Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women

Hoffman, Risa M.; Umeh, Obiamiwe C.; Garris, Cindy; Givens, Naomi; Currier, Judith S.

doi:10.1310/hct0806-371

Cited by 15 publications

(14 citation statements)

References 15 publications

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“…The Context Study, which assessed treatment-experienced patients, reported a discontinuation rate of 47% in women compared with 22% in men; however, women comprised only 15% of the 315 patients enrolled, limiting the interpretation of these data. 9 Additionally, in a study that enrolled 254 patients, including a high proportion of women (50%), black (40%), and Hispanic (37%) treatment-naïve patients, Kumar et al 18 reported an overall discontinuation rate of 49%; specific differences by sex were not reported. The Women First Study was specifically designed to assess the efficacy and safety of combination ARV therapy in protease inhibitor-naïve women and also to evaluate treatment compliance and continued study participation.…”

Section: Discussionmentioning

confidence: 99%

“…4,7,8 In contrast, post hoc analyses of several other studies have not identified sex-based differences in the efficacy and safety of ARV therapy; however, these studies were not designed for sex-based comparisons. [9][10][11] Although the number of 1 Tibotec Therapeutics, Titusville, New Jersey. 2 The Well Project, Inc., Nellysford, Virginia.…”

Section: Introductionmentioning

confidence: 99%

“…2504 treatment-naïve women enrolled into clinical trials has been steadily increasing, recruitment and retention of treatmentexperienced women in trials have been less successful. 4,9,12 Clinical trials that are specifically designed to recruit and retain a sufficient number of HIV-infected women will ensure that studies are adequately powered for between-sex comparisons and provide meaningful data on the effects of ARVs in women.…”

Section: Introductionmentioning

confidence: 99%

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Recruitment and Retention of Diverse Populations in Antiretroviral Clinical Trials: Practical Applications from the Gender, Race And Clinical Experience Study

Falcon¹,

Bridge²,

Currier

et al. 2011

Journal of Women's Health

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Background: Women, particularly women of color, remain underrepresented in antiretroviral (ARV) clinical trials. To evaluate sex-based differences in darunavir/ritonavir-based therapy, the Gender, Race And Clinical Experience (GRACE) study was designed to enroll and retain a high proportion of women representative of the racial/ethnic demographics of women with HIV/AIDS in the United States. The recruitment and retention strategies used in GRACE are described in this article. Methods: Recruitment and retention strategies targeting women included selecting study sites that focused on women, involving community consultants, site-specific enrollment plans, access to other ARV drugs, study branding, site and patient toolkits, targeted public relations, site grants for patient support, and subsidized child care and transportation. Results: The recruitment strategies were successful; 287 (67%) women were enrolled, primarily women of color (black, n = 191 [67%], Hispanic, n = 60 [21%]). Despite the focus on retention, a greater proportion of women (32.8%) discontinued compared with men (23.2%). Conclusions: The successes of GRACE in enrolling a representative population of women were rooted in pretrial preparation, engagement of community advisors, enrollment quotas, choice of study sites and site support. Lessons learned from GRACE may be applied to future study design. Further focus on factors that influence discontinuation is warranted.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Recruitment and Retention of Diverse Populations in Antiretroviral Clinical Trials: Practical Applications from the Gender, Race And Clinical Experience Study

Falcon¹,

Bridge²,

Currier

et al. 2011

Journal of Women's Health

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“…Fasting triglyceride elevations were more common in men than women, as has been observed in other ARV trials that enrolled either treatment-naïve or treatment-experienced patients. [4][5][6][7] The incidence of LDL elevations was numerically higher in women than men; this is supported by the cross-sectional FRAM (Fat Redistribution And Metabolic change) study, which recently demonstrated that HIV-infected women had higher LDL levels compared to uninfected women. In contrast, HIV-infected men had lower LDL levels than uninfected men, 13,14 suggesting the LDL elevations may be more prevalent in HIV-infected women than men.…”

Section: Discussionmentioning

confidence: 92%

“…[4][5][6][7] For instance, men receiving ARV therapy are more commonly reported to develop hypertriglyceridemia compared to women. [5][6][7] Few of these trials, however, have enrolled a population of women large enough to draw definitive genderbased conclusions regarding metabolic effects of individual ARV agents.…”

