[Ip-health] BMS/GSK 3-in-1 Combo Pill
Mike Palmedo
mpalmedo@cptech.org
Wed, 10 Jul 2002 17:24:18 -0400
http://www.stockhouse.com/news/news.asp?tick=BMY&newsid=1227210
BMS Press release
Once-Daily HIV Medications Pave Way for Simplified Combination Drug
Regimens
7/10/02
- New Formulations May Help Patients Adhere to Medication Schedule -
PRINCETON, N.J., Jul 10, 2002 /PRNewswire-FirstCall via COMTEX/ -- A
once-daily drug regimen comprised of three leading anti-HIV medications
may allow HIV patients, who previously followed complicated, multi-dose
drug regimens, to create a once-daily combination therapy to reduce the
frequency of dosing of their HIV treatment. The combination of the
once-daily formulations of VIDEX EC(R) (didanosine, ddI), EPIVIR(R)
(lamivudine, 3TC-[GlaxoSmithKline]) and SUSTIVA(R) (efavirenz) therapy
provides a new option for simplifying patients' medication schedules.
Each drug is strongly recommended by the U.S. Department of Health and
Human Services (DHHS) Guidelines for use in first-line combination
treatment of HIV-infected individuals.
"Physicians and patients alike find that simple, easy-to-use HIV
regimens result in greater patient adherence and offer greater potential
for successful treatment outcomes," said Brian Boyle, MD, assistant
professor, Cornell University Medical College and attending physician,
New York-Presbyterian Hospital. "By reducing the pill burden, once-daily
regimens may enable patients to manage their regimen and may help
improve patient adherence. In turn, this may lessen the burden
associated with complicated dosing schedules."
Combination therapy for the treatment of HIV/AIDS typically involves a
burdensome pill-taking regimen, in which patients may take upward of 20
pills per day at various intervals. The burden of maintaining this
regimen may interfere with everyday living and negatively impact patient
adherence.
Research has shown that adherence is important to virologic success.
Yet, only 25 percent of HIV patients achieve adherence rates of 80
percent or better. Poor adherence can compromise the effectiveness of a
regimen and can increase the likelihood of developing resistance to
medication(s).
"BMS Virology has the distinct mission of being a leader in the fight
against HIV/AIDS," said Jeffrey Hatfield, senior vice president,
Bristol-Myers Squibb Virology. "The availability of VIDEX EC(R) and
SUSTIVA(R) is a major advancement in providing HIV patients once-daily
dosing simplicity in the management of HIV."
Data and Opinion Polls Point to Patient Preference for Once-Daily
Regimens
Data presented at a major medical meeting indicated that patients prefer
to take an all-inclusive, once-daily HIV regimen (7.59 patient impact
score on a 10-point scale) compared to a twice-daily regimen (4.91 out
of 10) (n=550; p value less than 0.05). Additional surveys reveal a
strong patient preference for once-daily dosing regimens. Seventy-three
percent of 280 patients surveyed indicated they would prefer taking all
their medication once during the day, either in the morning or in the
evening. Almost 89 percent of 256 respondents reported that they would
be more likely to follow their dosing regimen if they could take their
medication once daily.
VIDEX EC (didanosine), in combination with other antiretroviral agents,
is indicated for the treatment of HIV-1 infection in adults.
Fatal and non-fatal pancreatitis (inflammation of the pancreas) have
occurred. Your doctor will tell you to stop taking VIDEX EC if
pancreatitis is suspected. An increase of lactic acid in the blood
(lactic acidosis), an enlarged liver, and liver failure, which can cause
death, have been reported. Fatal lactic acidosis has occurred in
pregnant women receiving the combination of didanosine and stavudine.
VIDEX EC(R) (didanosine) may cause vision changes and numbness,
tingling, or pain in the hands or feet (neuropathy). If you are taking
VIDEX EC in combination with other medicines that may cause similar side
effects, you may have a higher chance of developing these effects.
