Approval based on DELPHI study that demonstrated 74 per cent of pediatric patients taking PREZISTA® in combination with other antiretrovirals had at least a 90 per cent reduction in viral loads at 24 weeks
Toronto, ON (February 9, 2010) – Tibotec, a division of Janssen-Ortho Inc., announced that Health Canada has approved PREZISTA® (darunavir) for use in children with HIV between the ages of six and 18, dosed twice daily in combination with ritonavir and other antiretroviral agents. PREZISTA® is a protease inhibitor that works by blocking an enzyme critical for the growth of the virus within the body.1
According to the Public Health Agency of Canada, approximately 500 children under the age of 15,2 and more than 900 people between the ages of 15 and 19,3 were diagnosed with HIV in Canada between 1985 and 2008. Specifically, in 2008, there were 2,623 positive HIV tests reported in Canada.4 Of these, 29 were in children under the age of 15 and 60 were in people between the ages of 15 and 19.5
“Growing up with HIV impacts a child’s physical health and their social, emotional and cognitive development,” says Dr. Christos Karatzios, Infectious Disease Specialist, Montreal Children’s Hospital. “It is encouraging that we can now offer PREZISTA® as part of a combination therapy to a patient population that traditionally has had fewer treatment options than adults.”
Survival rates in children have improved as a result of effective treatment with combination antiretroviral therapy.6 While PREZISTA® does not cure HIV infection or AIDS, or prevent a child from passing HIV to others, it may decrease the blood levels of HIV and thereby improve a child’s immune system and decrease the risk of secondary infections.
PREZISTA® has been available for use in adults with HIV in Canada since 2006, and has proven to be effective in significantly reducing viral load and increasing CD4+ cell counts in adults living with HIV. 7 PREZISTA® dosing for children is different from adults; it is based on body weight.
About DELPHI
The approval for PREZISTA® in children ages six to 18 was based on data from the DELPHI trial. In this open-label, Phase 2 trial, the pharmacokinetics, safety, tolerability and efficacy of PREZISTA® dosed twice daily in combination with other antiretrovirals in treatment-experienced HIV-1 infected pediatric patients, six to 18 years of age, weighing at least 44 pounds were analyzed. Virologic response was evaluated at week 24 and was defined as a decrease in plasma HIV-1 RNA (viral load) of at least 1 log10 (at least a 90 per cent reduction in viral loads) versus baseline.
At week 24, 74 per cent of subjects had at least 1 log10 HIV-1 RNA decrease from baseline. The proportion of pediatric subjects reaching undetectable viral load (<50 HIV-1 RNA copies/mL) was 50 per cent. The mean CD4+ cell count increase from baseline was 117 cells/mm3.
In treatment-experienced pediatric patients six to 18 years of age, the most common side effects (greater than or equal to two per cent) reported were vomiting (12.5 per cent), diarrhea
(11.3 per cent) and abdominal pain (10 per cent). Frequency type and severity of adverse drug reactions in the DELPHI pediatric patient population were comparable to those observed in adults.
About HIV/AIDS
Acquired Immune Deficiency Syndrome (AIDS) is an illness caused by a chronic infection with a retrovirus (HIV, Human Immunodeficiency Virus). The breakdown of the immune system resulting from HIV leads to increased susceptibility to other infections and immune disorders. UNAIDS estimates that approximately 33 million people worldwide were living with HIV in 2008.8
It is estimated that between 2,300 and 4,500 overall new HIV infections occurred in Canada in 2005. 9 In Canada, there were an estimated 73,000 people living with HIV infection by the end of 2007.10
Tibotec – Division of Janssen-Ortho Inc.
Tibotec, a division of Janssen-Ortho Inc., is dedicated to delivering innovative virology therapeutics that improve Canadian patients’ survival and quality of life and that address serious unmet health care needs.
Tibotec Pharmaceuticals
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company’s main research and development facilities are in Mechelen, Belgium, with offices in Yardley, PA, USA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
For more information, please contact:
Suzanne Frost
Tibotec - Division of Janssen-Ortho Inc.
Tel: 416-449-9444
sfrost@its.jnj.com
Marsha Knoll
Edelman
Tel: 416-979-1120, ext. 329
marsha.knoll@edelman.com
*All trademark rights used under license.
1 PREZISTA® Product Monograph, Janssen-Ortho Inc., 2009.
2 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. 2008. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 16.
3 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. 2008. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 18.
4 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. 2008. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 2.
5 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 18.
6 Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf, page 32.
7 PREZISTA® Product Monograph, Janssen-Ortho Inc., 2009, page 62.
8 UNAIDS/WHO AIDS epidemic update 2009, http://data.unaids.org/pub/Report/2009/JC1700_Epi_Update_2009_en.pdf , page 6. Retrieved January 14, 2010.
9 Public Health Agency of Canada, http://www.phac-aspc.gc.ca/aids-sida/publication/epi/pdf/epi2007_e.pdf, Retrieved March 2, 2009.
