Viread (Tenofovir) Study To Reduce HIV Transmission in Sexually Active Adults
Bill & Melinda Gates Foundation grant to evaluate once-daily antiretroviral
as a potential method of HIV prevention
Bill & Melinda Gates Foundation
Ward Cates, M.D.
Family Health International (FHI)
SEATTLE, WA and RESEARCH TRIANGLE PARK, NC - The Bill & Melinda Gates
Foundation announced today that it has awarded Family Health International
(FHI) a $6.5 million, three-year grant for a multinational clinical trial to
evaluate an antiretroviral treatment as a novel approach to HIV prevention.
The trial will focus on sexually active adults in resource-poor countries
with high HIV incidence.
The FHI study is designed to evaluate the safety and efficacy of the
antiretroviral tenofovir disoproxil fumarate (tenofovir DF) as a method of
reducing the risk of HIV infection in sexually active adults who are
regularly exposed to the virus. The study will also assess the acceptability
of, and adherence to, a regimen of one tenofovir DF tablet taken once daily.
Gilead Sciences developed tenofovir DF and is supplying the drug for this
study. As an antiviral treatment, tenofovir DF has several characteristics
that make it a promising candidate as a method of HIV prevention, including
its safety, efficacy, pharmacokinetic and resistance profiles.
Although condoms are a proven method for preventing the spread of sexually
transmitted diseases, including HIV, women often are unable to successfully
negotiate the use of this method by their partners. Thus, the urgency for
expanded prevention options is greatest for women. If shown to be safe and
effective in this setting, tenofovir DF could be an HIV prevention method
used by men or women.
"It is imperative that we not only strive to develop new drugs, but that we
also consider new uses for existing ones, such as tenofovir DF, which has
tremendous potential as a dual HIV treatment and prevention technology," said
Ward Cates, president of FHI's Institute for Family Health. "Our goal with
this unique study is to help guide public health decision-making that spurs
the delivery of HIV prevention tools to men and women around the world."
"Convenient, reliable and effective methods of HIV prevention are urgently
needed," said Helene Gayle, director HIV/AIDS and TB at the Bill & Melinda
Gates Foundation. "Previous experience with antiretroviral therapy in
reducing the acquisition risks in healthcare workers and newborns exposed to
HIV gives us hope that they may be an effective method of preventing sexual
transmission of HIV."
Dr. Gayle serves as co-chair of the Global HIV Prevention Working Group,
which this summer issued its blueprint for action. In its report, the
working group highlighted the need for new, novel technologies to reduce
transmission of HIV. The working group also underscored the importance of
efforts that will empower women to decrease their vulnerability to HIV.
About Tenofovir DF
Tenofovir DF is marketed as Viread® for the treatment of HIV infection in the
United States and Europe by Gilead. Tenofovir DF, or Viread, is the first
nucleotide analogue reverse transcriptase inhibitor (NtRTI) approved for the
treatment of HIV. It was approved in the United States in October 2001 and
in the European Union in February 2002. The drug works by blocking reverse
transcriptase, an enzyme involved in the replication of HIV. The approved
dose of tenofovir DF for the treatment of HIV infection is 300 mg once daily
taken orally with a meal.
The Bill & Melinda Gates Foundation is dedicated to improving people's lives
by sharing advances in health and learning with the global community. Led by
Bill Gates' father, William H. Gates, Sr., and Patty Stonesifer, the
Seattle-based foundation has an endowment of approximately $24 billion.
Family Health International is a non-profit organization with three decades
of global leadership in health research, service delivery and technical
assistance in reproductive health and HIV prevention. With corporate
headquarters in Research Triangle Park, NC, FHI operates management centers
in Washington, DC, Bangkok and Nairobi and implements programs through
offices in more than 40 countries.
On the Internet:
Bill & Melinda Gates Foundation, www.gatesfoundation.org
Family Health International, www.fhi.org
Gilead Sciences, www.gilead.com