Table 1.
Recommended doses of antiretroviral medications in adolescenta patients according to WHO and US guidelinesb
Drug | WHO guidelines | US guidelines |
---|---|---|
Abacavir (ABC, Ziagen®) |
Children <16 years or body weight <37.5 kg—8 mg/ kg/dose twice daily. Maximal dose—>16 years or ≥37.5 kg—300 mg/dose twice daily. Once daily dosing is not yet approved in children but encouraging PK data is available. Adults—300 mg/dose twice daily or 600 mg once daily. Combination ART:
|
Pediatricc 8 mg/kg/dose (maximal dose, 300 mg) twice daily. Adolescent: There is limited ABC data for adolescents. Adolescent >16 years/adults: 300 mg/dose twice daily or 600 mg/dose once daily. Combination ART (adults):
|
Didanosine (dideoxinosine, ddI, Videx®) |
Children <13 years of age—90–120 mg/m2/dose twice daily. Maximal dose—>16 years or body weight >60 kg—200 mg/dose twice daily or 400 mg/dose once daily (enteric coated (EC)). Once daily dosing for chewable tablets is authorized in the United Kingdom for children >6 years of age. Adults—body weight >60 kg—400 mg once daily, body weight <60 kg—250 mg once daily. |
Pediatric: 90–150 mg/m2/dose twice daily (average dose 120 mg/m2) or in treatment-naive patients 3–21 years of age 240 mg/m2/dose once daily. Adolescent/adults: oral solution—body weight >60 kg—200 mg/dose twice daily or 250 mg/dose, if co-administered with TDF. Body weight <60 kg—125 mg/dose twice daily. The total daily dose may be administered once daily, twice daily dosing is preferred. |
Emtricitabine (FTC, Emtriva™) |
No dosing guidelines for children. Adults—200 mg/dose once daily. |
Pediatric: oral solution—6 mg/kg/dose (maximal dose, 240 mg) once daily. Capsules (body weight >33 kg)—200 mg/dose once daily. Adolescent >18 years/adults: oral solution—240 mg/dose once daily, capsules— 200 mg/dose once daily. Combination ART (adults):
|
Lamivudine (3TC, Epivir®, Epivir HBV) |
Body weight <50 kg—4 mg/kg/dose twice a day to a maximum of 150 mg/dose twice daily. Body weight >50 kg—150 mg/dose twice daily. Adults—150 mg/dose twice daily or 300 mg once daily. Combination ART:
|
Pediatric: 4 mg/kg/dose (maximal dose, 150 mg) twice daily. Adolescent ≥16 years/adults: body weight >50 kg—150 mg/dose twice daily or 300 mg/dose once daily. Body weight <50 kg—4 mg/kg/dose (maximal dose, 150 mg) twice daily. Combination ART (adolescents >12 years/adults):
|
Stavudine (d4T, Zerit®) |
Body weight <30 kg—1 mg/kg twice daily. Body weight >30 kg—30 mg/dose twice daily. Body weight >60 kg—40 mg/dose twice daily (using 30 mg dosing leads to delay or reduction of toxicity, although limited data on efficacy is available). Adults—body weight >60 kg—40 mg/dose twice daily, body weight <60 kg—30 mg/dose twice daily. Combination ART:
|
Pediatric: body weight <30 kg—1 mg/kg/dose twice daily. Adolescent (body weight ≥30 kg)/adults: body weight 30–<60 kg—30 mg/dose twice a day. Body weight ≥60 kg—40 mg/dose twice daily. |
Tenofovir (TDF, Viread®) |
No dosing guidelines for children. Adults—300 mg once daily. |
Pediatric: investigational dose—210 mg/m2/dose (maximal dose, 300 mg) once daily. Adolescent >18 years/adults: 300 mg/dose once daily. Combination ART (adults):
|
Zidovudine (ZDV, AZT, Retrovir®) |
Children—180–240 mg/m2/dose (maximal dose, 300 mg) twice daily. Adults—250–300 mg/dose twice daily. Combination ART:
|
Pediatric: 160 mg/m2/dose every 8 hours (three times daily) or 180–240 mg/ m2/dose twice daily. Adolescent ≥12 years/adults: 200 mg/dose three times daily or 300 mg/dose twice daily. Combination ART (adolescent/adults):
|
Efavirenz (DMP-266EFV, Sustiva™) |
Body weight <40 kg—19.5 mg/kg/day (syrup) or 15 mg/kg/day (capsule/tablet). Body weight >40 kg—600 mg/dose once daily. Adults—600 mg/dose once daily. |
Pediatric: body weight <40 kg (20–<25 kg—300 mg; 25–<32.5 kg—350 mg; 32.5–<40 kg—400 mg) once daily. Adolescent (body weight ≥40 kg)/adults: 600 mg/dose once daily. Combination ART (adults):
|
Etravirine (ETR, Intelence™, ™C125) |
No dosing guidelines for children. No dosing guidelines for adults. |
Pediatric: not approved for use in children. Adolescent/adults: adult dose for ARV-experienced patients 200 mg/dose twice daily. |
Nevirapine (NVP, Viramune®) |
