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Datum nieuwsfeit: 17-11-2005
Voorbereidende 24-weekse data betreft impact van overgang van tweemaal daags Combivir naar eenmaal daags Truvada voor patienten met HIV op tiende Europese AIDS conferentie gepresenteerd
( BW)(CA-GILEAD-SCIENCES)(GILD) Preliminary 24-Week Data Evaluating
the Impact of Switching from Twice-Daily Combivir to Once-Daily
Truvada in Patients with HIV Presented at 10th European AIDS
Conference
Business Editors/Health/Medical Writers
BIOWIRE2K
10th European AIDS Conference
DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 17, 2005--Gilead Sciences,
Inc. (Nasdaq:GILD) today announced the presentation of preliminary
24-week data from the COMET (Combination of Efavirenz and Truvada)
study at the 10th European AIDS Conference (EACS), November 17-20,
2005 in Dublin, Ireland. Data suggest that in HIV-infected
treatment-experienced patients who switched from twice-daily
Combivir(R) (lamivudine 150 mg/zidovudine 300 mg) to once-daily
Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), both in
combination with efavirenz, the percentage of patients that achieved
virologic suppression below 50 copies/mL was significantly higher at
week 24 compared to baseline. Hemoglobin levels also increased
significantly from baseline. Data will be presented (Poster #PE7.3/5)
by study investigator Peter Ruane, MD of Lifesource Medical Inc. in
Los Angeles, California.
"The simplicity, tolerability and virologic benefit provided by a
fixed-dose combination backbone are important considerations in
helping promote long-term positive clinical outcomes," said Norbert
Bischofberger, PhD, Executive Vice President, Research and
Development, Gilead Sciences. "These data suggest that switching
virologically suppressed patients from Combivir to Truvada may be a
valuable treatment strategy for physicians and patients who are
seeking to further simplify a regimen or address side effects observed
with other therapies."
Study Results
The COMET study is a U.S.-based, single-arm, multi-center 24-week
Phase IV clinical trial evaluating the impact of switching
virologically suppressed HIV-infected treatment-experienced patients
from a regimen of twice-daily Combivir and once-daily efavirenz to a
simplified once-daily regimen of Truvada and efavirenz. Enrollment in
the COMET study was completed in August 2005 with 411 patients
enrolled in the study. At study entry, all patients were to have
received Combivir for at least eight weeks and have a viral load less
than 400 copies/mL. Study endpoints include viral suppression less
than 400 and 50 copies/mL, change in CD4 cell count, changes in
patients' hemoglobin levels and lipid profile and responses to a
questionnaire evaluating symptoms, adherence and treatment
satisfaction (SATS).
Of the 411 total enrolled patients, 198 reached week 24 at the
time of this analysis. Nineteen patients discontinued the study prior
to week 24, of which six withdrew due to adverse events, two for
pregnancy, five for protocol violation or noncompliance and six were
lost to follow up, withdrew consent or withdrew for other reasons.
Baseline characteristics were assessed on 217 patients, who either
reached week 24 (n=198) or withdrew early from the study (n=19). Of
these 217 patients, 86 percent were male, 71 percent were white, 22
percent were black and the median age was 42 years. Eighty-nine
percent of patients had taken Combivir for longer than one year and
the median duration of prior Combivir use (or use of its component
drugs) was four years. Eighty-six percent of patients switched to
Truvada for regimen simplification, 6 percent of patients switched
because of Combivir-related adverse events and 8 percent of patients
cited both regimen simplification and Combivir-related adverse events
as reasons for switching.
Based on analysis of all available 24 week data, 76 percent of
patients had viral load of less than 50 copies/mL compared to 59
percent at baseline (n=189; p less than 0.001). Ninety-four percent of
patients maintained viral load of less than 400 copies/mL (n=189).
Hemoglobin increased significantly from baseline (median +0.6 g/dL;
n=191; p less than 0.001) with 32 percent of patients experiencing at
least 1 g/dL increase in hemoglobin. The most common adverse events
observed were nausea, diarrhea and headache. Of the 172 patients who
completed a SATS questionnaire, a significantly greater percentage of
patients reported being very satisfied with the treatment regimen at
24 weeks (85 percent) compared to baseline (58 percent; p less than
0.001).
Data from the COMET study have not been reviewed by the United
States Food and Drug Administration (FDA). Changes in body fat have
been observed in patients taking anti-HIV medicines, including the
component drugs of Truvada. The cause and long-term health effect of
this condition is unknown. For the detailed indication and important
safety information from the U.S. prescribing information for Truvada,
see below.
The parent compound of one of the component drugs in Truvada,
tenofovir disoproxil fumarate, was discovered through a collaborative
research effort between Dr. Antonin Holy, Institute for Organic
Chemistry and Biochemistry, Academy of Sciences of the Czech Republic
(IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical
Research, Katholic University in Leuven, Belgium. The inventors have
agreed to waive their right to a royalty on sales of products
containing tenofovir in the developing countries served by the Gilead
Access Program to ensure the product can be offered at a no-profit
price in parts of the world where the AIDS epidemic has hit the
hardest.
It is important that patients be aware that individual HIV
medications must be taken as part of combination regimens, and that
they do not cure HIV infection or prevent passing HIV to others.
