The GRACE study (Gender, Race And Clinical Experience) is now recruiting participants for the largest clinical study to date in treatment-experienced adult women with HIV to evaluate gender and race differences in response to an HIV medication. On the occasion of the seventh annual National Black HIV/AIDS Awareness Day on February 7, the study's sponsor, Tibotec Therapeutics Clinical Affairs, a division of Ortho Biotech Clinical Affairs, LLC, is seeking to raise awareness among African-American women of the trial and its importance to the treatment of HIV.
Today, women account for nearly one-third of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color. African-American women, who represent only 13% of the U.S. female population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents. We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications," said Debbie Hagins, M.D., Clinical Director of Outpatient Services, a Ryan White funded clinic in Savannah, GA, and an investigator in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with ritonavir and other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes. Eligibility is open to men and women of all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24- week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I am encouraged to see studies like GRACE that are designed to learn more about HIV treatment in treatment-experienced African-Americans and women in the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy Award-winning journalist. "GRACE is an example of the steps that need to be taken to address the evolving HIV epidemic in the African-American community, and those who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women and people of color."
The GRACE study will include approximately 50 sites in the United States, Mexico and Canada, and will seek to enroll approximately 420 participants, 70 percent of whom will be women. Participants must be of 18 years or older, have a viral load of 1000 copies/mL or greater and have previous intolerance or failure to prior therapy consisting of a protease inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based highly active antiretroviral treatment regimen of at least 12 weeks. All participants will receive PREZISTA/r (600/100mg twice a day) with an optimized background regimen chosen by the investigator and based on resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in treatment-naГЇve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/rtv. This list of potential drug interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical trials (n=924), rash (all grades, regardless of causality) occurred in seven percent of subjects treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic impairment. There are no data regarding the use of PREZISTA in patients with varying degrees of hepatic impairment; therefore, specific dosage recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women. The effects of PREZISTA on pregnant women or their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently reported drug-related adverse events of at least moderate to severe intensity in patients receiving PREZISTA/rtv-containing regimen were headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of 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 Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Therapeutics
http://www.tibotectherapeutics.com
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