November 16, 2016
Brooks, Senior Director for Community Engagement
Gilead Sciences, Inc.
We are writing as a group of U.S., Canadian, and European
community advocates and HIV NGO workers to express deep dismay that Gilead has
proceeded with the DISCOVER trial of Descovy versus Truvada as PrEP without
engaging stakeholders in a substantial or meaningful way.
In 2007, the HIV/AIDS field adopted Good Participatory
a formal set of guidelines approved by UNAIDS for stakeholder engagement in HIV
prevention clinical trials. These guidelines were carefully developed by a
robust cross section of experienced, skilled advocates and experts to protect
research subjects and their communities and to maximize the potential for
effective, ethical, and successful research.
It is astonishing that
Gilead has failed to follow GPP guidelines in the design and implementation of
DISCOVER, since GPP was developed partly as a response to the failure of
previous prevention trials involving tenofovir.
These include the discontinued 2003-2005 trials of
tenofovir as PrEP in Cambodia and Cameroon and more subtly the Bangkok IVDU
tenofovir PrEP trial. Poor community engagement and resulting dissent during
the latter yielded a trial design that could not discern whether the reduction
in HIV acquisition was related to parenteral or sexual exposure. Lack of
structured engagement among researchers, participants and their communities may
have been factors in unfocused recruitment, poor adherence, or lack of trust
between participants and researchers which ultimately yielded disappointing
results from other biomedical prevention trials.
Failing to enlist the community’s help in conducting the
already-challenging DISCOVER trial similarly establishes conditions for failure
and is fundamentally bad practice. Gilead has never conducted this kind of
large HIV prevention trial and frankly lacks the experience and expertise to do
so properly according to GPP guidelines.
Those who realize they are at risk of acquiring HIV and who
are highly motivated to seek access to Truvada as PrEP often find it to be
unavailable, encounter multiple barriers to access, or in some cases must go to
extraordinary lengths to obtain it. Individuals who meet the criteria for
participation in this trial have a demonstrably high risk of contracting HIV.
The efficacy of Descovy as PrEP has obviously not been demonstrated. The
potential for these concurrent realities to create perverse incentives for
enrollment of individuals who would be better off receiving immediate
assistance with accessing Truvada as PrEP heightens our concern.
We acknowledge and appreciate Gilead’s recent responses to
some of the community’s concerns which include a move to amend the protocol to
eliminate a requirement that enrollees stop current PrEP use for 30 days prior
to entering the DISCOVER trial, plans to create an ad hoc advisory group for
the trial, and the appointment of a respected community member to the trial’s
independent data monitoring committee.
To date, however, Gilead has ignored urgent requests to
temporarily halt DISCOVER until the community’s serious and immediate concerns
can be fully addressed. These include a troubling informed consent document and
process as well as marketing materials that fail to accurately or adequately
portray the precise nature of the study. GPP provides a blueprint for
addressing these shortcomings.
While a November 10, 2016 communiqué from Gilead affirms
that they have made a number of changes to the protocol and its implementation,
documentation of those changes has not been provided to those of us with whom
Gilead shared previous versions. While Gilead states that it has subjected
informed consent and marketing materials to additional internal reviews and
revisions, the community has not been given a role in those reviews. Despite
its promises, Gilead has yet to substantially demonstrate a commitment to real
stakeholder engagement or Good Participatory Practice guidelines.
Given the scale and
urgency of the matters at hand we demand that Gilead immediately:
• Commit to
equitably share responsibility for the creation and operation of two Community
Advisory Groups for North America and Europe respectively which will be
empowered to address marketing and enrollment of the trial along with other
concerns. The community must have a major role in establishing these bodies’
terms of reference and the selection of member representatives.
• Consult with
these CAGs to enlist collaborating partner organizations experienced with GPP
to help Gilead conduct DISCOVER in a manner that is ethical, ensures the
wellbeing of the individuals and communities involved, and maximizes its
chances of success.
• Impose a
temporary halt to enrollment of and withdrawal of current marketing materials
for the DISCOVER trial so that these CAGs may have time to meet and adequately
inform the trial’s operation and in order for individual sites to have an
opportunity to engage local stakeholders for guidance related to informed
consent, marketing, and recruitment targeting.
Should Gilead fail to
impose a temporary halt, our organizations will be forced to consider how best
to act and to further inform our communities about the DISCOVER study and its
ADAP Advocacy Association
The Afiya Center
The African Eye Trust
AIDS Committee of Toronto
AIDS Foundation of Chicago
Albos Care Foundation
ARAS - Romanian Association Against AIDS
The Association of CT Services - Chicago
Bayheal AIM-Prevention USA
CAC CRT/USP (CAB - SP- Brazil)
The Care Center
Chicago Women's AIDS Project
Community Access National Network
European AIDS Treatment Group
European Patients' Academy (EUPATI)
Fundación Latinoamericana de Acción Social Inc. (Houston)
Grupo de Incentivo a Vida (GIV)
HIV Prevention Justice Alliance
Hyacinth AIDS Foundation
International Rectal Microbicide Advocates
I'm Still Josh Blog
Lowcountry AIDS Services CAB
Memphis Health Center, Inc.
National Black Leadership Commission - Detroit
National Female Condom Coalition
New Jersey Association on Correction
Peel HIV/AIDS Network
REZO Santé et Mieux-être
Tennessee Association of People With AIDS
Treatment Action Group
A DISCOVER trial factsheet
has been developed through an international collaboration of agencies and
advocates and can be read here.
from additional organizations are being accepted through November 30, 2016.
Click here to join.