Newswise — Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that it is launching a new initiative to raise awareness of issues affecting women and people of color living with HIV/AIDS. Through a comprehensive campaign including local educational events, media outreach and a new Web site, www.TheGraceStudy.com, the company is sharing learnings from the GRACE study, the largest clinical trial in North America among women with HIV who had previously taken HIV medications. GRACE, which stands for Gender, Race and Clinical Experience, examined differences in response to an HIV medication in combination with other HIV medications.
The GRACE campaign will include perspectives from study participants, physicians, and advocates. Campaign materials, which will be available in English and Spanish, and supporting activities, will address the unique design of the GRACE study and the novel recruitment and retention strategies that were used to encourage women and people of color to enroll and stay in the trial. These novel strategies and the study findings have important implications for the long-term care of women and people of color living with HIV.
“The GRACE study not only provides a new model for HIV research, it also has implications for the care of women and people of color living with HIV,” said Dawn Averitt Bridge, Founder and Chair of The Well Project, and a paid consultant on the GRACE study. “GRACE proves that women and people of color can and will participate in clinical trials if they are designed and supported in the right way, and these strategies and support techniques can be applied to the everyday care of people living with HIV.”
In the United States, HIV/AIDS is on the rise among women and people of color. Today, women account for more than one-quarter of all new HIV/AIDS diagnoses, and African-American and Latina women represent 79 percent of women living with the disease. Overall, 65 percent of people living with HIV in the United States are people of color. Despite these staggering statistics, women and people of color are under-represented in clinical treatment studies, often due to barriers such as availability of child care, lack of transportation, financial burden, and stigma.
The GRACE study enrolled 67 percent women and 84 percent people of color, despite the fact that these groups are typically less likely to participate in clinical trials. The study was designed in partnership with the HIV community and used unique strategies to encourage women and people of color living with HIV to participate in the trial. For example, GRACE participants could receive support to cover costs associated with study participation, including assistance for travel, childcare and food vouchers, and study sites could access grants for patient support activities such as lunch-and-learn sessions and patient support groups for ongoing education and camaraderie.
“The GRACE trial was made possible through widespread collaboration between Tibotec Therapeutics and the HIV community, providing an example of what needs to be done to truly address disparities in HIV care,” said Glenn Mattes, President of Tibotec Therapeutics. “Individuals who participated in GRACE have played a historic role in advancing the understanding of HIV treatment in women and people of color.”
GRACE Study DesignGRACE (Gender, Race And Clinical Experience) compared gender differences in the efficacy, safety, and tolerability of PREZISTA (600 mg with 100 mg ritonavir twice daily) in combination with other HIV medications over 48 weeks in HIV-1-infected women and men who have previous treatment experience.
What the HIV Community Can Learn from GRACEThe GRACE study showed that successful management of HIV comes from a combination of support and appropriate treatment. People who are living with HIV can develop a strong network of support by:• Identifying friends and family members who will offer encouragement and care• Drawing on the support of others living with HIV, either on a one-on-one basis or by joining a support group for people living with HIV • Tapping into local HIV/AIDS service organizations and community groups for information and a broad range of assistance and services• Partnering with their health care providers to understand their treatment options and take an active role in managing their disease
For more information about the GRACE study, local GRACE events, and information for people living with HIV, visit www.TheGraceStudy.com.
Selected Important Safety Information• PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others• PREZISTA, together with Norvir, has rarely been observed to cause liver problems which may be life-threatening.• Rarely, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare professional if you develop a rashPlease see additional Safety Information below.
About PREZISTAPREZISTA® (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 the likelihood of your overall treatment response. Your healthcare professional will work with you to find the right combination of other HIV medicines• The long-term effects of PREZISTA therapy are unknown at this time. It is important that you remain under the care of your healthcare professional
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.Please read Important Safety Information below, and talk to your healthcare professional to learn more about PREZISTA.
Important Safety Information• PREZISTA, together with Norvir, has rarely been observed to cause liver problems which may be life-threatening. It was not always clear if PREZISTA caused these liver problems because some patients had other illnesses or were taking other medicines. Your healthcare professional should do blood tests prior to initiating combination treatment including 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
Talk to your healthcare professional about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale-colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs• Skin rashes have been reported in patients taking PREZISTA. Rarely, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare professional if you develop a rash • Taking PREZISTA with certain medicines could cause serious and/or life-threatening side effects or may result in loss of its effectiveness. Do not take PREZISTA if you are taking the following medicines: dihydroergotamine (D.H.E.45®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), lovastatin (Mevacor®, Altoprev®, Advicor ® ), pravastatin (Pravachol®), simvastatin (Zocor®, Simcor®, Vytorin®), or products containing St. John's wort• Before taking PREZISTA, tell your healthcare professional if you are taking sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®), atorvastatin (Lipitor®), atorvastatin/amlodipine (Caduet®), or rosuvastatin (Crestor®). 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• 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• Before taking PREZISTA, tell your healthcare professional if you have any medical conditions, including allergy to sulfa medicines, diabetes, liver problems (including hepatitis B or C), or hemophilia • Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeedingo 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 youo Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby• 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• As with other protease inhibitors, taking PREZISTA may strengthen the body’s immune response, enabling it to begin to fight infections that have been hidden. Patients may experience signs and symptoms of inflammation that can include swelling, tenderness, or redness • The most common side effects related to taking PREZISTA include diarrhea, nausea, headache, and abdominal pain. Uncommon but severe side effects such as inflammation of the pancreas and increased blood fat levels have also been rarely reported. This is not a complete list of all possible side effects. If you experience these or other symptoms, 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
This is not a complete list of all adverse drug reactions reported with the use of PREZISTA/r. Please see full Prescribing Information for more details. Full prescribing information is also available at www.PREZISTA.com.
About Tibotec TherapeuticsTibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
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