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.” 

                          

Investment with Impact: Closing the HIV treatment gap

A presentation on the importance of global viral load monitoring to contain the HIV pandemic. 

I was pleased to speak at the United Nations this week as part of the Cavendish Global Health Impact Forum. The idea of the forum is to introduce good investment opportunities that have positive social impact with individuals and foundations who want to make a difference. Typically, these are investors who wish to invest in businesses within the health and life sciences, where the financial return is magnified by the social good derived from helping the business venture.  This is a criteria well-suited for Cavidi’s aim to help contain the HIV pandemic by creating greater access to HIV-related monitoring solutions.

“Cavendish assists family offices in identifying the best scientific minds, accomplished healthcare delivery professionals, innovative private sector companies, philanthropic organizations, and health policy experts engaged in transforming medical outcomes on a regional, national and global basis.” Cavendish Mission

The Global Health Impact Forum is hosted by the Global Partnerships Forum together with Cavendish Global, The New York Academy of Sciences, and International Telecommunication Union at the United Nations Headquarters in New York. Participants are a mixture of scientists and CEOs, carefully vetted and invited to present their case before the investors. I was honored to be included in this select group and proud to represent everyone at Cavidi who has worked so hard to get us to where we are today. 

Given the venue, I was pleased to see global health elevated on par with global peace, climate change, and human rights as one of the most pressing issues of our time. Innovation and technology play key roles in making this happen.

As Amir Dossal, Chairman of the Global Partnerships Forum, mentioned in his opening remarks at the event, one of the most critical issues facing the UN, and society in general, is providing global access to healthcare, particularly in developing countries. Mr. Dossal specified the need for technology and training to help medical workers on the front lines monitor and manage disease. I don’t think I could have asked for a more appropriate introduction to my talk and the important work that Cavidi is doing today. 

Below is a video of my presentation, where I make the case for the impact that Cavidi and our new automated viral load monitoring platform can make to the nearly 36 million people infected with HIV around the world today, and future generations to come.  I would welcome any comments or questions you have about the event or Cavidi’s involvement. 

For those who would like more details on the event,  you can see the entire Cavendish Global Health Impact Forum 2014 program from this link. And if you would like to know more about our new automated HIV viral load monitoring platform, feel free to contact me.

Viral load monitoring enters the mainstream

Last night I attended a dinner in Stockholm hosted by the Swedish Ministry for International Development & Cooperation. I was fortunate to have the chance to chat with Dr. Mark Dybul, Executive Director of the Global Fund. The subject of HIV viral load monitoring came up. As you might imagine, this topic has been a central theme of my dinner conversations for several years. But last night’s discussion took on a very different tone. 

Viral load monitoring officially endorsed by the world’s most respected public health authority

With almost ten million people in developing nations currently receiving antiretroviral treatment (ART) for HIV, it’s fair to say that great progress has been made in addressing the HIV pandemic. However, one area has remained well behind the curve when comparing treatment standards in developed nations to those in the developing world. That deficiency is most strikingly evident in HIV viral load monitoring. Antiretroviral drugs (ARVs) can be used much more effectively when combined with viral load monitoring. Conversely, administering ARVs in the absence of viral load monitoring means replacing data with guesswork, which puts patients at risk and can waste resources. That is why every HIV patient in the developed world receives regular viral load monitoring as a central part of treatment. And, why it’s a shame that this diagnostic has not been widely regarded as a critical component of routine practice in the areas hardest hit by the HIV pandemic.

Which brings me back to my dinner with Dr. Dybul…During our discussion it suddenly occurred to me that I no longer felt like a radical evangelist advocating viral load monitoring from the sidelines of the war on HIV. It felt more like preaching to the choir. That’s because, for the first time, routine viral load monitoring has been officially endorsed by the world’s most respected public health authority. The World Health Organization (WHO) recently revised their guidelines for HIV treatment and now strongly recommends implementing routine viral load monitoring in resource-limited settings. 

