ViiV Healthcare Announces FDA Approval to Lower the Weight Limit for dolutegravir in Children and Adolescents Living With HIV - Seite 2

adolescents have a limited number of treatment options available to
meet their particular needs, with many antiretroviral therapies not
approved for use in these populations.[4]

In 2014, ViiV Healthcare granted a voluntary licence to the
Medicines Patent Pool (MPP) and Aurobindo Pharma to allow the generic
manufacture of paediatric formulations of dolutegravir without paying
a royalty in 121 countries where most (99%) children with HIV live.
Under the terms of these agreements, Aurobindo Pharma and generics
companies sub-licensed by the MPP are permitted to manufacture the
new 10mg and 25mg formulations of dolutegravir, subject to local
regulatory approvals. This means that dolutegravir may be made
available to children and adolescents weighing at least 30kg in low
income, least developed, sub-Saharan African and middle income
countries in the future, subject to local regulatory approvals.

ViiV Healthcare is committed to further investigating the
potential of dolutegravir in younger age-groups. The ongoing P1093
study is continuing the evaluation of dolutegravir in paediatric
populations down to four weeks of age, weighing at least 3kg.[5]

About HIV

HIV stands for the Human Immunodeficiency Virus. Unlike some other
viruses, the human body cannot get rid of HIV, so once someone has
HIV they have it for life. There is no cure for HIV, but effective
treatment can control the virus so that people with HIV can enjoy
healthy and productive lives.

About the P1093 IMPAACT study

P1093 is a Phase I/II, multi-center, open-label, non-comparative
intensive pharmacokinetic and safety study of dolutegravir in
combination regimens in HIV-1 infected infants, children and
adolescents.[5] The primary objectives of the study are to select a
dolutegravir dose for chronic dosing; to determine the safety and
tolerability of the dose, to evaluate the steady-state
pharmacokinetics of dolutegravir in combination with other
antiretrovirals and to determine the dose of dolutegravir that
achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary
PK endpoint) in children and adolescents.[5]

About Tivicay® (dolutegravir)

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor
(INSTI) for use in combination with other antiretroviral agents for
the treatment of HIV. Integrase inhibitors block HIV replication by
preventing the viral DNA from integrating into the genetic material
of human immune cells (T-cells). This step is essential in the HIV
replication cycle and is also responsible for establishing chronic
infection. Tivicay is approved in over 100 countries across North