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) |
| DDD | 1 U O |
| Therapeutic area | Infectious diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
- 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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