How you can help make viral load testing a reality this World Aids Day

The time for viral load testing is now.”For years this has been the focus of this company and each of our employees. Today, it has become policy for developing nations around the world as recommended by the World Health Organization (WHO).

Last year, the WHO published their 2013 revised guidelines, calling for developing countries to roll out routine virological monitoring. Since then, more people have come to understand the role of HIV viral load testing and the benefits it provides to patients and the healthcare systems that support them. 

In 2014 the debate over HIV viral load testing in resource-limited settings evolved from “Should we?” to “How can we?” Our friends at The Load Zero Foundation have answered that question with this clever “At-a-Glance” HIV viral load comparison infograhic. This much needed overview promotes awareness of the six HIV Viral Load assays that:

1. Exceed the WHO’s recommendation for test sensitivity

2. Have performance that has been verified by peer-reviewed journals

3. Are commercially available today

For World Aids Day 2014, I encourage you to share this infographic with your networks and spread the word that “The Time for Viral Load Testing is Now.” 

                          

”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

Advancements in Technology Lead to Early HIV Detection in Kenya’s Infants

With over five million people infected with HIV in Southern Africa, it’s close to a fourth of the total number of Africans living with the virus today. Worldwide, there are approximately forty million individuals infected with HIV, half of which can be located in sub-Saharan Africa. And in 2009, nearly one point three million Africans died from the virus known as AIDS. With the passing of World Aids Day (Dec 01), it’s important that we remember the severity of the virus and some of the great advancements we’ve made in medical treatment and technologies.

Advanced, yet inexpensive vaccines and microbicides are amongst the top developments in medicine as preventative measures. Similarly, low costing, antiretroviral drugs have given infected populations the ability to live longer, healthier and happier lives. As important as these medicines, technologies and treatments are however, it’s even more important that we understand who’s doing what. Particularly, there has been major progress  in the technologies surrounding early detection in infants. Behind such an endeavor are The Clinton Global Initiative (CGI 2005) and The Clinton Health Access Initiative (CHAI 2002). As the brainchild of Doug Band, a close personal aid to President Clinton, the CGI has done exceptional work in the areas of global health, technology, education and more. Similarly, Clinton’s Health Access Initiative is committed to strengthening health systems in developing nations like Africa. In fact, part of their mission is to “…expand access to care and treatment for HIV/AIDS, malaria and tuberculosis.” This includes investing monies into technological studies surrounding medicine and treatment programs.  

Before Doug Band and the CGI came into the spotlight, President Clinton ventured deep into poverty-stricken China (the area formally known as Burma) in a 60 Minutes special labeled Bill Clinton. In the segment, Dan Rather discusses how Clinton’s foundation has helped fund multiple testing labs. In the interview, Clinton states “…and there’s everything right with fighting for them to have a normal life…” Since it’s beginning, CHAI has assisted over two million people in acquiring access to medicines essential for suitable treatment. But the efforts of Former President Clinton did not end there. In the technology sector, The CGI, alongside CHAI, continues to receive funding for HIV related projects in third world countries like in Southern Africa.  

Lately, they’ve joined up with Hewlett Packard (HP) to deliver technologies that will take, manage and return early diagnosis for infants in Kenya. In other words, this new technology will identify the virus in an infant within one to two days, which is a significant upgrade from traditional detection, derived from paper based systems.  

But why is such early detection important? Newly borne children are very vulnerable, as their carriers can very easily transmit. Subsequently, early treatments help ensure survival. Without this immediate care, those infected typically don’t make it past age two. In a statement to the press, Former President Clinton stated, “I’m pleased HP's technology and expertise will enable the partnership with CHAI to save the lives of more than 100,000 infants in Kenya each year, and in the process, demonstrate how the private sector can and should operate in the developing world.” 

In their first year, HP will be able to help over 70,000 infants in Kenya. These technologies will also permit real-time medical data, which will be viewable to health professionals across Kenya.  

Still, Africa remains one of the biggest challenges for associations and non-profits like CHAI and The CGI. Recent improvements in technology have helped lessen casualty rates and lengthened lives. And although a cure remains missing, HP, CHAI and the CGI have provided a great technological progress towards abolishing the virus for good. 

Jack Lundee is the chief editor for Everything Left and Shades of Green. He's an avid follower of all things green and progressive. To find out more about what Jack has to say, follow him @J_Lundee.

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. 

Nobel Prize Gives Credit Where It’s Due…sort of

HIV has always sparked controversy – all the way back to when it was first discovered. Françoise Barré-Sinoussi and Luc A. Montagnier were recently awarded this year’s Nobel prize for their role in the discovery of the virus. More than two decades ago they identified a virus they named LAV, which later became known as HIV.

But who discovered the virus first would be disputed for many years after. A year after the French team’s discovery, Dr Robert Gallo, who was working in the States, discovered a virus he called HTLV-3 that would turn out to be the same virus. It eventually became clear the specimen the new discovery was taken from had come from the French team’s lab.

So it isn’t really disputable who discovered it first (though they gave it their best shot), but at that early stage Gallo’s research and the methods developed at his lab were instrumental in discovering HIV and propelling understanding of the virus forward. The Karolinska Institute were quoted by the New York Times saying, “Never before has science and medicine been so quick to discover, identify the origin and provide treatment for a new disease entity.”

So I say we take this moment to thank all the scientists involved in that remarkable achievement. Their effort made developing the tests, drugs and monitoring assays that now save millions of lives possible. Beyond the controversy of who deserves what that always comes with these awards, that’s all that really matters – advancing medicine and improving human lives. 

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.

A Viral Load Monitoring Success Story from Zambia

I’ve heard a lot of great stories about how viral load monitoring has helped doctors in resource-limited settings. One in particular always jumps to mind. A Dutch physician named Dr. Piet van Hasselt was working at the Kara Clinic in Lusaka, Zambia when he decided to give viral load testing a try to see if it made a significant difference in his treatment practice.

Up until that point, he only had access to CD4 tests. For his trial, he tested 40 patients with low CD4 counts. He intended to switch them to second-line therapy, assuming their treatment was no longer effective. The viral load tests showed that 60% of them had undetectable viral loads, and as such could remain on first-line treatment.

This gave the patients more time on effective therapy and kept more treatment options open in the future. It also saved the clinic a lot of money as second-line therapy is many times more expensive than first line – money which could then be used to provide more patients with treatment.

These are the kinds of results I believe all clinics should be entitled to and why I push for universal accessibility to viral load monitoring. When you look at stories like this, the medical and financial implications of universal accessibility are staggering.