen and set to work finding me another medication.  He didn’t make me feel bad, he just got on with the business of making me well.

In the last ten or more years, I have come to know another Julio - an extremely strong advocate for people with HIV.  He has not been afraid to speak out against governments and has “named names” of politicians who are hampering the struggle to end the disease.

Finally, I hope Julio will not be offended when I compare him to my doberman... doggedly determined, quick-witted, exceedingly loyal, a defender... and never truly appreciated by those he serves, very misunderstood.

There has been a flurry of articles recently with headlines like “Undetectable Viral Load? Not Necessarily in Semen” like this one in POZ.  Discovery of this connection isn’t the least bit new, of course, but what’s drawn attention is new research from Boston which furthers our understanding of the associated risk a little more. More on what that research says in a moment.

The headlines may sound alarming for those who thought, because they’d reached undetectable, they were much less infectious because of low levels of virus in their blood. But if there is in fact virus in the semen, are we back to square one, the walking time bombs we’ve always been? Certainly the headlines seem to imply that. And certainly the headlines seem to reinforce the message for poz guys everywhere “wear a condom, whatever your viral load”.  But do the headlines reveal the full picture?

It’s clear we’ve made good progress towards quantifying what IS the risk of virus in the semen, and in the associated risk of HIV transmission. Today I want to look at what we’ve learned and what are the implications for people living with HIV.

Semen – the traditional view

The virus in the blood vs. virus in the semen debate is a complicated and technical one. As a result, there has been a tendency for prevention experts to try and make things simple for us. Here’s how CATIE, for example, answers the question “If my viral load is undetectable, can I still pass HIV to others?”  

“Yes. While HIV may not be detectable in the blood, there might still be enough to infect someone. Also, there may be higher levels of HIV in semen or vaginal secretions. So, even if you have an undetectable viral load, you might still infect someone if you share needles or have unprotected sex.”

There is nothing here that isn’t absolutely correct.  But the answer doesn’t help quantify the risk for us – and quantifying risk, or trying to, is exactly what informed decisions are built on. In this particular case, we need to know what science tells us about three key questions:

• What is the likelihood of virus appearing in the semen if it can’t be detected in the blood?
• Where virus is detected in semen, what are the likely concentrations?
• Are those concentrations likely to cause HIV transmission?

All three questions are answerable, albeit with provisos, from research. That research suggests, in a nutshell, that while a quarter of ‘undetectable’ gay men have HIV in semen, the risk of transmission is likely quite low.

The research on “undetectable” gay men’s semen.

The Boston research has helped quantify the likelihood of both virus being present in the semen in "undetectable" men and the likelihood of it causing transmission. This study involved 101 gay/bi men. This AIDSmeds article summarizes the results. Eighty-three of the 101 men had undetectable levels of HIV in their blood samples. Though most also had undetectable HIV in their semen samples, 25% of those had detectable seminal viral loads. This is in the range that previous studies have confirmed.

What’s interesting is that the men who had an STI were 29 times more likely to have viral discordancy. The implication is that without an STI, undetectable in the blood means, way more often than not, undetectable in the semen.

Now let’s look at those 25% of undetectable men where virus was detected in their semen, because it’s important to understand how much virus was present.  The median level in the semen was 200 - in other words, unlikely to infect anyone.  A viral load below 1,000 has in fact, rarely been associated with HIV transmission.

So let’s summarize what we’ve learned from Boston: if you have an undetectable viral load there is a one-in-four chance of virus being measurable in your semen, considerably smaller if no STIs are present. And if that virus in your semen reflects median levels found in the study, the chances of transmission are tiny.

The problem is that median levels are just that – some men will in fact have higher levels of seminal virus, thus increasing the risk of transmission.  So, while the median range for measurable semen may have been 200, the actual range was 80 to 2,560 copies. We need to look at other research to find out whether those higher levels of seminal virus are likely to cause transmission.

