IPRs An Issue In Latest HIV Treatment Monitoring Test, Group Says

CAPE TOWN, SOUTH AFRICA – Intellectual property rights represent a hurdle to lower-priced, high quality tests of HIV treatment monitoring in developing countries, public health group Médecins Sans Frontières (MSF, Doctors without Borders) said today.

The “gold standard” test for HIV treatment monitoring is “viral load testing,” according to MSF, a way to test the amount of HIV virus in the patient’s blood to make sure treatment is working and address any problems with adherence or treatment failure.

But due in part to intellectual property royalties, prices of viral load tests – which are the norm in developed countries – are too high for many in developing countries to obtain, according to preliminary data from MSF. The HIV monitoring test most commonly used today is based on “CD4” cell response, which reveals problems much later than viral load.

The World Health Organization has recommended the use of one viral load test once a year for each person on treatment.

Viral load testing measures how many copies of the virus are in the blood, which indicates how well the virus is being suppressed by the antiretrovirals. For people doing well with their treatments, the test ideally shows an “undetectable” level of virus in the blood (below the lowest level of detection in the test).

MSF is among the hundreds of health workers and others in Cape Town for the 7-11 December International Conference on AIDS And STIs In Africa (ICASA).

MSF is working to scale up viral load testing in numerous countries, and found that prices for these tests currently ranges from about US$25 to $44, which is considered expensive in poor countries. The Clinton Health Access Initiative has negotiated a rate of under US$11 per test in Kenya. Intellectual property costs have been calculated to be between 19-63 percent of costs.

A six-country survey by MSF showed that prices of roughly US$17-$29 per test, including implementation, could be obtained if countries had access to lowest price available. The group called for related IP to be licensed at a lower cost when sold to low and middle-income countries.

MSF found that costs could go even lower based on analysis of costs of materials required to run each test. It showed estimated costs of manufacturing reagents and consumables – which account for some 75 percent of running a test – to be as low as US$1.60 – $4.50 for the three most commonly used tests in Africa. This does not include IP costs.

Price was also found to be dependent on the volume of tests run, MSF said, so it is encouraging global health actors, such as the Global Fund for HIV, Tuberculosis and Malaria, PEPFAR and countries themselves, to negotiate lower viral load prices by pooling their procurement. It should also be ensured that viral load instruments are used at maximal capacity to lower price per test.

MSF analysis showed IP costs as a percentage of the total viral load test costs to be:

Lab-based tests:

Abbott 63%
Roche 29%
BioMerieux 0%
Cavidi 0%

Point-of-care tests:
Alere 24%
Diagnostics for the Real World 26%
Wave 80 Biosciences 19%
Lumora 21%

“Looking ahead to the development of new viral load tests, global health actors should support strategies, such as pooling of patents from third parties, with reasonable royalty payments, in order to enable the development of open diagnostic platforms and to ensure affordability,” MSF said in a brochure.

“If we want to close the gap between rich and poor countries when it comes to making sure people’s HIV treatment is working, we need to see the price of viral load testing come down fast,” Sharonann Lynch, HIV Policy Advisor for MSF’s Access Campaign, said in the press release. “The big agencies paying for global HIV treatment – the Global Fund and PEPFAR – need to wake up and see the potential they have to push viral load test prices down and into the reach of countries affected by the epidemic.”

The MSF press release is available here.

The MSF issue briefs are available here and here.