Table 2.
Dolutegravir dosing in odyssey main trial participants by protocol versiong
| 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