About Truvada
Truvada combines Emtriva(R) (emtricitabine) and Viread(R)
(tenofovir disoproxil fumarate) in one tablet taken once a day in
combination with other antiretroviral agents. In the United States,
Truvada is indicated in combination with other antiretroviral agents
(such as non-nucleoside reverse transcriptase inhibitors or protease
inhibitors) for the treatment of HIV-1 infection in adults. Safety and
efficacy studies using Truvada tablets or using Emtriva and Viread in
combination are ongoing.
Emtriva and Viread have each been studied as part of multi-drug
regimens and have been found to be safe and effective. In clinical
study 303, Emtriva and lamivudine (3TC) demonstrated comparable
efficacy, safety and resistance patterns as part of multidrug
regimens. These data, and those from study 903, in which lamivudine
and tenofovir were used in combination, support the use of Truvada for
the treatment of HIV-1 infection in treatment-naive adults. In
treatment-experienced patients, the use of Truvada should be guided by
laboratory testing and treatment history.
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogues
alone or in combination with other antiretrovirals. Truvada is not
indicated for the treatment of chronic hepatitis B virus (HBV)
infection and its safety and efficacy has not been established in
patients co-infected with HBV and HIV. Severe acute exacerbations of
hepatitis B have been reported in patients who have discontinued
Viread or Emtriva. Hepatic function should be monitored closely with
both clinical and laboratory follow-up for at least several months in
patients who discontinue Truvada and are co-infected with HIV and HBV.
If appropriate, initiation of anti-hepatitis B therapy may be
warranted.
There are no study results demonstrating the effect of Truvada on
clinical progression of HIV-1, and it is not recommended that Truvada
be used as a component of a triple nucleoside regimen. Truvada should
not be used with Emtriva or Viread, or other drugs containing
lamivudine, including Combivir, Epivir(R), Epivir-HBV(R), Epzicom(TM)
or Trizivir(R). No drug interaction studies have been conducted using
Truvada. Drug interactions have been observed when didanosine,
atazanavir, or lopinavir/ritonavir are co-administered with Viread, a
component of Truvada, and dose adjustments may be necessary. Data are
not available to recommend a dose adjustment of didanosine for
patients weighing less than 60 kg. Patients on atazanavir or
lopinavir/ritonavir plus Truvada should be monitored for
Truvada-associated adverse events that may require discontinuation.
When co-administered with Viread, it is recommended that atazanavir
300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir
should not be co-administered with Viread. Immune reconstitution
syndrome has been reported in patients treated with combination
antiretroviral therapy, including Emtriva and Viread.
Two-hundred eighty-three patients have received combination
therapy with Emtriva and Viread with either a non-nucleoside reverse
transcriptase inhibitor or protease inhibitor for 24 to 48 weeks in
ongoing clinical studies. Based on these limited data, no new patterns
of adverse events were identified and there was no increased frequency
of established toxicities.
Adverse events that occurred in more than 5 percent of patients
receiving Emtriva with other antiretroviral agents in clinical trials
include abdominal pain, asthenia (weakness), headache, diarrhea,
nausea, vomiting, dizziness and rash (rash, pruritis, maculopapular
rash, urticaria, vesiculobullous rash, pustular rash and allergic
reaction). Approximately 1 percent of patients discontinued
participation because of these events. All adverse events were
reported with similar frequency in Emtriva and control treatment
groups with the exception of skin discoloration which was reported
with higher frequency in the Emtriva treated group. Skin
discoloration, manifested by hyperpigmentation on the palms and/or
soles, was generally mild and asymptomatic. The mechanism and clinical
significance are unknown.
The most common adverse events and those occurring in more than 5
percent of patients receiving Viread with other antiretroviral agents
in clinical trials include asthenia, pain, abdominal pain, headache,
nausea, diarrhea, vomiting, rash (rash, pruritis, maculopapular rash,
urticaria, vesiculobullous rash and pustular rash), flatulence,
dizziness and depression. Less than 1 percent of patients discontinued
participation because of gastrointestinal events. Renal impairment,
including serious cases, has been reported. Renal impairment occurred
most often in patients with underlying systemic or renal disease or in
patients taking concomitant nephrotoxic agents, though some cases have
appeared in patients without identified risk factors. Decreases in
bone mineral density (BMD) at the lumbar spine and hip and increases
in biochemical markers of bone metabolism have been seen with the use
of Viread. The clinical significance of changes in BMD and biochemical
markers is unknown and follow-up is continuing to assess long-term
impact.
For complete prescribing information for Truvada, visit
www.truvada.com. For safety and efficacy studies using Emtriva or
Viread in combination with other antiretroviral agents, please consult
the prescribing information for these products.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of unmet
medical need. The company's mission is to advance the care of patients
suffering from life-threatening diseases worldwide. Headquartered in
Foster City, California, Gilead has operations in North America,
Europe and Australia.
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995, that
are subject to risks, uncertainties and other factors, including the
risk that the safety and efficacy data obtained through the COMET
study will not be observed through longer treatment periods or in
other studies. These risks and uncertainties could cause actual
results to differ materially from those referred to in the
forward-looking statements. Risks are described in detail in the
Gilead Annual Report on Form 10-K for the year ended December 31, 2004
and in Gilead's Quarterly Reports on Form 10-Q, all of which are on
file with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead and Gilead assumes no obligation to update any
such forward-looking statements.
For full prescribing information, please visit www.Truvada.com.
Truvada is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the
company's website at www.gilead.com or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
--30--AD/sf*
CONTACT: Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
James Loduca, 650-522-5908 (Media)