Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2) – Stribild®
HIV infection, 12 to < 18 years
Characteristics
| Start date | 15.11.2017 – Marketing authorisation: 19.10.2017 |
|---|---|
| Resolution | 03.05.2018 |
| INN | Elvitegravir/Cobicistat/Emtricitabin/Tenofovirdisoproxil |
| Brand name | Stribild® |
| Pharm. company | Gilead Sciences GmbH |
| G-BA Procedure ID | D-324 |
| ATC code | J05AR09 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 |
| Therapeutic indication of the resolution |
|---|
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Stribild is also indicated for the treatment of HIV-1 infection in adolescents aged 12 to < 18 years weighing ≥ 35 kg who are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Antiretroviral pre-treated (therapy-experienced) adolescents aged 12 years and older 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 |
- Clinical trials
- No data were presented to assess the additional benefit of elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil compared with the appropriate comparator therapy in antiretrovirally pre-treated (treatment-experienced) adolescents aged 12 years and over.
Adolescents aged 12 years and over who have previously received antiretroviral treatment (treatment-experienced)
- An additional benefit is not proven.
- No data were submitted to assess the additional benefit of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil compared with the appropriate comparator therapy in antiretrovirally pre-treated (treatment-experienced) adolescents aged 12 years and over.
- Appropriate comparator therapy
- an individualised antiretroviral regimen depending on previous treatment(s) and taking into account the reason for the change in therapy, in particular treatment failure due to virological failure and any associated development of resistance, or due to side effects.
Courtesy translation only, please refer to the German original.
Associated procedures
| Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2) | Stribild® | Gilead Sciences GmbH | HIV infection, 12 to < 18 years | 100 | 100% additional benefit not proven | |
| Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (1) | Stribild® | Gilead Sciences GmbH | HIV infection | 49,800 | 100% additional benefit not proven |
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