U.S. FDA approves Gilead's low-dose Biktarvy for young HIV-infected children

Recently, Gilead announced that the US FDA has approved a new three-in-one compound drug Biktary for HIV-1 children who weigh at least 14 kg to 25 kg, have achieved virological suppression, or have begun treatment with antiretroviral drugs (ARV).
The person
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This approval expands Biktarvy's indications to include young children infected with HIV-1
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The expansion of Biktarvy's indications will help close the gap between HIV treatment options available to adults and children
.

This approval is based on data from the Phase 2/3 open-label, single-arm study cohort 3.
The study found that Biktarvy low-dose tablets are effective in virologically suppressed HIV-1 children infected with HIV-1 and are tolerable within 24 weeks Good
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This study included 22 subjects weighing 14-25kg who continued to receive treatment for 48 weeks, and continued to receive study drug treatment during the expansion phase.
After switching to Biktarvy treatment, 91% of the subjects remained in the 24th week.
Maintaining virological suppression, the average change of CD4 from baseline was 0.
2%
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In pediatric studies, no new adverse reactions were found
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 Biktarvy is a complete HIV-1 single-tablet treatment plan for the treatment of HIV-1 infection.
It combines a new integrase transfer inhibitor (INSTI) bictegravir (BIC) and the marketed drug Descovy, once a day, It has limited drug interaction potential and high resistance barrier
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In the Phase 3 clinical study, Biktarvy achieved a very high rate of virological inhibition and did not develop drug resistance when used to treat patients who had not previously received treatment and patients who achieved virological suppression and switched treatment options
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 In February 2018, the FDA approved Biktarvy for the treatment of adult HIV-1 infection
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In June 2019, the FDA approved a label revision for Biktarvy, which expanded the patient population and included pediatric patients weighing at least 25kg into the scope of treatment
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In October of this year, the FDA approved a new low-dose Biktarvy tablet regimen for HIV pediatric patients weighing 14-25kg
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For all patient groups, Biktarvy is only suitable for the treatment of HIV-1 infected patients without a history of antiretroviral therapy, or to replace the current antiretroviral regimen in patients with virologically suppressed stable antiretroviral regimens
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 According to relevant data, in 2020, about 120,000 children and adolescents will die from AIDS-related causes, mainly because they cannot adequately access HIV care and treatment services.
Therefore, providing effective treatment programs for HIV-infected children is a current one.
Urgently needed
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 In response to this approval, a professor of pediatrics at the University of South Florida Morsani School of Medicine stated that “with this expanded indication approval, clinicians can add Biktarvy to their selection library to help these children with illness Meaningful treatment to maintain virological suppression"
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