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GRACE Study in HIV+ Women of Color: racial & gender health disparities in HIV
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Data From Landmark Study Evaluating Gender Differences in Response to an HIV Therapy Published in Annals of Internal Medicine - (09/23/10)
below are links to data/reports emanating from this study over the past 2 yrs
from Jules: 88% of women in the study were women of color (67% black, 21% hispanic), 85% of men were black men 84% were black or hispanic, so this was a study predominantly in black women showing black women but also suggesting black women too need support services to have better outcomes to HIV and HAART, as we have known for years but GRACE and the HEAT Studies were the first to highlight these problems so much. Response rates to HAART in these studies are not due to the efficacy of the ART therapies used in the study but due to the inequities or health disparities suffered in our society but even more often in HIV by African-Americans and Latinos, because HIV+ people of color suffer more inequities than HIV-negative people of color. These issues are racial and gender based health disparities reflected in our society for other diseases as well as in HIV, like in HCV, African-Americans & Hispanics face very significant barriers to care and outcomes to therapy even more than in HIV because African-Americans do not respond as well to peginterferon/ribavirin due to genetics and immunity, as well Hispanics face this issue but not as much as African-Americans. This problem is becomes critically important to be addressed now with the advent of oral HCV drugs that allow everyone the possibility of cure, but without addressing the special need for intensive support services for these patient populations they face an increased risk to be left behind in the capacity to achieve a cure.
"Black race was correlated with lower response in the final multivariate model; however, in North America, race is likely a surrogate for other factors both measured and not measured in GRACE; Black patients had numerically lower adherence rates (63.3%) than Hispanics (66.7%) or Caucasians (73.9%), which may have contributed to their lower response rate. Black patients had more advanced disease at baseline than the other groups, which, among other potential reasons, could reflect differences in care and may have led to increased treatment complexity Lower response rates in blacks in GRACE may have been due to socioeconomic and other factors unique to North America. participation at a study site with limited experience in conducting a clinical trial and ETR in the OBR were predictors of improved response in GRACE These factors may include lower health literacy, more poverty or incarceration, or higher levels of depression. The HEAT study, another North-American based trial, also observed this correlation between race and virologic response"
"This analysis of the Week 48 results from GRACE, stratified by race, demonstrates that DRV/r treatment is safe and effective in treatment-experienced patients regardless of race..... black patients had a higher discontinuation rate (mainly due to loss to follow up and 'other' reasons).... Black patients had more advanced disease at baseline which, among other potential reasons, could reflect differences in care and may have led to increased treatment complexity.... Black patients also had lower adherence rates.... We believe higher discontinuation rates among black patients in GRACE may have been due to socioeconomic and other factors unique to North America that were not measured in the trial. These factors may include lower health literacy and higher levels of depression and injection drug use"
"post-hoc multivariate analysis of all 429 patients enrolled in GRACE showed that being of a non-black race was significantly associated with improved response and a lower likelihood of discontinuation for reasons other than VF or AEs" ...... "The rate of confirmed VF was 32.2% (n=85) in black patients, 24.0% (n=23) in Hispanic patients and 21.5% (n=14) in Caucasian patients"
1. GRACE PK Study: Median (range) AUC12h and C0h were similar between ...
GRACE was a Phase IIIb study specifically designed to enroll a high proportion of treatment-experienced women and people of color to assess sex- and ...
www.natap.org/2010/PK/PK_18.htm - Cached
2. GRACE: New HIV Study Shows that Large Numbers of Women and People ...
Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, the sponsor of the GRACE study, assembled a group of physicians and ...
www.natap.org/2009/IAS/IAS_15.htm - Cached - Similar
3. African-American Women Need Services is Highlighted in: GRACE ...
by K Squires
Alan Tennenberg7; Joseph Mrus7; on behalf of the GRACE Study Group 1Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA; ...www.natap.org/2009/IAS/IAS_14.htm - Cached - Similar
4. GRACE (Gender, Race And Clinical Experience): Outcomes by Race at ...
by CA San Francisco
Aug 22, 2009 ... GRACE (Gender, Race And Clinical Experience), a 48-week study, was designed to enroll a high proportion of women and people of color to add ...www.natap.org/2009/ICCAC/ICCAC_42.htm - Cached - Similar
5. (IDSA) Darunavir, Ritonavir, and Etravirine Steady-state ...
Nov 1, 2009 ... GRACE was a multicenter, open-label, single-arm, Phase IIIb study conducted at 65 sites across the United States, Puerto Rico and Canada, ...
www.natap.org/2009/IDSA/IDSA_01.htm - Cached - Similar
6. (IDSA) Predictors of Response in GRACE (Gender, Race And Clinical ...
Nov 1, 2009 ... Enrollment into the study was planned to ensure that the racial/ethnic distribution of the women in GRACE was representative of the ...
www.natap.org/2009/IDSA/IDSA_02.htm - Cached
7. Pharmacokinetic Profile of Darunavir (DRV) Co-Administered With ...
Apr 9, 2008 ... At Week 4, in this subset of predominantly non-white, treatment-experienced HIV patients from the GRACE study: ...
www.natap.org/2008/Pharm/Pharm_08.htm - Cached - Similar
8. Safety, Tolerability and Efficacy of Darunavir/Ritonavir in ...
Aug 8, 2008 ... The GRACE study is fully enrolled (287 women, 142 men), demonstrating that HIV-infected women from North America, including women of color, ...
www.natap.org/2008/IAS/IAS_29.htm - Cached - Similar
9. Recovery of Functional Immunity over 48 Weeks with Darunavir-based ...
GRACE was a multicenter, open-label, single-arm, Phase IIIb study conducted at 65 sites across the United States, Puerto Rico and Canada, which enrolled ...
www.natap.org/2009/IAS/IAS_25.htm - Cached
10. Darunavir Levels Not Affected by Gender, Race, or Age in GRACE Trial
GRACE investigators measured darunavir concentrations in everyone at study weeks 4, 8, 24, and 48. A subgroup had intensive sampling for darunavir-level ...
www.natap.org/2010/PK/PK_04.htm - Cached
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