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<sup>1</sup> BIC avail. only as part of fixed-dose combo tab (BIC/FTC/TAF; Biktarvy), approved for use in children/adolescents ≥14 kg. Two strengths of the fixed-dose combo are avail., w/ dosing according to wt. Biktarvy approved for ARV tx-naïve pts; can also be used to replace current ARV regimen in pts virologically suppressed (HIV RNA <50 copies/mL) on stable ARV regimen, w/ no hx of tx failure and no known substitutions assoc w/ resistance to fixed-dose combo components. For pts unable to swallow the whole tab, tabs may be split and each part taken separately, as long as all parts ingested w/in 10min.
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<sup>2</sup> ABC/DTG/3TC fixed-dose combo avail. as dispersible tablets approved for children weighing ≥6 kg and <25 kg and as a film-coated tablet for children weighing ≥25 kg.
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<sup>3</sup> TAF is an oral prodrug of tenofovir, w/ lower risk of renal and bone adverse effects compared w/ TDF. TAF is avail. in an FDC tablet w/ emtricitabine in 2 strengths, w/ dosing according to wt. Approved for use in children/adolescents weighing ≥14 kg w/ CrCl ≥30 mL/min. Coadministration w/ boosted ATV, DRV, or LPV increases TAF concentrations. Because no data exist on use of this combo in children <35 kg, use of FTC/TAF w/ a boosted PI in these pts is not recommended. Wt gain and incr. obesity risk observed in adults treated w/ TAF, but not clearly demonstrated in children; also assoc w/ dyslipidemia.
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<sup>4</sup> DRV/c-based regimens may be used if there are concerns about INSTI resistance (e.g., pts w/ hx of CAB-LA use for PrEP). DRV/c is FDA approved for use in children ≥40 kg and is avail. as part of an FDC tablet containing DRV/c/FTC/TAF (Symtuza). Twice-daily dosing is <i>not</i> recommended w/ DRV/c. If DRV-associated resistance mutations are present, twice-daily DRV/r is recommended.
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<sup>5</sup> TDF is avail. in powder and tablet forms, and in an FDC as FTC/TDF. Decreased BMD has been observed in adults and children, though clinical significance is unknown and routine DEXA monitoring is not recommended in children. Renal toxicity has also been observed; SCr, urine protein, and glucose should be monitored during tx.
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<sup>2</sup> ABC/DTG/3TC fixed-dose combo avail. as dispersible tablets approved for children weighing ≥6 kg and <25 kg and as a film-coated tablet for children weighing ≥25 kg.
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<sup>3</sup> TAF is an oral prodrug of tenofovir, w/ lower risk of renal and bone adverse effects compared w/ TDF. TAF is avail. in an FDC tablet w/ emtricitabine in 2 strengths, w/ dosing according to wt. Approved for use in children/adolescents weighing ≥14 kg w/ CrCl ≥30 mL/min. Coadministration w/ boosted ATV, DRV, or LPV increases TAF concentrations. Because no data exist on use of this combo in children <35 kg, use of FTC/TAF w/ a boosted PI in these pts is not recommended. Wt gain and incr. obesity risk observed in adults treated w/ TAF, but not clearly demonstrated in children; also assoc w/ dyslipidemia.
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<sup>4</sup> DRV/c-based regimens may be used if there are concerns about INSTI resistance (e.g., pts w/ hx of CAB-LA use for PrEP). DRV/c is FDA approved for use in children ≥40 kg and is avail. as part of an FDC tablet containing DRV/c/FTC/TAF (Symtuza). Twice-daily dosing is <i>not</i> recommended w/ DRV/c. If DRV-associated resistance mutations are present, twice-daily DRV/r is recommended.
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<sup>5</sup> TDF is avail. in powder and tablet forms, and in an FDC as FTC/TDF. Decreased BMD has been observed in adults and children, though clinical significance is unknown and routine DEXA monitoring is not recommended in children. Renal toxicity has also been observed; SCr, urine protein, and glucose should be monitored during tx.
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Recommendations for initial ART regimens for adolescents are also incl. in the <a href=https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/special-populations-adolescents-and?view=full><u>Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV</u></a>. See “Adolescents and Young Adults With HIV.”