It’s not as clear cut as one would like, but AIDSmap reports a small 2008 study from San Francisco found that the median seminal viral load in men transmitting HIV to partners was 4,300 and the lowest was 110. A larger (1,199 gay men) 2009 study from the UK found that two out of 41 transmissions of HIV (5%) were from men with an apparently undetectable viral load, as measured in their blood.

BUT as AIDSmap  qualifies “studies of the link between viral load and transmission suffer from it being difficult to pin down transmitters in a cohort of gay men with multiple partners and where viral load may be measured months after the transmission.”  In other words, it is wrong to conclude the men had undetectable virus (in the blood) at the time of transmission.

What does all this mean? It’s hard not to suggest that in “undetectable” men, virus in semen at levels likely to result in HIV transmission represents anything other than a small but nevertheless potential risk.

How we process risk.

It’s notoriously difficult to turn research data like this in to helpful risk guidelines, a topic which was explored in some depth in my recent interview with CATIE’s James Wilton here. 

What is clear is that the risk associated with semen in otherwise undetectable men is low, but cannot be expressed as zero.

But what risk CAN be expressed as zero? Certainly not with  condoms, the cornerstone of our HIV prevention programs.  A recent literature review reported in CATIE concluded condoms can be highly unreliable. CATIE summarizes “The review found that there is a variety of ways in which condoms are being used incorrectly and the prevalence of incorrect condom use is surprisingly high.”  That and breakages, even when condoms are used properly, present an alarming  picture.  Breakage and slippage or complete failure of the condom to afford protection was reported in 25-45% of those studied, with an event rate of up to 8%.  (“Fit or feel” issues, by the way, were reported in 7-30% of those  studied and in up to 45%  of events, with erection difficulties reported by 19-20%  and up to 20% of events.)

How do condoms stack up to undetectable viral load as a means of affording protection?  Some prominent advocates have suggested that the use of condoms in people living with HIV affords LESS protection than having an undetectable viral load.  Respected POZ magazine founder Sean Strub said that here. Even Canada’s most prominent AIDS researcher, BC’s Dr Julio Montaner said in a PositiveLite.com interview “I’m very comfortable that HAART is at least as protective – or more – than condoms.”

Overall though, we’ve been slow to acknowledge the risk from unprotected sex amongst sero-discordant partners has changed radically since the advent of undetectable viral load.  But here’s a recent exception. The ever-progressive Heath Initiative for Men (HiM) said just this month ”Most of the time, guys with undetectable blood viral loads who are taking treatment as prescribed, and get tested regularly for STIs (and treated if need be), also have undetectable viral loads in cum and rectal secretions.”

They go on, very significantly, that “for some gay men, if their partner is on treatment as prescribed by his doctor, has an undetectable blood viral load that is monitored regularly and is getting tested (and treated if need be) for STIs regularly, their risk of picking up HIV is greatly reduced, even without condoms. This may be something you want to talk about with your partner, together with his doctor.”

Conclusion

Given the evidence, even with its gaps, it’s not unreasonable to suggest that  the risk of transmission associated with semen when your blood viral load is undetectable has been over emphasized and overstated.  Why? It’s hard not to think it’s connected with our desire to see condom use maintained.

Not that this desire isn’t well founded. Condoms may not be 100% effective, or even close, but they are the best prevention technology we have right now.  So let’s be clear; it’s inappropriate for people living with HIV to stop using condoms, whatever their viral load, without carefully reviewing the risk to themselves and their partners.  That, as HiM suggests, may involve discussion with your partner and your doctor, hopefully an informed one.

But ultimately it depends, as does life in general, on what risk you consider reasonable. You make similar informed decisions every time you cross the road.

PositivelIte.com writer Michael Bouldin said “It’s not that we don’t know what constitutes risky behavior; it’s that it’s simply not possible to always avoid it, or in a given moment even desirable. Walking a red light can get you killed; it can also get you to a job interview on time.”

How we process risk is fluid too.  It depends on the context – the time, the place, the partner – and to what extent we are informed.  And to be frank, there are problems here. Canadian Treatment Action Council (CTAC) chair  Alex McLelland recently said on PositiveLite.com “As a community, we have not developed or even responded with relevant guidelines on how to incorporate the new reality that people living with HIV who are on treatment and have viral suppression do not always need to use condoms.”   