WHO recognized the importance of viral load monitoring as early as 2003, but fell short of including the test in its official HIV treatment guidelines for developing nations. Priorities back then were focused on getting ARVs into resource-limited countries. Now that the ARVs have arrived, viral load monitoring takes on much more significance. The revised WHO guidelines call for developing countries to roll out routine virological monitoring, with viral load tests at both six and twelve months after treatment initiation, and then at least every twelve months thereafter. In this way, treatment adherence problems are corrected more quickly and patient treatment can be adjusted immediately as indications arise.

WHO Consolidated ARV guidelines 2013

A recent report from Médecins Sans Frontières (MSF) highlighted the importance of routine viral load monitoring for a number of reasons, some of which include confirmation of treatment failure, prevention of HIV mother-to-child transmission, and improvement in HIV treatment outcomes in low-income countries. MSF currently provides treatment for 285,000 HIV patients in 21 countries. Today, most clinics in resource-limited settings try to monitor disease progression with CD4 tests alone. This research provides ten specific benefits that programs in developing nations can hope to achieve by adopting the WHO recommendation for routine viral load testing. These include:

• Support of treatment adherence
• Confirmation of treatment failure early, before CD4 decline
• Revelation of previously hidden viral loads, then help reducing them
• Enablement of program decentralization and task shifting
• Improvement of treatment efficacy
• Help meeting programwide goals
• Improvement of early infant diagnosis
• Delivery of systemic benefits, from the individual to the institution
• Cost benefits for programs by reducing:
  • cost of drugs by preserving first-line therapy
  • costs associated with redundant testing
  • cost for viral load equipment and operations
  • testing costs through the use of pooled samples
• Prolongation of treatment options for patients

Clearly, the addition of routine viral load testing offers significant gains for both programs and patients in resource-limited settings. Now that WHO has endorsed viral load monitoring, the biggest barricade to access will be ensuring that we provide viral load tests at an affordable cost. Our own viral load monitoring product, ExaVir™Load, was purposely designed with that aim in mind. It is an RT-based ELISA test that measures viral load with comparable sensitivity and reliability to standard DNA-based tests. The difference is that ExaVir™Load can be run in simple and/or rural laboratory environments with low initial investment. An automated version of the test is currently in development, as outlined in the recent UNITAID HIV Diagnostic Landscape report.

Viral load monitoring is no longer a fringe consideration when treating HIV in resource-limited settings. That’s great news for people with HIV in the developing world. The revised WHO guidelines have helped viral load monitoring enter the mainstream. On behalf of Cavidi, I promise to keep it there with tests that are both reliable and affordable. I am proud that Cavidi can play a central role in carrying out the WHO’s recommendation. Moreover, I’m pleased to see that leadership in organizations such as WHO and the Global Fund are all in agreement that the time for viral load monitoring is now. 

John Reisky de Dubnic

CEO

Cavidi

Time for a new gold standard in HIV viral load monitoring

This past year has brought more good news in the battle against HIV/AIDS with UNAIDS stating, “On the cusp of the fourth decade of the AIDS epidemic, the world has turned the corner—it has halted and begun to reverse the spread of HIV.” UNAID’s 2012 report cited 700,000 fewer new HIV infections in 2011 than in 2001. AIDS-related deaths have been reduced by one-third in the past six years. And access to antiretroviral therapy (ART) continues to grow at unprecedented rates. But as the battle against HIV enters a new phase, it introduces new challenges to the healthcare community, particularly with regard to diagnostics. In response, the World Health Organization and UNITAID have dubbed the next ten years, “the decade of diagnostics.” In their session at AIDS 2012 in Washington D.C. they emphasized the important role that cheaper, simplified diagnostics must play in the next phase of the campaign to stem the HIV pandemic. This emphasis is redefining the role of HIV viral load testing in treatment and is placing new demands on how these tests are conducted. 

