More Updated: May 6, 2020 For Immediate Release
Media Contact: Sybil Miller
October, 28 2019
C: (585) 705-6477
O:
smiller@sisterlove.org
NEW FRAMEWORK WITH THE FEDERAL DRUG ADMINISTRATION ON AN INNOVATIVE TRIAL DESIGN FOR cisGENDER WOMEN AND ADOLESCENT FEMALES CITED
Atlanta, GA, October 28, 2019 – Gilead Sciences, Inc. (GILD) NASDAQ, while attending SisterLove’s 30th Anniversary Gala honoring women leaders living with HIV held in Atlanta, GA on October 18, made a statement that it has agreed in principle for a framework on a trial design with the Federal Drug Administration (FDA) to study cisgender women and adolescent girls for its new Descovy drug as HIV prevention.
The statement read:
“Despite accounting for most new HIV infections globally, cisgender women remain under-represented in HIV research, including PrEP studies. We actively work to further expand the participation of under-represented communities in our clinical studies. To that end, we have agreed with the FDA on the framework of an innovative trial design to conduct a study evaluating PrEP medications in cisgender women and adolescent females. In addition, we also are seeking input from African-based Community Advisors on key elements of the study, such as site selection, recruitment and ongoing study management,” as stated by Thamara Jean-Louis, Regional Director/Northeast for Gilead Sciences.
On October 3rd, 2019, the FDA approved Descovy for prevention of infection with HIV. But the FDA’s approval of Descovy explicitly excluded “individuals who have receptive vaginal sex,” which may include cisgender women and many transgender men, and did not outline a plan for making the drug available to this group. Gilead only tested Descovy “in cisgender men and transgender women.” Gilead came under global criticism from activists and scientists claiming the approval “set a dangerous precedent by allowing companies to dodge the expensive trials needed to test medicines in cisgender women and other groups at risk of HIV infection.”
“We were very pleased that Gilead elected to make this important statement at our 2020 Gala honoring women leaders living with HIV,” said Dázon Dixon Diallo, Founder and CEO of SisterLove. “We were all stunned and disappointed to learn that Gilead had not included cisgender women and adolescent girls in their trial studies for Descovy. We recognize this is only the beginning of our efforts to work with them and hold them accountable to our communities at home and abroad,” she continued.
“It is not new that cisgender women are greatly overlooked when it comes to HIV prevention research, and frankly, for most sexual and reproductive justice matters,” she continued. “Gilead has begun to set things right with the FDA. We look forward to working with Gilead to conduct these trials in important locales, and in accordance with the needs and desires of populations of cisgender women in all our diversities,” Diallo concluded.
In addition, SisterLove is convening a meeting at the International Conference on AIDS & STIs (ICASA 2019) during the first of week of December in Kigali, Rwanda to provide Gilead with a set of recommendations and expectations for conducting an HIV prevention study of this magnitude with cisgender women. SisterLove will host an advisory group, primarily comprised of cisgender women of African descent who are researchers, clinicians, advocates, activists, and former PrEP trials participants. The group will help craft the protocol, informed consent process, community engagement strategy, trial design and outcomes dissemination.
SisterLove is the oldest and largest women-centered HIV and sexual reproductive justice organization in the Southeastern United States. It was founded in 1989 to address HIV-related education, prevention, advocacy, research, and leadership to support reproductive justice for all women and girls. SisterLove’s mission is to eradicate the impact of HIV and other sexual and reproductive oppressions for all women and their communities in the US and globally. SisterLove is headquartered in Atlanta, Georgia with a satellite office in South Africa.
The Handmaid’s Tale Just Became Reality
PRESS RELEASE: Voting Rights Advocates Primed Battle Against Voter Suppression
Voting Rights Advocates Primed to Continue Battle Against Voter Suppression
March 10, 2022 (ATLANTA, GA) - Today, in a partisan vote, members of the Georgia state House passed HB 1464, legislation that would restrict access to voting for many marginalized communities. The bill, which has been widely criticized by voting rights advocates, is just the latest in a series of attempts to suppress the voices of underrepresented groups in the state.
The Election Protection Coalition, a group dedicated to ensuring fair and equal access to the ballot box, has been fighting against voter suppression efforts for years. With 27 days remaining until the U.S. Senate runoffs, the Coalition is doubling down on their efforts to protect the rights of all voters.
“We will not stand idly by while politicians try to silence the voices of marginalized communities,” said a spokesperson for the Coalition. “We will continue to fight for fair and equal access to the ballot box for all Georgians.”
The Coalition is urging voters to stay informed and to report any instances of voter suppression they may encounter. They are also providing resources and assistance to those who may face barriers to voting.
PRESS RELEASE: Election Protection Coalition Says Enough is Enough...
With 27 days remaining until the U.S. Senate runoffs, the Election Protection Coalition is fighting double duty to ensure that all eligible voters have the opportunity to cast their ballots. The Coalition, made up of various organizations and individuals dedicated to protecting voting rights, is calling on state officials to take action against voter suppression tactics.
“Enough is enough,” said a spokesperson for the Coalition. “We will not allow politicians to silence the voices of marginalized communities and deny them their right to vote. We are calling on state officials to take immediate action to protect the integrity of our elections and ensure that all eligible voters have the opportunity to cast their ballots.”
The Coalition is urging voters to stay informed and to report any instances of voter suppression they may encounter. They are also providing resources and assistance to those who may face barriers to voting.
For more information on the Election Protection Coalition and their efforts to protect voting rights, please visit their website at www.electionprotectioncoalition.org.
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