So risk is a very fluid concept for us consumers, isn’t it? It’s less so for HIV educators, who need to ensure that anything less than zero risk constitutes a warning shot across our bows.

Warning shots are fine and we need them. But we need to interpret them, try to qualify the degree of risk that might apply to us, just as we hover on the curb before crossing the road. In the case of the danger of virus in semen in those of us who are undetectable, the warning shot doesn’t pack a lot of punch for me, if you peel its skin away and look at the underlying research. But your experience may vary. In the context of informed decision making, you really need to make up your own mind.

Bob Leahy: James, you gave a presentation at the Gay Men’s Sexual Health Summit in Toronto last week on Understanding and Communicating Risk: Viral Load and HIV Transmission. That’s a topic that fascinates us here, and one we’ve been following on PositiveLite.com for some time. Clearly it’s important for people living with HIV to have the best possible understanding of this too.  With this in mind, thank you for agreeing to talk to PositiveLite.com and helping us understand more.

I guess we should start with the basics.  Tell us what an undetectable viral load means in plain language.

James: Undetectable basically means that the amount of virus (also known as the viral load) in a body fluid is below the limit that our viral load tests can detect. Viral load is regularly measured in the blood to monitor how well treatment is working for someone living with HIV. Generally, successful antiretroviral treatment can reduce the blood viral load to undetectable levels within a few months of starting. In Canada, an undetectable blood viral load normally means that there are less than 40 copies of the virus per ml of blood. Tests to detect the amount of virus in other body fluids such as semen, vaginal fluid, and rectal fluid, are not available to people living with HIV but have been developed for research purposes.

Bob: So a person with a lower viral load is likely less infectious than one whose viral load isn’t under control?

James: A lot of research shows that a lower viral load in the blood is generally associated with a lower risk of sexual HIV transmission. Although blood isn’t a fluid that’s often involved in the sexual transmission of HIV, the viral load in the blood is generally correlated with the viral load in the fluids that are, such as semen, vaginal fluid, and rectal fluid. In other words, if the viral load is controlled in the blood, it’s also generally controlled in those other body fluids. However, this isn’t always the case and some people living with HIV can have detectable amounts of virus in the genital and rectal fluids even though the viral load is undetectable in the blood. This is more common if someone has a sexually transmitted infection (STI) but can also happen when there isn’t an STI.

It’s important to note that pretty much ALL the research that has been done to date around viral load and HIV transmission has been among heterosexual couples.

Bob: I guess the big question is HOW MUCH less infectious and how we communicate that risk so that people can make decisions appropriate to their own situation? There is research from last year that made international headlines - HPTN 052 – with its conclusions that in the right circumstances, the chance of transmission in sero-discordant (heterosexual) couples was reduced by 96%.   Can you comment on how important was that study in trying to understand our own risk?

James: There are two different pieces of information people living with HIV normally want to know with regards to antiretroviral treatment, viral load, and the risk of HIV transmission. The first is HOW MUCH treatment can reduce their risk of transmission, also known as the relative-risk reduction. The second is HOW LOW that risk is reduced to when they are on treatment, also known as the absolute risk of transmission. People living with HIV are often most interested in the latter; their absolute risk of transmitting HIV when they are on treatment and have an undetectable viral load.

Unfortunately, biomedical HIV prevention trials such as the HPTN 052 study are not designed to provide information on an individual’s absolute risk of HIV transmission. These trials tell us about the change in risk of HIV transmission in a population using an intervention relative to a “control” population not using the intervention, in other words the relative risk-reduction. The relative risk-reduction is important to know because it tells us how effective a strategy is at reducing the risk of HIV transmission and can be used to compare the effectiveness of one strategy to another. The 96% relative risk-reduction calculated in the HPTN052 study tells us that antiretroviral treatment is highly effective at reducing the risk of HIV transmission among heterosexual couples who are mostly having vaginal sex.

