|
WHO weight-band
|
FDA approvala
|
EMA approvalb
|
ODYSSEY v2.0a
|
ODYSSEY v3.0
|
ODYSSEY v4.0
|
ODYSSEY v5.0/v6.0
|
|---|
|
(Sep 2016 onwards)
|
(Mar 2017 onwards)
|
(May 2018 onwards)
|
(May 2019/Feb 2020 onwards)
|
|---|
|
3 to < 6 kg
| | |
–
|
–
|
–
|
–
|
|
6 to < 10 kg
| | |
–
|
–
|
–
|
–
|
|
10 to < 14 kg
| | |
–
|
–
|
–
|
–
|
|
14 to < 20 kg
| |
20 mgc
|
Feb-2017
|
20 mg FCTd
|
20 mg FCTd
|
25 mg FCT → 25 mg DTf
|
25 mg DT
|
|
20 to <25 kg
| | |
25 mg
|
Feb-2017
|
25 mg FCT
|
25 mg FCT
|
25 mg FCT → 30 mg DT or 50 mg FCTf
|
50 mg FCT
|
|
25 to < 30 kg
| | |
25 mg
|
Feb-2017
|
25 mg FCT
|
25 mg FCT → 50 mg FCTe
|
25 mg FCT → 50 mg FCTe
|
50 mg FCT
|
|
30 to < 35 kg
|
35 mg
|
Jun-2016
|
35 mg
|
Feb-2017
|
35 mg FCT
|
35 mg FCT → 50 mg FCTe
|
35 mg FCT → 50 mg FCTe
|
50 mg FCT
|
|
35 to < 40 kg
|
35 mg
|
Jun-2016
|
35 mg
|
Feb-2017
|
35 mg FCT
|
35 mg FCT → 50 mg FCTe
|
35 mg FCT → 50 mg FCTe
|
50 mg FCT
|
|
≥40 kg
|
50 mg
|
Aug-2013
|
50 mg
|
Jan-2014
|
50 mg FCT
|
50 mg FCT
|
50 mg FCT
|
50 mg FCT
|
- Abbreviations: FCT Film-coated tablets, DT Dispersible tablets, v Version
- a Approval in ≥12 years in Aug 2013, restriction removed Jun 2016
- b Approval in ≥12 years in Jan 2014, ≥6 years in Feb 2017
- c 20 mg FCT approved by EMA in children weighing 15 to < 20 kg only
- d From May 2017, ≥6 years, in children weighing 15 to < 20 kg only
- e From 1st of Apr 2018, after ethics notification, sites following protocol version 3.0 and above were recommended to increase the DTG dose of children 25 to < 40 kg to 50 mg FCT QD at their next scheduled study visit based on the results of the weight-band pharmacokinetic sub-study [23]
- f Protocol version 4.0 also allowed for the adjustment of weight-band dose based on findings from the ongoing weight-band pharmacokinetic sub-study with ethics notification
- g Protocol version 1.0 was not used
