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GRACE Survey Sheds Light on Treatment Benefits and Barriers for HIV+ Women

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Caring for children, unemployment, and transportation difficulties were among the factors most likely to lead to poor adherence, early dropout, and suboptimal response to antiretroviral therapy (ART) among participants in the GRACE trial, which tested darunavir (Prezista) in a study population consisting largely of women of color. Overall, they said participation was a positive experience and they would encourage others to join a clinical trial.

Most large trials of antiretroviral drugs have including a majority -- often an overwhelming one -- of white gay men, who were the first population to be heavily affected by HIV/AIDS in the in the U.S. and Europe, and more likely than some other groups to have access to care.

Tibotec (now part of Janssen Therapeutics) designed the Gender, Race and Clinical Experience (GRACE) study, conducted between October 2006 and December 2008, to evaluate sex- and race-based differences in outcomes after treatment with ART containing boosted darunavir. As previously reported, the trial found that, overall, women responded to treatment as well men.

As described in the June 3, 2013, issue of AIDS Patient Care and STDs, between June 2010 and June 2011 former GRACE participants were asked to complete a 40-item questionnaire regarding demographic and personal characteristics, experiences, and opinions about their participation in the trial. A total of 151 participants completed the survey, of whom 64% were women and 55% were black/African-American.

Participants reported that the best aspect of being in the study was access to treatment, while the worst aspect was too many blood draws. The most important factor related to completion of the trial was support from study site staff (cited by 47%). In a univariate analysis, being a primary caregiver for children was named as the major factor associated with non-adherence to study drugs, while unemployment was associated with early study discontinuation, and transportation difficulties were linked with poor virological response.

Overall, participation in GRACE was "a very positive experience for most survey participants," the researchers concluded.

"Patients with certain characteristics may be at risk for poor study outcomes and may benefit from additional efforts with the aim of improving drug adherence, study retention, and, ultimately, clinical outcomes," they suggested. "Acknowledging these characteristics may be useful when designing future clinical trials for patients with HIV, especially women."

Below is an edited except from a Janssen press release describing the GRACE survey findings in more detail.

Survey of Participants from Landmark GRACE Trial Provides Patients’ Perspectives from an HIV Clinical Study

Most Survey Participants Would Recommend Joining a Study to Others

Titusville, N.J. -- May 30, 2013 -- A survey of a segment of clinical trial participants from the GRACE (Gender, Race And Clinical Experience) trial, the largest-ever study of treatment-experienced adult women with HIV to examine gender differences in response to HIV therapy, found that after taking part in the study, 96 percent of survey responders would recommend participation in a clinical trial to others. The results of the participant survey were published in the June 2013 issue of AIDS Patient Care and STDs.

The GRACE participant survey assessed the characteristics of patients, and reported on their experiences with and opinions about that study. The results from 151 patients showed that access to treatment and support from study site staff were important factors in enrollment and completion of the GRACE trial. Janssen Therapeutics, Division of Janssen Products, LP, conducted the GRACE trial and the participant survey.

The GRACE study was a Phase 3b trial that evaluated sex- and race-based differences in outcomes associated with Prezista (darunavir)/ritonavir-based therapy in 429 treatment-experienced HIV-infected adults. The study included 65 sites throughout the United States, Puerto Rico, and Canada. By using specific recruitment and retention strategies, the trial achieved enrollment of 67 percent women (and 33 percent men), successfully demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

Survey respondents (n=151) reported that the best part of the GRACE study was access to treatment (41 percent), with most becoming more focused on their health (82 percent) and continuing treatment after the trial (87 percent). Additionally, 47 percent of survey participants cited support from study staff as the most important factor in completing the trial, describing the "professional, supportive, comforting, nonjudgmental, confidential, [and] caring" staff as willing to take extra time to help the participants. Survey respondents also reported feeling more confident about themselves and their future as a result of participating in the GRACE study. Negative experiences as reported by the participants included too many blood draws (26 percent), travel to the study site (13 percent), and the opinion that medicines were hard to take (12 percent). Factors associated with non-adherence, study discontinuation, and poor virologic response cited by respondents included being the primary caregiver for children, unemployment, and difficulties with transportation, respectively.

"As researchers, we spend much time analyzing the data points pulled from a clinical trial. The results of the GRACE Participant Survey provide us with the unique opportunity to view the clinical trial experience through the eyes of a patient," said Kathleen Squires, MD, Director, Division of Infectious Diseases, Thomas Jefferson University, who was a primary investigator in the GRACE study and is the lead author for the patient survey manuscript. "The survey has the potential to help shape how future studies are conducted, as it further addresses some of those barriers that may prevent individuals from participating in clinical research. We now can begin to understand how to better anticipate the barriers and help patients in overcoming them."

