The HIV viral load blog

”Getting to Zero” will require more than funding to succeed

Observations on the role of innovation in the battle against HIV/AIDS

Getting to Zero is the theme of this year’s World AIDS Day:  Zero HIV/AIDS-related new infections, deaths and discrimination by 2015.  I wholeheartedly endorse the idea and admire the ambition level. But this World AIDS Day falls on the heels of some bittersweet news.  

On one hand we have last week’s report from the Joint United Nations Programme on HIV/AIDS (UNAIDS) telling us that 2011 has been a “game-changing” year in the fight against HIV/AIDS with unprecedented progress in science, political leadership and results.  On the other hand the Global Fund had a “getting to zero” announcement of a different sort. Last week they announced there would be zero funding for new HIV/AIDS-related initiatives until 2014.  A statement from Médecins Sans Frontières (MSF) summed up the situation: “The dramatic resource shortfall comes at a time when the latest HIV science shows that HIV treatment itself not only saves lives, but is also a critical form of preventing the spread of the virus, and governments are making overtures that there could be an end to the AIDS epidemic.”   The statement goes on to urge governments to step up and find the money required by the Global Fund. A second statement issued two days later went further asserting that “The international community must recognize that we are at a critical crossroads: we either use the science, tools, and policies already at our disposal to save lives and prevent new infections; or see the hard-fought gains of the last decade lost.”

No doubt, fundraisers will need to work hard to stimulate giving in the current global economy.  When they succeed, I hope they will turn their attention to a much less publicized but equally important issue: stimulating competition and innovation in the markets where those funds will be disbursed. Because that is what will be needed to get to zero in the countries hardest hit by HIV/AIDS — particularly if funds are frozen and we find ourselves in a catch-up situation one, two or more years down the road. 

I have complete confidence in the ability of the biotech industry to accelerate progress in the war against HIV. But to do that they will need a balanced playing field on which to compete. Currently, that is not case in several critical and underserved areas of HIV diagnostics.  For instance, a 2008 report from the Global AIDS Alliance (themselves the victim of funding woes in 2010) cites one company that “controls roughly 80% of the overall NAT [nucleic-acid-based tests] market share, which gives the company a near monopoly on global diagnostics and even greater domination in the area of EID.”   

More recently, at the IAS in Rome this past summer, Maurine Murtagh reported that the market conditions in resource-limited settings for three of the most critical and under-served areas on HIV management are monopolized by a few large companies.  One company controls 80% of all CD4 testing.  Two companies have 70% market share in viral load testing. And one company has 90% market share in early infant diagnosis (EID).  

At the same time Ms. Murtagh highlights the inadequacies of the solutions provided under these monopolies. “Diagnostic delivery of EID, CD4 and viral load testing is generally via large and relatively expensive laboratory-based systems that require well-trained technicians and good sample transport networks to provide access to testing for those in some urban, and virtually all peri-urban and rural settings.”  

I have spent most of my career in the private sector where monopolies are frowned upon if not banned outright.  As we all know, monopolies create huge barriers of entry for new products, stifle innovation, discourage investment and keep prices inflated. When I became CEO of Cavidi, a biotech firm specialized in HIV diagnostics, I was surprised to discover how monopolies are a fact of life in the very markets that are most in need of innovation and investment. I was equally surprised at how resistant to change these resource-limited markets are despite the clear limitations of the current diagnostic solutions. 

This is not to slight the contributions made by the companies who dominate these markets. In Cavidi’s diagnostic area, imbedded technology can be credited with contributing to the progress detailed in last week’s UNAIDS report. However much of this technology was created for use in developed nations and has changed little over the past 20 years to adapt to the very different environment we see in resource-limited settings.  This is the predictable result of any monopoly — stagnation.  In the case of HIV diagnostics, stagnation means that many of the people who need the tests most cannot access them for the reasons cited by Ms. Murtagh. 

This situation is not the byproduct of a market that lacks innovative solutions from creative companies. A look at the UNITAID HIV/AIDS Diagnostic Landscape publication gives you an idea of the vast number of more effective solutions including our own RT-based diagnostic assay which, in addition to lab-based viral load monitoring in resource-limited settings, has the potential to provide a viable, cost-effective solution to elusive problems like EID and near-patient viral load monitoring. 

Of course these solutions need financing to scale up. But they also need an efficient market that promotes competition and encourages new ideas and better solutions.  Until those conditions exist very few new ideas from smaller, entrepreneurial companies like ours will ever be allowed to contribute on par with their potential. So with regard to diagnostics, the real challenge in getting to zero by 2015 isn’t,  “Where can we find the next big idea?” It is, “How can we hasten the uptake of ideas we already have in the presence of a monopoly?”

