Dolutegravir (3) – Tivicay®

• Clinical trials
  • The IMPAACT P1093 trial is a single-arm, multicentre, open-label trial of dolutegravir in children and adolescents aged ≥ 4 weeks to < 18 years who are infected with HIV-1 and weigh at least 3 kg.
  • The ODYSSEY WB-PK1/2 study is a pharmacokinetic sub-study of the ODYSSEY RCT.

a) Treatment-naive children with HIV-1 infection aged ≥ 4 weeks to < 6 years

• The additional benefit is not proven.
• Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of dolutegravir compared with the appropriate comparator therapy.

b) Treatment-experienced children with HIV-1 infection aged ≥ 4 weeks to < 6 years

• An additional benefit is not proven.
• Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of dolutegravir compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.