Access to HIV medications was often cited as an important reason for participating in the GRACE trial. Respondents also reported that participation in GRACE increased their awareness of the importance of medication adherence --something that is of the utmost importance in U.S. healthcare, and a particular issue among those on treatment for HIV/AIDS.

"When GRACE was completed, the study investigators, and HIV community encouraged Janssen to conduct a survey of participants. The positive patient feedback on their experience participating in the study speaks to the design and the care provided by the sites," said Bryan Baugh, MD, Medical Director at Janssen Therapeutics. "We want to commend everyone who helped us develop the study and the investigators who helped to make being in the study a positive experience for many participants."

GRACE Participant Survey: Design and Results

The present study was a non-interventional, multicenter, cross-sectional survey completed by former participants of the GRACE trial, including those who did and did not complete the trial. Of the 57 GRACE sites located in the United States and Puerto Rico that enrolled patients, 22 chose to participate in the survey study, which was conducted between June 2010 and June 2011. The primary objective of the survey was to examine GRACE participants’ characteristics (beyond data obtained during the study), and their experiences with and opinions about participating in the study. The secondary objective was to explore statistically the associations between survey responses and adherence to study medications, study discontinuation and virologic response. Patients completed a 40-question multiple-choice and open-ended survey in a single visit.

Respondents reported that the best part of the GRACE experience was access to treatment (41 percent), being part of something bigger (18 percent), and feeling better (17 percent). Seventy-six percent felt that the GRACE trial made them feel differently about their health/HIV care, and most (82 percent) became more focused on their health, with 87 percent of respondents continuing treatment after GRACE. In all, 68 percent would be interested in sharing their GRACE experience and 96 percent would recommend participation in a clinical trial to others.

Some of the worst parts of the GRACE experience as reported by respondents were too many blood draws (26 percent), travel to the study site (13 percent), and the opinion that medicines were hard to take (12 percent). Although 88 percent reported having completed the GRACE trial, only 74 percent actually did so. Support from site study staff (47 percent) was noted as the most important factor in completing the study. Other common success factors were feeling better or healthier (16 percent), receiving support from family/friends (15 percent), and having access to medications (13 percent). Of the 12 percent who reported not completing the study, the most cited reason for discontinuation was intolerable side effects/not liking how they felt (50 percent).

The majority (71 percent) reported that GRACE was their first HIV study and that they learned about the study from the staff at their clinic (82 percent). Most (79 percent) felt that receiving other medications in addition to the main study drug, darunavir, was very important in their decision to participate in the GRACE study. The majority (76 percent) participated in GRACE at their primary HIV care location and 77 percent did not have any difficulty arranging transportation to the study site. Nearly all (99 percent) participants reported being comfortable or very comfortable with the study site, indicating that the site was very flexible with scheduling visits (93 percent).

The results of the survey were published in an article in the June 2013 issue of AIDS Patient Care and STDs (Volume 27, Number 6), and can be accessed here: http://online.liebertpub.com/doi/full/10.1089/apc.2013.0015.

About the GRACE Study

GRACE was a multi-center (65 sites), open-label Phase 3b trial that compared the efficacy, safety, and tolerability of the protease inhibitor Prezista (600 mg) boosted with a low dose of ritonavir (100 mg) twice a day, in combination with an investigator-selected optimized background regimen for 48 weeks in men (n=142) and women (n=287).

The study was designed to enroll a high proportion of North American, treatment-experienced women that was reflective of the distribution and demographics of women with HIV in the United States. Trial sites were selected to correspond with the geographic distribution of women with HIV, with the majority of sites located in the Northeastern (16 sites) and Southeastern (29 sites) United States. Study sites were initially required to enroll three women before enrolling a man, and thereafter, each site was required to maintain at least 70 percent female enrollment. Men could only be enrolled if their addition did not compromise the 70 percent female quota.

Additional analyses were conducted as part of the GRACE study, including a sub-study examining efficacy and safety differences in response to race, as well as an immunology sub-study.

Study details and results were presented at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) and published in September 2010in Annals of Internal Medicine.

About Janssen Therapeutics

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Visit www.JanssenTherapeutics.com for more information and follow us on Twitter at @JanssenUS.

6/6/13

Reference

K Squires, JFeinberg, DA Bridge, et al. Insights on GRACE (Gender, Race, And Clinical Experience) from the Patient's Perspective: GRACE Participant Survey. AIDS Patient Care and STDs 27(6):352-62. June 3, 2013.

Other Source

Janssen Therapeutics. Survey of Participants from Landmark GRACE Trial Provides Patients’ Perspectives from an HIV Clinical Study. Press release. May 30, 2013.