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Alan Franciscus
Editor-in-Chief
To download pdf version click here
In This Issue:
• Bristol-Myers Squibb
Submits Applications in U.S. and Europe to Market Entecavir,
an Investigational Antiviral Treatment for Chronic Hepatitis
B Infection
• Valeant Pharmaceuticals to Present Remofovir
Pharmacokinetic and Pharmacodynamic Data from Phase 1 Clinical
Trial
• Money Unfairly Spent: Hep C Victims
• FDA Grants Priority Review to Market
Leader Pegasys(R) with Copegus(R) for Treatment of Hepatitis
C in HIV Patients
• Lamivudine Delays Clinical Progression
of Hepatitis B
• Dosanjh Asks Provinces How They Used
Money Intended for Hepatitis C Victims
• Clean-Needle Bill Passed by Assembly,
43-28
• Rituxan May Be Associated with HBV Reactivation
and Fulminant Hepatitis
October 4th,
2004
Bristol-Myers
Squibb Submits Applications in U.S. and Europe to Market Entecavir,
an Investigational Antiviral Treatment for Chronic Hepatitis
B Infection
Source: PRNewswire
PRINCETON, N.J.,-- Bristol-Myers Squibb
Company (NYSE: BMY - News) today announced the submission
of a New Drug Application to the U.S. Food and Drug Administration
for entecavir, an investigational antiviral agent under development
for the treatment of chronic Hepatitis B. In the European
Union, the Company also submitted a marketing authorization
application for entecavir to the European Medicines Evaluation
Agency.
Entecavir is an investigational oral antiviral
discovered at Bristol-Myers Squibb that is designed to selectively
inhibit the Hepatitis B virus, blocking all three steps in
the replication process.
Bristol-Myers Squibb is a global pharmaceutical
and related health care products company whose mission is
to extend and enhance human life.
Source: Bristol-Myers Squibb Company
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October 5th, 2004
Valeant
Pharmaceuticals to Present Remofovir Pharmacokinetic and Pharmacodynamic
Data from Phase 1 Clinical Trial
Source: PRNewswire
COSTA MESA, Calif., -- Valeant Pharmaceuticals
(NYSE:VRX) announced that an abstract based on remofovir pharmacokinetic
(PK) and pharmacodynamic (PD) study data has been posted to
the American Association for the Study of the Liver Conference
(AASLD) Web site. Valeant submitted the abstract based on
data from a Phase 1 clinical trial of remofovir, which is
being developed in oral form for the treatment of chronic
hepatitis B (HBV), for presentation at AASLD. Valeant will
present the data at AASLD in Boston on November 2, 2004.
The remofovir double-blind, placebo-controlled,
parallel group, multiple-dose Phase 1 study consists of 45
adult Asian patients with compensated HBV infection. All patients
were 18 years or older and had an HBV DNA viral load greater
than or equal to 3,000,000 copies/mL at screening. Eight to
ten patients were randomized to each of the remofovir dose
groups (5, 10, 20 and 30 mg) or placebo and were dosed for
28 days. Safety assessment included adverse events, physical
examination, vital signs and safety laboratory tests. Serum
HBV DNA levels were also determined in all patients predosing,
and on days one, eight, 15, 21 and 28 of treatment. Following
discontinuation of therapy, HBV levels were determined at
weeks four, eight and 12 using the COBAS Amplicor assay.
The most frequently reported adverse event
among all study patients was upper respiratory infection (30
percent). No dose-related trends regarding safety were identified
and no events resulted in a patient being withdrawn prematurely
from treatment.
At all doses, serum HBV DNA levels decreased
with time. After 28 days of remofovir treatment, the median
log(10) HBV decline from baseline was 1.64 at the 5 mg dose,
2.48 at the 10 mg dose, 2.72 at the 20 mg dose and 2.66 at
the 30 mg dose. In contrast, the placebo dose group had a
median log(10) drop of HBV DNA of 0.03.
