A landmark African HIV study, in which 88% of patients survived over a five-year period, has shown that HIV treatments, including Viread (tenofovir disoproxil fumarate), can effectively and safely be provided in settings where the availability of laboratory monitoring is limited.
The Development of Anti-Retroviral Treatment in Africa (DART) study conducted by Gilead Sciences and sponsored by the UK's Medical Research Council and conducted at sites in Uganda and Zimbabwe examined whether antiretroviral therapy could be effectively provided in remote settings.
Without treatment, the researchers estimated that approximately 80–90% of DART patients would have died within five years. After five years of receiving combination HIV therapy, 88% of DART participants were alive.
These results were presented at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town, South Africa. The study demonstrated one of the best survival rates ever observed in an HIV treatment programme or study conducted in Africa.
The DART trial was an open-label, randomised study comparing clinical and laboratory monitoring to clinical monitoring alone for efficacy and toxicity. In this study, 74% of patients were on a treatment regimen containing Viread.
The results indicated that Viread was well tolerated and that the incidence of renal adverse events in a population where more than 50% of patients had reduced renal function was low.
The conclusion of the DART trial is that renal function test results were similar in both arms of the trial for up to five years, suggesting that routine monitoring of Viread may not be necessary in resource-limited settings.
Gilead Sciences chairman and chief executive officer John Martin said that the DART study provides important clinical evidence that HIV treatment utilising Viread helps to extend life in developing countries where the AIDS pandemic has hit the hardest.
"In addition, we were pleased to see Viread was well tolerated in the study, and that kidney monitoring tests were shown not to be necessary in resource-limited settings when using the product as part of a first-line HIV treatment regimen," Martin said.