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Gilead Reduces Prices in Developing Countries for Tenofovir and
for Emtricitabine and Tenofovir Fixed-dose Combination Tablet
 Gilead
Sciences, Inc. this week announced a significant price reduction
for tenofovir
(Viread)
and for emtricitabine/tenofovir
(Truvada) made available through the company's
Access Program in the developing world. Both once-a-day antiretroviral
medications for HIV are available at no-profit prices in 97 developing
countries around the world through this program. Following is an
edited version of Gilead’s announcement:
The
price decreases announced [this week] are due to increased economies
of scale, production at a new plant in the Bahamas that manufactures
active pharmaceutical ingredient for both Viread and Truvada, and
continued improvements in the manufacturing process.
As
a result of these changes, Viread and Truvada are now priced at
US$17.00 and US$26.25 for a 30-day supply, or $0.57 and $0.87 per
day, respectively, for private and public programs treating people
with HIV/AIDS in the 97 nations of the program. The new prices represent
approximately a 31 percent and 12 percent reduction in t he no-profit
prices for Viread and Truvada, respectively.
Complete
program information, including the countries
eligible to receive Viread and Truvada through the Gilead Access
Program, and request
forms are available.
Programs
without Internet access can contact the Gilead Access Program in
the United States at +1-650-574-3000 (option 1).
The
parent compound of Viread, tenofovir, 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
of Viread have agreed to waive their right to a royalty on sales
of Viread and Truvada in the Gilead Access Program countries 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®
(emtricitabine) and Viread into 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
(Epivir)
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.
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®, Epivir-HBV®, Epzicom,® or Trizivir®. 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. For additional
safety information about Viread or Emtriva in combination with other
antiretroviral agents, please see "About Viread" and "About
Emtriva," below.
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. Viread, Emtriva
and Truvada are not indicated for the treatment of chronic hepatitis
B virus (HBV)
infection and the safety and efficacy of these drugs 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 Viread, Emtriva
or Truvada and are co-infected with HIV and HBV. If appropriate,
initiation of anti-hepatitis B therapy may be warranted.
Immune
reconstitution syndrome
has been reported in patients treated with combination antiretroviral
therapy, including Viread. Changes in body
fat have been observed in patients taking
Viread, Emtriva, Truvada and other anti-HIV medicines. The cause
and long-term health effect of these conditions are unknown.
About Viread
In
the United States, Viread is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection. This
indication is based on analyses of plasma HIV-1 RNA levels and CD4
cell counts in controlled studies of Viread in treatment-naive adults
and in treatment-experienced adults. There are no study results
demonstrating the effect of Viread on clinical progression of HIV-1.
The use of Viread should be considered for treating adult patients
with HIV-1 strains that are expected to be susceptible to tenofovir
as assessed by laboratory testing or treatment history.
Drug
interactions have been observed when didanosine, atazanavir
(Lexiva) or lopinavir/ritonavir
(Kaletra)
is co-administered with Viread 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 Viread should be monitored for Viread-associated
adverse events which 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.
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.
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.
About Emtriva
In
the United States, Emtriva is indicated, in combination with other
antiretroviral agents, for the treatment of HIV-1 infection in adults.
This indication is based on analyses of plasma HIV-1 RNA levels
and CD4 cell counts from controlled studies of 48 weeks duration
in antiretroviral-naive patients and antiretroviral-treatment-experienced
patients who were virologically suppressed on an HIV treatment regimen.
In antiretroviral-treatment-experienced patients, the use of Emtriva
may be considered for adults with HIV strains that are expected
to be susceptible to Emtriva as assessed by genotypic
or phenotypic
testing.
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.
For
more information on the Gilead Access Program, please visit www.gileadaccess.org
For
complete U.S. prescribing information, please visit www.truvada.com,
www.viread.com or www.emtriva.com
For
more information on Gilead Sciences, please visit www.gilead.com
or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).
Viread and Truvada Articles on HIV and Hepatitis.com:
Viread: An
Overview
Truvada: An
Overview
Selected Journal Articles on Emtricitabine and Tenofovir
More Truvada
Articles Posted on HIV and Hepatitis.com 2004- 2005
More Viread
Articles Posted on HIV and Hepatitis.com
Emtricitabine
Articles Posted on HIV and Hepatitis.com
09/02/05
Sources
Gilead
Sciences www.gilead.com
HIV
and Hepatitis.com
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