A Phase 2 trial of remofovir was initiated
in July 2004. The Phase 2 study is an open-label, randomized,
multiple dose study that will enroll 220 patients at approximately
20 sites in the U.S., Taiwan, Singapore and Korea. The study
consists of five treatment groups: remofovir -- 5, 10, 20
and 30 mg/day, and adefovir dipivoxil -- 10 mg/day. Treatment
duration will be 48 weeks, with an interim analysis planned
for 24 weeks to evaluate safety and efficacy. Enrollment is
ongoing. Phase 2 is one phase in a multi-phase clinical evaluation
that may lead to the filing of a New Drug Application
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a global,
publicly traded, research-based specialty pharmaceutical company
that discovers, develops, manufactures and markets a broad
range of pharmaceutical products. More information about Valeant
can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of the federal securities laws relating to expectations,
plans or prospects for Valeant Pharmaceuticals, including
funding and conducting clinical trials and expected research
and development expenses. These statements are based upon
the current expectations and beliefs of Valeant Pharmaceuticals'
management and are subject to certain risks and uncertainties
that could cause actual results to differ materially from
those described in the forward-looking statements. These risks
and uncertainties include market conditions and other factors
beyond Valeant Pharmaceuticals' control, the company's success
in identifying and enrolling patients in the clinical trials
program, the absence of adverse events that would require
the clinical trials to be prematurely terminated, clinical
results that indicate continuing clinical and commercial pursuit
of Viramidine is advisable, and the risk factors and other
cautionary statements discussed in Valeant Pharmaceuticals'
filings with the U.S. Securities and Exchange Commission.
For more information, please contact Jeff
Misakian of Valeant Pharmaceuticals, +1-714-545-0100, ext.
3309.
Source: Valeant Pharmaceuticals International
CONTACT: Jeff Misakian of Valeant Pharmaceuticals,
+1-714-545-0100, ext. 3309
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October 6th, 2004
Money
Unfairly Spent: Hep C Victims
Source: www.cbc.ca
TORONTO - Advocates for hepatitis C victims
say they will ask the federal auditor general to investigate
whether provinces are unfairly diverting money promised years
ago.
In 1998, then federal health minister Allan Rock announced
$300 million for people who got hepatitis C from bad blood
prior to 1986 and after 1990. It was to be distributed among
the provinces to cover health-care costs not covered by medicare.
However, in the case of Ontario, the money promised to victims
is sitting in the province’s general revenue fund.
FROM MAY 22, 2001: Hep C victims say money being misdirected
Ontario Health Minister George Smitherman says the money received
from Ottawa to defray medical expenses from the blood-borne
disease was never intended to go directly to victims.
He says the previous Conservative government signed a legal
agreement with Ottawa to use the money to pay for care for
all people with hepatitis C, not just those who contracted
it from contaminated blood.
“My understanding is Ontario has been applying these
funds in exactly the same manner as every other province in
the land. And that is in keeping with the legal agreement
that was signed,” said Smitherman.
Health ministers from Alberta and Nova Scotia say they’ve
been using the money the same way as Ontario.
“The money went into helping all patients with hepatitis
C, as I indicated, we’re helping them with the issue
of education, prevention and treatment,” said N.S. Health
Minister Angus McIsaac.
John Plater, the president of Hemophilia Ontario, says the
money was supposed to go to people infected by tainted blood.
He plans to ask the federal auditor general to investigate.
“The federal government shouldn’t be allowed to
stand up in public and tell the world how they’re going
to spend their money, and then behind close doors, do deals
that doesn’t send the money where they said it would
go,” said Plater.
Plater says hundreds of people infected by tainted blood have
died without the enhanced care and treatment they were promised.
Written by CBC News Online staff
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FDA
Grants Priority Review to Market Leader Pegasys(R) with Copegus(R)
for Treatment of Hepatitis C in HIV Patients
Source: PRNewswire
-- Signals Major Step Toward Satisfying Unmet Medical
Need --
NUTLEY, N.J., -- The U.S. Food and Drug
Administration (FDA) has granted a six-month Priority Review
Status to the supplemental new biologics license application
(sBLA) for Roche’s combination therapy of Pegasys®
(peginterferon alfa-2a) in combination with Copegus® (ribavirin,
USP) for the treatment of chronic hepatitis C in patients
co-infected with HIV. Roche submitted this file with the FDA
in August 2004.
Pegasys, the most prescribed hepatitis C medication in the
U.S., is approved for use alone and in combination with Copegus
for the treatment of adults with chronic hepatitis C. Priority
review designation was granted for the Pegasys and Copegus
submission in co-infected patients because the indication
would address an unmet medical need.
“There are currently no approved treatments for the
approximately 300,000 people in the United States with HIV
who are infected with hepatitis C,” said Juan Carlos
Lopez-Talavera, M.D., Ph.D., Senior Medical Director, Roche.