Section: Introductionmentioning

confidence: 99%

Effects of Darunavir/Ritonavir-Based Therapy on Metabolic and Anthropometric Parameters in Women and Men Over 48 Weeks

Currier

Martorell²,

Osiyemi³

et al. 2011

AIDS Patient Care and STDs

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Gender-based differences in lipids have been noted in antiretroviral clinical trials. We present the metabolic and anthropometric data from the GRACE (Gender, Race And Clinical Experience) study by gender. Treatmentexperienced adults received darunavir/ritonavir (DRV/r) 600/100 mg twice daily, plus a background regimen, over 48 weeks. Fasting blood samples were obtained for lipid, glucose, and insulin measurements at baseline and at weeks 24 and 48/early discontinuation. Anthropometric measurements were taken at baseline and at weeks 12, 24, and 48/ discontinuation. The Assessment of Body Change and Distress questionnaire was administered at baseline and regular intervals. Descriptive statistics as well as comparisons using a Wilcoxon rank-sum test are reported. Four hundred twenty-nine patients (women, n = 287; men, n = 142) enrolled in GRACE; 94 women (32.8%) and 33 men (23.2%) discontinued the trial. Median changes in triglycerides from baseline to week 48 were higher in men (25 mg/ dL versus 8 mg/dL; p = 0.006); the mean change in triglycerides was higher in men than in women in all racial subgroups. Other lipid and glucose level changes were similar between genders. Anthropometric parameters increased for both genders, with larger increases in women. Patients' perceptions of body changes concurred with physical measurements. The proportion of women who were ''satisfied'' or ''very satisfied'' with their bodies increased from 45.2% to 57.8% from baseline to week 48 ( p = 0.005), while the proportion of men who were ''satisfied'' or ''very satisfied'' with their bodies increased from 56.3% to 61.5% from baseline to week 48 ( p = 0.317). DRV/r-based therapy was associated with small to moderate changes in metabolic parameters, and few between-gender differences were observed. Levels of self-reported, body-related distress improved for women and men over 48 weeks.

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Treating Women with HIV: Is it Different than Treating Men?

Aziz

Smith

2012

Curr HIV/AIDS Rep

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While antiretroviral therapy (ART) has had a tremendous impact on the morbidity and mortality of patients with HIV, there is evidence that many HIV-infected women experience treatment challenges that are different from men and these challenges are often associated with poorer outcomes. In the United States, blacks and Latino women are disproportionately affected by the HIV epidemic related to lack of access to high-quality HIV care, and socioeconomic factors. In Africa and Asia, HIV infection in women is affected by gender norms that often leave women dependent upon men (either emotionally or financially) and vulnerable in relationships. These gender norms and, in some cases, fears of violence make it difficult for women to refuse unprotected sex, and can contribute to higher infection rates in women and delayed entry to care. Many African migrants in Europe and Australia may feel stigmatized and fear discrimination when accessing care. As a consequence, despite the availability of highly active antiretroviral therapy, women with HIV often have delayed entry into care and experience poor outcomes. With the notable exception of treatment during pregnancy, there is little in the published literature to suggest that the treatment of choice for treatment-naïve patients should be determined by the patient's sex. While virologic efficacy of ART may be similar in large clinical trials, differences in the frequency of treatment-related side effects and the impact of pregnancy and/or child-bearing status on treatment choice is well documented. In this paper we aim to discuss antiretroviral therapy in HIV-infected women, the sex-specific barriers to starting care, the differences in outcomes, and complications.

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Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women

Abstract: The absence of major sex differences provides reassurance, but the small number of women in these trials limited the ability to draw conclusions. Future trials should be specifically powered to detect sex differences in safety and efficacy.

Cited by 15 publications

References 15 publications

Recruitment and Retention of Diverse Populations in Antiretroviral Clinical Trials: Practical Applications from the Gender, Race And Clinical Experience Study

Recruitment and Retention of Diverse Populations in Antiretroviral Clinical Trials: Practical Applications from the Gender, Race And Clinical Experience Study

Effects of Darunavir/Ritonavir-Based Therapy on Metabolic and Anthropometric Parameters in Women and Men Over 48 Weeks

Treating Women with HIV: Is it Different than Treating Men?

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