Number of people newly infected with HIV, Global, 1990-2011

UNAIDS Report (2012)

For decades the gold standard for HIV viral load diagnostics have been RNA-based tests. But in this new diagnostic landscape I see centralized RNA-based testing rapidly losing relevance to tools that are better suited to meet the diagnostics challenges that we see today in both the developed and developing world. Most notable among these are: a) the need to scale HIV viral load monitoring in step with the burgeoning number of men, women and children entering treatment, b) managing the rise in drug-resistant HIV strains that accompany greater access to ARV treatment and c) address the diagnostic needs of infants born to HIV-positive mothers. 

In low-to-middle income countries, access to HIV viral load testing has become a more critical issue given the recent increase in access to ART.  According to the World Health Organization (WHO), there was a 20-fold increase in the number of people receiving ART in developing countries between 2003 and 2011, and a 20% increase in just one year (from 6.6 million in 2010 to more than 8 million in 2011). The rapid increase in access to Antiretroviral drugs (ARV) has triggered a corresponding increase in the need to monitor those receiving treatment. This helps to ensure the virus is being suppressed and helps the doctor know when the patient needs to be switched to a new treatment regimen.  

Originally developed for use in North America and Europe, RNA-based tests are proving impractical for decentralized use in low-to-middle income countries. Around 70% of the world’s HIV population live in sub-Saharan Africa. As a result, district hospitals and clinics outside the capital have to either send blood samples away to a central reference hospital or, more likely, forgo HIV viral load monitoring altogether. In light of this, it seems the gold standard is shifting in favor of a HIV viral load monitoring solution that can deliver the same reliability in a decentralized model with testing conducted near-patient.

This has created a flurry of innovation in the HIV viral load POC testing arena. Maurine Murtagh has identified 13 different entrants in this area in the 2nd edition of UNITAID Diagnostic Technology Landscape Report.  Of the options available today, Reverse Transcriptase (RT)-based testing seems to offer the most plausible solution on several fronts. First, RT is a very stable marker since it is not affected by mutation and is always present when the HIV virus is replicating. Since RT-based tests do not target a specific nucleic acid sequence, they are able to quantify all types and subtypes of HIV, including new strains, without any modification to the test. RT-based tests have historically been significantly less expensive than RNA tests both in terms of start-up and running costs. Further, the RT platform has an unmatched track record among this next generation of HIV viral load tests. It has been in the field for over a decade with more than 40 peer-reviewed journal articles and over 350,000 tests run. Several studies over the past decade have compared ExaVir™ Load to the gold standard PCR tests and all have found excellent correlation with RNA-based tests. 

The benefits of RT-based HIV viral load testing go beyond resource-limited settings. In the developed world, HIV viral load monitoring is a main line of defense against the rise in drug resistant strains of HIV.  Eric Rubin, professor of immunology and infectious diseases at HSPH put it eloquently, "Drug resistance is the product of success: With treatment, we have drug resistance." Since ARV treatment has been more prevalent in developed countries, resistance has mainly been a problem for these nations.  For instance, a recent study in San Francisco revealed that 60 percent of new HIV infections are drug resistant. One of the key factors in stemming this tide is early detection of treatment failure through HIV viral load monitoring of all HIV positive patients. Since healthcare systems the world over are straining to manage budgets, a more cost-effective decentralized HIV viral load monitoring solution may benefit developed nations as much as it does low-to-middle income countries.  

In areas where the subtype of the individual may be unknown RT-based testing provides additional advantages. This has not been much of a concern in the US where the vast majority of HIV-1 infections are subtype B—98 percent according to some surveys. But an article from CAP Foundation asserts that it may be time for the US to  “catch up to what’s happening in Tanzania and elsewhere in Africa. Specifically, HIV-1 subtypes common in Africa may be making inroads in the United States, as they have in Europe.”  Of the testing options available, only RT-based testing is able to detect any HIV activity without modifying the test — including new HIV strains.

World map of Global distribution of HIV-1 strains

IAVI Report (2003)

Lastly, with half of the world’s HIV population being women and many of them of child-bearing age, there has been increased focus in recent years on mother-to-child transmission. Here too we see great strides have been made with 57% of HIV positive pregnant woman living in low-and middle-income countries receiving treatment in 2011. One persistent problem has been the early infant diagnosis (EID) since standard rapid tests won’t work on newborns. This is another area where RT-based testing has been found to convey an advantage. Over the past year more studies have confirmed that in addition to RT-based EID solutions being significantly less expensive than RNA-based tests, they are also able to detect and quantify HIV infection in infants more reliably and at a much younger age.  