“Roche invested in the research to pursue an indication
for Pegasys combination therapy in co-infected patients because
we recognized that the need is urgent. Liver failure resulting
from chronic hepatitis C is now one of the leading causes
of death in people with HIV.”
HCV and HIV are the two most prevalent blood-borne infections
in the United States, and HCV/HIV co-infection is increasingly
recognized as a growing public health problem. According to
the Centers for Disease Control, hepatitis C has become a
major cause of death for people with HIV. Almost four million
Americans are believed to have chronic hepatitis C.
The file submitted to the FDA includes results from APRICOT
(AIDS Pegasys Ribavirin International Co-infection Trial),
the largest study conducted to date evaluating chronic hepatitis
C treatment in patients co-infected with HIV and HCV. APRICOT
is one of the six Pegasys studies published in The New England
Journal of Medicine. The results showed that 40 percent of
patients treated with Pegasys and Copegus achieved a sustained
virological response (SVR). SVR refers to a patient’s
continued undetectable hepatitis C virus levels in the blood
24 weeks after finishing a course of treatment.
About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus were approved
by the FDA in December 2002 for use in combination for the
treatment of adults with chronic hepatitis C who have compensated
liver disease and have not previously been treated with interferon
alpha. Patients in whom efficacy was demonstrated included
patients with compensated liver disease and histological evidence
of cirrhosis.
Pegasys is dosed at 180mcg as a subcutaneous injection taken
once a week. Copegus is available as a 200mg tablet, and is
administered orally two times a day as a split dose.
Roche has backed Pegasys with the most extensive clinical
research program ever undertaken in hepatitis C, with major
studies initiated to advance treatment for hepatitis C patients
with unmet needs, including patients co-infected with HIV
and HCV, African Americans, patients with cirrhosis, patients
with normal ALT levels, and patients who have failed to respond
to previous therapy.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is
the U.S. prescription drug unit of the Roche Group, a leading
research-based health care enterprise that ranks among the
world’s leaders in pharmaceuticals and diagnostics.
Roche discovers, develops, manufactures and markets numerous
important prescription drugs that enhance people’s health,
well-being and quality of life. Among the company’s
areas of therapeutic interest are: dermatology; genitourinary
disease; infectious diseases, including influenza; inflammation,
including arthritis and osteoporosis; metabolic diseases,
including obesity and diabetes; neurology; oncology; transplantation;
vascular diseases; and virology, including HIV/AIDS and hepatitis
C.
For more information on the Roche pharmaceuticals business
in the United States, visit the company’s web site at:
http://www.rocheusa.com
Facts About Pegasys (Peginterferon
alfa-2a) in Combination with Copegus Indication
• Pegasys®, a pegylated alpha interferon,
alone or in combination with Copegus® (ribavirin, USP)
is indicated for the treatment of adults with chronic hepatitis
C who have compensated liver disease and have not previously
been treated with interferon alpha. Patients in whom efficacy
was demonstrated included patients with compensated liver
disease and histological evidence of cirrhosis (Child-Pugh
class A).
Dosing and Administration
• Pegasys, a premixed solution, is dosed at 180mcg as
a subcutaneous injection once a week. Copegus, available as
a 200mg tablet, is administered at 800 to 1200mg taken twice
daily as a split dose. The two products are sold separately.
Combination Therapy Clinical Studies
• The two combination therapy pivotal study findings:
• Study 5, published in the March 2, 2004 Annals
of Internal Medicine, including 1,284 patients receiving
medication, showed that patients with certain genotypes (strains)
of the hepatitis C virus should be treated with different
dosing regimens of Pegasys and Copegus. The treatment regimens
and resulting sustained virological response rates for these
groups treated with Pegasys and Copegus therapy were:
• Genotype 1: 48 week duration with 1000 - 1200mg Copegus:
51 percent
• Genotype non-1: 24 week duration with 800mg Copegus:
82 percent , Study 4, published in the September 26, 2002
New England Journal of Medicine, including 1,121 patients
receiving medication, showed that Pegasys and Copegus combination
therapy is a more effective treatment for chronic hepatitis
C than interferon alfa-2b and ribavirin. The sustained virological
response rate in the Pegasys and Copegus treated patients
was 53 percent compared to 44 percent in the interferon alfa-2b
and ribavirin group. Sustained virological response refers
to a patient’s continued undetectable serum hepatitis
C RNA levels 24 weeks after finishing a course of treatment.