Children: 160–200 mg/m2/dose (maximal dose, 200 mg) twice daily. Scale up the dosing schedule at initiation starting at 160 mg/m2 once daily for the first 14 days, and moving up to full dose if no rash or untoward effects after 14 days. Adults—200 mg/dose once daily for 14 days, followed by 200 mg/dose twice daily. Combination ART: 30 mg d4T/150 mg 3TC/200 mg NVP—1 tablet/dose twice daily. |
Pediatric: 150–200 mg/m2/dose (maximal dose, 200 mg) twice daily. Scale up the dosing schedule at initiation starting at 150 mg/m2/dose once daily for the first 14 days, and moving up to full dose if no rash or untoward effects after 14 days. Adolescent/adults: 200 mg/dose twice daily. Combination ART (adolescents >12 years/adults):
|
Atazanavir (ATV, Reyataz™) |
No dosing guidelines for children. Adults—300 mg ATV plus 100 mg RTV once daily. |
Pediatric: Not approved for use in children. Currently under the study in PACTG/ IMPAACT 1020 A. Adolescent ≥16–21 years/adults: in treatment-naive patients—400 mg daily (this dose may be inadequate). In treatment-experienced patients—300 mg plus 100 mg RTV once daily. Combination ART (adults):
|
Darunavir (DRV, ™C114, Prezista®) |
No dosing guidelines for children. No dosing guidelines for adults. |
Pediatric: Not approved for use in children <18 years. Currently under the study in PACTG/IMPAACT 1020 A. Adolescent ≥18 years/adults: 600 mg/dose DRV plus 100 mg RTV twice daily. DRV should not be used without RTV. Combination ART (adults):
|
Fosamprenavir (f-AMP, Lexiva™) |
No dosing guidelines for children. Adults—700 mg f-AMP plus 100 mg RTV twice daily. |
Pediatric >6 and <18 years: in treatment-naive patients—30 mg/kg/dose (maximal dose, 1,400 mg, can be used in patients with body weight ≥47 kg) twice daily without RTV or 18 mg/kg/dose (maximal dose, 700 mg, can be used in patients with body weight ≥39 kg) plus RTV 3 mg/kg/dose (maximal dose, 100 mg) twice daily (can be used in patients with body weight ≥33 kg). In treatment-experienced patients—18 mg/kg/dose (maximal dose, 700 mg, can be used in patients with body weight ≥39 kg) plus RTV 3 mg/kg/dose (maximal dose, 100 mg, can be used in patients with body weight ≥33 kg) twice daily. Adultsd: in treatment-naive patients—1,400 mg/dose twice daily without RTV or 700 mg plus 100 mg RTV both twice daily or 1,400 mg plus 200 mg RTV or 100 mg RTV both given once daily. In treatment-experienced patients—700 mg plus 100 mg RTV twice daily. Only boosted f-AMP with RTV should be used in treatment-experienced patients. Combination ART (adults):
|
Indinavir (IDV, Crixivan®) |
No dosing guidelines for children. Adults—800 mg IDV plus 100 mg RTV twice daily. |
Pediatric: Not approved for use in children. Investigational dose of 500 mg/m2 of body surface area every 8 hours (three times daily) in children 4–15 years of age resulted in adequate AUC and low plasma IDV trough. Adolescent >18 years/adults: 800 mg/dose every 8 hours. Adult dose in combination with RTV—800 mg IDV plus 100 mg RTV twice daily. Combination ART(adults):
|
Lopinavir/ritonavir (LPV/RTV, Kaletra, ABT 378) |
Body weight 14–39.9 kg—10 mg LPV/kg/dose twice daily (equivalent to 300 LPV mg/m2). Body weight 15–40 kg—2.5 mg RTV/kg/dose twice daily (equivalent to 75 mg/m2). Maximal dose—400 mg LPV plus 100 mf RTV twice daily. Adults/combination ART—capsules (133.3 mg LPV/33.3 mg RTV) 3 capsules twice daily or 4 capsules twice daily when co-administered with EFV (600 mg once daily) or NVP (150 mg twice daily); tablets (200 mg LPV/100 mg RTV) for treatment- naive patients—2 tablets twice daily, for treatment- experienced patients—3 tablets twice daily when co-administered with EFV (600 mg once daily) or NVP (150 mg twice daily). |
Pediatric: body weight >15–<40 kg—10 mg/kg LPV/2.5 mg/kg RTV twice daily with food. Approximately equivalent to 230 mg/m2 LPV/57.5 mg/m2 RTV per dose. Body weight >40 kg—400 mg or 230 mg/m2 LPV/57.5 mg/m2 RTV per dose (maximal dose, 400 mg LPV/100 mg RTV). Use of 230 mg/m2 LPV dose provides adequate AUC for LPV, but might produce lower trough, higher doses may be considered. Adolescent >12 years: 400 mg LPV/100 mg RTV per dose twice daily with food. Adolescent >18 years/adults: in antiretroviral naive patients—800 mg LPV/200 mg RTV per dose once daily. Combination ART (adolescents >12 years/adults):
|
Nelfinavir (NFV, Viracept®) |
Body weight ≥20 kg—maximum recommended dose of 1,250 mg/dose twice daily. Adults—1,250 mg/dose twice daily. |
