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

London (ots/PRNewswire) -

Reduction of weight limit to at least 30kg means more children
and adolescents will be eligible for dolutegravir

ViiV Healthcare today announced that the US Food and Drug
Administration (FDA) has approved a supplemental New Drug Application
(sNDA) for dolutegravir 10mg and 25mg oral tablets, reducing the
weight limit from at least 40kg to at least 30kg, in ages 6 to less
than 12 years old, for the treatment of HIV-1 in children and
adolescents.[1] Dolutegravir, in line with the current label, will be
available for use in two paediatric populations: paediatric patients
weighing at least 30kg living with HIV-1 who are treatment naïve (not
previously treated) and who are treatment experienced (previously
treated), as long as they have not taken an integrase inhibitor.[1]

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This approval is based on 24-week data from the Phase I/II
multi-centre, open-label P1093 study conducted in collaboration with
the International Maternal Pediatric Adolescent AIDS Clinical Trial
(IMPAACT) Network. IMPAACT P1093 is an ongoing pharmacokinetic (PK),
safety and efficacy study of dolutegravir plus optimised background
regimen (OBR) in children and adolescents infected with HIV-1 in age
defined cohorts.[1]

Results from the study show that treatment with dolutegravir plus
OBR was generally well tolerated and provided efficacy through to
week 24 in HIV-1 infected children and adolescents from 6 to 12 years
of age weighing at least 30kg.[1] The adverse event (AE) profile in
the study was similar to that for adults.[1] Grade 2 AEs reported by
more than one patient were decreased neutrophil count (n = 3) and
diarrhoea (n = 2).[1] There were no Grade 3 or 4 drug-related AEs
reported, and no AEs led to discontinuation.[1]

"From day one children and adolescents have been, and remain, a
key focus in our drive to improve outcomes for people living with
HIV," said John C. Pottage, Jr., MD, Chief Scientific and Medical
Officer, ViiV Healthcare. "Through our research and development
efforts, corporate social responsibility programmes, partnerships and
access initiatives, we have made a difference for younger
populations. This approval by the FDA provides more children and
adolescents the option to be treated with dolutegravir in the US, and
supports the global UNAIDS paediatric treatment target."

According to UNAIDS, there were 3.2 million children living with
HIV in 2013, and 2.1 million adolescents living with HIV in 2012,
most of whom live in sub-Saharan Africa.[2],[3] Children and younger