Adverse Events
• Alpha interferons, including Pegasys, may cause or
aggravate fatal or life-threatening neuropsychiatric, autoimmune,
ischemic, and infectious disorders. Patients should be monitored
closely with periodic clinical and laboratory evaluations.
Therapy should be withdrawn in patients with persistently
severe or worsening signs or symptoms of these conditions.
In many, but not all cases, these disorders resolve after
stopping Pegasys therapy (see Contraindications, Warnings,
Precautions and Adverse Events in complete product information).
• Use with Ribavirin. Ribavirin, including Copegus may
cause birth defects and/or death of the fetus. Extreme care
must be taken to avoid pregnancy in female patients and in
female partners of male patients. Ribavirin causes hemolytic
anemia. The anemia associated with ribavirin therapy may result
in worsening of cardiac disease. Ribavirin is genotoxic, mutagenic,
and should be considered a potential carcinogen (see Contraindications,
Warnings, Precautions and Adverse Events in complete product
information).
• Pegasys is contraindicated in patients with hypersensitivity
to Pegasys or any of its components, autoimmune hepatitis,
and decompensated hepatic disease (Child-Pugh class B and
C) before or during treatment with Pegasys. Pegasys is also
contraindicated in neonates and infants because it contains
benzyl alcohol. Benzyl alcohol has been reported to be associated
with an increased incidence of neurological and other complications
in neonates and infants, which are sometimes fatal. Pegasys
and Copegus therapy is additionally contraindicated in patients
with a hypersensitivity to Copegus or any of its components,
women who are pregnant, men whose female partners are pregnant,
and patients with hemoglobinopathies (eg, thalassemia major,
sickle-cell anemia).
• Copegus therapy should not be started unless a report
of a negative pregnancy test has been obtained immediately
prior to initiation of therapy. Women of childbearing potential
and men must use two forms of effective contraception during
treatment and during the six months after treatment has concluded.
Routine monthly pregnancy test must be performed during this
time. If pregnancy should occur during treatment or during
six months post-therapy, the patient must be advised of the
significant teratogenic risk of Copegus therapy to the fetus.
Physicians and patients are strongly encouraged to report
any pregnancies that do occur to Roche by calling 1-800-526-6367.
• The most common adverse events reported for Pegasys
and Copegus combination therapy, observed in clinical trials
(nE1), were fatigue/asthenia (65%), headache (43%), pyrexia
(41%), myalgia (40%), irritability/anxiety/nervousness (33%),
insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting
(25%), rigors (25%), anorexia (24%), injection site reaction
(23%), arthralgia (22%), depression (20%), pruritus (19%)
and dermatitis (16%).
• Serious adverse events include neuropsychiatric disorders
(suicidal ideation and suicide attempt), serious and severe
bacterial infections, bone marrow toxicity (cytopenia and
rarely, aplastic anemia), cardiovascular disorders (hypertension,
arrhythmias and myocardial infarction), hypersensitivity (including
anaphylaxis), endocrine disorders (including thyroid disorders
and diabetes mellitus), autoimmune disorders (including psoriasis
and lupus), pulmonary disorders (dyspnea, pneumonia, bronchiolitis
obliterans, interstitial pneumonitis and sarcoidosis), colitis
(ulcerative and hemorrhagic/ischemiccolitis), pancreatitis,
and opthalmologic disorders (decrease or loss of vision, retinopathy
including macular edema and retinal thrombosis/hemorrhages,
optic neuritis and papilledema).
• The complete package inserts for Pegasys and Copegus
are available at http://www.pegasys.com
, or by calling 1-877-PEGASYS.
SOURCE: Roche
Web Sites: http://www.rocheusa.com;
http://www.pegasys.com
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Lamivudine
Delays Clinical Progression of Hepatitis B
Source: www.gastrohep.com
Continuous treatment with lamivudine delays disease progression
in patients with hepatitis B and advanced fibrosis or cirrhosis
by reducing risk of hepatocellular carcinoma, reports October
7th issue of The New England Journal of Medicine.
At present it is unknown just how effective antiviral therapy
is in preventing disease progression in patients with chronic
hepatitis B and advanced fibrosis or cirrhosis.
Professor Yun-Fan Liaw and colleagues selected 651 patients
with chronic hepatitis B who had histologically confirmed
cirrhosis or advanced fibrosis.
