By
Liz Highleyman
Unlike many HIV treatment trials, which have
enrolled mostly men, the Phase 3b GRACE study was designed to include enough HIV
positive women to evaluate gender differences in treatment outcomes. The trial
enrolled 287 women and 142 men.
The
cohort was also racially/ethnically diverse, although the study was not powered
to determine racial/ethnic differences in response. Overall, 264 participants
self-identified as black, 65 as white or Caucasian, and 96 as Hispanic or Latino/a.
About three-quarters of the black participants, about 60% of the Hispanic participants,
and about half the white participants were women
As
previously reported, overall 48-week results were presented this past summer
at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment
and Prevention in Cape Town.
The
first analysis presented at ICAAC looked at racial/ethnic
differences in response. About 33% of black participants discontinued the study,
compared with 24% of Hispanics and 26% of whites. The difference was largely attributable
to loss to follow-up.
About
3% of both blacks and whites discontinued due to virological failure, compared
with 1% of Hispanics. At week 48, 62% of Hispanics and 60% of whites had HIV viral
load < 50 copies/mL, compared with 49% of blacks. Furthermore, Hispanics and
whites gained about 86 CD4 cells, compared with 69 for blacks.
Despite
the trial design, the researchers noted, "we were not able to account for
socioeconomic and other differences that we believe led to more black patents
discontinuing than Hispanic or Caucasian patients and the resulting lower response
rate in black patients."
"Further
investigation of factors, such as differences in care, socioeconomic disparities,
health literacy and adherence, which may impact race-based difference in response
and discontinuation, is warranted.
The
complete poster is available online. 
Etravirine
The
second analysis focused on the 207 GRACE participants (48%) who took regimens
that included etravirine; 58% were women, 64% were black, 17% were Hispanic, and
16% were white.
Response rates at 48 weeks in an intent-to-treat TLOVR
analysis were 58% for women and 61% for men, not a statistically significant difference.
Patients who took etravirine did better overall than those who used regimens that
did not include this drug. In an observed (as-treated) analysis, women experienced
larger CD4 cell gains than men (128 vs 95 cells/mm3).
Etravirine
was well-tolerated overall, and there was little difference between women and
men for most adverse events. Women, however, were more likely to experience nausea,
while men more often had elevated triglyceride levels. More women taking etravirine
developed rash compared with women in the full GRACE cohort.
The
complete poster is available online.
New
Jersey Med. School, Newark, NJ; Univ. of Miami School of Med., Miami, FL; Tibotec
Therapeutics, Bridgewater, NJ; Tibotec, Inc., Yardley, PA.
9/18/09
References
K
Smith, F Garcia, R Ryan, and others. GRACE
(Gender, Race and Clinical Experience): Outcomes by Race at Week 48. 49th Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2009). San Francisco.
September 12-15, 2009. Abstract H-918.
SL Hodder, D Jayaweera, J Mrus,
and others. GRACE
(Gender, Race And Clinical Experience): Etravirine (ETR) Subgroup Analysis at
Week 48. ICAAC 2009. Abstract H-919.
