Delivering more effective, cheaper HIV therapy in Africa

The Developing Anti-Retroviral Therapy for Adults in Africa, or DART trial

In the largest clinical trial ever carried out in Africa, scientists provided evidence that clinicians don't necessarily need routine lab tests to treat HIV, allowing for more effective, cheaper delivery.

Antiretroviral therapy (ART) has been proven to effectively treat HIV positive adults. However, the cost of the extensive laboratory testing and monitoring can substantially increase the cost of delivering the treatment.

The Developing Anti-Retroviral Therapy for Adults in Africa — or DART trial — proved that ART can be delivered in a far more cost effective way, potentially allowing a third more people to be treated, and suggests that treatment can be extended to those living in remote areas far from hospital laboratories.

The research

Over 3000 people participated in the DART trail.
Image: Jackie Conciatore/USAID
 

Over 3000 people with advanced HIV infections took part in a 6 year clinical trial that began in 2003.

All participants were given Antiretroviral therapy (ART), medication for treating infectious disease which is known to cut the risk of death by more than 90%. Half the participants were treated by clinicians who had access to the patient’s full laboratory results whereas the second group were treated by clinicians who did not automatically have these results, but could access them if needed.

With no significant difference in 5 year survival rates between the groups, the results demonstrate that first-line ART can be delivered safely using clinical assessment without routine laboratory monitoring.

However, the study did show that routine monitoring of CD4-cell count (also known as T-cells) has a small but significant benefit in terms of disease progression and mortality. This suggests a role for CD4-cell testing from the second year on ART to guide the switch to second-line ART.  Simpler, cheaper point-of-care CD4 tests need to be developed for this purpose.

The trial also found that giving participants a daily dose of co-trimoxazole – a low-cost antibiotic used in low income countries to treat and  prevent common infections – in combination with ART, cuts the risk of death by 50% in the first 18 months of treatment.

Saving money, saving lives

The DART trail has shown that expensive laboratory tests are not essential for HIV treatment.

Health economists in the research team suggest  that the money saved by reducing costly laboratory tests could fund treatment for a third more people.  Furthermore, it means fully trained and qualified health care workers in remote communities without access to laboratories can still provide treatment.

Research funders:

• UK Medical Research Council
• UK Department  for International Development
• Rockefeller Foundation
• GlaxoSmithKline
• Gilead Sciences
• Boehringer-Ingelheim
• Abbott Laboratories

• University of Zimbabwe
• Medical Research Council and Uganda Virus Research Institute (MRC/UVRI)
• Joint Clinical Research Center (JCRC)
• Mulago Hospital – Academic Alliance – Infectious Diseases Institute
• MRC Clinical Trials Unit
• Imperial College London