However, the relative risk-reduction is not something that an individual can use to easily assess their absolute risk of HIV transmission. It’s really difficult to quantify someone’s absolute risk of HIV transmission while on treatment because it depends on a number of different factors unique to an individual such as how often they are having sex, how often they are using condoms, how well they are adhering to treatment, if they have any STIs, and the type of sex they are having. Therefore someone’s absolute risk of HIV transmission while on treatment may be higher or lower than another individual on treatment. We really need studies that try to calculate the absolute risk of HIV transmission from a single exposure to HIV through different types of sex (when the viral load is undetectable).

In the absence of additional information on absolute risk and in the face of these uncertainties, there are still messages that we can give to individuals so they can make informed choices and keep their risk of HIV transmission as low as possible while using “treatment as prevention.” This includes using condoms correctly and as often as possible, adhering to meds, regular viral load testing and regular STI testing and treatment for STIs.

Bob: Of course that leaves gay men a little in the dark doesn’t it, because that HPTN 052 data doesn’t necessarily reflect the realities of the risk associated with anal sex, for instance?

James: There is a much larger research gap when it comes to gay men.

We really don’t know if the relative risk-reduction while on treatment will be the same for gay men as for heterosexual couples. However, researchers think that it could be similar.

Even if the relative risk-reduction is the same for gay men, the absolute risk of HIV transmission while on treatment may be higher for gay men (who are having anal sex) than for heterosexual couples (who are mostly having vaginal sex). We know that bottoming without a condom (unprotective receptive anal sex) is up to 20 times more likely to lead to HIV transmission than unprotected receptive vaginal sex. Therefore, the higher initial risk associated with anal sex may mean that the absolute risk of HIV transmission when undetectable is much higher for anal sex than for vaginal sex.

The 96% relative-risk reduction from being on treatment is equivalent to approximately a 20-times reduced risk of HIV transmission. Furthermore, when not on treatment, we know that the risk of HIV transmission through bottoming is up to 20-times higher than vaginal sex. Therefore, if being on treatment reduces the risk of HIV transmission through bottoming by 20-times, the absolute risk of HIV transmission after this reduction in risk may still be in the same range as vaginal sex when not on treatment. 

This is all hypothetical and really emphasizes the need for more research

Bob: So the message here is that we need more research in to the impact of undetectable viral load on MSM, right?  Is anything going on?

James: Yes, we need more research. I know of some that’s going on in Australia and the Netherlands, hopefully we will see some results at the next International AIDS Conference in Washington this summer.

Bob: Let’s talk about risk guidelines for a moment.  Tell us how risk factors – percentages like 96% - are ultimately translated in to low-high risk language. What degree of certainty needs to be in place before they are formulated in this way?

James: There is no guide for translating risk-reduction percentages (relative risk reduction) into low-high risk language (absolute risks). The CAS Transmission Guidelines do not use risk-reduction percentages to determine which activities or behaviors should be placed into “high” or “low” risk categories. The CAS Transmission Guidelines were developed when our knowledge of HIV was much more limited. At the time the guidelines were developed, we knew that unprotected vaginal/anal sex was significantly more risky than oral sex and that condoms could significantly reduce that risk. It was this knowledge that formed the basis of these guidelines.

In the past decade there has been a significant amount of research emerging around the biology of HIV transmission and new HIV prevention technologies. It’s only recently that we have had to deal with these relative risk-reduction percentages and we really haven’t figured out the best way to incorporate all this information into our discussion of risk. It’s difficult because the use of “treatment as prevention” and other new prevention options have a number of caveats and uncertainties and there are still large gaps in the research.

Bob: So in the case of risk guidelines which include reference to undetectable viral load, we don’t yet have that degree of certainty? What about for heterosexual couples?  Isn’t the data strong enough there for risk guidelines to be in place, based on HPTN 052, do you think?

James: There is strong evidence that being on treatment and having an undetectable viral load significantly reduces the risk of HIV transmission for heterosexual couples. However, simply saying that the risk is “low” doesn’t reflect some of the caveats and uncertainties of this approach or the research gaps that exist, particularly among gay men.

