FDA expands use of Tivicay for HIV-1 in children of lower weight
ViiV Healthcare announced the FDA approved an expansion of the drug label for Tivicay 10 mg and 25 mg oral tablets, reducing the weight limit from at least 40 kg to at least 30 kg, for the treatment of HIV-1 in patients aged 6 to 12 years.
Tivicay (dolutegravir) will be available for use in pediatric patients weighing at least 30 kg living with HIV-1 who are either treatment naive or treatment experienced, provided they have not previously been administered an integrase inhibitor.
“From day 1, children and adolescents have been, and remain, a key focus in our drive to improve outcomes for people living with HIV,” John C. Pottage Jr., MD, chief scientific and medical officer of ViiV Healthcare, said in a press release. “Through our research and development efforts, corporate social responsibility programs, 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 U.S., and supports the global UNAIDS pediatric treatment target.”
The FDA based its approval on 24-week data from the phase 1/2 multicenter, open-label P1093 safety and efficacy study of dolutegravir plus optimized background regimen among children and adolescents infected with HIV-1 in age defined cohorts.
Study results demonstrated that treatment with dolutegravir plus an optimized background regimen was generally well-tolerated and provided efficacy through to week 24 in HIV-1 infected children and adolescents aged 6 to 12 years weighing at least 30 kg.
The most common adverse events associated with the use of dolutegravir among adults included insomnia (3%), fatigue (2%) and headache (2%). According to study results, grade 2 adverse events reported by more than one patient were decreased neutrophil count (n = 3) and diarrhea (n = 2); no grade 3 or 4 drug-related adverse events were reported, and no adverse events caused discontinuation of the drug regimen.
ViiV Healthcare reported that its ongoing P1093 study will continue to evaluate dolutegravir in pediatric populations down to age 4 weeks, weighing at least 3 kg.