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Roche
Offers Fuzeon Free for 60 Days to Patients Enrolled in HIV Drug
Expanded Access Programs
Roche and Trimeris, developers
of the HIV entry
inhibitor enfuvirtide (Fuzeon),
are offering free access to the drug “for patients who are starting
treatment with Fuzeon in combination with an investigational anti-HIV
drug obtained through an expanded access program (EAP).”
At this time in the US,
the only anti-HIV agent available through an expanded access program
is the experimental protease inhibitor tipranavir. The tipranavir EAP in
the US opened on December 1 and is currently accepting applications
from eligible patients. For more information on the tipranavir EAP,
see Boehringer
Ingelheim Will Provide Free Access to New Protease Inhibitor Tipranavir
Through Expanded Access Program.
Roche and Trimeris have issued a press
release on the FUZEON Accelerated Simultaneous Access Program
(ASAP). An abbreviated version of that release follows:
“To address the needs of
treatment experienced patients living with HIV disease, Roche and
Trimeris are launching the FUZEON Accelerated Simultaneous
Access Program (ASAP). This new initiative
will provide immediate access to FUZEON for patients who are starting
treatment with FUZEON in combination with an investigational anti-HIV
drug obtained through an expanded access program (EAP).
“FUZEON ASAP will
help facilitate simultaneous initiation of FUZEON with an active
investigational agent in a regimen where deemed medically appropriate
by a physician. FUZEON, co-developed by Roche and Trimeris, is the
first and only fusion inhibitor for the treatment of HIV.
“Most patients enrolled
in EAPs have limited treatment options due to extensive antiviral
drug resistance. According
to the 2004 HIV treatment guidelines just issued by the U.S.
Department of Health and
Human Services, it is recommended that patients with moderate treatment
experience and documented drug resistance be placed on regimens
with two active agents to maximize virus suppression and limit further
drug resistance,” said Cal Cohen, M.D., Research Director, Community
Research Initiative of New England.
“For patients who are starting
treatment with FUZEON in combination with an investigational drug in
expanded access, FUZEON ASAP will provide up to a 60-day
supply of FUZEON at no cost to the patient, which consists of an
immediate shipment of a 30-day supply and an additional 30-day supply
if reimbursement is still pending.
Upon request, patient support
and adherence programs, including at-home nurse visits, will be
provided to help facilitate successful initiation and continuation
of therapy throughout the duration of treatment.
“Roche and Trimeris cannot
ensure access to FUZEON for all patients beyond the initial 60 days
if reimbursement is not then established. However, reimbursement
assistance will be available to assist in securing coverage for
continued FUZEON use. Patients may also qualify for drug coverage
under the Roche Patient Assistance Program.
“Data recently presented
at the 44th Interscience Conference on Antimicrobial
Agents and Chemotherapy (44th ICAAC)
and the 2004 Infectious Diseases Society of America (IDSA) Annual
Meeting reiterate the importance of a regimen containing FUZEON
along with an active boosted protease inhibitor (PI) for treatment-experienced
patients:
• In the RESIST-1 trial,
a Phase III study of the investigational PI tipranavir in treatment-experienced patients,
the highest response rates seen were in patients receiving both FUZEON and
boosted tipranavir together in their treatment regimen.
Almost half (47 percent)
of patients who took FUZEON with boosted tipranavir and other anti-HIV drugs achieved
undetectable levels of HIV (less than 400 copies/mL).
Participants in the study
were very treatment-experienced, including prior experience with several protease inhibitor-containing
regimens.
• A retrospective subset
analysis of 48-week data from the TORO phase III studies demonstrated that almost
twice as many (52 percent) treatment-experienced patients who took FUZEON with an
active boosted PI regimen achieved undetectable levels of HIV (less than 400 copies/mL),
compared to those receiving an active boosted PI regimen without FUZEON
(27 percent).
Patients taking FUZEON with an active boosted PI regimen
also experienced a significantly greater immunological response,
with a median increase of 104 cells/mm3 vs. an increase of 57 cells/mm3
among patients receiving an active boosted PI regimen
without FUZEON. These results demonstrate that, in triple-class
experienced patients, the use of a new class (fusion inhibitors)
significantly enhances the antiviral activity of new active boosted
PIs.
