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From: UCSF News Services <[log in to unmask]>
Date: Apr 17, 2007 6:36 PM
Subject: RESISTANCE TO ANTI-HIV DRUGS ARISES FROM DRUG SUPPLY ISSUES
To:

UC SAN FRANCISCO

Corinna Kaarlela, News Director
Source: Jeff Sheehy (415) 597-8165
E-mail: [log in to unmask]
Web:    www.ucsf.edu

EMBARGOED FOR RELEASE
12:01 AM (ET), SUNDAY, APRIL 22, 2007
TO COINCIDE WITH PUBLICATION IN THE JOURNAL "AIDS"

RESISTANCE TO ANTI-HIV DRUGS IN UGANDA LINKED TO SUPPLY PROBLEMS

Some HIV-infected patients in Uganda who self-paid for their
antiretroviral medications experienced interruptions in drug supply due
to either financial demands or supply logistical disruptions.  These
treatment interruptions led to the development of resistance to
antiretroviral medications in patients.

These findings by a team led by researchers at the Infectious Diseases
Institute at Makerere University, Kampala, and UCSF are reported in the
April 22, 2007 issue of the journal "AIDS."

"We have found the concern is not about the occasional missed dose-most
of the patients had near perfect adherence and full suppression of the
virus- but about supply interruptions that led to longer multi-day
treatment interruptions allowing resistance to develop," said study lead
author Jessica Oyugi, MD, from the Infectious Diseases Institute at
Makerere University, Kampala, Uganda.

The study followed just under 100 patients who self paid for generic
fixed-dose antiretroviral formulations. Findings showed that medications
were very effective at suppressing the virus, with full viral
suppression in over 80 percent of people on treatment for 6 months.
Resistance developed in people during treatment interruptions, and 90
percent of all missed doses were due to treatment interruptions as
opposed to the occasional skipped dose.  Further, almost 50 percent of
the participants interrupted treatment due to financial difficulties. In
addition, at one point during the study period, supply of one product
was halted due to customs issues.  A two-week nationwide shortage
resulted that created gaps in treatment for some individuals taking that
medication.

"In a context where the ability of poor people to adhere to medications
regimens has been questioned, the issue is not so much about behavioral
strategies to increase adherence, but about structural failures that
interrupt access to treatment. Free access to treatment leads to better
survival than self-pay therapy because free treatment may be less
susceptible to interruptions that lead to resistance" said study senior
author David R. Bangsberg, MD, MPH, director of the UCSF Epidemiology
and Prevention Interventions Center at San Francisco General Hospital.

The climate in Uganda has changed since the study took place between
September 2002 and April 2004. At that time, most patients paid for
antiretroviral therapy.  Today, most HIV patients are receiving drugs
supplied for free by either PEPFAR-the U.S. President's Emergency Plan
for AIDS Relief, a five-year, $15-billion, multifaceted approach to
combating HIV/AIDS around the world-or The Global Fund to Fight AIDS,
Tuberculosis and Malaria, which was created to dramatically increase
resources to fight three of the world's most devastating diseases, and
to direct those resources to areas of greatest need.

"Notwithstanding the current programs providing free antiretrovirals,
these findings do highlight the need for strong logistics and drug
supply management in any antiretroviral therapy program as well as
continued monitoring of adherence. While our patients did a great job of
taking their medications as directed when they were affordable and
available, their overall adherence did wane a bit over the study
period," said Oyugi.

Co-authors include Jayne Byakika and Roy Mugerwa, Makerere University,
Kampala: Kathleen Ragland, UCSF Epidemiology and Prevention
Interventions Center; Oliver Laeyendecker and Thomas Quinn, Johns
Hopkins University; and Cissy Kityo and Peter Mugyenyi, Joint Clinical
Research Program, Kampala, and the UCSF Positive Health Program at San
Francisco General Hospital.

Funding from the National Institutes of Health, the UCSF Center for AIDS
Research, and the Doris Duke Charitable Foundation supported the
research.

The UCSF Epidemiology and Prevention Interventions Center and the UCSF
Positive Health Program at San Francisco General Hospital are programs
of the AIDS Research Institute at UCSF. The AIDS Research Institute
coordinates all of the HIV/AIDS research, treatment, and prevention
activities at UCSF.  Combining the best basic science, bench-to-bedside
research, behavioral studies, direct care services, and policy
development, the ARI at UCSF is one of the premier HIV/AIDS medical,
education, and research institutions in the world.

UCSF is a leading university that advances health worldwide by
conducting advanced biomedical research, educating graduate students in
the life sciences and health professions, and providing complex patient
care.

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Michael Balter
Contributing Correspondent, Science
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