REYATAZ(R) (atazanavir) Capsules Approved for Paediatric Use by The European Commission

By Bristol-myers Squibb, PRNE
Tuesday, July 6, 2010

PARIS, June 7, 2010 - Bristol-Myers Squibb announced that on 5th of July, the European
Commission has approved boosted REYATAZ(R) (atazanavir sulfate) capsules to
treat HIV-1 infection in paediatric patients aged six to eighteen years and
greater than 15 kg, as part of combination HIV therapy.(1) This decision
grants marketing authorisation in the 27 countries of the European Union.

"Globally, more than two million children under 15 years of age are
living with HIV, and between 1,000 and 1,500 become newly infected with HIV
every day. Once a child is infected with HIV, he/she faces a high chance of
illness and death, unless treatment is provided. In countries of North
and Europe, where treatment options are accessible, the vast majority
of children infected around the time of birth are surviving into adulthood.
Despite the availability of treatment options, there are still many unmet
needs in this patient population," said Dr Gareth Tudor-Williams, Reader in
Paediatric Infectious Diseases, Department of Medicine at Imperial College
London and Consultant in Paediatric Infectious Diseases, St. Mary's Hospital.
"The European Commission approval of REYATAZ(R) is a milestone in addressing
these challenges for children with HIV. We look forward to REYATAZ(R)
capsules being available for our paediatrics patients across the European

In 2004, REYATAZ(R) was the first once-daily protease inhibitor to be
launched in the European Union for pre-treated HIV patients.(1,2,3) The use
of boosted REYATAZ(R), in combination with other antiretrovirals, was
approved for treatment-naïve patients in the European Union in June 2008.(4)
The United States Food and Drug Administration (FDA) approved REYATAZ(R)
capsules in 2008 to treat HIV-1 infection in paediatric patients aged six
years and older, as part of combination HIV therapy.(5) The safety,
tolerability and efficacy of REYATAZ(R) capsules with ritonavir have been
established in paediatric patients at least six years of age from the open-
label, multicentre clinical trial, PACTG 1020A.(1)

About PACTG 1020A Study

The Pediatric AIDS Clinical Trial Group (PACTG) 1020A study is a
multicentre, open-label, phase I/II study conducted in HIV-infected children
from 3 months to 21 years of age in the United States and South Africa to
determine pharmacokinetics, safety, tolerability and efficacy of REYATAZ(R)
in paediatric population(6).

Overall in this study, 182 paediatric patients antiretroviral-naive or
experienced received once daily atazanavir, with or without ritonavir, in
combination with two NRTIs(1). Forty-one of them (16 treatment-naïve and 25
experienced paediatric patients 6 years to less than 18 years of age) were
treated with REYATAZ capsules with ritonavir. The clinical data derived from
these 41 patients support the new paediatric indication.

Clinical Trial Results

About Efficacy

The 48-week PACTG 1020A study results confirmed that dosing ATV capsules,
administered with RTV in naive and experienced patients, was generally safe
and efficacious.(1)

The response rates for HIV RNA < 50 copies/ml were: 81% (13/16) in
ARV-naive patients and 24% (6/25) in ARV-experienced patients. The response
rates for HIV RNA < 400 copies/ml were 88% (14/16) and 32% (8/25) in ARV
naive and experienced patients, respectively.(1)

About Safety

In clinical studies, the safety profile of REYATAZ(R) was overall
comparable to that seen in adults. Both asymptomatic first-degree (23%) and
second-degree (1%) atrioventricular block were reported in paediatric
patients. The most frequently reported laboratory abnormality in paediatric
patients receiving REYATAZ(R) was elevation of total bilirubin (greater than
or equal to 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.(1)

