-- DART Study Investigators Present Favorable Viread Safety
Results at IAS Conference --
Gilead Sciences, Inc. (Nasdaq:GILD) today 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 resource-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.
DART, which was sponsored by the United Kingdom’s Medical Research
Council and conducted at sites in Uganda and Zimbabwe, examined whether
HIV treatment, including Viread, can effectively and safely be provided
in settings where availability of laboratory monitoring is limited.
Without treatment, the researchers estimated that approximately 80 to 90
percent of DART patients would have died within five years. After five
years of receiving combination HIV therapy, 88 percent of DART
participants were alive. This is one of the best survival rates ever
observed in an HIV treatment program or study conducted in Africa.
“The DART study provides important additional clinical evidence that HIV
treatment utilizing Viread helps to extend life in developing countries
where the AIDS pandemic has hit the hardest,” said John Martin, PhD,
Chairman and Chief Executive Officer, Gilead Sciences. “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. We congratulate the DART team on their success in
this important research effort.”
About the DART Study
DART was a five-year, open-label, randomized trial among 3,316
treatment-naïve adults with advanced HIV disease in Uganda and Zimbabwe.
All trial participants received HIV treatment. Patients were randomized
(1:1) into one of two treatment groups. In the first group, patients’
laboratory test results were provided to their physicians to help inform
their treatment decisions. In the second group, doctors were not given
the laboratory test results and made decisions about patient care based
on clinical assessments alone. As a safeguard, results were provided for
all patients whose laboratory safety results were seriously abnormal.
Seventy-four percent of patients received a combination regimen of
Viread with lamivudine/zidovudine. Sixteen percent of patients received
nevirapine/lamivudine/zidovudine and nine percent of patients received
abacavir/lamivudine/zidovudine.
Exclusion criteria for DART enrollment included creatinine levels of
more than 360 μmol/l (4.1 mg/dl) and/or urea levels of more than five
times the upper limit of normal. Sixty-five percent of patients in the
DART trial were female and the median age of trial participants was 37
(18-73). The median CD4 cell count was 86 cells/mm3.
Among patients whose doctors received regular laboratory test results,
the survival rate after five years was 90 percent. Among patients whose
doctors relied on clinical assessments alone, the survival rate
similarly was 87 percent.