We definitely need the latest science to be incorporated into guidelines so people are getting accurate information on “treatment as prevention” and this information is accompanied by the appropriate messages to keep this risk as low as possible. This information is already starting to show up in different guidelines, including treatment guidelines which are suggesting that physicians discuss the role of treatment as prevention with patients. Mostly people are considering undetectable viral load as an additional strategy for HIV prevention, along with regular condom use. However, the HPTN 052 study was only released last year and there is still a lot we don’t know. We are still trying to figure out how to communicate this information and incorporate it into different guidelines.

Bob: You’re probably aware that all this is a bit frustrating for some poz folks. Community leader and POZ magazine founder Sean Strub, for instance questions  (Five Things  about HIV They’re not Telling You)  the risk associated with undetectable viral load and what we are being told.  Strub says “We have neglected to recognize the extent to which a person who is on treatment and undetectable is rendered non-infectious.”  How fair a statement do you think is that?

James: Well first of all we need to avoid using the term non-infectious. There is a general consensus that the risk of HIV transmission is not eliminated when the viral load is undetectable.

Among people who are well versed with the research, I think most agree that being on antiretroviral treatment and having an undetectable viral load significantly reduces the risk of HIV transmission for heterosexual couples.

I don’t think that information is being withheld, we just don’t have a consensus yet on what we should be saying. For most people, the research that we have only provides partial answers to the key questions and this information is difficult to communicate accurately because of the caveats and uncertainties. There are no simple messages yet that applies to everyone. There is the potential for a lot of misunderstanding to occur which could have negative consequences. A major concern is that people may switch from the correct and consistent use of condoms to a strategy that is less protective.

However, I do think we need to acknowledge that not everyone consistently uses condoms (for a variety of reasons) and these individuals need accurate messages on other ways to reduce their risk of HIV transmission, including “treatment as prevention.”

Bob: Strub also talks about the relative risk associated with undetectable viral load and the use of condoms, saying that undetectable may afford the greater protection of the two. When I interviewed Dr Julio Montaner he said much the same thing “I think you should be fully comfortable with advising fully suppressed individuals on HAART that they are as well protected as when using condoms, if not better protected” is what he said to me.   What do you think of these comparisons?

James: I think we need to be careful when we make comparisons to condoms because these are two very different strategies and both have their own caveats.

We also have to make sure we aren’t always pitting condoms against “treatment as prevention” and creating an either/or situation. Both can fail to prevent transmission in their own ways and using both in combination may add an extra “backup” layer of protection.

We know that if a condom is used consistently and correctly (and the condom doesn’t break, slip or leak), then the risk of HIV transmission is pretty close to zero because no exposure to HIV can take place. HIV cannot pass through the material that is used to make condoms. Of course, condoms are not without their own caveats. Condoms aren’t always used consistently and there are lots of ways in which condoms can be used incorrectly. Also, we know that a condom can break even if it’s used correctly.

The use of “treatment as prevention” is different and there are more uncertainties. Unlike condoms which prevent an exposure occurring in the first place, “treatment as prevention” aims to reduce the risk that an exposure leads to infection. Since an exposure is occurring, other factors that influence the risk of HIV transmission from an exposure also come into play and may decrease the effectiveness of this strategy. For example, we know that tearing and inflammation, anal sex, and other STIs can increase the risk of HIV transmission from an exposure and therefore may increase the risk of transmission when the viral load is undetectable.

Also, with “treatment as prevention” you are relying on the viral load in the body fluids to be undetectable. However, it’s difficult to know what the viral load in the blood is at any given time and it’s even more difficult to know what the viral load is in the genital and rectal fluids. In addition, undetectable doesn’t mean that there is no virus, so there is still HIV present that could lead to transmission. All these uncertainties make it very difficult to know if, and how well, this strategy will work.

So which is more effective: Condoms or “treatment as prevention”? It really depends on the individual, their risk factors and how well they are able to use the prevention strategy. We know that both are highly effective in reducing the risk of HIV transmission through vaginal sex if used consistently and correctly. In this case, some people may find the consistent and correct use of one option easier than the other and therefore that option may be more effective for them.

