European Commission Approves Viread® for HIV-1 Infection in Children and
Adolescents and for Chronic Hepatitis B in Adolescents
-- New Oral Granule Formulation and Lower-Strength Tablets Available for New
FOSTER CITY, Calif. -- November 27, 2012
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European
Commission has granted marketing authorization for two new indications for
once-daily Viread^® (tenofovir disoproxil fumarate). The first new indication
permits the use of Viread in combination with other antiretroviral agents for
the treatment of HIV-1 infected pediatric patients aged 2 to less than 18
years with nucleoside reverse transcriptase inhibitor (NRTI) resistance or
toxicities precluding the use of first line pediatric agents. Additionally,
Viread is now approved for the treatment of chronic hepatitis B virus (HBV)
infection in adolescent patients aged 12 to less than 18 years with
compensated liver disease and evidence of immune active disease. Today’s
authorization covers all 27 countries of the European Union (EU). Viread was
approved for use in combination with other antiretroviral agents as a
treatment for HIV-1 infection in adults and for chronic HBV in 2002 and 2008,
respectively, and is the most-prescribed molecule for these diseases in major
Today’s decision includes marketing authorization for a new oral granule
formulation of Viread for HIV-1 infected children aged 2 to less than 6 years,
and for HIV-1 infected children above 6 years of age for whom a solid dosage
form is not appropriate. The agency also approved three new reduced-strength
Viread tablets in doses of 123 mg, 163 mg and 204 mg for HIV-1 infected
children aged 6 to less than12 years. The use of the lower-strength tablets
and the oral granule formulation are based on the patient’s age and weight.
The existing, full-strength 245 mg Viread tablet formulation is now available
for use by adolescents aged 12 to less than 18 years to treat both HIV-1
infection and chronic HBV infection in those with compensated liver disease.
For adolescents and adults for whom the 245 mg tablets are not appropriate,
the oral granule formulation may be used.
“We are pleased to provide new therapeutic options for younger patients living
with HIV and chronic hepatitis B and will work to make these pediatric
formulations available as quickly as possible,” said Norbert Bischofberger,
PhD, Executive Vice President, Research and Development and Chief Scientific
Officer, Gilead Sciences.
The new indications are supported by clinical data from three studies
examining the use of Viread among children and adolescents with HIV and among
adolescents with chronic HBV. The safety and efficacy of Viread has not been
established in children less than 2 years of age for HIV treatment, or in
children less than 12 years of age for the treatment of chronic HBV.
In an effort to accelerate the availability of pediatric formulations in
low-income countries, where the majority of children with HIV live, Gilead has
established incentives to encourage its Indian generic manufacturing partners
to develop pediatric formulations of its HIV treatments. Through these
partnerships, Gilead already makes Viread available at significantly reduced
cost for adults living with HIV and chronic HBV in low-income countries.
EU Important Safety Product Information About Viread, Including Boxed Warnings
*Lactic acidosis, usually associated with hepatic steatosis, has been
reported with the use of nucleoside analogues, including tenofovir
disoproxil fumarate. Lactic acidosis has a high mortality and patients at
increased risk should be followed closely.
*A multidisciplinary approach is recommended for the management of children
and adolescents to weigh on a case-by-case basis the benefit-risk balance
*Rare events of renal failure, renal impairment, elevated creatinine,
hypophosphataemia and proximal tubulopathy (including Fanconi syndrome)
have been reported with the use of tenofovir disoproxil fumarate.
*It is recommended that creatinine clearance is calculated in all adult
patients prior to initiation therapy with Viread and renal function
(creatinine clearance and serum phosphate) is also monitored every four
weeks during the first year and the very three months. In patients at risk
for renal impairment, more frequent monitoring should be considered. In
children and adolescents, renal function (creatinine clearance and serum
phosphate) should be evaluated prior to treatment and monitored during
treatment as in adults.
*If renal abnormalities are detected or suspected in children and
adolescents, consultation with a nephrologist should be obtained to
consider interruption of Viread treatment.
*Use of Viread should be avoided with concurrent or recent use of
nephrotoxic medications. If concomitant use of Viread and nephrotoxic
agents is unavoidable, renal function must be monitored weekly.
*Dose interval adjustment is recommended in adult patients with moderate
renal impairment (creatinine clearance 30-49 mL/min).
*Viread is not recommended in adult patients with severe renal impairment
(creatinine clearance < 30 mL/min). If no alternative treatment is
available, prolonged dose intervals may be used.
*Viread is not recommended for use in children and adolescents with renal
*Bone abnormalities (infrequently leading to fractures) may be associated
with proximal renal tubulopathy and appropriate consultation should be
obtained if suspected.
*Viread may cause a reduction in bone mineral density (BMD) and the effects
of Viread associated changes in BMD on long term bone health and future
fracture risk are currently unknown in children and adolescents. If bone
abnormalities are detected or suspected in children and adolescents,
consultation with an endocrinologist and /or nephrologist should be
*Immune reconstitution syndrome has been reported in patients treated with
combination therapy, including Viread.
*Redistribution and/or accumulation of body fat have been observed in
patients taking anti-HIV medicines. The cause and long-term effect of
these conditions are unknown.
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 Asia Pacific.
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 healthcare
providers may not see advantages of Viread for HIV-infected children and
HBV-infected adolescents over other formulations and may therefore be
reluctant to prescribe the product. These risks, uncertainties and other
factors could cause actual results to differ materially from those referred to
in the forward-looking statements. The reader is cautioned not to rely on
these forward-looking statements. These and other risks are described in
detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2012, as filed 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
EU Summary of Product Characteristics for Viread is available at
Viread is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company’s website at
www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead
Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936 (Investors)
Stephen Head, +44 (208) 587-2359 (Media, Europe)
Cara Miller, +1 650-522-1616 (Media, U.S.)
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