The participants were randomly assigned in a 2:1 ration to
receive lamivudine (100mg per day) or placebo for a maximum
of 5 years.
The researchers assigned 436 participants to receive lamivudine
and 215 to receive placebo.
The researchers were using ‘time to disease progression’
as their endpoint and this was defined by hepatic decompensation,
hepatocellular carcinoma, spontaneous bacterial peritonitis,
bleeding gastroesophageal varices, or death related to liver
disease.
The study was monitored by an independent data and safety
monitoring board that also performed the interim analyses
of the data.
The researchers terminated the study after a median duration
of treatment of 32.4 months because they found that there
was a significant difference between treatment groups in the
number of end points reached.
Hepatocellular carcinoma occurred in 3.9% in the lamivudine
group and 7.4% in the placebo group. --New England Journal
of Medicine
The researchers found that end points were reached by 7.8%
of patients receiving lamivudine and 17.7% of those receiving
placebo.
The researchers also found that the Child-Pugh score increased
in 3.4% of patients receiving lamivudine and 8.8% of those
receiving placebo.
However, hepatocellular carcinoma occurred in 3.9% of those
in the lamivudine group and 7.4% of those in the placebo group.
The team found that overall, 12% of the patients in the lamivudine
group and 18% of the patients in the placebo group reported
serious adverse events.
Professor Liaw, speaking on behalf of the team concluded,
“Continuous treatment with lamivudine delays clinical
progression in patients with chronic hepatitis B and advanced
fibrosis or cirrhosis by significantly reducing the incidence
of hepatic decompensation and the risk of hepatocellular carcinoma”.
N Engl J Med 2004; 351: 1521-31
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October 8th, 2004
Dosanjh
Asks Provinces How They Used Money Intended for Hepatitis
C Victims
Dennis Bueckert
Source: www.canada.com
Ottawa - Health Minister Ujjal Dosanjh
says provinces should tell the public now what they did with
$300 million intended for hepatitis C victims but never received
by them.
"Yes, I'm going to ask them (the provinces)
for accountability," Dosanjh told the Commons on Thursday.
"I have said my preference is, when there are very, very
serious questions being asked, about people who are suffering,
people who have suffered injury, the answers should come now
so their concerns are satisfied. Yes, I'm asking them (the
provinces) to be accountable."
An aide to Dosanjh said the minister is
making a suggestion, not issuing a directive.
Each of the provinces signed a separate
agreement with Ottawa for a share of the $300 million "care
instead of cash" fund. Each province agreed to report
in five years, and for most of them that would mean 2007.
The program was intended for victims excluded
from cash compensation because their infection with the virus
occurred outside the 1986-1990 period for which Ottawa admitted
liability.
Former health minister Allan Rock told
the Commons at the time the money would be given to the provinces
to make certain "anyone who got hepatitis C through the
blood system will have access to the needed medical services
and drugs for treatment and care without paying out of their
own pockets."
Victims say they have not received any
help and most provinces have been reluctant to explain where
the funds went. Alberta, the exception, has openly said the
money went to improved treatment for hepatitis C in general,
not for the specified pre-'86, post-'90 victims.
The issue is awkward for Ottawa because
hundreds of so-called forgotten victims are facing hardship,
and accumulating evidence has undercut the government's argument
that there was nothing it could have done to protect the blood
system from hepatitis C before 1986.
Also, the fact federal money was apparently
used in unintended ways raises questions about the principle
of provincial accountability - relevant in light of the recent
$41-billion federal-provincial health deal.
Hepatitis C activist Mike McCarthy said the federal government
should admit its original compensation plan was poorly formulated
and extend full cash compensation to all victims regardless
of when they were infected.
He said there is still $1 billion in the
compensation fund, unclaimed because there were fewer eligible
victims than expected
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Clean-Needle
Bill Passed by Assembly, 43-28
Terrence Dopp
Source: The Express-Times
Trenton-- The state Assembly on Thursday
approved a controversial bill giving intravenous drug users
legal access to clean needles, a move supporters said would
stop the spread of AIDS.
Capping weeks of debate on a contentious
initiative, the lower house approved two pieces of legislation,
one allow over-the-counter syringe sales and another letting
communities institute needle exchange programs. Both bills
passed 43- 28.
Lawmakers also earmarked $10 million for
expanded drug rehabilitation programs.
