Press Release: GILEAD SCIENCES, INC MAKES STATEMENT REGARDING DESCOVY-FDA TRIAL DESIGN AT SISTERLOVE
Updated: May 6, 2020
For Immediate Release Media Contact: Sybil Miller
October, 28 2019 C: (585) 705-6477
O: (404) 505-7777
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 Johannesburg, South Africa.