Table 2. Approved Antiretrovirals for Pediatric Treatment of HIV Infection

Drug (Click for Full Prescribing Information)

Recommended Age for Use[ref: DHHS Pediatric]

Pediatric Formulation

NRTIs

 

 

  • [Abacavir]

1 mo or older and HLA-B*5701 negative

  • Oral solution 20 mg/mL
  • Scored 300-mg tablet
  • [drug: Abacavir/Lamivudine]

Pediatric patients with body weight ≥ 25 kg

  • Fixed-dose combination

 

  • [Emtricitabine]

All ages

  • Oral solution 10 mg/mL
  • [drug: Emtricitabine]/Tenofovir AF

Combined with NNRTI or INSTI in pediatric patients with body weight ≥ 25 kg

Combined with NNRTI, INSTI, or boosted PI in pediatric/adolescent patients with body weight ≥ 35 kg

  • Fixed-dose combination

 

  • [drug: Emtricitabine/Tenofovir] DF

Pediatric/adolescent patients with body weight ≥ 35 kg

  • Fixed-dose combination

 

  • Emtricitabine-Tenofovir DF Low Strength Preparations
  • Emtricitabine 167 mg/Tenfovir DF 250 mg
  • Emtricitabine 133 mg/Tenfovir DF 200 mg
  • Emtricitabine 100 mg/Tenfovir DF 150 mg

 

Pediatric patients with body weight ≥ 28 kg

Pediatric patients with body weight ≥ 22 kg

Pediatric patients with body weight ≥ 17 kg

  • Fixed-dose combinations

 

  • [Lamivudine]

All ages

  • Oral solution 10 mg/mL
  • Oral solution 5 mg/mL
  • Scored 150- and 300-mg tablets

[drug: Lamivudine/Tenofovir] DF

Pediatric/adolescent patients with body weight ≥ 35 kg

  • Fixed-dose combination

 

[drug: Lamivudine/Zidovudine]

Pediatric/adolescent patients with body weight ≥ 30 kg

  • Fixed-dose combination

 

  • [drug: Tenofovir] AF

Pediatric/adolescent patients with body weight ≥ 25 kg

  • Only available as part of fixed-dose combinations
  • [Tenofovir] DF

2 yrs of age or older

  • Oral powder
  • 150-, 200-, 250-, and 300-mg tablets
  • [Zidovudine]

4 wks or older

  • Syrup 10 mg/mL
  • 100-mg capsules
  • 300-mg tablet

NNRTIs

 

 

  • [Efavirenz]

3 yrs or older

  • Capsules may be sprinkled on food
  • Efavirenz 600 mg/Lamivudine/Tenofovir DF

Pediatric/adolescent patients with body weight ≥ 40 kg

  • Fixed-dose combination
  • Take on an empty stomach
  • Efavirenz 400 mg/Lamivudine/Tenofovir DF

Pediatric/adolescent patients with body weight ≥ 35 kg

  • Fixed-dose combination
  • Take on an empty stomach
  • [Etravirine]

ARV-experienced children 2 yrs of age or older and body weignt ≥10 kg

 

  • 25-mg, 100-mg, 200-mg tablets
  • [Nevirapine]

 

Any age (oral and immediate-release tablet)

 

  • Oral suspension 10 mg/mL
  • Immediate-release 200 mg tablets

6 yrs of age or older

  • Extended-release 100-mg and 400- mg tablets
  • [drug: Rilpivirine]

12 yrs of age or older and body weight ≥ 35 kg with HIV-1 RNA ≤ 100,000 copies/mL

  • 25-mg tablet
  • [drug: Emtricitabine/Rilpivirine/Tenofovir] DF

12 yrs of age or older and body weight ≥ 35 kg with HIV-1 RNA ≤ 100,000 copies/mL

  • Fixed-dose combination
  • Take with a meal
  • [drug: Emtricitabine/Rilpivirine/Tenofovir] AF

12 yrs of age and older and body weight ≥ 35 kg with HIV-1 RNA ≤ 100,000 copies/mL

  • Fixed-dose combination
  • Take with a meal

PIs

 

 

  • [Atazanavir]

3 mos of age or older and body weight ≥ 5 kg and < 25 kg

  • Oral powder 50 mg/packet

 

6 yrs of age or older and ≥ 15 kg

  • 150-, 200-, and 300-mg capsules
  • [drug: Atazanavir/Cobicistat]

Pediatric/adolescent patients with body weight ≥ 35 kg

  • Fixed-dose combination
  • Take with food
  • [drug: Cobicistat/Darunavir]

Pediatric/adolescent patients with body weight ≥ 40 kg

  • Fixed-dose combination
  • Take with food
  • [drug: cobicistat darunavir emtricitabine tenof: Cobicistat/Darunavir/Emtricitabine/Tenofovir] AF

Pediatric/adolescent patients with body weight ≥ 40 kg

  • Fixed-dose combination
  • Take with food
  • [Darunavir]

3 yrs of age or older and body weight ≥ 10 kg

  • Oral suspension 100 mg/mL
  • 75- and 150-mg tablets
  • [Lopinavir/ritonavir]

Neonates at postmenstrual age of 42 wks and postnatal age ≥ 14 days

  • Oral solution 80/20 mg/mL
  • 100/25-mg tablet
  • [Ritonavir]

Older than 1 mo

  • Oral solution 80 mg/mL

INSTIs

 

 

  • [drug: Abacavir/Dolutegravir/Lamivudine]

Pediatric patients with body weight ≥ 25 kg

  • Fixed-dose combination
  • [drug: Bictegravir/emtricitabine/tenofovir] AF

6 years of age or older and body weight ≥ 25 kg

  • Fixed-dose combination
  • [drug: Cobicistat/elvitegravir/emtricitabine/tenofovir] AF

Pediatric patients with body weight ≥ 25 kg

  • Fixed-dose combination
  • [drug: Cobicistat/elvitegravir/emtricitabine/tenofovir] DF

12 yrs of age or older and body weight ≥ 35 kg and SMR 4 or 5

 

  • Fixed-dose combination
  • [drug: Dolutegravir]

4 wks of age or older and body weight ≥ 3 kg

  • 10-mg or 25-mg tablets
  • [Raltegravir]

2 yrs or older

  • Chewable tablets (100 mg scored and 25 mg)

 

4 wks or older and body weight 3 kg to
< 20 kg

  • Powder for oral suspension 10 mg/mL

 

Full-term newborn to 4 wks of age and body weight ≥ 2 kg

  • Powder for oral suspension 10 mg/mL

 

CCR5 Antagonist

 

 

  • [drug: Maraviroc]

Body weight ≥ 6 kg and CCR5-tropic HIV

  • Oral solution 20 mg/mL
  • 25-, 75-, 150-, and 300-mg tablets

N/A, not available.