The benefits of such competition and ingenuity in places like Sub-Saharan Africa, India and Southeast Asia don’t stop there. The solutions developed for resource-limited settings are often just as applicable in developed nations. For instance our ExaVir™ viral load test is as sensitive as the gold standard but it can also detect all known HIV subtypes.  This is something that the gold standard cannot do and the reason why our test is also being used in some of the world’s most prestigious medical institutions, such as the Royal Free Hospital in London and the University of Maryland School of Medicine IHV (Institute of Human Virology) in the U.S.  Further, given the burden felt by most healthcare systems in developed nations the need for more cost-effective diagnostic solutions is not limited to developing nations. 

Today, the science exists to address some of the most pressing challenges in getting to zero but is often confounded by a market that clearly does not welcome new entrants gladly. This is not the type of problem that is solved by money alone. It’s also a matter of mindset. So on this World AIDS Day I join the plea for donor nations to ensure that their pledges to the Global Fund are honored. And to that I would add a plea for recipient nations to ensure that the entire HIV treatment spectrum, including diagnostics, is allowed to evolve and thrive under market conditions that encourage competition and innovation. With both funding and innovation nothing can stop us from getting to zero in record time.  That is my wish today, and my colleagues and I are honored to be part of this historic endeavor.

John Reisky de Dubnic

 CEO

 Cavidi

 

Testing viral load just once a year could change the face of HIV

Despite great strides in increasing access to antiretroviral drugs in resource-limited settings, access to viral load monitoring continues to lag behind. The general consensus seems to be that it would be great to have, but with drugs in hand, patients can make do without. A new study has revealed just how extensively this lack of viral load monitoring is undermining treatment.

The study, which monitored 2,333 patients across the Asia-Pacific region, found that patients were 35% more likely to develop severe HIV related illnesses, or die, when viral load monitoring was performed less than once a year. Given that the majority of the world’s 33+ million HIV positive patients live in similar resource scarce settings, that adds up to millions of preventable fatalities. The study also found that, in these settings, monitoring viral load multiple times throughout the year did not significantly alter the effect of treatment, so one annual test is enough to improve a patient’s long term outlook.

Viral load tests not only let healthcare workers see if a treatment regimen is effective, it allows them to monitor adherence to the regimen – a frequent a problem and often the cause of spikes in viral load. Monitoring otherwise provides vital information in determining when certain drugs are no longer working and need to be switched. This is both to find a treatment that more effectively suppresses the virus and to prevent the development and passing on of resistant strains of HIV.

A visualzation of viral load levels. Image from www.gileadhbv.com

 

But the test remains uncommon in resource-limited settings, primarily because traditional test kits are expensive and demanding of both laboratories and the people running them. It is also not a priority because, in many cases, even if a treatment regimen is discovered to be failing, there are no other options available to switch to. 

The focus going forward needs to be, beyond providing 2nd and 3rd line treatment options, providing viral load solutions tailored to the resource-limited setting so the drugs can be used effectively and drug resistance limited. As the study revealed that only one test a year is required to see 35% fewer cases of sever illness and death, hopefully mindsets about the feasibility of scaling up access to viral load monitoring will start changing.

For more details about the study, check out the story on AidsMap. 

A solution hiding right under our noses

Viral load monitoring shown to be an effective way to boost compliance in HIV patients

Even when ARVs are available, patient compliance has always been a problem. Some programs go to the extreme of having a nurse supervise every dose, every day. The reason it’s such a big deal is that even missing a few doses gives HIV the chance to adapt to the medication and develop resistance. Treatment options are limited and expensive, especially in developing countries.

 

So why are patients putting their own lives at risk by skipping doses? Sometimes it’s a money issue. Sometimes it’s a lack of knowledge about the drugs and their disease. Sometimes it’s because of the side effects. But in the end, we don’t know what they do when they take the drugs and go home. When their doctors inquire about their compliance, they often just say what the doctor wants to hear. Which makes it difficult to know before it’s too late which patients need extra help to consistently take their ARVs.

 

A recent study from Doctors Without Borders has shown that viral load monitoring may be the solution. A group of HIV patients in Thailand were put on monitoring for the first time. Many of them showed detectable viral loads. Most of these were linked to poor compliance.

 

By monitoring viral load, doctors were able to see quite early which patients were not responding well to treatment. With this knowledge they could single them out for counseling early on in their treatment regimen. Moreover, the patients’ viral load could be used as a tool to educate and motivate the patient during counseling.

 

Virtually all of the patients who were given extra counseling in this manner saw their viral load drop to undetectable levels indicating better compliance. The few who didn’t were flagged as non-responsive and put on second line treatment. This reduced the chance of drug resistant strains developing and being passed on, and avoided wasting valuable drugs that were no longer effective for those patients.

 

In an ideal world, patients would follow their doctor’s instructions to the letter and they’d be honest about everything to do with their treatment. But that’s not the world we live in. In the interest of public health, for both individuals and populations as a whole, we should explore these potential solutions to nagging problems wherever we find them. Especially when it is as easily addressed as this issue is.