This World AIDS Day, as Cavidi celebrates the 25^th Anniversary of our RT-technology, I’m pleased to report that we are making steady progress on three fronts to address the challenges above.  First, we continue to support the increasing uptake of our manual ExaVir Load HIV viral load monitoring test which is increasing access to affordable HIV viral load testing around the world.  Second, we have made excellent progress developing a new automated platform for near patient HIV viral load monitoring. The platform design is now entering final stages of prototype development and testing. And third, over this past year we have initiated further studies into the development of an RT-based EID test. I look forward to sharing more details on these exciting developments over the next year.

New challenges require new solutions. As we enter the decade of diagnostics I hope to see a new gold standard emerge that will make HIV viral load testing more accessible and reliable. My team will do their part as they continue to bring innovative RT-based diagnostics to the world in 2013 and beyond. 

 John Reisky de Dubnic

CEO

Cavidi

HIV Viral load monitoring: from patient to public health issue

Amazing strides have been made in providing access to Antiretroviral Therapy (ART) in resource-limited settings. In 2011, around 8 million HIV-infected patients living in low- and middle-income countries have access to ART compared to just 400,000 a decade a go. Greater access to Antiretroviral drugs (ARVs) is good news, but it has magnified the need for HIV viral load monitoring to properly administer these drugs. A recent Médecins Sans Frontières (MSF) review of data from 12 low- and middle-income countries found that only 2% of patients had ever received a HIV viral load test result, no less received them every 6-months as recommended by the World Health Organization (WHO).

One Hope by Joe Average was used for the XI International AIDS Conference in Vancouver in 1996The direct benefits of HIV viral load testing to the patient are well documented in terms of better outcomes with decreased mortality. That’s why HIV viral load testing has long been a standard part of treatment in middle- to upper-income nations. But if we look beyond the patient, there is an equally compelling public health case to be made for ensuring access to HIV viral load testing in the low- and middle-income countries where the vast majority of HIV patients live. Here are four ways HIV viral load testing protects the public as well as the patient. 

 1. Help clinical resources go further by targeting counseling where it is needed. Some patients will take their medication as instructed – many will not. Noncompliant patients will usually show elevated viral activity which can lead to increases in treatment failure, transmission, comorbidity, drug resistance, and mortality. Counseling has been found to be very effective at helping with adherence issues but is labor intensive.  This can be an enormous strain affecting the entire clinic. With HIV viral load monitoring the clinic can identify noncompliant patients early and more efficiently target counseling only to those who need it. 

 2. Reduce treatment costs by helping less-expensive first-line ART last longer.  HIV mutates at such a remarkable rate that it is a foregone conclusion the virus will eventually be able to resist first-line treatment. The only question is when. If proper concentrations of the drugs are not properly maintained in the blood it makes this job a lot easier for the virus and thus will lead to treatment failure sooner. Monitoring viral load helps identify viral activity and address it before the treatment fails and the patient needs to be moved to a new treatment (if available).  Without viral load measurement, doctors can also misattribute patient symptoms to treatment failure and switch them before it is required. Since first-line ART is always cheaper than second-line treatment (in some cases one-quarter the price), keeping patients on first-line treatment for as long as possible helps resources go further. 

3. Reduce the spread of HIV.  Studies have found that transmission among HIV-infected persons with a viral load below 1,500 copies/ml is rare.  Put simply, if there is no virus circulating in the patient’s blood, then they are unlikely to spread the disease.  So managing HIV viral load can, in itself, contribute to prevention. But you can’t manage what you can’t measure. This is where HIV viral load monitoring contributes. A mathematical model published in the AIDS journal this year demonstrated that routine virological monitoring combined with ART can lead to a 31% reduction in HIV transmission. 

