Broken System: The Research & Development Crisis

MSF Cooperates on Crucial Research and Development Project

Caring for children with HIV/AIDS is charged with obstacles. The struggle begins with doctors not being able to tell whether antibodies found in a small baby's blood are from the mother or whether they suggest the child itself is infected with the virus. Frustrated with the situation, MSF has been cooperating with scientists working on a new technology.

The HIV test on the left is negative, while the strip on the right shows a positive result. © David Levene

Children are rarely born with HIV in industrialized countries, where transmission of the virus from the mother to the unborn child is usually successfully avoided, and children can be routinely diagnosed and treated. But there are 2.2 million children living with HIV/AIDS in the world. Most of them live —and die— in Africa.

New health tools specifically designed for use in resource-poor settings are direly needed, but they are not developed because industry sees no prospect of profit in addressing the needs of those who live below the poverty line.

This is why MSF has chosen to participate in a research and development project that aims to make detecting HIV in children under 18 months possible. MSF and the Diagnostics Development Unit at Cambridge University, UK, are entering into an agreement to develop a simple, cheap and rapid HIV viral load test for use in resource-poor settings. Headed by Dr. Helen Lee, the team at Cambridge consists of scientists who left industry to be able to develop inexpensive tests for detecting infectious diseases in patients in developing countries.

"If successful, the SAMBA (‘Simple Amplification Based Nucleic Acid Test') test would make it possible to diagnose HIV in infants under a year and half while the parents are waiting, a procedure that is currently too complicated to be done at district level in resource-poor settings. Today, this level of diagnosis in infants is limited to specialized laboratories in the capitals," explains Dr. Tido von Schoen-Angerer, Director of R&D with MSF's Campaign for Access to Essential Medicines. Performed with a simple plastic device, the SAMBA test will radically simplify the technology that amplifies the viral RNA, that is, the virus¹s genetic material, thus making it detectable in the patient's blood.

An MSF patient has blood drawn for an HIV test at Danane Hospital, Ivory Coast. © David Levene

Having a simpler and cheaper test to measure the amount of the HIV virus in the blood is also important when treating HIV//AIDS because it shows how the immune system is responding to antiretroviral treatment. "The other use of SAMBA would be to check adherence and to determine when exactly to switch patients to more powerful second-line drugs," says Dr. von Schoen-Angerer.

"Even when patients take their treatment very regularly, resistance inevitably ends up developing after a few years. Without viral load testing, problems may be recognized too late, reducing the chances that a second-line combination will be successful," said Dr. Eric Goemaere, head of mission for MSF's AIDS programs in South Africa, where 16 percent of patients who have been treated by MSF for four years have needed to be switched to a second-line combination.

In the past months, MSF has been supporting the Cambridge research team in defining the required characteristics for the test to address the specific needs in resource-poor settings. An experts¹ meeting convened by MSF helped determine cut-off thresholds for adherence monitoring and the "when to switch to second-line" decision. MSF will be involved in field-testing the device.

Getting involved in an R&D project is not a traditional role for a humanitarian organization like MSF. "We are so desperate to have a simple test like this that we decided to step in. It is outrageous that research like this that specifically addresses the needs of resource-poor settings is of no interest to companies and is still not prioritized more and funded by governments, says Dr. von Schoen-Angerer.