Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2) – Genvoya®

HIV infection, 6 to < 12 years

Characteristics

Start date 15.01.2018 – Marketing authorisation: 08.12.2017
Resolution 05.07.2018
INN Elvitegravir/Cobicistat/Emtricitabin/Tenofoviralafenamid
Brand name Genvoya®
Pharm. company Gilead Sciences GmbH
G-BA Procedure ID D-334
ATC code J05AR18 Antivirals for treatment of HIV infections, combinations (J05AR)
ICD-10 codes (AIS) B24, Z21Asymptomatic human immunodeficiency virus [HIV] infection status
Alpha-ID codes (AIS) I24822HIV infection, I29605HIV disease
DDD 1 U O
Therapeutic area Infectious diseases HIV
Reason for procedure New therapeutic indication
Specialty ACT change

Therapeutic indication of the resolution

Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:

• In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.
Subpopulation Indication Comparator
a) Non-pretreated HIV-1 infected children aged ≥ 6 years to < 12 years. Atazanavir + ritonavir + abacavir + emtricitabine or atazanavir + ritonavir + abacavir + lamivudine or dolutegravir + abacavir + emtricitabine or dolutegravir + abacavir + lamivudine
b) Pre-treated children aged ≥ 6 years to < 12 years with HIV-1 infection Individual antiretroviral therapy

Studies and Results

No. of studies
(best subpopulation) 		0 (no data submitted)
Study design
(best subpopulation) 		no data submitted
ACT change 19.06.2018 – EBM - Leitlinen nach Stellungnahmeverfahren

  • Clinical trials
    • No data were submitted to assess the additional benefit of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide compared with the appropriate comparator therapy.

a) HIV-1-infected children aged ≥ 6 years to < 12 years who have not previously received antiretroviral treatment

  • The additional benefit is not proven.
  • No data were submitted to assess the additional benefit of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide compared with the appropriate comparator therapy.

b) HIV-1-infected children aged ≥ 6 years to < 12 years who have received prior antiretroviral treatment

  • The additional benefit is not proven.
  • No data have been submitted to assess the additional benefit of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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