African-American Women Who Have Received HIV Treatment Are Sought To Participate In GRACE Study

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-na??ve 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

tibotectherapeutics


View drug information on Prezista.