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Tibotec Therapeutics Recognizes National Latino AIDS Awareness Day With Information and Insights for the Latino Community
Date:10/15/2009

BRIDGEWATER, N.J., Oct. 15 /PRNewswire/ -- In support of National Latino AIDS Awareness Day, Tibotec Therapeutics is launching a new initiative to expand its commitment to raising awareness of HIV/AIDS issues in the Latino community. The company is sharing findings from the GRACE (Gender, Race And Clinical Experience) study, the largest clinical study to date in North American women previously treated with HIV medications (treatment-experienced) to compare gender differences in the efficacy, safety, and tolerability of an HIV medication as part of combination therapy.

In addition, Tibotec is hosting a series of local patient education events in which a panel of patients, physicians, and advocates will discuss the design of the GRACE study and what the HIV community can learn from it.

"National Latino AIDS Awareness Day gives us an opportunity to look at racial disparities in the treatment of HIV/AIDS and search for solutions to help break down barriers in education and access to quality care," said Guillermo Chacon Interim Executive Director of the Latino Commission on AIDS. "Studies like GRACE show us that managing HIV takes more than just treatment--it also requires finding a network of support through family, friends, community, health care professionals and treatment education."

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.

Latinos, in particular, may face certain challenges when it comes to HIV treatment and prevention. For example, the rates of sexually transmitted diseases, which can increase the chances of contracting HIV, are higher for Hispanics/Latinos than for other groups. In addition, more than 1 in 5 Hispanics/Latinos live in poverty. Problems associated with poverty, including unemployment, a lack of formal education, inadequate or lack of health insurance, and limited access to high-quality health care, can increase the risk for HIV infection.

The GRACE study enrolled 67 percent women and 84 percent people of color. Feedback from the HIV community and HIV treaters was used in developing the study design. For example, GRACE participants could receive assistance for travel, childcare, and food, and study sites could access grants for activities such as patient support groups and lunch-and-learn sessions for ongoing education and camaraderie.

GRACE Study Design

GRACE evaluated gender differences in the efficacy, safety, and tolerability of PREZISTA® (tablets)/ritonavir (600mg/100 mg twice daily) in combination with other HIV medications over 48 weeks in HIV-1-infected women and men who have received HIV treatments in the past. The main purpose of this study was to measure the percentages of women and men achieving an undetectable viral load of <50 copies/mL at week 48. Among Hispanic patients in the study, 63 percent were women, compared with 72 percent and 52 percent of African American and Caucasian patients, respectively.

What the HIV Community Can Learn from GRACE

"With HIV on the rise in multicultural communities, it's critical that we conduct studies like GRACE that reflect the realities of HIV prevalence today," said Dr. Carmen Zorrilla, an investigator for the GRACE study and professor of OB-GYN at University of Puerto Rico School of Medicine. "The GRACE study showed us that large numbers of women and people of color can be successfully recruited and treated in a clinical trial when the right strategies are in place to help them do so."

The GRACE study showed that 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 community groups for information and a broad range of assistance and services
  • Partnering with their health care providers to take an active role in managing their disease

For more information about the GRACE study, local GRACE events, and tips and tools for living with HIV, visit www.TheGraceStudy.com.

Selected Important Safety Information for PREZISTA

  • 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 rash

Please see additional Important Safety Information below.

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 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.

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 supplement
  • 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 breastfeeding
    • 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
    • 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 accompanying full Prescribing Information for more details. Full prescribing information is also available at www.PREZISTA.com.

About Tibotec Therapeutics

Tibotec 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.

About the Latino Commission on AIDS

The Latino Commission on AIDS (LCOA) is a nonprofit membership organization founded in 1990 dedicated to fighting the spread of HIV/AIDS in the Latino/Hispanic communities. The Commission is the leading national Latino AIDS organization coordinating National Latino AIDS Awareness Day and other prevention and advocacy programs in more than 40 States and Puerto Rico. For more information visit: www.latinoaids.org or www.nlaad.org. UNIDOS PODEMOS / UNITED WE CAN

SOURCE Tibotec Therapeutics


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SOURCE Tibotec Therapeutics
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