Madam Speaker, I rise today to commend and congratulate Tibotec Therapeutics, part of the Johnson & Johnson family of companies, for demonstrating continued innovation and corporate responsibility in the fight against HIV/AIDS by…
Madam Speaker, I rise today to commend and congratulate Tibotec Therapeutics, part of the Johnson & Johnson family of companies, for demonstrating continued innovation and corporate responsibility in the fight against HIV/AIDS by conducting the groundbreaking GRACE study. GRACE, which stands for Gender Race And Clinical Experience, is the largest study to date in treatment- experienced women with HIV to examine gender and race differences in response to an HIV therapy. Findings from this historic study were recently presented at the International AIDS Society conference in Cape Town, South Africa.
In the United States, women are increasingly affected by HIV/AIDS, accounting for more than one quarter of all new HIV/AIDS diagnoses, with African American and Latina women representing seventy-nine percent of women living with the disease. People of color, both women and men, have been historically underrepresented in clinical trials in the United States, and HIV/AIDS disproportionately impacts our African American and Latino communities. In my home state of Texas, there are about 73,000 people living with AIDS, and Latinos represent almost one- quarter of these cases. There are over 5,000 people living with HIV/ AIDS in San Antonio, and many more in the surrounding counties. In terms of new HIV infections, Latina women are infected at a rate almost four times as high as white women.
Through innovative strategies, the GRACE study was able to enroll approximately seventy percent women, sixty percent African Americans and twenty-two percent Latinos. The trial was designed to help overcome some of the barriers which have historically deterred women and people of color from participating in clinical studies, including stigma, language and cultural barriers, and lack of child care, transportation, and personal support systems. Based upon advisor and community input, study participants could obtain assistance to cover costs associated with their participation in the study, including funds for travel and childcare, as well as food vouchers. I am very proud that one of the study sites in this historic clinical trial is located in my congressional district.
Results of the GRACE study showed that there were no statistical differences in the safety, tolerability, or effectiveness of the HIV regimens used in the study between male and female participants, or for people of different ethnicities. Importantly, from my perspective, the GRACE study clearly showed that, with the appropriate commitment from the trial sponsor and input from affected communities and providers, clinical trials can, indeed, enroll meaningful numbers of women and racial and ethnic minorities.
With the GRACE study, Tibotec Therapeutics and Johnson & Johnson continue to demonstrate their leadership and corporate social responsibility as innovators and leaders in the pharmaceutical industry. I commend them for their continuing commitment to the fight against HIV/AIDS and for their leadership in addressing the disproportionate impact of the HIV/AIDS epidemic on women and people of color.