“TORO and RESIST-1 are
two large trials conducted in treatment-experienced patients, and both studies demonstrate
substantial virologic and immunologic responses from antiretroviral regimens
containing FUZEON plus an active boosted PI.
“Physicians participating
in expanded access programs of investigational anti-HIV therapies can enroll their
patients in FUZEON ASAP by contacting the FUZEON Answer Center
at 1-877-4FUZEON (877-438-9366).
Facts About FUZEON
Unlike other HIV drugs
that work after HIV has entered the human immune cell, FUZEON works
outside the CD4 cell, blocking HIV from entering the cell. For this
reason, FUZEON is effective in treatment-experienced patients who
have developed resistance to other anti-HIV drugs, though patients
may still develop resistance to FUZEON.
FUZEON was granted accelerated
approval by the U.S. Food and Drug Administration (FDA) in March
2003 on the basis of 24-week data, and was granted traditional (full)
approval on Oct. 15, 2004 on the basis of long-term 48-week data.
TORO Study Design
“TORO 1 [T-20 (FUZEON)
vs. Optimized Regimen Only] and TORO 2 were
randomized, open label Phase III trials that enrolled approximately
1,000 HIV-1 infected patients at 112 centers internationally. Patients
were treatment-experienced and/or had documented resistance to each
of the other three classes of anti-HIV drugs.
“At entry, resistance testing
and patient treatment history were used together to aid in the selection
of an individualized regimen of three to five anti-HIV drugs for
each patient. After selection of the regimen, patients were randomized
2:1 to receive either the regimen in combination with FUZEON (FUZEON
arm) or the individualized regimen alone (control arm).
“Patients randomized not
to receive FUZEON were allowed to add FUZEON to their regimens after
week eight if they met virological failure criteria or at the 48-week
time point. At baseline, patients were heavily treatment-experienced:
they had a median HIV RNA level of more than 5.0 log10 copies/mL, a median CD4
cell count of less than 100 cells/mm3, and had been treated
with anti-HIV drugs for an average of seven years.
“Injection Site Reactions
(ISRs):
ISRs are the most common adverse events associated with FUZEON.
ISRs occurred in 98% of patients studied and 4% discontinued FUZEON
due to ISRs. Signs/symptoms may include pain and discomfort, hardened
skin, redness, bumps, itching and swelling. Eleven percent of patients
had local reactions that required analgesics or limited usual activities.
“Pneumonia: An increased rate of
bacterial pneumonia was observed in subjects treated with FUZEON
in the Phase III clinical trials compared to the control arm. It
is unclear if the increased incidence of pneumonia is related to
FUZEON use. Patients with HIV infection should be carefully monitored
for signs and symptoms of pneumonia. Risk factors for pneumonia
included low initial CD4 cell count, high initial viral load, intravenous
drug use, smoking and a prior history of lung disease.
“Hypersensitivity Reactions:
Systemic hypersensitivity reactions have been associated with FUZEON
therapy and may recur on rechallenge. Hypersensitivity reactions
have included individually and in combination: rash, fever, nausea
and vomiting, chills, rigors, hypotension and elevated serum liver
transaminases. Other adverse events that may be immune mediated
and have been reported in subjects receiving FUZEON include primary
immune complex reaction, respiratory distress, glomerulonephritis
and Guillain-Barre syndrome.
“Other Adverse Events:
The events most frequently reported in patients receiving FUZEON plus an optimized
background regimen were diarrhea (32%), nausea (23%) and fatigue
(20%). These events were seen at a lower incidence in patients taking
a FUZEON-based regimen compared to those receiving an optimized
background regimen without FUZEON when taking into account the uneven
number of patients in each arm and the length of time they are in
that arm. As measured in number per 100 patient-years, the incidence
was: diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based
regimens vs. 73 per 100 patient-years in patients who did not receive
FUZEON), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38,
respectively).”
Source
Roche Pharmaceuticals. New Program
Offers Immediate Access to FUZEON®for Patients in Expanded Access
Programs of Investigational HIV Therapies. Press Release. December
1, 2004.
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