Pediatric <13 years: 45–55 mg/kg/dose twice daily or 25–35 mg/kg/dose three times daily. Adolescent/adults: 1,250 mg/dose twice daily or 750 mg/dose three times daily. |
Ritonavir (RTV, Norvir®) |
Children <16 years—400 mg/m2/dose (maximal dose, 600 mg) twice daily. Scale up the dosing schedule at initiation starting at 250 mg/m2/dose of body surface area twice daily with increments by 50 mg/m2/dose at 2- to 3-day intervals to full dose as tolerated. As a booster for LPV for body weight 15–40 kg—2.5 mg/kg/dose twice daily. No dosing guidelines for adults. |
Pediatric: 350–450 mg/m2/dose (maximal dose, 600 mg) twice daily. Scale up the dosing schedule at initiation starting at 250 mg/m2/dose twice daily with increments by 50 mg/m2 at 2- to 3-day intervals to full dose as tolerated. Adolescent/adults: 600 mg/dose twice daily. Scale up the dosing schedule at initiation starting at 300 mg/dose twice daily; and in stepwise increase until full dose is reached over 5 days as tolerated. Combination ART (adolescents/adults):
|
Saquinavir (SQV, Invirase®) |
Not licensed for use in children <16 years of age or less than 25 kg. Never should be taken unboosted. Adults—1,000 mg SQV plus 100 mg RTV twice daily. |
Pediatric: Not approved for use in children. Investigational dose of 50 mg/kg/dose every 8 hours (three times daily) provided inadequate AUC and plasma trough. Co-administration with RTV, LPV/RTV and NFV is being investigated. Adolescent >16 years/adults: 1,000 mg plus 100 mg RTV twice daily. Never should be used unboosted. Combination ART (adults):
|
Tipranavir (TPV, Aptivus®) |
No dosing guidelines for children. No dosing guidelines for adults. |
Pediatric: Not approved for use in children. Currently under study in PACTG1051/BI1182.14. Adult dosed: 500 mg plus 200 mg RTV twice daily. Combination ART (adults):
|
Maraviroc (MVC, Selzentry®) |
No dosing guidelines for children. No dosing guidelines for adults. |
Pediatric: Not approved for use in children <16 years. No data currently available on dosage below this age. Combination ART (adolescents/adults): When given with CYP3A4 inhibitors (with or without CYP3A4 inducers) including all PIs (except TPV/RTV)—150 mg/ dose twice daily. When given with other drugs that are not strong inhibitors or inducers of CYP3A4, such as NRTIs, T-20, TPV/RTV, and NVP—300 mg/dose twice daily. When given with CYP3A4 inducers including EFV—600 mg/dose twice daily.e |
Enfuvirtide (Fuzeon™, T-20) Fusion Inhibitor |
No dosing guidelines for children. No dosing guidelines for adults. |
Pediatric: 2 mg/kg (maximal dose, 90 mg [1 ml]) twice daily injected subcutaneously into the upper arm, anterior thigh, or abdomen. Adolescent >16 years/adults: 90 mg (1 ml) twice daily injected subcutaneously into the upper arm, anterior thigh, or abdomen. |
Raltegravir (MK-0518, RGV, RAL, Insentress®) |
No dosing guidelines for children. No dosing guidelines for adults. |
Pediatric: Not approved for children <16 years. Currently in phase I/II study in IMPAACT P1066 for children aged 2–18 years. Adolescent >16 years/adults: 400 mg/dose twice daily. |
The recommended doses are taken verbatim from the public-domain guidelines available at http://www.who.int/hiv/pub/guidelines/art/en/index.html and http://aidsinfo.nih.gov/Guidelines, respectively.
ART, antiretroviral therapy; AUC, area under the curve; CYP3A4, cytochrome P450 3A4; IMPAACT, International Maternal Pediatric Adolescent AIDS Clinical Trials; PACTG, Pediatric AIDS Clinical Trials Group; PI, protease inhibitor; PK, pharmacokinetic; WHO, World Health Organization.
Both weight and age are used to define “adolescent” patient. In certain references neither is used and “adolescent” is referred to as a category.
The table does not provide food requirements or the dosing recommendations for patients with hepatic and renal insufficiency. Please refer to the actual guidelines available online at: http://www.who.int/hiv/pub/guidelines/art/en/index.html and http://aidsinfo.nih.gov/Guidelines.
Pediatric doses for younger children and neonates and infants are not represented in the table.
No adolescent dose is referenced in the guidelines.
The list of other than ARV drugs considered for the Maraviroc (MVC) dose adjustment is available under Pediatric HIV Guidelines at http://aidsinfo.nih.gov/Guidelines.