Dolutegravir (3) – Tivicay®

HIV-Infection, children ≥ 4 weeks to < 6 years

Characteristics

Start date 01.02.2021 – Marketing authorisation: 11.01.2021
Resolution 15.07.2021
Limitation date 01.04.2022 limitation repealed
INN Dolutegravir
Brand name Tivicay®
Pharm. company ViiV Healthcare GmbH
G-BA Procedure ID D-637
ATC code J05AJ03 Integrase inhibitors (J05AJ)
ICD-10 codes (AIS) B24, Z21Asymptomatic human immunodeficiency virus [HIV] infection status
Alpha-ID codes (AIS) I24822HIV infection, I29605HIV disease
DDD 50 mg O
Therapeutic area Infectious diseases HIV
Reason for procedure New therapeutic indication
Specialty Combination therapy

Therapeutic indication of the resolution

Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.
Subpopulation Indication Comparator
a) Treatment-naïve children with HIV-1 infection aged ≥ 4 weeks to < 6 years Abacavir with lamivudine or abacavir with emtricitabine, in each case in combination with - lopinavir/ritonavir or - raltegravir or - nevirapine
b) Therapy experienced Children with HIV-1 infection aged ≥ 4 weeks to < 6 years Patient-specific antiretroviral therapy with a selection of the approved active substances; taking into account the previous therapy(ies) and the reason for the change in therapy, in particular therapy failure due to virological failure and any associated development of resistance or due to side effects.

Studies and Results

No. of studies
(best subpopulation) 		0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: Evidence transfer)
Reason for dividing into subpopulations (G-BA) Previous treatment

  • 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.

Associated procedures



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