Landmark Five-Year African Study Indicates That HIV Therapy May Be Given Safely In Re-Limited Settings Without Routine Laboratory Monitoring
Gilead Sciences, Inc. (Nasdaq:GILD) highlighted results from a study known as DART (Development of Anti-Retroviral Treatment in Africa), which evaluated the need for routine laboratory monitoring in adults taking antiretroviral therapy in Africa. The DART trial was an open-label, randomized study comparing clinical and laboratory monitoring to clinical monitoring alone for efficacy and toxicity. In this study, 74 percent of patients were on a treatment regimen containing Viread® (tenofovir disoproxil fumarate). At baseline, more than 50 percent of patients had reduced renal function. The results indicated that Viread was well tolerated and that the incidence of renal adverse events was low. DART researchers concluded 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 re-limited settings when using the product as part of a first-line HIV treatment regimen. The results of the study were presented today at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009) in Cape Town, South Africa.
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