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

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 nonadherence, 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,” sai d 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[1].

“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, M.D., 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 2010 in Annals of Internal Medicine.

About PREZISTA®
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.

• The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir®) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines
• It is important that you remain under the care of your healthcare professional during treatment with PREZISTA®

• PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”
• PREZISTA® may cause liver problems. Some people taking PREZISTA®, together with Norvir® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA®. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems
• Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite
• PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild

Who should not take PREZISTA®?

• Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45®, Embolex®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor®, Altoprev®, Advicor®), simvastatin (Zocor®, Simcor®, Vytorin®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™)
• Before taking PREZISTA®, tell your healthcare professional if you are taking sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), pravastatin (Pravachol®), or colchicine (Colcrys®, Col-Probenecid®). Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms

This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

What should I tell my doctor before I take PREZISTA®?

• Before taking PREZISTA®, tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia
• Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding
  1. The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you
  2. Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk

What are the possible side effects of PREZISTA®?

• High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA®
• Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA®. The cause and long-term health effects of these conditions are not known at this time
• Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden
• The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without first talking to your healthcare professional

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.

Please see full Prescribing Information for more details, available at http://PREZISTA.com/sites/default/files/pdf/us_package_insert.pdf

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.

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[1] Problems taking pills: understanding HIV medication adherence from a new perspective. AIDS Care. 2011 Dec; 23(12):1652-9. Accessed May 2, 2013.

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