Proponents see the measures as a way to
stem the spread of blood-borne diseases such as HIV and Hepatitis
C, which they said have ravaged New Jersey's cities.
"New Jersey is sadly behind the curve
on this issue," said Assembly Majority Leader Joseph
Roberts, D-Camden, sponsor of the exchange proposal. "This
is a life and death issue."
During a 7-hour hearing on the bill and
throughout discussion on the issue, the opposing sides cited
conflicting studies on exchange success rates done in the
U.S. and Canada. New Jersey and Delaware are the only states
without legalized needle exchanges.
Under the measure approved by the Assembly,
registered users could get free needles by turning in used
ones at sites selected by communities. Also, people would
be able to buy fewer than 10 syringes without a prescription
at pharmacies.
Both pieces of legislation still need the
approval of the state Senate and governor.
"No shred of evidence exists that
needle exchange programs encourage drug use," said Kathy
Ellis, spokeswoman for Gov. James E. McGreevey, who called
for the legislation after announcing his resignation. "There
is evidence that needle exchange programs save lives."
Roseanne Scotti, an activist who worked
to pass the bill, said the state has the fifth-highest number
of adult AIDS/HIV cases and the third-highest number of pediatric
AIDS cases. She said establishing a needle exchange initiative
has taken so long in New Jersey because the impacts of drugs
are felt primarily in urban areas.
"It has a lot to do with who we are
taking about. The people who are getting infected are poor.
They're addicted. And they are largely in the minority community,"
said Scotti, director of the Drug Policy Alliance. "They
don't have anybody to advocate for them."
Detractors claim the programs make the state complicit in
drug use and are unfair to taxpayers who don't want to see
addicts given access to the syringes.
"It's the wrong approach to a very
complex problem," said Assemblywoman Alison Littell McHose,
R-Sussex/Morris/Hunterdon. "This is nothing more than
the state sponsoring an illegal and socially destructive activity."
Assemblyman John Burzichelli, D-Gloucester/Cumberland/Salem,
said health concerns overpower concerns over abetting drug
use.
"It's a topic that no one really wants
to talk about. Intravenous drug use, and any drug use, still
is epidemic in this country in some quarters," he said.
"We're not condoning drug use. What we're doing is taking
a public health step."
Earlier this month, a Superior Court judge
invalidated a needle exchange program in Atlantic City. It
has also been tried unsuccessfully in New Brunswick.
Two founders of the New Brunswick program,
dubbed the Chai Project, were arrested in 1996 and charged
with violating the state's ban on distribution of syringes.
In 1997, they were each fined $500 and had their drivers licenses
revoked for six months. Terrence Dopp is Trenton correspondent
for The Express-Times. He can be reached at 609-292-5154 or
by e-mail at tdopp@sjnewsco.com.
Back to top
October 9th, 2004
Rituxan
May Be Associated with HBV Reactivation and Fulminant Hepatitis
Yael Waknine
Source: Medscape
The U.S. Food and Drug Administration (FDA),
Biogen Idec, Inc., and Genentech, Inc., have warned healthcare
professionals via letter of postmarketing clinical safety
reports of hepatitis B virus (HBV) reactivation along with
fulminant hepatitis, hepatic failure, and death in some patients
with hematologic malignancies taking rituximab (Rituxan) therapy,
according to an alert sent yesterday from MedWatch, the FDA's
safety information and adverse event reporting program.
Rituximab is indicated in the treatment
of patients with relapsed or refractory low-grade or follicular
CD20-positive B-cell non-Hodgkin's lymphoma.
According to the letter, the majority of
patients affected received rituximab in combination with chemotherapy.
Median time to diagnosis was four months after the initial
dose of rituximab and approximately one month after the last
dose.
The FDA recommends that patients at high
risk of HBV infection be screened before initiation of rituximab
therapy. Hepatitis B carriers should be closely monitored
for clinical and laboratory signs and symptoms of active HBV
infection during rituximab therapy and for several months
thereafter.
Rituximab and concomitant chemotherapy should be discontinued
in patients developing viral hepatitis, and appropriate treatment
including antiviral therapy initiated. The FDA notes that
insufficient information is available concerning the safety
of resuming rituximab therapy in these patients.
Adverse events related to use of
rituximab should be reported to Genentech Drug Safety at 1-888-835-2555.
Alternatively, this information can be reported to the FDA's
MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178,
online at http://www.fda.gov/medwatch,
or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Reviewed by Gary D. Vogin, MD
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