About HIV in Children

Recent statistics suggest that, globally, approximately 2.1 million
children younger than 15 years of age have HIV, out of 33 million patients
worldwide.(7) About 90% of HIV-positive children live in sub-Saharan
Africa.(8) Generally, HIV and AIDS have affected Western Europe more than
Central Europe.(9) Switzerland has the highest HIV prevalence, followed
closely by France, Italy, Portugal and Spain.(9) The European Region of the
World Health Organization (WHO), particularly its Eastern countries, has one
of the fastest-growing HIV/AIDS epidemics in the world.(10) This is likely
due to the steady rise of HIV-infected women, and subsequently, the rise in
the transmission rate of HIV infection to newborn babies.(10) Most children
acquire the virus from their HIV-infected mothers during pregnancy, birth or
breastfeeding.(11) Currently, children represent nearly 16% of the newly
HIV-infected population.(7)

AIDS has become one of the major killers of young children. In 2008, two
million people died from HIV, 14% of which were children.(7) Worldwide, one
in seven people dying of HIV-related illness is a child under 15 years

The number of children receiving antiretroviral therapy increased from
about 75,000 in 2005 to almost 200,000 in 2007.(11)


Developed by Bristol-Myers Squibb, REYATAZ(R) is an antiviral drug used
in combination with other medicines to treat individuals infected with the
human immunodeficiency virus-1 (HIV-1).(1) REYATAZ(R) was the first
once-daily protease inhibitor launched in Europe.(2,3)

Important Information About REYATAZ(R) (atazanavir sulfate) for
Paediatric Patients Ages 6 years and older


REYATAZ(R) capsules, co-administered with low dose ritonavir, are
indicated for the treatment of HIV-1 infected adults and paediatric
patients 6 years of age and older in combination with other antiretroviral
medicinal products.(1)

Based on available virological and clinical data from adult patients, no
benefit is expected in patients with strains resistant to multiple protease
inhibitors (greater than or equal to 4 PI mutations). There are very limited
data available from children aged 6 to less than 18 years.(1)

The choice of REYATAZ(R) in treatment-experienced adult and paediatric
patients should be based on individual viral resistance testing and the
patient's treatment history. Available data do suggest that atazanavir in
combination with ritonavir may not be effective in treatment experienced
children with very few (<3) PI mutations.(1)

The dosing of REYATAZ(R) capsules for paediatric
patients is based on body weight as follows:

    Body Weight (kg)           REYATAZ(R) dose QD     ritonavir dose QD
      15 to less than 20           150 mg                100 mg
      20 to less than 40           200 mg                100 mg
        at least 40                300 mg                100 mg(1)

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company committed to
discovering, developing and delivering innovative medicines that help
patients prevail over serious diseases.



(2) European Medicines Agency. REYATAZ: EPAR Summary for the public.
Updated March 2009. Available at Accessed
26 May 2010

(3) The Body, Switching Antiretroviral Therapy. Available at Accessed 25 May 2010

(4) AidsMap, Atazanavir approved for first-line treatment in Europe.
Available at
Accessed 25 May 2010

(5) FDA Paediatric Reyataz. Available at:
vities/ucm121737.htm. Accessed 17 May 2010

(6) CROI 2007 abstract #715: "The PACTG 1020A Protocol: Atazanavir with
or without Ritonavir in HIV-infected Infants, Children, and Adolescents."
Available at Accessed 26
May 2010

(7) UNAIDS, AIDS Epidemic Update. Available at
. Accessed 17 May 2010

(8) UNICEF. Condensed Guide. Available at
Accessed 17 May 2010

(9) AVERT, HIV and AIDS in Western and Central Europe. Available at Accessed 25 May 2010

(10) WHO, Child and Adolescent Health and Development. Available at: Accessed 17 May

(11) WHO, Paediatric HIV and Treatment of Children Living with HIV.
Available at:
Accessed 17 May 2010

(12) WHO, Taking Stock: HIV in Children. Available at Accessed 17 May 2010

Annie Simond, +33-01-58-83-65-66, or Joanna Ritter, +33-01-58-83-65-09

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