10 AIDS epidemic update 2008. 1-362. 2008. UNAIDS/WHO (World Health Organization)
Approval based on DELPHI study that demonstrated 74 per cent of pediatric patients taking PREZISTA® in combination with other antiretrovirals had at least a 90 per cent reduction in viral loads at 24 weeks
Toronto, ON (February 9, 2010) – Tibotec, a division of Janssen-Ortho Inc., announced that Health Canada has approved PREZISTA® (darunavir) for use in children with HIV between the ages of six and 18, dosed twice daily in combination with ritonavir and other antiretroviral agents. PREZISTA® is a protease inhibitor that works by blocking an enzyme critical for the growth of the virus within the body.1
According to the Public Health Agency of Canada, approximately 500 children under the age of 15,2 and more than 900 people between the ages of 15 and 19,3 were diagnosed with HIV in Canada between 1985 and 2008. Specifically, in 2008, there were 2,623 positive HIV tests reported in Canada.4 Of these, 29 were in children under the age of 15 and 60 were in people between the ages of 15 and 19.5
“Growing up with HIV impacts a child’s physical health and their social, emotional and cognitive development,” says Dr. Christos Karatzios, Infectious Disease Specialist, Montreal Children’s Hospital. “It is encouraging that we can now offer PREZISTA® as part of a combination therapy to a patient population that traditionally has had fewer treatment options than adults.”
Survival rates in children have improved as a result of effective treatment with combination antiretroviral therapy.6 While PREZISTA® does not cure HIV infection or AIDS, or prevent a child from passing HIV to others, it may decrease the blood levels of HIV and thereby improve a child’s immune system and decrease the risk of secondary infections.
PREZISTA® has been available for use in adults with HIV in Canada since 2006, and has proven to be effective in significantly reducing viral load and increasing CD4+ cell counts in adults living with HIV. 7 PREZISTA® dosing for children is different from adults; it is based on body weight.
About DELPHI
The approval for PREZISTA® in children ages six to 18 was based on data from the DELPHI trial. In this open-label, Phase 2 trial, the pharmacokinetics, safety, tolerability and efficacy of PREZISTA® dosed twice daily in combination with other antiretrovirals in treatment-experienced HIV-1 infected pediatric patients, six to 18 years of age, weighing at least 44 pounds were analyzed. Virologic response was evaluated at week 24 and was defined as a decrease in plasma HIV-1 RNA (viral load) of at least 1 log10 (at least a 90 per cent reduction in viral loads) versus baseline.
At week 24, 74 per cent of subjects had at least 1 log10 HIV-1 RNA decrease from baseline. The proportion of pediatric subjects reaching undetectable viral load (<50 HIV-1 RNA copies/mL) was 50 per cent. The mean CD4+ cell count increase from baseline was 117 cells/mm3.
In treatment-experienced pediatric patients six to 18 years of age, the most common side effects (greater than or equal to two per cent) reported were vomiting (12.5 per cent), diarrhea
(11.3 per cent) and abdominal pain (10 per cent). Frequency type and severity of adverse drug reactions in the DELPHI pediatric patient population were comparable to those observed in adults.
About HIV/AIDS
Acquired Immune Deficiency Syndrome (AIDS) is an illness caused by a chronic infection with a retrovirus (HIV, Human Immunodeficiency Virus). The breakdown of the immune system resulting from HIV leads to increased susceptibility to other infections and immune disorders. UNAIDS estimates that approximately 33 million people worldwide were living with HIV in 2008.8
It is estimated that between 2,300 and 4,500 overall new HIV infections occurred in Canada in 2005. 9 In Canada, there were an estimated 73,000 people living with HIV infection by the end of 2007.10
Tibotec – Division of Janssen-Ortho Inc.
Tibotec, a division of Janssen-Ortho Inc., is dedicated to delivering innovative virology therapeutics that improve Canadian patients’ survival and quality of life and that address serious unmet health care needs.
Tibotec Pharmaceuticals
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company’s main research and development facilities are in Mechelen, Belgium, with offices in Yardley, PA, USA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
For more information, please contact:
Suzanne Frost
Tibotec - Division of Janssen-Ortho Inc.
Tel: 416-449-9444
sfrost@its.jnj.com
Marsha Knoll
Edelman
Tel: 416-979-1120, ext. 329
marsha.knoll@edelman.com
*All trademark rights used under license.
1 PREZISTA® Product Monograph, Janssen-Ortho Inc., 2009.
2 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. 2008. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 16.
3 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. 2008. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 18.
4 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. 2008. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 2.
5 Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance Report to December 31, 2008. ISBN 978-1-100-50239-7. Surveillance and Risk Assessment Division, Centre for Communicable Diseases and Infection Control, Public Health Agency of Canada, 2008., page 18.
6 Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf, page 32.
7 PREZISTA® Product Monograph, Janssen-Ortho Inc., 2009, page 62.
8 UNAIDS/WHO AIDS epidemic update 2009, http://data.unaids.org/pub/Report/2009/JC1700_Epi_Update_2009_en.pdf , page 6. Retrieved January 14, 2010.
9 Public Health Agency of Canada, http://www.phac-aspc.gc.ca/aids-sida/publication/epi/pdf/epi2007_e.pdf, Retrieved March 2, 2009.
10 AIDS epidemic update 2008. 1-362. 2008. UNAIDS/WHO (World Health Organization)