World AIDS Day 2008 – Economic crisis raises significance of this year’s event

December 1st is World AIDS Day. This year it's more important than ever. It was instituted in 1988 to spread awareness of the severity of the HIV pandemic and how much work needs to be done to stem the tide. Local governments and organisations around the world answered the call and have been doing their part to fulfil the promise of the event each year since. But this year we face a big distraction – the economy.

All around the world, organisations are slashing their budgets and consumers like you and me are looking for ways to cut back. Where will these organisations and individuals look to cut? I guess I’d be naïve not to assume that funding of HIV treatment initiatives would escape their fiscal fitness program.

If you’re in a position to provide assistance or funding to HIV-related programs (and that’s all of us), I’d ask you to consider the cost of cutting back now.

Over the past 20 years, the global HIV community has made astounding advances in battling the pandemic. Back in 1988, the percentage of people receiving treatment who needed it was negligible. Today, millions have access to ARVs, including those in developing countries. Prevention and education campaigns are reaching new audiences all the time. Real strides have also been made in developing the medication and diagnostics required for proper treatment. The investment of time and money since 1988 is paying dividends today in terms of both hampering the spread of the disease and treating those already infected.

Unfortunately, HIV doesn’t slow down during a recession. It is always striving to move forward and will take swift advantage of any weakening of resolve. If treatment is interrupted for those already on ART, their health will be compromised and an increase in drug resistance is certain. If we don’t keep the number of people on treatment rising, AIDS deaths will jump even higher than the millions it already claims annually. And if we don’t keep prevention campaigns going strong, the virus will spread even faster.

This isn’t only a humanitarian concern, but an economic one as well. These negative consequences will result in enormous financial strain on the battle against HIV in the long run. This economic crisis is not just in Africa, but in everyone’s backyard. We need to keep in mind that life will go on during, and after, the recession, and we don’t want to undermine all the work we’ve done up to this point by not looking ahead.

HIV affects everyone and has the potential to be an even greater problem than it already is, on both our health and our economy. So do your part to spread awareness on this World AIDS Day. Here are 5 things you can do to keep the fight against HIV moving in the right direction.

1.    Write a blog post about World AIDS Day, or use other social media to spread the word
2.    Write a letter to the editor or an opinion column for your newspaper
3.    Call or write your local government official and tell them you believe that fighting HIV is still a priority
4.    Get involved in local World AIDS Day events, or create one if nothing is planned in your community
5.    Wear a red ribbon and encourage others to do so

If you have any ideas of your own, please share them in the comments section.

The HIV Subtype Picture

If you live in the West, you might be a little surprised by the subhead on this map. In Western countries, we’re used to it being a given that subtype B is the most prevalent strain of HIV. This map is a great visualization of where the HIV epidemic actually stands in terms of subtype distribution and concentration.

It also makes it clear why there is such a great need for a subtype-independent viral load monitoring assay like our ExaVir Load. It’s not only because the traditional assays were developed for measuring subtype-B and are of limited use outside the Western world, but because the spread of that huge prevalence of other subtypes Westward is only a matter of time.

 

As far as our ExaVir Load’s performance goes, that whole map might as well be the same color. But with the diagnostics most prevalently in use today, we’re facing a problem in providing accurate disease monitoring. And the problem will only get bigger as subtypes continue to migrate and mix. 

This is why we’re continually developing diagnostics that are subtype-independent and why we believe it’s so important. We have every opportunity to be ready for when the need for such diagnostics can no longer be ignored, so let’s stay a step ahead this time. 

The Answers to Your HIV Viral Load Questions

The people at The Body have put together this pretty comprehensive resource of information about HIV viral load and what it means to patients. They do a good job of addressing the questions that patients may be worried or confused about, like sudden spikes in viral load and signs of drug resistance. The Body is a great HIV info resource in general, not a bad page to keep in your bookmarks.

Watch How HIV Works

Do you know what Reverse Transcriptase (RT) is? For one thing, measuring it is what makes our ExaVir HIV viral load test unique. But unless you have a medical background, it’s hard to get your head around RT. That’s why I’m so happy someone sent me this YouTube video. It’s a bit thick on technical-speak but the animation is fantastic and the role of RT very well depicted.

RT is the perfect marker for measuring HIV viral load because a retrovirus, like HIV, requires a functional RT in order to be infectious. This means that by measuring RT activity we can accurately measure viral load regardless of subtype. If you have any other videos related to RT or HIV viral load please let me know.

HIV quiz widget

Here is an educational widget I heard about here at the 2008 International AIDS
Conference in Mexico City. It demonstrates the impact that the HIV
pandemic is having on children in a quick and clever way. Nice idea.

Get this widget!