However, if used consistently and correctly, condoms are the still most reliable and effective strategy available because they prevent an exposure from occurring in the first place and there are fewer uncertainties and caveats associated with condoms compared to the use of “treatment as prevention.” Also, condoms can lower the risk of HIV transmission to the same level for anal and vaginal sex while the risk of HIV transmission may be higher for anal sex than for vaginal sex while using “treatment as prevention.”

In the end, HIV prevention needs to help individuals adopt strategies to reduce their risk of transmission that are appropriate to their individual circumstances and the acceptable level of risk they and their partners are willing to take. We definitely need guidelines for people who want to use “treatment as prevention” and are willing to accept the risk that comes along with its uncertainties. These guidelines need to include important messages that can help a person keep the risk of HIV transmission as low as possible while using “treatment as prevention”.

Bob: I want to turn to what we know about semen. Almost every prevention message you see discussing undetectable warns that undetectable viral load in the blood doesn’t necessarily translate to undetectable viral load in the semen. But isn’t it true that in more cases than not there is that correlation?

James: Many people who have an undetectable viral load in the blood also have an undetectable viral load in the semen and other bodily fluids. However, studies suggest that this isn’t always true. The percent of people in these studies who have an undetectable viral load in the blood, but a detectable viral load in the semen, ranges widely, from 3% to 48%. Similar studies suggest that the same also applies to vaginal and rectal fluid.

We really need more research to gain a better understanding of how common this is, and why it happens, among people living with HIV who are undetectable in the blood.

Bob: How about the amount of viral load in the semen?  Isn’t it true that where it IS detectable in the semen but not in the blood, the viral load in the semen isn’t typically very high, the research seems to indicate, and thus not very infectious?

James: Most research has looked at the association between the risk of HIV transmission and the viral load in the blood, not the viral load in other fluids. This means we don’t really know what a “high” viral load in semen (or other bodily fluids) is in terms of infectiousness.

We do know that, in some cases, the amount of virus in the semen (among people who are undetectable in the blood) can be quite a lot higher than undetectable, over 5000 copies/ml. This difference may be quite significant in terms of HIV transmission but we don’t really know and need more research in this area.

Bob: Do you think we are moving towards a place in time when we will see risk guidelines which take in to account the impact of undetectable viral load?  Any guesses when that might be?

James: I definitely think we need to move in that direction. I know of a lot of organizations in Canada that are reviewing the evidence and discussing what their key messages need to be around viral load and risk of HIV transmission. In terms of guidelines from Public Health, I am not sure when those will come. It’s difficult because there are lots of research gaps and the research is still emerging quickly.

Bob: In the meantime it’s being argued before the Supreme Court that a person with undetectable viral load translates to extremely low risk of transmission.  Do you think that has the potential to confuse people living with HIV?  If so what can be done to end that confusion?

James:  The Supreme Court is considering what constitutes a “significant risk” of HIV transmission under criminal law. We need to keep in mind that criminal negligence is a serious charge and the burden of proof is different than it is for public health messages.

We know that the evidence shows that the risk of heterosexual HIV transmission is significantly lowered when someone is on antiretroviral treatment and has an undetectable viral load. Whether this risk is lowered to below what the law defines as a “significant risk” to be considered criminally negligent is up to the Supreme Court.

The court’s decision shouldn’t change the prevention messages we give to people living with HIV who want to use “treatment as prevention.” Regardless of the court’s decision, we still need to inform individuals that treatment does not eliminate risk, there are a number of caveats associated with this approach, and there are certain things an individual can do to keep this risk as low as possible. We will also, of course, need to inform people living with HIV who want to use this as a prevention strategy about the law and any changes that happen with the Supreme Court decision.

Bob: James, thank you so much for talking to us.

James is the coordinator of the Biomedical Science of HIV Prevention Project at the Canadian AIDS Treatment Information Exchange (CATIE) where his work focuses on the biology of HIV transmission and new HIV prevention technologies.