Frequent side effects reported in VIDEX EC-containing triple combination
regimens are diarrhea, tingling or pain in the hands or feet, nausea,
headache, rash, and vomiting. Tell your doctor if you become pregnant
while taking VIDEX EC. VIDEX EC should be used during pregnancy only
after discussion with your doctor.
VIDEX EC should only be taken once a day. VIDEX EC does not cure HIV
infection or prevent passing HIV to others.
SUSTIVA(R) (efavirenz) is a once-daily non-nucleoside reverse
transcriptase inhibitor (NNRTI) used in combination therapy for the
treatment of HIV. In February of this year, the FDA approved a new
formulation of SUSTIVA-a 600 mg tablet once-daily -- as an alternative
to three 200-mg capsules once-daily (as SUSTIVA has been used since it
was approved in September 1998).
In February 2002, the U.S. Department of Health and Human Services
(DHHS) continued, for the third year in a row, to list SUSTIVA as the
only non- nucleoside reverse transcriptase inhibitor "strongly
recommended" for use in first-line combination with NRTIs for the
treatment of HIV-infected individuals. It is recommended that SUSTIVA be
taken on an empty stomach, preferably at bedtime.
Many patients have dizziness, trouble sleeping, drowsiness, trouble
concentrating, and/or unusual dreams. These feelings tend to go away
after taking SUSTIVA for a few weeks. A small number of patients taking
SUSTIVA have reported severe depression, strange thoughts, or angry
behavior. There have been occasional reports of suicide but SUSTIVA has
not been established as the cause. One of the most common side effects
is rash which is usually mild and goes away in a few weeks.
SUSTIVA should not be taken with Hismanal(R) (astemizole), Propulsid(R)
(cisapride), Versed(R) (midazolam), Halcion(R) (triazolam) or ergot
derivatives. Tell your doctor about any medication or herbal products
(particularly St. John's wort) that you are taking. Women should not
become pregnant or breastfeed while taking SUSTIVA(R) (efavirenz).
SUSTIVA does not cure HIV or prevent passing HIV to others.
Bristol-Myers Squibb Company (NYSE: BMY) is a $19 billion pharmaceutical
and related health care products company whose mission is to extend and
enhance human life.
For full VIDEX EC(R) (didanosine) or SUSTIVA prescribing information,
please visit the company's website at www.BMSVirology.com or call
1-800-426-7644.
SUSTIVA(R) is a registered trademarks of Bristol-Myers Squibb Pharma
Company.
VIDEX EC(R) is a registered trademark of Bristol-Myers Squibb Company.
EPIVIR(R) is manufactured by, and a registered trademark of,
GlaxoSmithKline.
The other brands listed are the registered trademarks of their
respective owners and are not the trademarks of Bristol-Myers Squibb.
CONTACT: David M. Rosen of Bristol-Myers Squibb Company, Mobile Phone in
Barcelona (until July 12, 2002), +011-44-77-30-91-8614, Office Phone,
+1-609-897-4763, david.m.rosen@bms.com , or Dan Lathitham of
Golin-Harris International, +1-312-729-4318, dlathitham@golinharris.com
, for Bristol-Myers Squibb Company.
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SOURCE Bristol-Myers Squibb Company
CONTACT: David M. Rosen of Bristol-Myers Squibb Company, Mobile
Phone in
Barcelona (until July 12, 2002),
+011-44-77-30-91-8614, Office Phone,
+1-609-897-4763, david.m.rosen@bms.com , or Dan
Lathitham of Golin-Harris
International, +1-312-729-4318,
dlathitham@golinharris.com , for Bristol-Myers
Squibb Company
URL: http://www.BMSVirology.com
http://www.prnewswire.com
--
Mike Palmedo
Consumer Project on Technology
Tel: 202-387-8030
Fax: 202-234-5176
P.O. Box 19367
Washington, DC 20036
mpalmedo@cptech.org