 4. Combat the global problem of HIV drug-resistance. If HIV is allowed to remain active in the presence of drugs meant to suppress it, then it is just a matter of time before it will produce a viable mutation that will be resistant to the drug. We are already seeing this. A 2010 study in resource-limited settings found that in the absence of HIV viral load monitoring, the incidence of drug-resistant mutations following treatment failure is high.  Of course this causes secondary resistance in these patients. But there’s a knock-on effect in that these resistant patients begin spreading a strain of HIV to others that drugs can’t treat. MSF reports that primary resistance in sub-Saharan Africa is already at 5.6% overall. If we look at countries where ART have been dispensed without HIV viral load monitoring for 10 years or longer we see a rate of 12%.  Worse still, the drug-resistant mutations that are being found in newly infected people who have never been on treatment are resistant to both first- and second-line drugs. That’s a trend that could unravel much of the progress made over the last 20 years in the battle against HIV. 

When we look at HIV viral load monitoring from a public health perspective it becomes clear that the issues above are not limited to low- and middle-income countries. First, because any HIV viral load monitoring solution that is inexpensive enough to be viable in resource-limited settings could lower the cost of HIV treatment for any healthcare system. Secondly, because issues like the spread of HIV infection and drug resistance know no borders. HIV/AIDS is a global problem and affordable HIV viral load monitoring is an important part of the solution whether you are in Nairobi, New York, Melbourne, Lusaka, London, Harare or Hong Kong. 

 As access to ARVs grows across low- and middle-income regions, so does the public health imperative to dispense those drugs in a responsible manner with regular HIV viral load monitoring of patients.  As MSF put it, “Funding the implementation of viral load should not be seen as a luxurious and avoidable expense, but should rather be recognized as a necessary and potentially cost-saving addition to current international commitments to scaling up treatment.”  Today, Cavidi and others have the technology to address this public health issue and provide inexpensive, near-patient HIV viral load monitoring where ever it is needed. Doing so will not only serve the patient but protect the public. All we need is the collective will to make it happen. One more reason why the time for HIV viral load testing is now. 

John Reisky de Dubnic

CEO

Cavidi

Further reading:

• Aghokeng AF, Kouanfack C, Laurent C, Ebong E, Atem-Tambe A, Butel C, Montavon C, Mpoudi-Ngole E, Delaporte E, Peeters M: Scale-up of antiretroviral treatment in sub-Saharan Africa is accompanied by increasing HIV-1 drug resistance mutations in drug-naive patients. AIDS 2011, 25: 2183 –2188.
• Estill J, Aubriere C, Egger M, Johnson L, Wood R, Garone D, Gsponer T, Wandeler G, Boulle A, Davies M-A, Hallett T, Keiser O: Viral load monitoring of antiretroviral therapy, cohort viral load and HIV transmission in Southern Africa: A mathematical modelling analysis. AIDS 2012, 26: 1413.
• Hamers RL, Wallis CL, Kityo C, Siwale M, Mandaliya K, Conradie F, Botes ME, Wellington M, Osibogun A, Sigaloff KCE, Nankya I, Schuurman R, Wit FW, Stevens WS, van Vugt M, de Wit TFR: HIV-1 drug resistance in antiretroviralnaive individuals in sub-Saharan Africa after rollout of antiretroviral therapy: a multicentre observational study. Lancet Infect Dis 2011, 11: 750 –759.
• Lynen L, Van Griensven J, Elliott J: Monitoring for treatment failure in patients on first-line antiretroviral treatment in resource-constrained settings. Curr Opin HIV AIDS 2010, 5: 1–5.
• Médecins Sans Frontières: Undetectable – How Viral Load Monitoring Can Improve HIV Treatment in Developing Countries, July 2012
• Murtagh M: UNITAID HIV/AIDS Diagnostic Landscape 2nd Edition. 2012.
• Quinn T, Wawer M, Sewankambo N: Viral Load and Heterosexual Transmission of Human Immunodeficiency Virus Type 1. N Engl J Med 2000, 342: 921–929.

”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.