AFRO-NETS> FHI receives grant to evaluate once-daily antiretroviral for HIV prevention

[David Hock <DHock@fhi.org>]

FHI receives grant to evaluate once-daily antiretroviral for HIV prevention
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Greetings and apologies for any cross-postings!

SEATTLE, WA and RESEARCH TRIANGLE PARK, NC - The Bill & Melinda Gates 
Foundation announced on Monday that it has awarded Family Health In-
ternational (FHI) a US$ 6.5 million, three-year grant for a multina-
tional 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 teno-
fovir DF tablet taken once daily. Gilead Sciences developed tenofovir 
DF and is supplying the drug for this study. As an antiviral treat-
ment, tenofovir DF has several characteristics that make it a promis-
ing 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 im-
perative 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 tech-
nology," 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 ur-
gently needed," said Helene Gayle, director HIV/AIDS and TB at the 
Bill & Melinda Gates Foundation. "Previous experience with antiretro-
viral therapy in reducing the acquisition risks in healthcare workers 
and newborns exposed to HIV gives us hope that they may be an effec-
tive 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 work-
ing group highlighted the need for new, novel technologies to reduce 
transmission of HIV. The working group also underscored the impor-
tance of efforts that will empower women to decrease their vulner-
ability to HIV.

About Tenofovir DF

Tenofovir DF is marketed as Viread® for the treatment of HIV infec-
tion in the United States and Europe by Gilead. Tenofovir DF, or 
Viread, is the first nucleotide analogue reverse transcriptase in-
hibitor (NtRTI) approved for the treatment of HIV. It was approved in 
the United States in October 2001 and in the European Union in Febru-
ary 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.

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 imple-
ments programs through offices in more than 40 countries.

On the Internet:

Bill & Melinda Gates Foundation:
http://www.gatesfoundation.org <

Family Health International:
http://www.fhi.org 

Gilead Sciences:
http://www.gilead.com 

The Bill & Melinda Gates Foundation is dedicated to improving peo-
ple'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 US$ 24 billion. 

--
David Hock
mailto:DHock@fhi.org

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